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Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer Study Overview ================= Brief Summary ----------------- RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer. Detailed Description ----------------- OBJECTIVES: I. To generally test whether the addition of CTLA-4 blockade can enhance clinical treatment response in advance prostate cancer patients compared with treatment with AA therapy alone. II. To specifically examine whether concomitant AA therapy + MDX-010 can be used to prolong the progression-free interval in advanced prostate cancer patients compared with inductive short-term AA therapy alone. III. To specifically examine whether concomitant AA therapy + MDX-010 can be used to enhance initial PSA responses in advanced prostate cancer patients compared with inductive short-term AA therapy alone. IV. To specifically examine whether delayed MDX-010 can be used to induce PSA response in patients experiencing disease progression following cessation of short-term AA therapy. V. To generally examine whether MDX-010 enhances host immune response that might be involved in conferring treatment advantages to patients receiving AA therapy. VI. To specifically examine whether MDX-010 potentiates T-cell responses in advanced prostate cancer patients initiating inductive short-term AA therapy. VII. To further examine whether treatment induced T-cell responses correlate with clinical response to treatment. VIII. To examine whether short-term AA there (+/- MDX-010) induces the appearance of newly emigrated T or immature and/or B cells. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy <= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy <= 21 days prior to enrollment) of AA therapy. Arm II: Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression. After completion of study treatment, patients are followed periodically. Official Title ----------------- A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer Conditions ----------------- Prostate Adenocarcinoma, Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage III Prostate Cancer, Stage IV Prostate Cancer Intervention / Treatment ----------------- * Drug: Bicalutamide * Drug: Flutamide * Drug: Goserelin Acetate * Drug: Ipilimumab * Drug: Leuprolide Acetate * Other: Pharmacological Study Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: NOTE: All values must be obtained =< 14 prior to study entry Histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, >cT2cN0/M0 stage with or without metastatic disease, with the exclusion of central nervous system (CNS) metastases; includes post radical prostatectomy patients with a rising PSA An initial PSA >= 4.0 ng/mL (Hybritech Assay) For those patients who have received hormone therapy =< 21 days, a documented PSA of >= 4.0 prior to initiation of hormone therapy is acceptable. For patients who are post radical prostatectomy, a rising PSA is acceptable. Adequate organ function defined as: WBC >= 3,000/uL; platelets >= 75,000/uL; total bilirubin =< 1.5 mg/dL; transaminases =< 2.5 x upper limit of normal (ULN); serum creatine =< 2.0 mg/dL or calculated creatinine clearance >= 60 mL/min ECOG performance status of 0-2 Able to understand and sign informed consent Exclusion Criteria: Underlying other serious medical condition which, in the opinion of the investigator precludes study participation; this includes immune-suppressive disease such as AIDS or autoimmune disorders such as multiple sclerosis, lupus, or myasthenia gravis Patients not recovered from major infections and/or surgical procedures Prior hormonal therapy > 21 days prior to enrollment, including estrogens, LH/RH agonists, or antiandrogens Recent (=< 3 months of informed consent) usage of immune-suppressive medication including steroids, Immuran, Cyclosporin; topical or inhalational steroid use is permissible Prior systemic chemotherapy Prior radiation therapy to the prostate Prior malignancy, unless the patient has been cancer-free for five years or more Uncontrolled underlying medical or psychiatric illness, or serious active infections Patient unwilling to complete all required follow-up visits History of motor neuropathy considered of the autoimmune origin (e.g. Guillian-Barre Syndrome) Concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer For patients who elect to undergo the baseline transrectal needle biopsy of the prostate, current usage of systemic anticoagulation therapy, i.e. heparin or Coumadin or inability to discontinue aspirin, aspirin-containing products or ibuprofen for seven days prior to the prostate biopsies required for this study No other investigational drugs will be allowed during the study Other chemotherapy, radiation therapy, immunotherapy, hormonal therapy, or biologic therapy may not be used while the patient is on study Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- Male Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Arm I<br>Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy <= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy <= 21 days prior to enrollment) of AA therapy. \| Drug: Bicalutamide<br>* Given orally<br>* Other names: ICI 176334;Drug: Flutamide<br>* Given orally<br>* Other names: Testotard;Drug: Goserelin Acetate<br>* Given SC<br>* Other names: Zoladex;Drug: Ipilimumab<br>* Given IV<br>* Other names: Yervoy;Drug: Leuprolide Acetate<br>* Given IM<br>* Other names: Viadur;Other: Pharmacological Study<br>* Correlative study<br>\| \| Active Comparator: Arm II<br>Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression. \| Drug: Bicalutamide<br>* Given orally<br>* Other names: ICI 176334;Drug: Flutamide<br>* Given orally<br>* Other names: Testotard;Drug: Leuprolide Acetate<br>* Given IM<br>* Other names: Viadur;Other: Pharmacological Study<br>* Correlative study<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Number of Participants Progression-free at 18 Months \| PSA progression is defined as a rise in PSA to >4.0 ng/mL demonstrated twice in measurements taken two weeks apart. \| 18 months from the start of AA therapy \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response \| Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over). \| 3 months \|	ctgov
Cancer, Physical Activity and Quality of Life- a Longterm Follow up Study Overview ================= Brief Summary ----------------- This project is a 6-8-years follow-up of a randomized controlled trial testing a stepped care stress management program. The main goal is to examining differences in long-term effects on cancer-related stress reactions and emotional reactivity between the intervention and control group. Secondary objectives is to investigate consequences of cancer and its' treatment over time, such as long term quality of life, objectively physical activity and experiences concerning follow-up and the transition from specialist health services to municipal health services. Detailed Description ----------------- Major improvements in cancer detection and treatment lead to longer life expectancy among cancer survivors. This may in turn lead to more late effects and many have to deal with long-term consequences of the disease and its' treatment. Returning to everyday life and to work is often an important part of returning to normal life for cancer survivors. There is increasing knowledge concerning late effects, but there is still lack of knowledge concerning the life of those experiencing late effects. There is a need for more knowledge about late effects' impact on the return to work prosess, physical activity and quality of life over time. Both quantitative and qualitative methods will be utilized. Standardized questionnaires will provide information on the effect of the intervention over time, in addition to quality of life over time. Sensewear armband will provide information about their physical activity over time. Official register data from the Norwegian Labour and Welfare Administration (the NAV administration) will provide us information about the work- and benefit situation through the whole follow-up period of 6-8 years. The register data include information about type of social benefits (sick-leave benefit, work assessment allowance (WAA), disability pension, unemployment benefit and retirement pension), as well as information about occupation, income and sick leave diagnosis. Focus group interviews will give us insight in the cancer survivors own experiences with quality of life over time, the transition from the specialist health services to the primary health care and the follow-up in the municipalities. Official Title ----------------- 6-8 Years Follow up of Cancer Survivors, Objectively Measured Physical Activity and Quality of Life Over Time. Conditions ----------------- Cancer, Rehabilitation, Stress Disorder, Fatigue, Quality of Life, Physical Activity Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Stage I-III disease Scheduled for neo/adjuvant or curative treatment (i.e. chemotherapy, radiation therapy or hormonal therapy or any combination of these therapies) Exclusion Criteria: On-going psychiatric condition Lack of fluency in Norwegian A previous diagnosis of cancer Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study. \| \| 2021 \| \| Objectively measured physical activity from diagnosis to 6-8 years follow up. \| \| 2022 \| \| The context between change in physical activity and quality of life over time \| \| 2023 \| \| Witch predictors has an impact on long term cancer survivors quality of life? \| \| 2024 \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study \| Experiences of the follow up. \| 2021 \|	ctgov
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure Study Overview ================= Brief Summary ----------------- We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure. Official Title ----------------- Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure Conditions ----------------- Ketosis, Heart Failure Intervention / Treatment ----------------- * Dietary Supplement: KetoneAid KE4 Pro Monoester * Dietary Supplement: Science in Sport Go Enegy Participation Criteria ================= Eligibility Criteria ----------------- Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40% Exclusion Criteria: Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Crossover Assignment Interventional Model Description: Patients are studied in a randomized single-blind cross-over design. Masking: Double Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Ketone Monoester<br>Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g) \| Dietary Supplement: KetoneAid KE4 Pro Monoester<br>* A dietary supplement containing ketone monoester.<br>\| \| Placebo Comparator: Placebo Treatment<br>Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm. \| Dietary Supplement: Science in Sport Go Enegy<br>* Dosis isocaloric to the KetoneAid Arm<br>\| \| Active Comparator: Ketone Monoester in presence of low-dose insulin clamp<br>Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism \| Dietary Supplement: KetoneAid KE4 Pro Monoester<br>* A dietary supplement containing ketone monoester.<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Cardiac Output (L/min) \| Change in Cardiac output measured by Swann-Ganz Catherization during study period, \| 3 hours - Area under the curve \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Left Ventricular Ejection Fraction \| Change in LVEF measured by echocardiography during study periode \| 3 hours - Area under the curve \| \| Blood Ketones \| Change in blood Ketones measured by venous blood samples \| 3 hours \| \| Blood pH \| Change in venous blood pH during the study period \| 3 hours \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Hemodynamics	ctgov
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis Study Overview ================= Brief Summary ----------------- The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm. Official Title ----------------- Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis Conditions ----------------- Vascular Disease, Atherosclerosis Intervention / Treatment ----------------- * Device: HDH Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Patient age above 18 (men and woman) Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm The abdominal aneurysm neck is longer than 1.5 cm Patient's physical condition allows performing general anesthesia Patient is willing to sign the informed consent and follow the study protocol. Exclusion Criteria: Patient Age under 18 years Patient's physical condition dose not allows to perform general anesthesia Patient's with terminal disease and life expectancy of less than 3 months Patient objects to the treatment or study protocol Anesthesiologist or personal care physician object Patient suffer from Supra/infrarenal AAA The abdominal aneurysm neck is smaller than 1.5 cm Aneurysm diameter is smaller than 5cm/ its annual growth is less than 0.5cm/ Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Intervention Model: Single Group Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: A<br>Aortic anastomosis surgery will be conducted using HDH device. \| Device: HDH<br>* sutureless vascular anastomosis<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events. \| \| within 1 month \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Time to complete the anastomosis \| \| during the surgery \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- sutureless vascular bypass	ctgov
Reducing Adverse Drug Events in the Nursing Home Study Overview ================= Brief Summary ----------------- Medications are the single most common form of treatment in the long-term care setting, and often represent the most efficacious (and cost-effective) therapeutic modality used in this clinical setting. However, the residents of nursing homes are at increased risk for experiencing adverse drug events. This risk is increased by the physiologic decline and pharmacologic changes that occur with aging, and also by the special clinical and social circumstances that characterize institutional long-term care. In a study funded by the National Institute on Aging (AG 14472), we have previously determined that adverse drug events are common and often preventable in the nursing home setting and that the more serious the adverse drug event, the more likely it is to be preventable. This study will test whether a computer-based clinical decision support system can lower the rate of adverse drug events (ADEs) and potential ADEs in the long-term care setting. The study design is a randomized trial based in the resident care units of two large long-term care facilities. Within each facility, half of the resident care units will be randomized to an intervention arm receiving the computer-based clinical decision support system which will display warnings, messages, and prompts based on resident and drug use characteristics; with over-rides by the prescriber required for some warnings. Rates of ADEs and potential ADEs will be tracked by the study's on-site clinical pharmacists prior to and during the intervention period. Rates will be compared between units receiving and not receiving the computer¬based clinical decision support system and to baseline, pre-intervention rates in the same units. We will track all project costs directly related to the development and installation of the computer-based clinical decision support system. We will also develop and test the sensitivity and specificity of a computerized adverse drug event monitor and assess the validity of a nursing home resident risk model developed in our prior study of adverse drug events in the nursing home setting. Detailed Description ----------------- This study was conducted in two large, academic long-term care facilities located in Connecticut and Ontario, Canada. The two facilities have a combined total of 1,229 beds. Patients residing in areas of the facilities related to short-term care (e.g., subacute care, hospital-level care, or rehabilitation) were not included in the study population. Each of the facilities had an existing computerized provider order entry system without a computer-based clinical decision support system. At the time of the study, approximately 90% of new medication orders were entered using the system. All medication prescribing was performed by contracted staff; in one of the study facilities this included 27 physicians, nurse practitioners, and physicians' assistants. In the other facility, medication prescribing was performed by 10 physicians. Across the two long-term care facilities, 26 resident care units, each with existing computer provider order entry, were randomized to having a clinical decision support system (intervention units) or not (control units). Bed size of the resident care units ranged from 20 to 60 beds. An effort was made to match the units according to bed size and general characteristics of the residents on the units. We block randomized within categories including: dementia units, units where mental health and behavioral problems were common among the residents, units where the residents had complex medical needs, and units where the residents had profound deficits in physical function. On intervention units, prescribers ordering drugs were presented with alerts in the form of warning messages; these alerts were not displayed to prescribers when ordering medications for residents of control units. Although efforts were initially made to limit crossover