TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer
Brief Summary: To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.


Options:
A: Progression Free Survival (every 6 weeks)
B: Progression-free survival rate at 6 months (6 months)
C: Progression-free survival (Every 8±1 Weeks until PD)
D: objective response rate (baseline and every 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Double-blind, Randomised, Parallel-group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tafenoquine (SB-252263, WR238605) in Subjects With Plasmodium Vivax Malaria.
Brief Summary: The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the control Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax Malaria.


Options:
A: Proportion of participants in the TQ group having retinal changes from Baseline in Central subfield thickness and Central retinal lesion thickness (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Total macular volume (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Ellipsoid zone disruption (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in abnormal auto-fluorescence patterns (Baseline and Day 90(follow-up))
B: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)
C: Percentage of Participants With Clinically Relevant Hemolysis. (Up to Day 180); Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis. (Up to Day 180)
D: Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose (6 months post dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.
Brief Summary: NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.


Options:
A: Patient vomiting
B: No Emetic Episodes and No Rescue Medication (>24 to 120 hours post chemotherapy)
C: Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) (0-24h, 24-120h , 0-120h following chemotherapy)
D: Percentage of Patients With Adverse Events (Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Acceptability and Effectiveness of Household Water Chlorination in Reducing the Prevalence of Diarrhea Among Under Five Children in Eastern Ethiopia
Brief Summary: The Millenium development goals (MDGs) call for reducing by half the proportion of people without sustainable access to safe drinking water. This goal was adopted in large part because safe drinking water has been seen as critical to fighting diarrheal disease. Source protection is considered the main intervention area to achieve this goal. However, research worldwide that has shown that even drinking water which is safe at the source is subject to frequent and extensive fecal contamination during collection, storage and use in the home. This contamination is through the introduction of cups, dippers or hands, contamination by flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can pose infectious disease risks if they become contaminated due to unsanitary collection, storage conditions and practices within households.

To reduce this problem, point-of-use water treatment has been advocated as a means to substantially decrease the global burden of diarrhea and to contribute to the MDGs. However, research indicates that there are many unanswered questions around Household water treatment (HWT) that require small or medium scale epidemiological studies and randomized controlled trials, especially with regard to effectiveness, acceptability and identifying suitable target populations. Some of the most urgent questions to be resolved are:(1) How much of the currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted? (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease is high.

hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive children? hypothesis: Do household water treatment with chlorine acceptable in the community?


Options:
A: Incidence of diarrhea (weekly)
B: Dysentery disease rate (12 month); Diarrhoea disease rate (12 months)
C: To assess the prevalence of diarrhea among under five children (four months)
D: 1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age. (6 weeks, 9 months, 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Investigator-initiated, Randomized, Open-label Single-center Study of the Effect of Denosumab on the Prevention of Bone Mineral Density Loss After Renal Transplantation
Brief Summary: The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.

* Trial with medicinal product


Options:
A: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 (Baseline and month 12)
B: De novo diabetes mellitus (2 years); Cardiovascular complications (2 years); De novo cancer (2 years); Patient death (2 years)
C: The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate (one year after kidney transplantation); Number of acute rejection episodes (one year after kidney transplantation); Number of infections (one year after kidney transplantation); CRP levels (one year after kidney transplantation); Courses of calcium levels (within the first year after kidney transplantation)
D: Correction of metabolic acidosis (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Translation of Obesity and Cognitive Research in a Rural State Via Senior Centers
Brief Summary: Obesity is a major public health problem among older adults, with 31% of non-institutionalized older persons (60 years+) in the US obese and projections indicating that this will rise to 40% by 2010. A second public health challenge on the horizon for the aging US population is the increasing number of individuals experiencing cognitive decline, dementia or Alzheimer 's disease. Recent clinical trials have demonstrated efficacy in reducing risks associated with both of these significant and increasingly pervasive health problems, which are more common among rural, low income and ethnic minority populations. The Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in a large, diverse population of high-risk individuals and dramatically reduced rates of type 2 diabetes onset, particularly among older adults. SeniorWISE produced improvements in memory in community dwelling older persons. Transferring these exciting technologies to community settings where they can benefit older adults is a pressing public health need. Therefore, the current project seeks to transfer these two evidence-based interventions to older adults in a rural state using senior centers as the venue for dissemination and lay health educators to deliver the interventions. Senior centers are a particularly attractive context for translation of evidence-based health promotion technologies in predominantly rural states like Arkansas because they have a well-established infrastructure in communities and share a common goal of promoting healthy aging and reducing health care costs. The 3-year randomized, controlled trial will evaluate translation of the interventions by randomizing senior centers (N=16) across Arkansas to implement either (1) the DPP Lifestyle Weight Loss Program or (2) the SeniorWISE Cognitive Training Program. Older (age \> 60) adults (N=288) nested within senior centers will receive the programs delivered in a group format by a trained lay health educator. Primary outcomes are changes in body weight and cognitive functioning at 12 months. The multi-level evaluation plan will characterize reach, effectiveness, adoption, implementation and maintenance of the interventions, with a cost effectiveness component.


