TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
Brief Summary: People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.


Options:
A: Diabetes Incidence (Baseline through end of follow-up (mean follow-up time = 3 years))
B: The primary outcome being measured is the level of activity monitored by the activity monitor. Control and Intervention subjects will be encouraged to wear the activity monitor on a daily basis for the 12 week course of the study. (12 weeks)
C: Number of at risk participants developing GDM during pregnancy
D: Changes in anthropometry (BMI, waist and hip cf) (3 years); Maximal oxygen uptake (VO2max) (3 years); Health-related quality of life (EQ 5D, SF-36) (3 years); Self-reported physical activity (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
Brief Summary: People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.


Options:
A: Incident diabetes mellitus (Up to 5 years)
B: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
C: Diabetes Incidence (Baseline through end of follow-up (mean follow-up time = 3 years))
D: 2-hour glucose levels; insulin resistance

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RiaSTAP vs. Conventional Transfusion for Patients Undergoing Valve Replacement Surgery: RiaCT
Brief Summary: Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The objective of this trial is to demonstrate the clinical equivalency and economic utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in patients in lieu of platelet transfusion.

Purified fibrinogen concentrate has been approved by FDA, and it has been used for the treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated with volume overload, bacterial/viral infection, immunological effects and excess blood clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare. Although platelet transfusion is widely used after heart surgery, there has been no randomized study to endorse this practice. In this study, patients undergoing heart valve replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if there is evidence of significant microvascular bleeding. Fifteen minutes after the initial treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be treated with blood transfusion per institutional standard of care.

The primary endpoints for this study are the hemostatic condition of the surgical field and 24-hour total of blood product transfusion.


Options:
A: Proportion of patients submitted to blood components transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterization (Day of randomization)
B: Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures (Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26)
C: Point Of Care (POC) Transfusion Algorithm Cardiac Study (2.5 years)
D: Bleeding Scores (intra-operatively and up to 24 hours postoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy
Brief Summary: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy and has serious health implications for both the pregnant woman and her child. In particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes and metabolic syndrome, perpetuating serious health consequences in subsequent generations.

Although regular exercise offers numerous benefits for both the mother and her child, its effectiveness in preventing GDM remains to be established. It has been recently shown that regular supervised home-based exercise may attenuate the decline in glucose tolerance in obese pregnant women. This study aims to conduct a single-centred, multi-sited, single-blinded randomised controlled trial examining the effect of 14 weeks of supervised home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM, along with other aspects of maternal and fetal wellbeing.

Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n = 100) or a control group (n = 100). The exercise intervention will involve three 60-minute home-based, supervised exercise sessions each week. This type of program overcomes many of the barriers to exercise in this population including transportation, child care issues and embarrassment associated with exercising in a public venue. The investigators have already shown this program to be both feasible and warmly accepted by obese pregnant women.


Options:
A: Change from Baseline in oral glucose tolerance test at variable time frames (1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28; 4) 6 weeks and 12 months post partum)
B: Infant growth (Growth from birth to anthrometry at 12mo)
C: Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development. (Participants will be followed for the duration of the study, an expected average of 6 years); Long-term evidence of early human programming of obesity measured by genetic biomarkers, and the offspring growth and development. (Participants will be followed for the duration of the study, an expected average of 6 years); Long-term evidence of early human programming of obesity measured biochemical perinatal biomarkers, and the offspring growth and development. (Participants will be followed for the duration of the study, an expected average of 6 years)
D: Diagnosis of gestational diabetes mellitus (After the 14 week intervention period (28 weeks gestation))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis
Brief Summary: This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.


Options:
A: Fold Change From Baseline in Fecal Calprotectin at Week 14 (Baseline, Week 14)
B: Clinical and Endoscopic Remission. (8 weeks)
C: Proportion of subjects who were relapse free after 6 months of treatment. (6 months)
D: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) (Week 12 (Day IP-85)); Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 (Month 12 (Day MP-365)); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation (Day OL-1 through the end of the OL); OL; Number of Participants With AEs of Special Interest (Day OL-1 through Day OL-729); OL; Number of Participants With Physical Examination Findings (Day OL-1 through Day OL-729); OL; Number of Participants With Marked Hematology Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities (Day OL-1 through Day OL-729)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Open Label, Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Settings
Brief Summary: The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa.

Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the government is continuing to study the PrePex™ device, developed to enable rapid adult male circumcision in resource limited settings.

The study will enroll one hundred and fifty (150) persons scheduled for voluntary circumcision. The subjects will be randomly divided into two unbalanced study arms, PrePex™ arm which will include about a hundred and twenty (100) subjects and surgical circumcision arm which will include about sixty (50) subjects.

Study duration per subject will be 9 weeks.


Options:
A: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing (Up to 30 minutes)
B: The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. (9 weeks)
C: HIV incidence (2 years); surgical complications (2 years)
D: Procedure time (9 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
Brief Summary: This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.


Options:
A: Quality of Life (0-100 Point) (6 weeks)
B: UTIs (Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).)
C: Mean Residual Urine Volume (3 catheterisations on 1 day)
D: Percentage of Participants (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Moderate Dose Hydrocortisone in Treatment of Severe Sepsis and Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome: A Randomized Controlled Trial
Brief Summary: Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.


Options:
A: Duration of mechanical ventilation (0-28 days)
B: Length of stay in ICU and length of stay in the hospital. (2 years)
C: All cause mortality (28 days)
D: All cause mortality at 90 days after randomisation (90 days after randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Moderate Dose Hydrocortisone in Treatment of Severe Sepsis and Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome: A Randomized Controlled Trial
Brief Summary: Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.


Options:
A: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
B: Hospital Mortality to Day 60. (60 days after randomization)
C: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)
D: All cause mortality (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
Brief Summary: The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.


Options:
A: Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation (an average of 4 to 6 hours)
B: IL-6 (1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours)
C: SOFA Score (24 hours before until day 9 post-surgery)
D: Evolution of pro-inflammatory and anti-inflammatory cytokines [TNF-alfa, IL-1, IL-6, IL-8 and IL-10 (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of complement C5a (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of CD 64 and CD 163 markers (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of miRNA (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of PON1, HDL and LDL (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
Brief Summary: The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.


Options:
A: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
B: Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation (an average of 4 to 6 hours)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
Brief Summary: The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.


Options:
A: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
B: Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) (Baseline (Week 0) up to Week 24)
C: Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment (Day 1 to Week 52)
D: Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo (11 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
Brief Summary: The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.


Options:
A: Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control (Baseline; Weeks 20 to 24)
B: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 52 or early withdrawal (EW))
C: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
D: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
Brief Summary: The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.


Options:
A: Change in Nasal Polyp Score (Week 5 and Week 25)
B: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
C: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
D: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)

Answer: C