of prescribers between intervention and control units, over the duration of the study, there were providers working simultaneously on both types of units, both on a temporary (coverage) basis and also permanently. The clinical decision support system was designed by a team of geriatricians, pharmacists, health services researchers, and information system specialists; the process of developing the clinical decision support system and its components has been described previously. The design principles were: 1) messages should be evidence-based; 2) messages should be perceived as useful and informative by practitioners; and 3) the system should have only modest impact on the time required for the practitioner to complete an order. The team reviewed the types of preventable adverse drug events based on previous research, as well as widely accepted published criteria for suboptimal prescribing in the elderly available at the time of this study. We also reviewed all serious drug-drug interactions from standard pharmaceutical drug interaction databases and included alerts for a limited number of more than 600 potentially serious interactions that were reviewed. Reasons for exclusion of alerts for specific drug interactions included that the medications were not on formulary at the facility, or that the medications were generally never used in elderly patients or in the long-term care setting. The clinical decision support system was designed to provide alerts in response to selected drug orders whenever the order: 1) involved selected high-severity drug interactions; 2) was for a patient with selected abnormal lab test results that suggested a possible danger related to use of the ordered medication; 3) could lead to adverse effects that require special monitoring in order to identify them early; 4) related to a medication that should be ordered within certain dose ranges to reduce the risk of adverse effects in elderly patients; or 5) should be accompanied by prophylactic measures to proactively address situations where there was a high likelihood of adverse drug effects (e.g., constipation with opioid use). Alerts included specific instructions for laboratory monitoring, as well as less explicit recommendations for reconsidering drug orders and monitoring for possible side effects. A summary of the alerts is provided in the appendix. The computerized provider order entry system in place at the time of the clinical decision support system implementation was capable of linking laboratory test orders and results and current drug orders in real-time. However, the system had several important limitations, as described previously. It was not capable of combining dose and strength information to determine the total daily dose associated with a drug order; therefore, some alerts displayed when they may not have been necessary (e.g., the medication order was already within the recommended dose range). The underlying software was not capable of distinguishing multiple orders for the same drug in different forms or strengths, or orders that had been cancelled and re-ordered within the same prescribing session. These orders were interpreted as multiple orders for drugs in the same category and triggered a number of inappropriate alerts about drug interactions. For example, an order for erythromycin that the prescriber initiated, cancelled, and then re-ordered within the same ordering session would be interpreted as an interaction signaling the need for an alert for increased risk of QT prolongation. Despite the fact that some triggers were likely to produce a substantial number of these unnecessary alerts, we opted to include them in the system if the potential impact of the type of drug interaction in question was considered clinically important. For residents on the intervention units, the alerts were displayed in a pop-up box to prescribers in real-time when a drug order was entered. The pop-up boxes were informational; they did not require specific actions from the prescriber and did not produce or revise orders automatically. On the control units, the alerts were not displayed to the prescribers. Our study was limited to adverse drug events occurring in the long-term care setting. Drug-related incidents were identified through review of medical records in monthly segments performed by trained pharmacist investigators for each eligible long-term care facility resident. These investigators, who were not aware of whether the resident was located on an intervention or a control unit, examined the records for possible drug-related incidents, such as new symptoms or events that might represent an adverse drug event, changes in medication regimens (including acute discontinuations or initiations of medications that might be used to treat a drug-induced event), abnormal laboratory values, and all emergency room transfers and hospitalizations. In addition to periodic reviews, medical records were specially targeted for review based on information derived from selected computer-generated signals including abnormal serum drug levels, abnormal laboratory results, and the use of medications considered to be antidotes for adverse drug effects. Administrative incident reports generated within each participating facility were also reviewed for any indication of a drug-related incident. The primary outcome of the study was an adverse drug event, defined as an injury resulting from the use of a drug. This definition is consistent with definitions used in previous studies. Adverse drug events may have resulted from medication errors (e.g., errors in ordering, dispensing, administration, and monitoring) or from adverse drug reactions in which there was no error. As described previously, the between-pharmacist investigator reliability for identifying relevant incidents in medical records was assessed through independent review of the same 10 medical records by each of the two pharmacists. Each identified the same incident in the 10 medical records; one pharmacist identified an additional incident in one record that had not been pre-specified as an incident warranting review. The possible drug-related incidents were presented by a pharmacist investigator to pairs of physician-reviewers (JHG, JJ, PR, LRH, and CB). These physician-reviewers independently classified incidents using structured implicit review according to the following criteria: whether an adverse drug event was present, the severity of the event, and whether the event was preventable. In determining whether an adverse drug event had occurred, the physician-reviewers considered the temporal relation between the drug exposure and the event, as well as whether the event reflected a known effect of the drug. This structured implicit review process has been used in numerous prior studies relating to adverse drug events across various clinical settings. Physician reviewers were not aware of whether a drug-related incident being reviewed had occurred in a resident of an intervention or a control unit. The severity of adverse events was categorized as less serious, serious, life-threatening, or fatal. Adverse drug events categorized as less serious included a non-urticarial skin rash, a fall without associated fracture, hemorrhage not requiring transfusion or hospitalization, and oversedation. Examples of events categorized as serious included urticaria, falls with associated fracture, hemorrhage requiring transfusion or hospitalization but without hypotension, and delirium. Examples of life-threatening events include hemorrhage with associated hypotension, hypoglycemic encephalopathy, and acute renal failure. Adverse drug events were considered to be preventable if they were judged to be due to an error and were preventable by any means available and not just in relation to the clinical decision support system. For the purpose of the analysis of the effect of the intervention, any event characterized as serious or greater in severity, was categorized as more severe. All other events were considered less severe. Preventability was categorized as preventable, probably preventable, probably not preventable, or definitely not preventable; results were collapsed into preventable (preventable and probably preventable) and nonpreventable (probably not preventable and definitely not preventable) categories in the analysis. When the physician-reviewers disagreed on the classification of an incident regarding the presence of an adverse drug event, its severity, or its preventability, they met and reached consensus; consensus was reached in all instances where there was initial disagreement. Official Title ----------------- Reducing Adverse Drug Events in the Nursing Home Conditions ----------------- Adverse Drug Events Intervention / Treatment ----------------- * Other: Clinical Decision Support Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: prescriber at the study facilities Exclusion Criteria: not a prescriber at the study facilities Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Health Services Research Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: I - Intervention units<br>nursing home units, provided HIT CDS intervention \| Other: Clinical Decision Support<br> <br> * Other names: CDS;\| \| No Intervention: C - control units<br>nursing home units, not provided the HIT CDS intervention \| \| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| adverse drug events \| \| March 2002 - February 2005 \|	ctgov
Tea and Forearm Blood Flow Study Overview ================= Brief Summary ----------------- The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar a placebo matched for taste and appearance in a blinded cross over design. Detailed Description ----------------- Epidemiological studies indicate that regular consumption of black tea reduces the risk of cardiovascular diseases. Tea consumption can result in improvements in endothelial function of conduit arteries as measured by flow mediated dilation. Less is known however about its effects in other vascular beds. The study will test the hypothesis that tea affects endothelial function in the muscle microcirculation. This will be done by assessment of forearm blood flow using venous occlusion plethysmography after consumption of black tea against or placebo in a randomised, full cross-over study in 20 healthy middle-aged to elderly subjects Official Title ----------------- Forearm Blood Flow Response to Acute Consumption of Black Tea Conditions ----------------- Vascular Function Intervention / Treatment ----------------- * Other: Tea * Other: Placebo Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Males and post menopausal (> 1 years) females Aged ≥ 45 and ≤ 75 years Body mass index (BMI) of ≥ 18.0 and ≤ 35.0 kg/m2 Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein). Normal blood coagulation as assessed by routine lab tests Exclusion Criteria: Strenuous exercise > 2 hours per week. Strenuous exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation Current smoker or has stopped smoking less than 6 months before start of study Self reported alcohol intake of > 21 units/week) Established cardiovascular disease or clinically significant arrhythmia Diabetes mellitus Blood pressure > 160/100 mmHg Taking medication that might affect endothelial function (as judged by the PI) Ages Eligible for Study ----------------- Minimum Age: 45 Years Maximum Age: 75 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Basic Science Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Black tea<br>Approximately 400 mg total polyphenols in 240 ml hot water (loading dose; 2 hours before the start of measurements; t=0) and 130 mg total polyphenols in 120 ml hot water (maintenance dose just before start of the measurements; t=120 min) \| Other: Tea<br>* Black tea infusion equivalent to approximately 530 mg total polyphenols expressed as gallic acid equivalents<br>\| \| Placebo Comparator: Placebo<br>Caramel colour, maltodextrin and tea flavour in 240 ml hot water (2 hours before the start of measurements; t=0) and 120 ml hot water (maintenance dose just before start of the measurements; t=120 min) \| Other: Placebo<br>* Placebo matched to tea with respect to taste and appearance<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Forearm blood flow response to acetylcholine \| Does tea ingestion change mean forearm blood flow response to acetylcholine when compared to placebo \| During acetylcholine infusion 120-140 min after first tea/placebo intake \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Forearm blood flow response to sodium nitropusside \| Does tea ingestion change mean forearm blood flow response to sodium nitropusside when compared to placebo \| During sodium nitropusside infusion 170-190 min after first tea/placebo intake \| \| Forearm blood flow response to L-NMMA \| Does tea ingestion change mean forearm blood flow response to L-NG-monomethyl Arginine (L-NMMA) when compared to placebo \| During L-NMMA infusion 220-240 min after first tea/placebo intake \|	ctgov
Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease Study Overview ================= Brief Summary ----------------- Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want. The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life. Detailed Description ----------------- The study was designed prospectively. Patients with COPD who apply to the pulmonary rehabilitation outpatient clinic will be included. The data of patients with COPD who are eligible for PR and have been pre-evaluated will be scanned. Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale will be used in the study. Patients with COPD who smoke will constitute the study group, and those who quit smoking will constitute the control group. Official Title ----------------- Clinical Characteristics of Chronic Obstructive Pulmonary Patients Who Continue to Smoke Conditions ----------------- Copd, Smoking Intervention / Treatment ----------------- * Other: Clinical Tests Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Smoker COPD Patients who smoker Exclusion Criteria: Not volunteer to participate the study Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 90 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Supportive Care Allocation: Non-Randomized Intervention Model: Parallel Assignment Interventional Model Description: Smoker COPD Ex Smoker COPD Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Smoker COPD<br>Patients who continue to smoke \| Other: Clinical Tests<br>* Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale<br>\| \| Active Comparator: Ex-smoker COPD<br>Patients who quit smoking. \| Other: Clinical Tests<br>* Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Exercise Capacity \| Six minutes walk test \| 6 minutes \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Respiratory Functions \| Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). \| 30 minutes \| \| Dyspnea Sensation \| Modified Medical Research Council (MMRC) dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. \| 20 minutes \| \| Disease Specific Quality of Life \| St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. \| 20 minutes \| \| Anxiety \| Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively. \| 20 minutes \| \| Depression \| Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively. \| 20 minutes \| \| Body Mass Index \| Body mass index is calculated by dividing body mass by the square of length in meters. \| 5 minutes \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- copd, smoking	ctgov
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Study Overview ================= Brief Summary ----------------- The purpose of this study is to evaluate the efficacy and safety of ensifentrine in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Official Title ----------------- A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD Conditions ----------------- Chronic Obstructive Pulmonary Disease Intervention / Treatment ----------------- * Drug: Ensifentrine * Drug: Placebo Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Informed Consent Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF). Age and Sex Age: Patient must be 40 to 80 years of age inclusive, at the time of Screening. Sex: Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication. Females are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions apply: Not a woman of childbearing potential (WOCBP) as defined in Or A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication. Smoking History Smoking History: Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years at Screening (Visit 0) [number of pack years = (number of cigarettes per day / 20) × number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 0. Smoking cessation programs are permitted during the study. COPD Diagnosis, Symptoms, Severity and Maintenance Therapy COPD Diagnosis: Patients with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD. COPD Symptoms: A score of ≥2 on the Modified Medical Research Council (mMRC) Dyspnea Scale. COPD Severity: Pre- and Post-albuterol/salbutamol FEV1/FVC ratio of <0.70. Post-albuterol/salbutamol FEV1 ≥30 % and ≤70% of predicted normal calculated using the National Health and Nutrition Examination Survey III. Maintenance Therapy: Patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy are eligible. Patients taking maintenance LAMA or LABA therapy must demonstrate stable use of the maintenance LAMA or LABA therapy for at least 3 months prior to Screening and agree to continue use for the duration of the study. Background maintenance LAMA or LABA bronchodilator therapy will be capped at 50% of patients. Other Requirements for Inclusion Capable of withholding SABAs for 4 hours prior to initiation of any spirometry. Patients in the maintenance LAMA or LABA therapy stratum must be capable of withholding Twice-Daily maintenance LAMA or LABA for 24 hours and Once-Daily maintenance LAMA or LABA for 48 hours prior to initiation of any spirometry. Capable of using the study nebulizer correctly and complying with all study restrictions and procedures. Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines. Inclusion Criteria at Randomization (RPL554-CO-301) Symptoms of COPD: A score of ≥2 on the mMRC Dyspnea Scale. Completion of the e-Diary at least 5 of the last 7 days of the Run-in period. Exclusion Criteria: Current Condition or Medical History History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation. Hospitalizations for COPD, pneumonia, or Corona Virus Disease 2019 (COVID-19) in the 12 weeks prior to Screening and/or a positive COVID-19 test result indicating an active infection at Screening. Patients with COVID-19 antibodies from a previous exposure with no active infection are not excluded. COPD exacerbation requiring oral or parenteral steroids within 3 months of Screening. Previous lung resection or lung reduction surgery within 1-year of Screening. Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤12 hours per day) is not exclusionary. Pulmonary rehabilitation, unless such treatment has been in a stable maintenance phase for 4 weeks prior to Visit 1 and remains stable during the study. Lower respiratory tract infection within 6 weeks of Screening. Other respiratory disorders including, but not limited to, a current diagnosis of asthma, active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, interstitial lung diseases, unstable sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases. Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study. Historical or current evidence of clinically significant cardiovascular disease defined as any disease that in the opinion of the Investigator would put the safety of the patient at risk through participation or which could affect the efficacy or safety analysis if the disease/condition were to exacerbate during the study, including, but not limited to: Myocardial infarction or unstable angina within 6 months prior to Screening. Unstable or life-threatening cardiac arrhythmia requiring intervention within 3 months prior to Screening. Diagnosis of New York Heart Association Class III and Class IV heart failure. Chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant. Unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones). History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin. Findings on physical examination that an investigator considers to be clinically significant at Screening. Prior/Concomitant Therapy Use of prohibited medications within the time intervals. History or Suspicion of Drug or Alcohol Abuse Current or history of past drug or alcohol abuse within the past 5 years. Laboratory and Other Diagnostic Parameters Glomerular Filtration Rate (eGFR) <30 mL/min. The Chronic Kidney Disease Epidemiology Collaboration Creatinine (2009) calculation will be used (Levey, 2009). Alanine aminotransferase (ALT) ≥ 2 x upper limit of normal (ULN), alkaline phosphatase and/or bilirubin > 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Any other abnormal hematology, biochemistry, or viral serology deemed by an investigator to be clinically significantly abnormal. Abnormal chemistry and/or hematology may be repeated during Screening. Chest X-ray (CXR; posterior-anterior) at Screening, or in the 12 months prior to Screening with clinically significant abnormalities not attributable to COPD. If a CXR within the past 12 months is not available but a computerized tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR. For subjects in Germany, if a CXR or CT scan is not available in the 12 months prior to Screening, the subject is not eligible for the study. Electrocardiogram (ECG) finding that is significantly abnormal on the 12-lead ECG obtained at Screening. Other Exclusions Use of an experimental drug within 30 days or 5 half-lives of Screening, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to Screening. Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to Screening. Intolerance or hypersensitivity to albuterol/salbutamol or ensifentrine (RPL554) or any of its excipients/components. Prior receipt of blinded study medication in an ensifentrine (RPL554) study. Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned. Inability to read, understand, and/or complete questionnaires (in the opinion of the Investigator). A disclosed history or one known to the Investigator of significant non-compliance in previous investigational studies or with prescribed medications. Any other reason that the Investigator considers makes the patient unsuitable to participate. Exclusion Criteria at Randomization (RPL554-CO-301) COPD exacerbation or lower respiratory tract infection between Screening and Randomization (defined as use of any additional treatment other than current treatment and rescue medication and/or emergency department or hospital visit). Patients with a severe COPD exacerbation that requires hospitalization may not be rescreened. Positive COVID-19 result at Screening or between Screening and Randomization. Prohibited medication use between Screening Visit 0 and Visit 1. Significantly abnormal ECG finding on the 12-lead ECG obtained at Screening as assessed by the investigator or site medical doctor/medically qualified person or on the pre-dose (prior to randomization) ECG obtained at Visit 1. In the event that the central ECG reviewer discovers a significant ECG abnormality on the Visit 1 ECG, the patient will be discontinued. Did not meet one or more of the Inclusion Criteria or met one or more of the Exclusion Criteria. Ages Eligible for Study ----------------- Minimum Age: 40 Years Maximum Age: 80 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Arm 1<br>Ensifentrine Nebulized Suspension; 3 mg BID \| Drug: Ensifentrine<br>* Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks<br>\| \| Placebo Comparator: Arm 2<br>Placebo Nebulized BID \| Drug: Placebo<br>* Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Least Square (LS) Mean Change From Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12 \| Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, <=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. \| Baseline (pre-dose on Day 1) and Week 12 \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| LS Mean Change From Baseline FEV1 to Peak FEV1 at Day 1 and Weeks 6, 12 and 24 \| Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Peak FEV1 is the maximum value in the 4 hours after dosing. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, <=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines. \| Baseline (pre-dose on Day 1), post-dose on Day 1, Weeks 6, 12, and 24 \| \| LS Mean Change From Baseline to the Mean Weekly Evaluating-Respiratory Symptoms (E-RS) Total Score at Weeks 6, 12 and 24 \| The E-RS scale consists of 11 questions, with 3 sub-domains of: breathlessness, cough and sputum, and chest symptoms. The E-RS sub-domain score was calculated as the sum from the relevant questions. The E-RS total score was derived as the sum of the raw scores of the 11 items ranging from 0 to 40. Higher scores indicates severe respiratory symptoms. Scores were derived weekly as the mean over 7 days prior to the visit, using only days where data was recorded. The E-RS was collected daily by electronic diary (e-diary). Baseline is the mean over the 7 days prior to the first intake of study medication, using only days where data was recorded. \| Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24 \| \| LS Mean Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 6, 12 and 24 \| The SGRQ questionnaire consists of 17 questions, split into 2 parts. Part 1 consisted of the first 8 questions and was related to the symptoms subdomain. The remaining 9 questions were in Part 2, which were related to the activity and impacts subdomains. The total score was calculated by dividing the summed weights by the maximum possible weight for all items in the questionnaire and expressing the result as a percentage. Score ranging from 0 to 100 and higher scores indicated a worse outcome. Baseline is the score calculated on Day 1 prior to 4 hour post-dose spirometry. \| Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24 \| \| LS Mean Change From Baseline FEV1 to Morning Trough FEV1 at Weeks 6, 12 and 24 \| Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Morning trough FEV1 was the last value collected prior to the morning dose. Baseline FEV1 is the mean of the two measurements taken before study medication on the day of first dosing, that is, <=40 minutes pre-dose on day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines. \| Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24 \| \| LS Mean Change From Baseline in Average FEV1 Area Under the Curve Over 4 Hours (AUC0-4h) at Day 1 and Weeks 6, 12 and 24 \| Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-4h was defined as area under the curve over 4 hours of the FEV1, divided by 4 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, <=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines. \| Baseline (pre-dose on Day 1), post-dose on Day 1, Weeks 6, 12, and 24 \| \| Percentage of SGRQ Responders at Weeks 6, 12 and 24 \| The SGRQ questionnaire consists of 17 questions, split into 2 parts. Part 1 consisted of the first 8 questions and was related to the symptoms subdomain. The remaining 9 questions were in Part 2, which were related to the activity and impacts subdomains. The total score was calculated by dividing the summed weights by the maximum possible weight for all items in the questionnaire and expressing the result as a percentage. Responder was a patient with an improvement from baseline in SGRQ total score of 4 or more. Percentage of SGRQ responders are reported. \| Weeks 6, 12 and 24 \| \| LS Mean Change From Baseline to the Mean Weekly Rescue Medication Use at Weeks 6, 12 and 24 \| Use of rescue medication (albuterol/salbutamol) per week was calculated as the LS mean use daily over 7 days. Daily rescue medication use was collected in an e-diary throughout the study. Baseline is the mean over the 7 days prior to the first intake of study medication, calculated as the sum of puffs taken, divided by number of days data has been recorded. \| Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24 \| \| LS Mean Transition Dyspnea Index (TDI) Questionnaire Total Score at Weeks 6, 12 and 24 \| The TDI is a questionnaire that focused on 3 sub-domains: functional impairment, magnitude of task and magnitude of effort. Sub-domain score was calculated as the sum from the related questions. Total score was calculated as the sum of the sub-domain scores. The TDI measures the change in dyspnea severity from the baseline as measured by the baseline dyspnea index. It was rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement). Higher scores indicate better outcome. Change from baseline was assessed with the Baseline Dyspnea Index. \| Weeks 6, 12 and 24 \| \| LS Mean Change From Baseline FEV1 to Evening Trough FEV1 at Week 12 \| Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Evening trough FEV1 was the value collected at 12 hours post-morning dose and prior to the evening dose. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, <=40 minutes pre-dose on day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines. \| Baseline (pre-dose on Day 1) and Week 12 \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- COPD	ctgov
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED) Study Overview ================= Brief Summary ----------------- This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid. Official Title ----------------- A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-small Cell Lung Cancer. Conditions ----------------- Breast Cancer, Colorectal Cancer, Non-small-cell Lung Carcinoma Intervention / Treatment ----------------- * Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) * Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen. Has a measurable, positron emission tomography (PET) assessable lesion Adequate blood, liver, bone marrow and kidney functions Has not received any chemotherapy for at least 4 weeks prior to entry in this study Agrees to take adequate measures to prevent pregnancy. Exclusion Criteria: Patient has had prior treatment with histone deacetylase (HDAC) inhibitor. Patient has had treatment with investigational agents within the last 30 days. Patient has active infection or had intravenous (IV) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs. Patient has HIV, hepatitis B or hepatitis C infection. Patient is pregnant or lactating. Patient has allergy to any component of the study drug. Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Arms and Interventions \| Intervention/Treatment \| \| --- \| \|Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)\|nan\| \|Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles\|nan\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria. \| \| \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days. \| \| \|	ctgov
Acute Exposure of Simulated Hypoxia on Pulmonary Artery Pressure and Right Heart Function (Echo) Study Overview ================= Brief Summary ----------------- Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on pulmonary artery pressure and right heart function (Echo). Detailed Description ----------------- Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, (six-minute walk test) 6MWT, pulmonary function test, clinical assessment and blood gas Analysis. Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the AMC Altitrainer) and shamed altitude with the same device. Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo. Official Title ----------------- Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise Conditions ----------------- Pulmonary Hypertension Intervention / Treatment ----------------- * Device: Simulated Altitude (FiO2: 15.1%) * Device: Shamed Hypoxia (FiO2: 20.9) Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Informed consent PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a (pulmonary artery wedge pressure) PAWP ≤15 mmHg during right heart catheterization at the time of initial diagnosis PH class 1 (PAH) or 4 (CTEPH) Stable condition, on the same medication for > 4 weeks Patient live permanently at an altitude < 1000m asl. Exclusion Criteria: Resting partial Oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed) Severe daytime hypercapnia (pCO2 > 6.5 kPa) Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes. Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation Residence > 1000m above sea level Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability Women who are pregnant or breast feeding Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Prevention Allocation: Randomized Intervention Model: Crossover Assignment Interventional Model Description: Including a baseline assessment and assessments under simulated altitude and normoxia. Masking: Single Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Order air-hypoxia<br>The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator (Altitrainer, SMTEC), simulated altitude (FiO2: 15.1%), with a facemask. \| Device: Simulated Altitude (FiO2: 15.1%)<br>* Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask.<br>Device: Shamed Hypoxia (FiO2: 20.9)<br>* Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask<br>\| \| Experimental: Order hypoxia-air<br>The participant will be exposed to hypoxia (FiO2, 15.1% equivalent to 2500m above sea level), simulated altitude (FiO2: 15.1%), and consecutively to shamed hypoxia (FiO2, 20.9%) administered by an altitude simulator (Altitrainer, SMTEC) with a facemask. \| Device: Simulated Altitude (FiO2: 15.1%)<br>* Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask.<br>Device: Shamed Hypoxia (FiO2: 20.9)<br>* Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Echocardiographic assessment under hypoxia (FiO2: 15.1) \| Pulmonary artery pressure measured by echo (TTE) \| 2 hours \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Echocardiographic assessment of the right heart under hypoxia (FiO2: 15.1) \| Right heart functions measured by echo (TTE) (fac, d-shaping, kinetic etc.) \| 2 hours \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Simulated altitude, Pulmonary artery pressure, Echocardiography, Right heart function	ctgov
EDWARDS INTUITY Valve System CADENCE Study Study Overview ================= Brief Summary ----------------- The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass. Detailed Description ----------------- This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts. Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints. Official Title ----------------- A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment Conditions ----------------- Aortic Valve Disease, Aortic Stenosis Intervention / Treatment ----------------- * Device: EDWARDS INTUITY * Device: Stented aortic bioprostheses Participation Criteria ================= Eligibility Criteria ----------------- Inclusion: ≥18 years of age aortic stenosis / mixed aortic stenosis and aortic insufficiency SAVR+CABG (1-4 distal anastomoses) Log. EuroSCORE ≥6 NYHA Class ≥II Exclusion (i.a.): pure aortic insufficiency pre-existing prosthetic heart valve or ring congenital true bicuspid / unicuspid aortic valve LVEF <20% Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Active Comparator: EDWARDS INTUITY<br>EDWARDS INTUITY Valve System, Model 8300A \| Device: EDWARDS INTUITY<br>* To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR & CABG.<br>* Other names: aortic valve replacement;\| \| Active Comparator: Stented aortic bioprostheses<br>Stented aortic bioprostheses \| Device: Stented aortic bioprostheses<br>* In comparison to control valves available on the market.<br>* Other names: aortic valve replacement;\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Average Subject Time Spent on Cardiopulmonary Cross Clamp \| Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. \| At time of surgery, an average of 1.5 hours \| \| Average Amount of Time Subject Spent on Cardiopulmonary Bypass \| Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. \| At time of surgery, an average of 2 hours \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. \| The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. \| Baseline and 2 Years \| \| Subject's Average Mean Gradients (mmHg) Measurements Over Time. \| Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subject's Average Peak Gradients (mmHg) Measurements Over Time. \| Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. \| 30 days, 3 months, 6 months, 1 year, 2 year \| \| Subject's Effective Orifice Area (EOA) Measurement Over Time. \| Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. \| 30 days, 3 months, 6 months, 1 year, 2 year \| \| Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. \| Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. \| 30 days, 3 months, 6 months, 1 year, 2 year \| \| Amount of Aortic Valvular Regurgitation Over Time. \| Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. \| 30 days, 3 months, 6 months, 1 year, 2 year \| \| Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery. \| Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery. \| Prior to Surgery \| \| Subjects Who Required a Thoracic Resternotomy Over Time \| Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects Who Received a Permanent Pacemaker Over Time. \| Number of Subjects who received a Permanent Pacemaker shown over various time points. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With a Major Paravalvular Leak (OPC) Over Time \| Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects Who Experienced Major Bleeding Over Time. \| Number of subjects who experienced Major Bleeding shown over various time points. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects Who Experienced Respiratory Failure Over Time \| Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood. \| 30 days, 3 Months , 6 Months, 1 Year, 2 Years. \| \| Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time \| Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With Renal Failure Over Time \| Number of subjects who experienced Renal (kidney) Failure shown over various time points. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With Endocarditis Over Time \| Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With a Deep Sternal Would Infection Over Time \| Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With a Myocardial Infarction Over Time \| Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With a Thromboembolism Over Time \| Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With a Cardiac Tamponade Over Time \| Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects With a Cardiac Reoperation for Any Reason Over Time \| Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points. \| 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subjects Who Died Intraoperatively \| Number of subjects who died during surgery. \| Surgery \| \| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time \| The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. \| Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time \| The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. \| Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time \| The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years. \| Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. \| \| Health Care Utilization \| The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure. \| Day of surgical procedure through discharge from the hospital, an average of 2 weeks \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY	ctgov
Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis Study Overview ================= Brief Summary ----------------- The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients. Official Title ----------------- Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Conditions ----------------- Perennial Allergy to House Dust Mite and/or Cat Intervention / Treatment ----------------- * Drug: CYT003-QbG10 Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens Exclusion Criteria: Clinical relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments. Use of any concomitant medication that could affect the patient's study treatment response or assessment results. Any clinically relevant concomitant disease as judged by the investigator. Pregnancy or female planning to become pregnant during the study. Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 65 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: 1<br> \| Drug: CYT003-QbG10<br>* 6 subcutaneous injections<br>\| \| Placebo Comparator: 2<br> \| Drug: CYT003-QbG10<br>* 6 subcutaneous injections<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life \| \| on 4 occations over 1 year \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Safety and tolerability of the vaccine by collection of adverse events \| \| at each visit \|	ctgov
A Phase IV Study to Assess the Safety of EupentaTM Inj Study Overview ================= Brief Summary ----------------- A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine} Official Title ----------------- A Prospective, Open-label, Interventional Phase IV Study to Assess the Safety of EupentaTM Inj. {Fully Liquid Pentavalent Vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [Recombinant-deoxyribonucleic Acid])-Haemophilus Influenzae Type b Conjugate Vaccine} Conditions ----------------- Hepatitis B, Diphtheria, Haemophilus Influenzae Type B Infection, Tetanus, Pertussis Intervention / Treatment ----------------- * Biological: Eupenta Inj. Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Written informed consent obtained from the parents or legally acceptable representatives (LARs) of the subject who have been informed of the purpose, method, effects, etc., of the study A male or female 6 to 8 weeks of age, inclusive, at the time of the first vaccination In good health as determined by medical history, physical examination, and judgment by the Investigator Body weight 3.2 kg and over at the time of screening Subjects for whom the Investigator believed that their parent(s)/LAR(s) could comply with the requirements of the protocol (e.g., completion of the Subject Diary Cards, return for site visits) Exclusion Criteria: Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB and/or Hib diseases Any history of allergy to any of the components or excipients of EupentaTM Inj., including aluminum hydroxide, sodium hydrogen phosphate heptahydrate, monobasic sodium phosphate dihydrate, polysorbate and thimerosal Any medical condition which can compromise the infant's safety, as per Investigator's discretion History of seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormality History of bleeding tendencies Household contact and/or intimate exposure with a confirmed case of diphtheria, pertussis, HB, polio and/or Hib diseases within in 30 days prior to screening History of fever ≥ 38°C/ 100.4°F within 3 days prior to screening and/or intake of anti-pyretic/analgesic medication. Subjects who meet this criterion will be rescreened to check the temperature after the temporary condition has resolved and if they are within the window period for age of first vaccination at the time of re-scheduled visit History of previous diphtheria-tetanus-pertussis (DTP), and/or Hib vaccination doses History of previous or concurrent vaccinations other than Bacillus Calmette-Guérin (BCG), HB vaccination at birth, Polio, Rotavirus and Pneumococcal vaccines Known or suspected immune disorders, or, received immunosuppressive therapy Participation 30 days prior to screening in the study or simultaneously in another study and/or received any investigational product Ages Eligible for Study ----------------- Minimum Age: 6 Weeks Maximum Age: 8 Weeks Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Prevention Intervention Model: Single Group Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Eupenta Inj.<br> \| Biological: Eupenta Inj.<br>* fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine single dose 0.5 mL/vial The vaccine is given at 6, 10 and 14 weeks of age in infants.<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination \| \| first 30 minutes after each study vaccination \| \| Incidence of solicited local and systemic adverse events (AEs) \| \| baseline(pre-vaccination) up to 7 days after each vaccination \| \| Incidence of any unsolicited AEs during the entire study \| \| through study completion, an average of 1 year \| \| Incidence of SAEs during the entire study period \| \| through study completion, an average of 1 year \|	ctgov
Eastern Caribbean Health Outcomes Research Network (ECHORN) Study Overview ================= Brief Summary ----------------- The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean. Detailed Description ----------------- The Eastern Caribbean Health Outcomes Research Network (ECHORN) has two aims: (1) To form a research collaborative across the Eastern Caribbean islands of Puerto Rico, the U.S. Virgin Islands, Barbados, and Trinidad & Tobago to recruit and follow a community-dwelling adult cohort to estimate the prevalence of known and potential risk factors associated with the development of heart disease, cancer, and diabetes and (2) To enhance health outcomes research leadership capacity in the region through a series of dedicated activities locally and abroad. ECHORN will expand clinical research with racial/ethnic minority populations in a transitioning part of the globe now threatened with an epidemic of noncommunicable chronic diseases (NCD). ECHORN's findings will have direct implications for the health disparities research and policy agenda in the mainland United States. In the long term, the links ECHORN will facilitate with local health policy delegations and global strategic organizational partners will promote the translation of research to improve health outcomes across the region. The collection and storage of biological specimens will also contribute to national biomonitoring projects and has the potential to identify unique risk and protective factors in the development of NCD. Official Title ----------------- Eastern Caribbean Health Outcomes Research Network (ECHORN) Conditions ----------------- Cancer, Cardiovascular Disease, Diabetes Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Greater than or equal to 40 years of age English or Spanish language speaking Resident of island at least 10 years Able to provide informed consent Non-institutionalized at the time of data collection Stable contact/residential information No plans to relocate from island within the next 5 years Ages Eligible for Study ----------------- Minimum Age: 40 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Prevalence of non-communicable diseases \| Prevalence of non-communicable diseases, including cancer, heart disease and diabetes. \| 5 years \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- cancer, cardiovascular disease, diabetes	ctgov
Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique Study Overview ================= Brief Summary ----------------- Investigators recruited 10 trimethylamine N-oxide (TMAO) producers to test the effect of garlic juice containing allicin on gut microbiota modulation and TMAO production. Detailed Description ----------------- Trimethylamine N-oxide (TMAO) was recently discovered as a novel and independent risk factor for promoting atherosclerosis while it is generated from dietary carnitine through the metabolism of gut microbiota for decades. Allicin, the major compound in raw garlic juice, is a naturally antimicrobial phytochemical found in raw garlic juice and easily acquired from the diet. Investigators' previous study suggests dietary allicin reduces the transformation of L-carnitine to TMAO through the impact on gut microbiota in mice. Therefore, it is worth investigating whether raw garlic juice intake could reduce the TMAO productivity of human gut microbiota as well as modulate gut microflora. Investigators plan to recruit 10 TMAO producers to receive garlic juice for one week. The plasma and urine TMAO concentration will be measured by the LC-MS, and the gut microbiota composition will be analyzed by the next-generation sequencing, through bioinformatics analysis. Investigators expected after intake garlic juice for one week, it could prevent the cardiovascular disease risk via gut microbiota modulation and reduction of plasma and urine TMAO. Screening of the TMAO producer: The healthy participants were recruited, the criteria as follows: (1) age ≥ 20 years old; (2) no exposure to antibiotics, probiotics, or carnitine supplements within the previous month; (3) have no history of chronic diseases including, diabetes mellitus, myasthenia gravis, chronic renal disease, hyperparathyroidism, epilepsy, and severe anemia; (4) Participants were excluded from the study if they reported recent gastrointestinal discomfort (such as abdominal pain or diarrhea). To screening the TMAO producer, Investigators use the oral carnitine challenge test (OCCT) method which previously exhibited better efficacy than fasting plasma TMAO to identify the TMAO producer phenotype. All of the participants fasted at least 8 hours before performing OCCT. 1500 mg of L-carnitine (3 tablets, General Nutrition Centers, Inc., USA) orally administrated to the participants. The blood and urine of participants were collected at 0, 24, 48, and 72 hours after carnitine intake. Participants with plasma TMAO ≧ 10 μM after OCCT were defined as high TMAO producers and proceeded into the garlic juice intervention test. Garlic Juice Intervention: High-TMAO producers asked to consume 55 mL of raw garlic juice (48 mg of allicin equivalent) once a day during dinner for one week. High-TMAO producers suggested consuming the garlic juice with a meal. The high-TMAO producers were free to choose their diet, no restriction on the type of food. After one week of raw garlic juice intervention, the second OCCT was performed. Official Title ----------------- Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique Conditions ----------------- Atherosclerosis Intervention / Treatment ----------------- * Dietary Supplement: Raw garlic juice containing allicin Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Age 20-65 years old Healthy subjects with TMAO producing ability Exclusion Criteria: Exposure to antibiotics, probiotics, or carnitine supplements within the previous month Have a history of chronic diseases including, diabetes mellitus, myasthenia gravis, chronic renal disease, hyperparathyroidism, epilepsy, and severe anemia Have gastrointestinal discomfort (such as abdominal pain or diarrhea) Ages Eligible for Study ----------------- Minimum Age: 20 Years Maximum Age: 65 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Basic Science Intervention Model: Single Group Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Raw garlic juice<br>Raw garlic juice treatment group \| Dietary Supplement: Raw garlic juice containing allicin<br>* Fresh garlic juice containing around 48mg allicin for 7 days<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Plasma and urine TMAO level (ppm) \| Quantitation of plasma and urine TMAO level by LC-MS \| 6 months \| \| Compositional analysis of gut microbiota (% of different bacteria species) \| Next-generation sequencing and bioinformatics \| 6 months \|	ctgov
Platelet-Rich Plasma in the Treatment of Patients With Idiopathic Carpal Tunnel Syndrome Study Overview ================= Brief Summary ----------------- This is a randomized controlled trial in a cohort of Egyptian patients suffered from mild to moderate idiopathic carpal tunnel. They were randomly divided into two groups. Group 1: patients received ultrasound-guided platelet-rich plasma injection and group 2 patients received ultrasound-guided corticosteroid injection. The outcome measures were assessed via Visual Analogue Scale, the Boston Carpal Tunnel Syndrome Questionnaire, electrophysiological findings in sensory and motor function of the median nerve and morphological changes of median nerve detected by ultrasound. Detailed Description ----------------- Intervention: PRP Injection Group(PRP-inj-G) - This group included 49 patients (40 females and 9 males). Their age ranged from 20 to 60 years. PRP Preparation: 16 ml of blood was obtained from each patient using special PRP kits (GD medical pharma, Dutch company). The blood was collected on citrated tubes with a mixing ratio of 9:1 by volume. Tubes underwent 1st centrifugation at speed of 3000 rpm (704g) for 3 minutes (to separate red blood cells from plasma). Plasma was then removed by syringe and then placed into another sterile tube with no anticoagulant and then underwent 2nd centrifugation at speed of at 4000 rpm (1252g) for 15 min. The supernatant platelet-poor plasma was then removed leaving 2 ml of PRP pellets in the sediment, and suspend the PRP pellets by gentle shaking of the tube. PRP is activated by adding 200 μl of 0.025 calcium chloride(Dhurat and Sukesh, 2014). Ultrasound-Guided Injection: Proper preparation with an antiseptic solution of skin overlying the point of injection was performed guided by ultrasonography (Siemens Acuson P300 machine). With the palm facing upward and the wrist joint in slight extension, the MN will be recognized at the inlet of the CT(Wu et al., 2017). The injection was guided by ultrasound with the use of the ulnar in-plane technique(Lee et al., 2014). Ulnar artery was identified by the means of Doppler imaging, and a 25-gauge needle was introduced from the ulnar side of the wrist between CT and MN. Then the entire CT was scanned to confirm that the injection had dispersed through the proximal to the distal area of the CT. All patients were observed for 30 minutes post-injection for the possibility of dysesthesia or bleeding(Wu et al., 2017). PRP injection: A 25-gauge needle was gently introduced one cm proximal to the distal wrist-flexion crease just to the ulnar side of the palmaris longus tendon and 2 ml of PRP was injected into the CT. Steroid injection Group(St-inj-G) - included 49 patients (41 females and 8 males)with their age ranged from 20 to 60 years. A single injection of methylprednisolone acetate 40 mg/ml using a technique similar to that described for the PRP injection Post-injection care for both groups: Some patients may have minimal to moderate discomfort after injection. So, to control pain, patients should apply ice on the injection site and also modify activity as tolerated. Rest for one day. The patient immediately returns to work two days after injection. Pain medication in the form of paracetamol only was allowed for the next 3 months if needed. The patients were instructed to stop analgesics 48 hours before the visit to allow proper symptoms assessment. Official Title ----------------- Platelet-Rich Plasma in the Treatment of Patients With Idiopathic Carpal Tunnel Syndrome Conditions ----------------- Carpal Tunnel Syndrome Intervention / Treatment ----------------- * Procedure: Platelet-Rich Plasma Injection Group Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Patients with mild-to-moderate idiopathic CTS with clinical manifestations failed to respond to conservative treatment ( such as splint, medications, Physical therapy) for at least 3 months and they were diagnosed by electrophysiological study and musculoskeletal ultrasound. Exclusion Criteria: Diabetes Hypothyroidism Rheumatoid arthritis Previous carpal tunnel decompressive surgery Cervical radiculopathy, polyneuropathy, brachial plexopathy, traumatic nerve injury, thoracic outlet syndrome Previous corticosteroid injection into the carpal tunnel in the preceding 4 weeks Anemia (hemoglobin <10gm%) Coagulopathy Pregnancy Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Active Comparator: PRP Injection Group<br>PRP Preparation: 16 ml of blood was obtained from each patient using special PRP kits (GD medical pharma, Dutch company). The blood was collected on citrated tubes with a mixing ratio of 9:1 by volume. Tubes underwent 1st centrifugation at speed of 3000 rpm (704g) for 3 minutes (to separate red blood cells from plasma). Plasma was then removed by syringe and then placed into another sterile tube with no anticoagulant and then underwent 2nd centrifugation at speed of at 4000 rpm (1252g) for 15 min. The supernatant platelet-poor plasma was then removed leaving 2 ml of PRP pellets in the sediment, and suspend the PRP pellets by gentle shaking of the tube. PRP is activated by adding 200 μl of 0.025 calcium chloride(Dhurat and Sukesh, 2014). \| Procedure: Platelet-Rich Plasma Injection Group<br>* Platelet-Rich Plasma Injection Group<br>\| \| Active Comparator: Steroid injection Group<br>A single injection of methylprednisolone acetate 40 mg/ml using a technique similar to that described for the PRP injection \| Procedure: Platelet-Rich Plasma Injection Group<br>* Platelet-Rich Plasma Injection Group<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Pain improvement \| The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain. \| three months \| \| Function improvement \| The Boston CT Questionnaire (BCTQ) is a patient-based outcome measure that was designed specifically for CTS patients. BCTQ has 2 distinct scales, the Symptom Severity Scale (BCTQ-SSS) containing 11 questions and the Functional Status Scale (BCTQ-FSS) containing 8 items. All questions were rated for degree of difficulty on a 5points scale. Each scale producesa final average score (sum of the scores divided by number of items) with a higher score indicative of greater disability. The BCTQ was used as an outcome measure in clinical trials, and has been reported as a validity and reliable tool for assessment of CTS. \| three months \| \| Edema \| US examination of the m-CSA for all patients was performed using a 7-13 MHz linear array probe with a calibrated device (Siemens, Acuson P300 apparatus) on the same day of EDX examination and clinical evaluation. All US examinations were performed with the wrists at the neutral position. The US examiner applied a minimal pressure force to avoid induction of artificial nerve deformation. Three measurements of the m-CSA at the level of most-protuberant portion of the pisiform bone were performed. The mean of the three measurements is calculated. \| three months \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Carpal Tunnel Syndrome, Platelet-rich plasma	ctgov
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis Study Overview ================= Brief Summary ----------------- The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis. Official Title ----------------- A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis Conditions ----------------- Hepatitis C Virus Infection Intervention / Treatment ----------------- * Drug: SOF/VEL * Drug: RBV Participation Criteria ================= Eligibility Criteria ----------------- Key Inclusion Criteria: Chronic HCV-infected males and non-pregnant/non-lactating females Treatment naive or treatment experienced individuals Child-Pugh-Turcotte Score 7-12 at screening Note: Other protocol defined Inclusion/Exclusion criteria may apply. Ages Eligible for Study ----------------- Minimum Age: 20 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: SOF/VEL<br>SOF/VEL for 12 weeks \| Drug: SOF/VEL<br>* 400/100 mg FDC tablet administered orally once daily<br>* Other names: Epclusa®;\| \| Experimental: SOF/VEL + RBV<br>SOF/VEL + RBV for 12 weeks \| Drug: SOF/VEL<br>* 400/100 mg FDC tablet administered orally once daily<br>* Other names: Epclusa®;Drug: RBV<br>* Capsules administered orally in a divided daily dose<br>* Other names: Rebetol®;\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) \| SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. \| Posttreatment Week 12 \| \| Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event \| \| Up to 12 weeks \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) \| SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. \| Posttreatment Week 4 \| \| Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) \| SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. \| Posttreatment Week 24 \| \| Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment \| \| Up to 12 weeks \| \| Change From Baseline in HCV RNA \| \| Baseline and up to 12 weeks \| \| Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score \| MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. No change was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; Decrease was assigned for differences that were less than or equal to -2; and Increase was assigned for values that were greater than or equal to 2. \| Baseline to Posttreatment Week 24 \| \| Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class \| CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard. \| Baseline to Posttreatment Week 24 \| \| Percentage of Participants With Virologic Failure \| Virologic failure was defined as: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement). \| Up to Posttreatment Week 24 \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Communicable Diseases, Hepatitis, Hepatitis C, Virus Diseases, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Velpatasvir, RNA Virus Infections, Ribavirin, Sofosbuvir, Antiviral Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Anti-Infective Agents, Decompensated Cirrhosis	ctgov
Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia Study Overview ================= Brief Summary ----------------- A short survey involving 100 participants was conducted online to explore the understanding of Covid 19 pandemic impact and importance of vaccination among cancer survivors. Official Title ----------------- Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia Conditions ----------------- Covid19, Vaccination Refusal, Survivorship Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Female cancer survivors or care-taker undergoing national covid 19 vaccine - Exclusion Criteria: Male, not cancer survivors - Sexes Eligible for Study ----------------- Female Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Vaccination refusal \| Number of cancer survivors refuse vaccine \| 8 months \| \| Reason for Refusal of Vaccine \| Number of cancer survivors refuse vaccine \| 8 months \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Covid19, Vaccination, Gynaeoncology cancer, Cancer survivor	ctgov
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma Study Overview ================= Brief Summary ----------------- The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information Official Title ----------------- A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study Conditions ----------------- Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma Intervention / Treatment ----------------- * Drug: ME-401 Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: [Phase 1 study (DLT evaluation)] Patients aged 20 years or older at the submission of the written informed consent form Patients with relapsed or refractory B-cell NHL Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date. Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors. Patients with ECOG PS 0 or 1. Exclusion Criteria: [Phase 1 study (DLT evaluation)] Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product. Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those. Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test. Patients with active interstitial lung disease or a history thereof. Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401. Ages Eligible for Study ----------------- Minimum Age: 20 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Intervention Model: Single Group Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: ME-401<br>ME-401 administered orally \| Drug: ME-401<br>* [Phase 1 study (DLT evaluation)] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability. [Roll over study] 60 mg ME-401 will be administrated on intermittent schedule (1 week on and 3 week off in every 4-week cycle)and will continue until the prescribed mediation in ME-401-004 study is completed or discontinuation criteria are met.<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Number of participants with treatment-emergent adverse events (TEAEs) \| \| Up to approximately 1 year \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401 \| \| Up to approximately 2 years \| \| [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax) \| \| Up to approximately 2 years \| \| [Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC) \| \| Up to approximately 2 years \| \| [Phase 1 study (DLT evaluation)] Terminal half-life (t1/2) \| \| Up to approximately 2 years \| \| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR) \| \| Up to approximately 2 years \| \| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR) \| \| Up to approximately 2 years \| \| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS) \| \| Up to approximately 2 years \| \| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR) \| \| Up to approximately 2 years \|	ctgov
Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine Study Overview ================= Brief Summary ----------------- To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT reaches the blood, what concentration of AZT is attained in the blood, and how long AZT remains in the blood) changes from day-to-day in the same patient. Also to determine whether the pharmacokinetics of AZT is changed by sulfamethoxazole/trimethoprim (SMX/TMP) given at the same time or whether the pharmacokinetics of SMX/TMP is altered by AZT therapy. AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an important cause of disease and death in patients with AIDS. It is important to know how drugs interact in patients because addition of a second drug may change the speed at which a drug is eliminated from the body, and cause increased toxic effects or decreased therapeutic effects. Detailed Description ----------------- AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an important cause of disease and death in patients with AIDS. It is important to know how drugs interact in patients because addition of a second drug may change the speed at which a drug is eliminated from the body, and cause increased toxic effects or decreased therapeutic effects. Patients take AZT every 4 hours and/or SMX/TMP every 12 hours by mouth for 4 days as outpatients and then come into the clinical research center for 2 days of studies. On day 5 the final dose of medicine is given orally (SMX/TMP) or by intravenous infusion (AZT). Blood samples are drawn 10-20 times over a period of 12 hours and urine is collected for 36 hours. Concentrations of the drugs in the blood and urine samples are determined. This sequence is repeated twice, so that each patient takes AZT alone, SMX/TMP alone, and the combination of AZT and SMX/TMP over a period of about 3 weeks. Patients may be included in the study if they are asymptomatic, or have been diagnosed with ARC or AIDS, but not if they have PCP or any other severe opportunistic infection. Official Title ----------------- Evaluation of the Interaction Between Low Dose Trimethoprim/Sulfamethoxazole and Zidovudine Conditions ----------------- HIV Infections Intervention / Treatment ----------------- * Drug: Sulfamethoxazole-Trimethoprim * Drug: Zidovudine Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria Prior Medication: Allowed: Zidovudine (AZT) for patients with AIDS. AIDS related complex (ARC). The presence of any one of the following findings within 12 months prior to entry and the absence of a concurrent illness or conditions other than HIV infection to explain the findings: Fever of > 38.5 C degrees persisting for longer than 3 weeks. Involuntary weight loss of > 15 lbs. or > 10 percent of baseline noted in a 120-day period prior to evaluation. Diarrhea (> 2 liquid stools per day) persisting for longer than 1 month. History of clinical diagnosis of oral candidiasis or hairy leukoplakia. Patients who have AIDS-defining opportunistic infections or tumors. Patients eligible for AZT under the labeling. A positive HIV antibody test. Exceptions will be made for patients with a previously positive HIV antibody test with progressive disease and patients where virus isolation has been made. A life expectancy of at least 3 months. Patient with stable Kaposi's sarcoma, mild herpes infection, mild or stable depression, asymptomatic or mild cytomegalovirus or Epstein-Barr virus infection, or a hepatitis B virus carrier state will be acceptable for study. Exclusion Criteria Concurrent Medication: Excluded: Phenytoin. Prior Medication: Excluded within 30 days of study entry: Other antiretroviral agents. Patient has any severe ongoing opportunistic infections including Pneumocystis carinii pneumonia (PCP), cryptococcal or toxoplasmosis meningoencephalitis, disseminated herpes simplex or herpes zoster. Patient has significant diarrhea at entry ( > 1 watery stool per day). Patient has demonstrated prior sensitivity or has experienced significant adverse effects during prior therapy with the drugs to be used in the study. Cannot abstain from alcohol or any other drugs during the study. Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 50 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Masking: None (Open Label) Arms and Interventions \| Intervention/Treatment \| \| --- \| \|Drug: Sulfamethoxazole-Trimethoprim\|nan\| \|Drug: Zidovudine\|nan\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Drug Interactions, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Sulfamethoxazole-Trimethoprim	ctgov
Muscle Relaxation for Short Procedures Study Overview ================= Brief Summary ----------------- Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), as well as patient satisfaction for these two muscle relaxants. Official Title ----------------- Comparing Intubating Conditions and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium for Rigid Bronchoscopy: A Randomized Study Conditions ----------------- Sore Throat, Intubating Conditions, Fasciculations, Postoperative Myalgia, Patient Satisfaction Intervention / Treatment ----------------- * Drug: Succinylcholine * Drug: Rocuronium/Sugammadex * Drug: Rocuronium Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: age > 18 yr scheduled for elective rigid bronchoscopy Exclusion Criteria: known neuromuscular disease significant hepatic or renal dysfunction family history of malignant hyperthermia known allergy to one of the drugs used in this protocol pregnancy or breastfeeding Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Active Comparator: Succinylcholine<br>Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy. \| Drug: Succinylcholine<br>* Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received succinycholine according to the study group.<br>\| \| Active Comparator: Rocuronium/Sugammadex<br>Patient received rocuronium (0.25 mg/ kg) as muscle relaxant for induction of anaesthesia for rigid bronchoscopy, at the end of procedure rocuronium was reversed with sugammadex (0.5mg/kg.) \| Drug: Rocuronium/Sugammadex<br>* Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium/sugammadex according to the study group.<br>\| \| Active Comparator: Rocuronium<br>Patients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy. \| Drug: Rocuronium<br>* Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium according to the study group.<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Intubating condition \| scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing \| After induction of general anaesthesia (after 3-5 minutes) \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Fasciculations \| Fasciculations were graded by the investigator on the following four-point scale 0 = no fasciculations = mild, fine fasciculations of the eyes, neck, face or fingers, without limb movement = moderate fasciculations occurring at more than two sites, or obvious limb movement = vigorous or severe, sustained and widespread fasciculations in the trunk and limbs \| After application of the neuromuscular blocking agent (after 3-5 min) \| \| Postoperative Myalgia (POM) \| The severity of POM was measured using a four-point scale 0 = no myalgia = minor pain limited to one area of the body = muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy = generalized, severe, or incapacitating discomfort \| 72 Hours after Intervention \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- succinylcholine, rocuronium, sugammadex, Intubating Conditions, short Procedures	ctgov
Balneotherapy and Anxiety During SARS-CoV-2 Pandemic Study Overview ================= Brief Summary ----------------- Investigators will measure the level of anxiety and fear of Covid during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state. Detailed Description ----------------- Investigators will measure the level of anxiety and fear of SARS-CoV-2 virus during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state. A number of between 300 and 800 inpatients are expected to get involved in the study. They suffer from cardiovascular disease, osteoarthritis, respiratory diseases and many others. Official Title ----------------- Balneotherapy and Anxiety During SARS-CoV-2 Pandemic Conditions ----------------- D001452 Intervention / Treatment ----------------- * Behavioral: Psychological measurement Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: enrolled in balneological treatment Exclusion Criteria: not enrolled in the balneological treatment Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Health Services Research Intervention Model: Single Group Assignment Interventional Model Description: General Trust mediates the relation between the level of anxiety at the beginning of the treatment and the end of the treament. Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Other: Longitudinal Study<br>A longitudinal study of anxiety over the balneological treatment. \| Behavioral: Psychological measurement<br>* Psychological assessment<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Level of Anxiety \| Low level of anxiety \| 10 days \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- balneology, anxiety, fear of SARS-CoV-2, resilience, general trust	ctgov
Accessory Pathway Antegrade Effective Refractory Period Among WPW Patients: the Risk in Relation to the Location Study Overview ================= Brief Summary ----------------- To correlate the antegrade effective refractory period of the accessory pathway with its anatomical location in the heart. To investigate whether the accessory pathway location can predict the high risk nature of the accessory pathway Detailed Description ----------------- The Wolf-Parkinson-White (WPW) syndrome is a clinical entity characterized by the presence of ≥1 accessory pathways between the atria and the ventricles pre-disposing patients to arrhythmias. Anterograde conduction through the accessory pathway leads to preexcitation of the ventricles and a delta wave in the ECG. The prevalence of preexcitation in the general population has been estimated to be 1 to 3 in 1000 individuals. Although most asymptomatic patients with pre-excitation have a good prognosis, there is also a lifetime risk of malignant arrhythmias and SCD, estimated to be 0.1 % per patient year. More worrisome is the fact that this event can be the first manifestation of the disease in up to 53 % of patients. Atrial fibrillation (AF) can be a life-threatening arrhythmia in the WPW syndrome if the AV AP has a short anterograde refractory period (RP), allowing too many atrial impulses to be conducted to the ventricle. This will result in very high ventricular rates with possible deterioration into ventricular fibrillation (VF) and sudden death. Parameters proved to indicate high risk AP include AP effective refractory period <240 ms, shortest preexcited RR interval <250 ms Certain Locations were thought to be associated with higher risk of the accessory pathway like Septal localization which was significantly more frequent in patients with VF when compared with individuals with no VF but the overall number of patients is limited . . These debatable relations between AP location and its risk stratification was not extensively studied in larger scale studies…. Official Title ----------------- Accessory Pathway Antegrade Effective Refractory Period Among Wolff Parkinson White Patients: the Risk in Relation to the Location Conditions ----------------- Wolff-Parkinson-White Syndrome Intervention / Treatment ----------------- * Procedure: electrophysiological study Participation Criteria ================= Eligibility Criteria ----------------- Inclusion criteria: all patients with WPW admitted to Assuit university hospital and subjected to invasive EPS Exclusion criteria: heart failure cardiomyopathy Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Wolff Parkinson White patients<br>The investigators will decide the location of the AP by: - Invasively: if the patient is subjected to (EPS) • There are different locations of AP To assess whether the AP is of high risk or not, for all patients the Antegrade refractory period of the APAERP of the AP will be determined by one of the following ways: ( AERP) is measured during EPS as the shortest cycle length with one-to-one conduction over the AP by incremental atrial stimulation after which the QRS becomes narrow or no conduction occurs due to block of the impulse in the AP. The shortest pre-excited R-R interval (SPERRI) during spontaneous or induced AF. The AERP and the risk category of the AP according to its value, will be recorded in relation to the site of the AP determined in every case and compared between different accessory Locations to see whether some of these positions are more liable to be of higher risk or there is no differerence between different positions. \| Procedure: electrophysiological study<br>* To assess whether the AP is of high risk or not, for all patients the AERP of the AP will be determined by one of the following ways: The cycle length at which abrupt and complete loss of pre-excitation occurs during exercise test. If this didn't happen, the patient will be subjected to invasive electrophysiologic study.. The Antegrade refractory period of the AP is measured during EPS as the shortest cycle length with one-to-one conduction over the AP by incremental atrial stimulation after which the QRS becomes narrow or no conduction occurs due to block of the impulse in the AP. The shortest pre-excited R-R interval during spontaneous or induced AF.<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| the antegrade refractory period during invasive EPS done for the patients \| the values will be correlated to the site of the AP diagnosed be EPS.. according to the previous studies and the current guidelines, if the refractory period is < 250 ms, this is considered a high risk AP \| 2 hours \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Wolff-Parkinson-White Syndrome	ctgov
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain. Study Overview ================= Brief Summary ----------------- To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain. Official Title ----------------- A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain Conditions ----------------- Toothache Intervention / Treatment ----------------- * Drug: Naproxen Sodium ER (BAYH6689) * Drug: Placebo Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Healthy, ambulatory, male and female volunteers between 16 to 45 Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any other pain reliever (Over The Counter or prescription), or herbal supplements within 5 days of surgery Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale Exclusion Criteria: History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study Current or past history of bleeding disorder(s) History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding) Ages Eligible for Study ----------------- Minimum Age: 16 Years Maximum Age: 45 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Naproxen sodium ER (BAYH6689)<br>single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. \| Drug: Naproxen Sodium ER (BAYH6689)<br>* Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery<br>\| \| Placebo Comparator: Placebo<br>Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. \| Drug: Placebo<br>* Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Summed Pain Intensity Difference (SPID) \| Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively. \| 0 to 24 hours post dose \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Total Pain Relief (TOTPAR) \| Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. \| 0-24 hours post dose \| \| Summed Pain Intensity Difference at Specific Time Intervals \| Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively. \| 0-16 hours post dose \| \| Time to First Use of Rescue Medication \| Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication. \| postdose to first use of rescue medication \| \| Global Assessment of the Investigational Product as a Pain Reliever \| Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4). \| at 24 hours postdose or immediately before first use of rescue medication \| \| Time to Onset of Effect \| Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both perceptible and meaningful pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them. \| from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Dental Pain, Analgesia	ctgov
The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients Study Overview ================= Brief Summary ----------------- The aim of this study is to evaluate the effect of telerehabilitation-based high-intensity interval upper extremity exercise training on biochemistry parameters and disease symptoms in fibromyalgia patients. It has been reported that substances such as serotonin and tryptophan are found at abnormal levels in the serotonergic system in patients with fibromyalgia, and symptoms such as depression, pain, and fatigue related to the disease may be associated with this condition. In the literature, there are studies conducted in other disease groups showing that aerobic exercise regulates tryptophan and serotonin levels and can produce positive results regarding these symptoms. This study was planned to evaluate the effect of high-intensity interval exercise training, which is an aerobic exercise form, whose benefits are frequently mentioned in recent publications, on both blood parameters and symptoms in fibromyalgia patients. Detailed Description ----------------- Fibromyalgia is a chronic musculoskeletal disease of unknown etiology accompanied by symptoms such as pain, hyperalgesia, sleep disorders, fatigue and mood disorders. It has been suggested that a defect in the serotonergic system is involved in the pathophysiology of the disease. The serotonergic system has been associated with many symptoms such as anxiety, depression, sleep problems, fatigue and pain. In studies on fibromyalgia, it was reported that plasma tryptophan and serotonin levels decreased in this patient group and that serotonin levels were abnormal in the endogenous pain blocking pathways. Although conflicting results have been reported, it was stated that vitamin D levels were also low in this patient group. Aerobic exercise makes muscles use branched-chain amino acids, reducing the amount of amino acids that compete with tryptophan and increasing the chance of tryptophan to cross the blood-brain barrier. Therefore, it has the potential to increase serotonin in the brain. In particular, aerobic exercise appears to modulate hormone, neurotrophin and neurotransmitter levels, depending on factors such as genes, age and hormonal status. On the other hand, it is reported that some types of exercise increase the production of free radicals and cause oxidative stress. It has been suggested that oxidative stress may be associated with pain, which is one of the main symptoms in fibromyalgia patients by affecting nociceptors. Studies have shown that when aerobic exercises are applied regularly for a long time, lipid peroxidation level, which is an indicator of oxidative stress, decreases and antioxidant enzyme activity increases. Regularly applied aerobic exercise programs have been reported as a suitable form of exercise for this patient group. Recent studies have focused on high-intensity interval training. This type of exercise; It is performed as successive short and intermittent sessions of high-intensity activity with periods of low intensity or rest. High-intensity interval training are shorter than moderate aerobic workouts and produce the same or more positive effects than moderate exercise. It is also reported that high-intensity interval training application improves oxidative capacity, antioxidant defense and endothelial functions. Telerehabilitation practices refer to the use of telematics procedures using telephone, video and computer technologies instead of traditional face-to-face approaches. The therapist ensures that patient communication and follow-up are maintained by maintaining social distance. It has been stated in studies that telerehabilitation can be used to increase the quality of life, to provide socialization and to treat pain in patients with fibromyalgia. This study was designed to evaluate the effectiveness of high-intensity interval training upper extremity exercise training, which is a form of aerobic exercise, on these parameters, associated symptoms and oxidative stress markers in fibromyalgia patients with negative effects on serotonin, tryptophan, vitamin D and related parameters. Official Title ----------------- Effect Of High Intensity Interval Upper Extremity Training On Biochemistry Parameters And Disease Symptoms In Patients With Fibromyalgia Conditions ----------------- Fibromyalgia Intervention / Treatment ----------------- * Other: High Intensity Interval Training * Other: Moderate Exercise Training Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Participants diagnosed with fibromyalgia according to the American College of Rheumatology 2016 criteria. Participants between the ages of 18-65 Participants who do not use a drug that will affect the treatment results Participants who volunteer Exclusion Criteria: Infection Fever Any known advanced-stage pathology associated with the locomotor system that contraindicates physical activity. Cardiopulmonary problem Presence of autoimmune disease Pregnancy Malignancy Severe psychiatric problem Neurological disorder Epilepsy Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 65 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: High Intensity Interval Training<br>With the arm ergometer given to the participants, a telerehabilitation-based upper extremity aerobic exercise program will be applied. Maximum Heart Rate (MHR) will be determined by the formula '220-age', and exercise intensity will be calculated, and exercise will begin with a 5 minute warm-up. Cycle will be created with 4 min MHR (80-95%) high intensity and 3 min MHR (70%) active recovery and exercise will be terminated with 5 min cool down. A total of 35 minutes of exercise program will be given. \| Other: High Intensity Interval Training<br>* Telerehabilitation-based high-intensity exercise training will be applied to the participants for 6 weeks, 3 times a week for 35 minutes, under the control of a physiotherapist.<br>\| \| Active Comparator: Moderate Exercise Training<br>An upper extremity exercise program with telerehabilitation (Zoom/videoconference) will be applied to the moderate-intensity exercise group. Maximum heart rate (MHR) will be determined by the formula 220-Age. A total of 55 minutes of moderate exercise training will be given at 65-70% of MHR, with five minutes of warm-up and cool-down. \| Other: Moderate Exercise Training<br>* The participants will be given telerehabilitation-based moderate exercise training under the control of a physiotherapist for 55 minutes, 3 times a week for 6 weeks.<br>\| \| No Intervention: Control<br>No aerobic exercise program will be applied to this group. \| \| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Assessment of serum free tryptophan \| Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen.The analysis will be completed by following the manufacturer's instructions of the appropriate kits. \| 6 weeks \| \| Assessment of 5-Hydroxyindolacetic Acid \| Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen.The analysis will be completed by following the manufacturer's instructions of the appropriate kits. \| 6 weeks \| \| Assessment of Superoxide dismutase \| Superoxide dismutase is the most important enzymatic antioxidants that prevent the initiation of lipid peroxidation. Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits. \| 6 weeks \| \| Assessment of Glutathione Peroxidase \| Glutathione Peroxidase is the most important enzymatic antioxidants that prevent the initiation of lipid peroxidation. Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits. \| 6 weeks \| \| Assessment of Malondialdehyde \| Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits. \| 6 weeks \| \| Assessment of Myeloperoxidase \| Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits. \| 6 weeks \| \| Assessment of 25-hydroxy vitamin D \| Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits. \| 6 weeks \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Pressure Pain Threshold Assessment \| Pressure pain threshold assessment will be done with an algometer. \| 6 weeks \| \| Evaluation of Grip Strength \| Grip strength will be evaluated with a dynamometer (Hydraulic hand dynamometer). \| 6 weeks \| \| Evaluation of Fatigue \| Fatigue will be evaluated with Fatigue Severity Scale. Each item of the scale, which consists of 9 items that patients can apply on their own, is scored between 1 and 7 (1 = strongly disagree, 7 = completely agree) and the total score is calculated by taking the average of 9 items. The lower the total score, the less fatigue. \| 6 weeks \| \| Evaluation of Depression and Anxiety \| Depression and anxiety will be evaluated with Hospital Anxiety and Depression Scale. Each item of the 14-item scale is scored between 0 and 3. For anxiety and depression values, 0-7 points are considered normal, 8-10 points are borderline, and 11 points and above are considered abnormal. \| 6 weeks \| \| Evaluation of Quality of Sleep \| Quality of Sleep will be evaluated with Pittsburgh Sleep Quality Index. The total score is between 0-21. A high total score indicates poor sleep quality. \| 6 weeks \| \| Evaluation of Functional Status Assessment \| Functional Status Assessment will be evaluated with The Revised Fibromyalgia Impact Questionnaire. A high score indicates that the disease affects the person more. \| 6 weeks \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- fibromyalgia, high intensity interval training, telerehabilitation, tryptophan	ctgov
The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma Study Overview ================= Brief Summary ----------------- This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome. Detailed Description ----------------- It has been reported that HBV replication can be reacted after chemotherapy or immunotherapy, which will lead to exacerbation of chronic hepatitis B (ECHB). It is still unknown that if percutaneous radiofrequency ablation or liver resection for hepatocellular carcinoma (HCC) will react the replication of HBV or not. This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome. Official Title ----------------- The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma Conditions ----------------- Hepatitis B, Hepatocellular Carcinoma Intervention / Treatment ----------------- * Procedure: radiofrequency ablation Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Age 18 - 75 years HBV carrier with HCC After percutaneous radiofrequency ablation; No history of encephalopathy, ascites refractory to diuretics or variceal bleeding No HCV or HIV co-infection No previous treatment of HCC No previous treatment of HBV except Lamivudine Exclusion Criteria: Patient compliance is poor Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) Known history of human immunodeficiency virus (HIV) infection Known Central Nervous System tumors including metastatic brain disease Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry Distantly extrahepatic metastasis History of organ allograft Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Excluded therapies and medications, previous and concomitant Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization Prior use of systemic investigational agents for HCC Autologous bone marrow transplant or stem cell rescue within four months of start of study drug Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 75 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| 1<br>patient with hepatocellular carcinoma after radiofrequency ablation \| Procedure: radiofrequency ablation<br>* radiofrequency ablation for HCC<br>* Other names: RFA;\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| The Rate of Exacerbation of chronic hepatitis B after RFA \| \| one week, one month, one year \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| survival \| \| 1, 3, 5-year \| \| mortality \| \| one month \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- hepatitis B, hepatocellular carcinoma, radiofrequency ablation, reactivation	ctgov
A Study in Healthy Men to Test How BI 456906 is Processed in the Body Study Overview ================= Brief Summary ----------------- This trial is intended to examine the basic pharmacokinetics of BI 456906 and total [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (SC) dose of BI 456906 (C-14) in (otherwise) healthy male volunteers with normal body weight, overweight or obesity. Official Title ----------------- A Phase I, Open-label, Single-dose, Single-arm Trial to Investigate Metabolism and Pharmacokinetics of BI 456906 (C-14) Administered Subcutaneously to (Otherwise) Healthy Male Volunteers With Normal Body Weight, Overweight or Obesity Conditions ----------------- Healthy Intervention / Treatment ----------------- * Drug: BI 456906 (C-14) Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Healthy male subjects with normal Body mass index (BMI) or otherwise healthy male subjects with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests Age of 18 to 65 years (inclusive) BMI of 23.0 to 34.9 kg/m2 (inclusive); body weight of at least 70 kg. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Exclusion Criteria: Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease assessed as clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply. Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 65 Years Sexes Eligible for Study ----------------- Male Accepts Healthy Volunteers ----------------- Accepts Healthy Volunteers Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Intervention Model: Single Group Assignment Masking: None (Open Label) Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: BI 456906 (C-14)<br> \| Drug: BI 456906 (C-14)<br>* BI 456906 (C-14)<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_urine, 0-tz) \| \| up to 7 weeks \| \| Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_faeces, 0-tz) \| \| up to 7 weeks \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Maximum measured concentration of the analyte (Cmax) \| \| up to 22 days \| \| Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point (AUC0-tz) \| \| up to 22 days \|	ctgov
Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study) Study Overview ================= Brief Summary ----------------- Heart failure is a disorder in which the heart does not pump blood adequately. This can lead to several serious problems, including reduced blood flow throughout the body, congestion of blood in the veins and lungs, and fluid accumulation in various organs and limbs. Diuretics are often used to address the problem of fluid accumulation, but the optimal dose and the amount of time over which to administer each dose are unclear. This study will compare high and low doses of diuretics administered over longer and shorter periods of time to determine the safest and most effective combination. Detailed Description ----------------- Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Heart failure symptoms include shortness of breath, swelling, and fatigue. Standard treatment for the swelling associated with heart failure includes the use of diuretic medications, such as furosemide, which cause urination and the removal of excess fluids in the body. Although furosemide has been used to treat heart failure patients for many years, it is still unclear how much of the drug to use, and over what time period the drug should be given. This study will evaluate whether furosemide treatment is safer and more effective when the drug is given in high doses versus low doses and in two to three separate doses versus one continuous infusion. Participants in this study will begin study procedures within the first 24 hours of their hospital admission for heart failure. Participants will be randomly assigned to receive one of the following four treatments: high dose furosemide via continuous intravenous (IV) infusion and placebo every 12 hours via IV bolus; low dose furosemide via continuous IV infusion and placebo every 12 hours via IV bolus; high dose furosemide every 12 hours via IV bolus and placebo via continuous IV infusion; and low dose furosemide every 12 hours via IV bolus and placebo via continuous IV infusion. Each participant will receive treatment for the first 72 hours of his or her hospital stay. Participants will answer questionnaires and undergo physical examinations and blood tests during the first 96 hours of hospitalization and again before hospital discharge or on Day 7, if that occurs first. Participants will be asked to return to their doctors 60 days following hospital discharge to evaluate their responses to treatment. Official Title ----------------- Diuretic Optimal Strategy Evaluation in Acute Heart Failure (The DOSE-AHF Study) Conditions ----------------- Heart Failure Intervention / Treatment ----------------- * Drug: Furosemide-Q12 hour bolus * Drug: Furosemide-Continuous Infusion * Drug: Furosemide-Low Intensification * Drug: Furosemide-High Intensification Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Prior clinical diagnosis of heart failure that was treated with daily oral loop diuretics for at least 1 month Current diagnosis of heart failure, as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) Daily oral dose of furosemide between 80 mg and 240 mg (or equivalent) Identified within 24 hours of hospital admission Current treatment plan includes IV loop diuretics for at least 48 hours Exclusion Criteria: Brain natriuretic peptide (BNP) less than 250 mg/mL or N-terminal prohormone brain natriuretic peptide (NT-proBNP) less than 1000 mg/mL Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for heart failure Substantial diuretic response to pre-randomization diuretic dosing such that higher doses of diuretics would be medically inadvisable Systolic blood pressure less than 90 mm Hg Serum creatinine level greater than 3.0 mg/dL at baseline or currently undergoing renal replacement therapy Hemodynamically significant arrhythmias Acute coronary syndrome within 4 weeks prior to study entry Active myocarditis Hypertrophic obstructive cardiomyopathy Severe stenotic valvular disease Restrictive or constrictive cardiomyopathy Complex congenital heart disease Constrictive pericarditis Non-cardiac pulmonary edema Clinical evidence of digoxin toxicity Need for mechanical hemodynamic support Sepsis Terminal illness (other than heart failure) with expected survival time of less than 1 year History of adverse reaction to the study drugs Use of IV iodinated radiocontrast material within 72 hours prior to study entry or planned during hospitalization Enrollment or planned enrollment in another randomized clinical trial during this hospitalization Inability to comply with planned study procedures Ages Eligible for Study ----------------- Minimum Age: 18 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Factorial Assignment Masking: Triple Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: Q12 hour bolus<br>Furosemide-Q12 hour bolus \| Drug: Furosemide-Low Intensification<br>* 1x oral dose<br>* Other names: Loop diuretic;Drug: Furosemide-High Intensification<br>* 2.5x oral dose<br>* Other names: loop diuretic;\| \| Experimental: Continuous Infusion<br>Furosemide-Continuous Infusion \| Drug: Furosemide-Low Intensification<br>* 1x oral dose<br>* Other names: Loop diuretic;Drug: Furosemide-High Intensification<br>* 2.5x oral dose<br>* Other names: loop diuretic;\| \| Experimental: Low Intensification<br>Furosemide-Low Intensification \| Drug: Furosemide-Q12 hour bolus<br>* Q12 hours bolus<br>* Other names: Loop diuretics;Drug: Furosemide-Continuous Infusion<br>* Continuous infusion<br>* Other names: Loop diuretic;\| \| Experimental: High Intensification<br>Furosemide-High Intensification \| Drug: Furosemide-Q12 hour bolus<br>* Q12 hours bolus<br>* Other names: Loop diuretics;Drug: Furosemide-Continuous Infusion<br>* Continuous infusion<br>* Other names: Loop diuretic;\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Patient Well Being, as Determined by a Visual Analog Scale \| Global Visual Analog Scale Scale Range 0-7200; higher score is better \| Measured at 72 hours \| \| Change in Serum Creatinine \| \| Measured at baseline and 72 hours \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Change in Weight \| \| baseline and 96 hours \| \| Proportion of Patients Free of Congestion \| \| Measured at 72 hours \| \| Dyspnea, as Determined by Visual Analog Scales \| Global Visual Analog Scale Scale Range 0-2400; higher score is better \| Measured at 24 hours \| \| Change in Serum Creatinine \| \| baseline and 24 hours \| \| Change in Cystatin C \| \| baseline and 72 hours \| \| Change in Serum Creatinine \| \| baseline and 48 hours \| \| Change in Serum Creatinine \| \| baseline and 96 hours \| \| Change in Serum Creatinine \| \| baseline and day 7 \| \| Change in Serum Creatinine \| \| baseline and day 60 \| \| Patient Well Being, as Determined by a Visual Analog Scale \| Global Visual Analog Scale Scale Range 0-2400; higher score is better \| Measured at 24 hours \| \| Patient Well Being, as Determined by a Visual Analog Scale \| Global Visual Analog Scale Scale Range 0-4800; higher score is better \| 48 hours \| \| Dyspnea VAS \| Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better \| 48 hours \| \| Dyspnea VAS \| Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better \| 72 hours \| \| Change in Cystatin C \| \| baseline and day 7 \| \| Change in Cystatin C \| \| baseline and day 60 \| \| Change in Uric Acid \| \| baseline and 72 hours \| \| Change in Uric Acid \| \| baseline and day 7 \| \| Change in Uric Acid \| \| baseline and Day 60 \| \| Change in B-type Natriuretic Peptide \| Change in NTproBNP \| baseline and 72 hours \| \| Change in NTproBNP \| \| baseline and Day 7 \| \| Change in NTproBNP \| \| baseline and Day 60 \| \| Presence of Cardiorenal Syndrome \| \| Within 72 hours \| \| Treatment Failure \| Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization \| Within 72 hours \| \| Net Fluid Loss \| \| Through 24 hours \| \| Net Fluid Loss \| \| Through 48 hours \| \| Net Fluid Loss \| \| Through 72 hours \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- Loop Diuretics, Furosemide, Fluid Overload, Cardio Renal Failure	ctgov
Surgical Therapy and Survival in HCC/ C.F. Zhang et al. Study Overview ================= Brief Summary ----------------- This study utilizes a new method to explore compare the overall survival (OS) and cancer-specific survival (CSS) in patients aged 18-45 years with stage I-II HCC who underwent different types of surgery. The SEER database, which is one of the most comprehensive and authoritative databases concerning cancer, was used to estimate the survival benefit of patients who underwent local tumor destruction (LTD), wedge or segmental resection (WSR), lobectomy resection (LR), liver transplantation (LT), or non-surgery. This study discovered surgery offered a survival benefit compared with non-surgery for young patients with stage I-II HCC. Furtherly, LT is associated with superior survival than WSR, LR and LTD in those patients. Our results facilitate the selection of surgical strategies. Detailed Description ----------------- The SEER data contain no identifiers and are publicly available for studies of cancer-based epidemiology and survival analysis. Therefore, the current study was deemed to be exempt from Institutional Review Board approval and the need for informed consent was waived. The submitted magazine requires registration on the website, so this operation is needed. Official Title ----------------- Surgical Therapy and Survival in Young Patients With Stage I-II Hepatocellular Carcinoma: A Retrospective Cohort Study Conditions ----------------- Hepatocellular Carcinoma, Surgery Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Patients were diagnosed with colorectal cancer only; Patients with simultaneous metastasis of liver and lung cancer cells; Patients without metastasis resection; whether they underwent palliative primary tumor resection was known; Their cause of death was known; Their survival time were known and greater than 0 month; Patients were diagnosed with microscopic confirmation. Exclusion Criteria: No Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 45 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Overall survival \| Overall survival was defined as the duration between the surgery and death or the last follow-up \| 2004.1.1-2013.12.31 \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Cancer-specific survival \| Cancer-specific survival was defined as the period between the surgery and death due to cancer to reduce the impact of life-threatening comorbidities. \| 2004.1.1-2013.12.31 \|	ctgov
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) Study Overview ================= Brief Summary ----------------- This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control. Official Title ----------------- A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis Conditions ----------------- Perennial Allergic Rhinitis Intervention / Treatment ----------------- * Drug: montelukast sodium * Drug: Comparator: cetirizine * Drug: Comparator: placebo Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Patient has a documented clinical history of perennial allergic rhinitis Patient is a nonsmoker Patient is in good general health Exclusion Criteria: Patient is hospitalized Patient is a woman who is <8 weeks postpartum or is breast-feeding Patient is a current or past abuser of alcohol or illicit drugs Ages Eligible for Study ----------------- Minimum Age: 15 Years Maximum Age: 85 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Design Details Primary Purpose: Treatment Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Experimental: 1<br>montelukast \| Drug: montelukast sodium<br>* montelukast 10 mg tablet orally once daily at bedtime for 6 weeks<br>\| \| Active Comparator: 2<br>cetirizine \| Drug: Comparator: cetirizine<br>* cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks<br>\| \| Placebo Comparator: 3<br>placebo \| Drug: Comparator: placebo<br>* placebo tablet orally once daily at bedtime for 6 weeks<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Mean Change From Baseline in Daytime Nasal Symptoms Score \| Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. \| Baseline and first 4 weeks of a 6-week treatment period \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Mean Change From Baseline in Nighttime Symptoms Score \| Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. \| Baseline and first 4 weeks in 6-week treatment period \| \| Mean Change From Baseline in Composite Symptoms Score \| Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)]. \| Baseline and first 4 weeks in 6-week treatment period \| \| Patient's Global Evaluation of Allergic Rhinitis \| An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. \| End of the first 4 weeks in 6-week treatment period \| \| Physician's Global Evaluation of Allergic Rhinitis \| An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. \| End of the first 4 weeks in 6-week treatment period \|	ctgov
Behavioral Pharmacology Associated With Cigar Smoking Study Overview ================= Brief Summary ----------------- Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This study will be evaluating the behaviors of cigar smokers and the short term effects of cigar smoking. A cigar is defined as a cylinder of tobacco wrapped in a tobacco leaf for smoking. There are small cigars with filters that resemble cigarettes and large cigars that do not have filters. Because cigars come in so many shapes and sizes, the nicotine content varies as well. The way that a cigar smoker consumes the cigar can also have an effect on how much nicotine is absorbed. This study seeks to understand nicotine consumption and addiction in cigar smokers. Study participation will last 1 to 4 weeks and will include 2 study-related visits. Your visits may include a physical exam, medical history review, questionnaires, blood collections, providing a urine sample, an exhaled breath test, having your vital signs collected and smoking a cigar. You will be videotaped while you smoke your cigar so that we can review the technique you use while smoking. STUDY HYPOTHESES: Significant reductions in craving and withdrawal will be reported after ad libitum smoking of a cigar compared to self-report prior to cigar smoking. Cigar smokers will show a range of nicotine dependence, with a subset of users exceeding minimal criteria for nicotine dependence. Levels of nicotine, cotinine, Carbon Monoxide (CO), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) will increase significantly from pre- to post-cigar smoking. Small cigar/cigarillo users will demonstrate greater levels of dependence and greater relief from craving and withdrawal compared to large cigar users. Detailed Description ----------------- This study seeks to better understand dependence behaviors in small and large cigar smokers. All recruited cigar smokers will be self-defined as users on ≥ 1 day(s) per week for the past 6 months. They will not be currently using any other type of tobacco product for the past 6 months. Study subjects will smoke their own type and brand of cigar upon at least 24 hours of abstinence from all tobacco products. Dependence (both real and perceived), withdrawal relief, and craving will be measured with existing and modified behavioral scales and assessments. In addition, smoking topography (including latency to first puff, puff number, interpuff interval, and smoking duration), self-reported inhalation behaviors, and exhaled CO will also be measured. This is a single center, un-blinded study seeking to better understand dependence behaviors in small and large cigar smokers. Subjects will be videotaped while smoking their cigar using a digital camcorder, and the video will immediately be burned to DVD for subsequent smoking topography scoring by two separate raters. These raters will directly observe the subject during the cigar smoking exposure. Urine samples and serial blood samples will be collected to measure biomarkers of exposure (including nicotine, cotinine, and total NNAL) before, during, and after subjects' smoking of their usual type and brand of cigar. A urine creatinine lab test will be collected pre and post exposure to correct for excreted cotinine levels. Subjects will be instructed to empty their bladders pre cigar exposure. They will then be instructed to rehydrate based on their BMI prior to the initiation of cigar smoke exposure and after 60 minutes post cigar initiation. Hepatic and renal function will be assessed at screening to determine any metabolism problems. Subjects will be asked to bring two (2) cigars of their usual type and brand. One cigar will be used to smoke; the 2nd cigar will be used to measure total nicotine content. The cigars will be stored at ambient temperature (59º - 86º F), away from light and moisture, until analysis. Nicotine concentrations will be determined from the 2nd cigar using an analytical approach developed by Lovelace Biomedical Environmental Research Institute (LBERI). Briefly, the cigar weight will be recorded, cigar broken apart, and mixed using a mortar and pestle to create a homogenous mixture of the entire cigar. 100 mg of the cigar mixture will be weighted and nicotine extracted from the tobacco using 1mL of 50/50 dichloromethane:dichloroethane repeated twice. The extract will be evaporated and re-dissolved in 1 mL of methanol for liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis. Plasma concentrations for nicotine and cotinine will be determined using LC-MS/MS and values exported to Phoenix WinNonlin for pharmacokinetic analysis. Plasma Tmax and Cmax will be reported using a table in a word document and in figures generated using WinNonlin. The amount of cotinine and total NNAL excreted will be reported by determining the urinary concentration of each compound by LC-MS/MS analysis and multiplying the determined concentration by the total volume of urine recovered. Individual data along with grouped results will be reported. The pharmacokinetic data will be provided to the sponsor after uploading to SAS. The subjects will be cigar smokers who are not seeking treatment for smoking cessation and who are not currently using any other type of tobacco, but may be former users. They must agree to abstain from smoking for at least 24 hours prior to the exposure day and will be informed that they must remain abstinent from all forms of tobacco including nicotine patches, gum, etc. Abstinence will be verified at the beginning of the test day through expired CO and self-report. While it could be desirable to use urinary cotinine levels as a further marker of abstinence, urinary cotinine levels do not appear to reach undetectable levels in smokers after 24 hours. Instead, in regular smokers, negligent levels are reached only after abstinence of 7-8 days, which would place significant burden on subjects for this study. All subjects should be healthy males and females, 18 years of age or older, with no self-reported psychiatric illnesses that would interfere with the subjects ability to complete the session (i.e. schizophrenia, severe depression). Women who are pregnant (as verified by a urine pregnancy test at Visit 1 and 2) or breastfeeding will be excluded. Subjects will be asked questions concerning the type and quantity of prescribed and non-prescribed drugs that they are currently using. If, as a result of the screening, the subject is determined to be ineligible to continue participation in the study, he/she will be excused from further participation. A target of sixty four (64) completed subjects will be recruited to ensure sufficient statistical power to test main effects across the following groups: Primary vs. secondary cigar users Self-reported inhaling behavior vs. self-reported non-inhaling behavior Small cigar (including cigarillos) vs. large cigar (including premium) users White vs. non-white adults Male vs. Female adults A power analysis was conducted to determine the overall sample size needed to test the main effects above. According to this power analysis (see below), the study will require 64 subjects assuming a balanced design across each of the above factors (i.e. subjects are stratified across the 5 factors for a total of 32 groups). However, given the potential difficulty in filling each group of the above design, we may recruit up to 50% more subjects (i.e. 96), which will ensure that each of the above groups are sufficiently represented in the final sample. Finally, assuming a 10% dropout rate, an additional 10 subjects may be enrolled for a total sample size of 106. Subjects will be monitored for adverse events (AEs) throughout the study. Official Title ----------------- Behavioral Pharmacology Associated With Cigar Smoking Conditions ----------------- Cigar Smoking Intervention / Treatment ----------------- * Other: Smoking topography Participation Criteria ================= Eligibility Criteria ----------------- Inclusion Criteria: Willing to voluntarily sign the IRB approved informed consent form (ICF) Willing to complete all the requirements of the study Male or Female, ≥ 18 years of age Female subjects must be either: Surgically sterile defined as having had a hysterectomy, bilateral oophorectomy, or tubal ligation, amenorrheic for at least two years prior to screening visit, or otherwise incapable of becoming pregnant Or Willing to practice an effective method of birth control if sexually active, taking hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy. A double barrier method such as condoms, diaphragms, or cervical caps with spermicidal foam, cream, or gel, or abstinence may be used as a method of birth control Must be either a primary cigar or a secondary cigar smoker. Must have a self-reported history of using cigars on ≥1 day per week for the past 6 months Primary cigar users must report no significant prior use of cigarettes (< 100 cigarettes in lifetime and no use of cigarettes in the past 6 months) Secondary cigar users must self-report regular use of cigarettes in the past before making the switch to cigars, and must report no use of cigarettes in the past 6 months Must be able to self-report inhaling behavior as either inhaler or non-inhaler Must be able to identify primary type of cigars smoked as either small cigar (including cigarillos), large cigars, or premium cigars English-speaking volunteers who are not seeking treatment for smoking cessation at the time of the study Have an exhaled carbon monoxide (CO) level of <10 ppm at visit 2 Demonstrate no clinically significant contraindications for study participation, in the judgment of the Principal Investigator Exclusion Criteria: Women of Child Bearing Potential (WOCBP) with a positive urine human chorionic gonadotropin (Urine β- hCG) pregnancy test within 10 days prior to Visit 2 Pregnant and/or nursing females Use of any other type tobacco product (except cigars), non-tobacco nicotine-containing product(s), smoking cessation medications, such as varenicline (Chantix®) and bupropion (Zyban®), or NRT (Nicotine Replacement Therapy) within 60 days of study enrollment Have any previous self-reported medical adverse reaction to nicotine or tobacco, (for example nausea, headache and chest pain) Subjects who self-report a clinically significant concomitant disease or illness at either screening or visit 2, including but not limited to depression, schizophrenia, uncontrolled respiratory or cardiovascular disease, which in the opinion of the Principal Investigator or designee would preclude safe and /or successful completion of this study Subject demonstrates an elevated liver function of ≥ 2 times the upper limit of normal at screening Subject demonstrates an elevated renal function of ≥ 2 times the upper limit of normal at screening Subject intends to stop smoking cigars in the next month Unwilling to abstain from cigar smoking and all tobacco and nicotine use for at least 24 hours prior to exposure, Visit 2 Ages Eligible for Study ----------------- Minimum Age: 18 Years Maximum Age: 99 Years Sexes Eligible for Study ----------------- All Accepts Healthy Volunteers ----------------- No Study Plan ================= How is the study designed? ----------------- Arms and Interventions \| Participant Group/Arm \| Intervention/Treatment \| \| --- \| --- \| \| Behavioral<br>Evaluation of cigar smoking topography \| Other: Smoking topography<br>* Evaluation of cigar smoking topography<br>\| What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Assess Beharioral/Self-Reported Aspects of Cigar Smoking \| Characterize and quantify dependence, withdrawal relief, cravings, puff topography \| 4 weeks \| Secondary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \| \| Evaluate smoking exposure \| Identifying smoking puff topography and laboratory markers of exposure (nicotine, NNAL, breath CO, and cotinine). \| 4 weeks \| Terms related to the study ================= Keywords Provided by Centre Hospitalier Valida ----------------- cigar smoker, smoking, behavioral pharmacology, smoking topography	ctgov
[Trial of device that is not approved or cleared by the U.S. FDA] Study Overview ================= Official Title ----------------- [Trial of device that is not approved or cleared by the U.S. FDA] Participation Criteria ================= Ages Eligible for Study ----------------- Minimum Age: Maximum Age: Study Plan ================= How is the study designed? ----------------- What is the study measuring? ----------------- Primary Outcome Measures \| Outcome Measure \| Measure Description \| Time Frame \| \| --- \| --- \| --- \|	ctgov

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TrialAlign

🤗 [Panacea Model] • 💻 [Github Repo] • 📃 [Panacea Paper]

TrialAlign datasets are the continual pretraining corpus for "Panacea: A foundation model for clinical trial search, summarization, design, and recruitment". TrialAlign contains 793,279 clinical trial design documents worldwide and 1,113,207 clinical study papers.

Statistics of TrialAlign

Source	Counts
ClinicalTrials.gov	432,676
ChiCTR (China)	65,181
EUCTR (EU)	43,315
JRCT (Japan)	60,645
ANZCTR (Australia/New Zealand)	23,374
ISRCTN.org	22,966
ReBEC (Brazil)	5,889
CRIS (Korea)	8,428
DRKS (Germany)	13,789
IRCT (Iran)	34,097
TCTR (Thailand)	7,443
LTR (Netherlands)	9,768
PACTR (Africa)	3,848
SLCTR (Sri Lanka)	421
Trial Papers (Embase + PubMed)	1,113,207

Citation

If you find our work useful, please consider citing Panacea:

@article{lin2024panacea,
  title={Panacea: A foundation model for clinical trial search, summarization, design, and recruitment},
  author={Lin, Jiacheng and Xu, Hanwen and Wang, Zifeng and Wang, Sheng and Sun, Jimeng},
  journal={arXiv preprint arXiv:2407.11007},
  year={2024}
}

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939,130

Estimated number of rows:

1,718,124