Options:
A: body weight (12 months)
B: Fasting Glucose (Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)
C: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
D: weight loss (4 and 12 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-blind, Vaccine-controlled Dose-escalating Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotavin-M1) in Healthy Infants in Vietnam
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.


Options:
A: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
B: Endpoint: immunogenicity and reactogenicity; Proportion of subjects with vaccine take
C: Percentage of Participants Developing New Grade >=3 Adverse Events (From study entry until at least 42 days after third vaccination); Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1. (Prior to first vaccination and at least 14 days after third vaccination)
D: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-blind, Vaccine-controlled Dose-escalating Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotavin-M1) in Healthy Infants in Vietnam
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.


Options:
A: 116E rotavirus vaccine (6,10 and 14 weeks)
B: Rotavirus vaccine lots Immunogenicity (Four weeks after the third dose of vaccination); Immunogenicity of UIP vaccines (Four weeks after the third dose of vaccination)
C: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
D: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-blind, Vaccine-controlled Dose-escalating Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotavin-M1) in Healthy Infants in Vietnam
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.


Options:
A: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
B: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
C: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
D: 1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone vs. Buprenorphine
Brief Summary: The investigators will randomize 210 opioid-dependent participants to one of two outpatient detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day 15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient naltrexone induction procedure, consisting of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term outcome of the initial treatment. The primary outcome will be percentage of patients in each group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day detoxification, and percentage of patients in each group who return for additional Vivitrol injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop an improved outpatient opioid detoxification strategy, with particular relevance to newly diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist maintenance.

Specific Aim #1: To develop procedures for outpatient opioid detoxification which include naltrexone to facilitate detoxification.

Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and buprenorphine groups following short-term outpatient opioid detoxification approach for initiating treatment for opioid dependence.


Options:
A: opioid use (baseline, 1-month, 3-months, 6-months); HIV risk behavior (baseline, 1-month, 3-months, 6-months)
B: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
C: Percentage of patients in each group successfully inducted onto Vivitrol (Completion of 7-day detoxification)
D: Illicit Opioid Use (18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone vs. Buprenorphine
Brief Summary: The investigators will randomize 210 opioid-dependent participants to one of two outpatient detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day 15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient naltrexone induction procedure, consisting of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term outcome of the initial treatment. The primary outcome will be percentage of patients in each group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day detoxification, and percentage of patients in each group who return for additional Vivitrol injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop an improved outpatient opioid detoxification strategy, with particular relevance to newly diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist maintenance.

Specific Aim #1: To develop procedures for outpatient opioid detoxification which include naltrexone to facilitate detoxification.

Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and buprenorphine groups following short-term outpatient opioid detoxification approach for initiating treatment for opioid dependence.


Options:
A: OOWS Score (Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration))
B: Opiate abstinence
C: Withdrawal intensity (6 days)
D: Percentage of patients in each group successfully inducted onto Vivitrol (Completion of 7-day detoxification)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol and Atherosclerosis Pilot Study
Brief Summary: We propose a pilot study to determine the feasibility of a long-term clinical trial of alcohol intake on atherosclerosis, the first step in determining whether moderate drinking prevents cardiovascular disease and hence in understanding the full health effects of alcohol across the population. We will randomize 40 participants aged 55 and older to a six-month period of consumption of 1 glass per day of either pure alcohol (diluted to the strength of wine) or water. At baseline and after 6 months, we will measure several standard and novel cardiovascular risk markers in the blood and will perform magnetic resonance imaging to measure atherosclerosis of the aorta.


Options:
A: Differences in mean systolic blood pressure in the two diet/sport arms (4 months)
B: Blood Pressure (2 hours after consuming beverage)
C: Adherence to alcohol intake and MRI examinations (6 months)
D: adherence, HbA1c, Glc

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.


Options:
A: Faces Pain Scale-Revised (5 mins before and immediate after vaccination)
B: Visual Analogue Scale (sevral minutes before and after BTX injections)
C: Observation Scale of Behavioral Distress-Revised (OSBD-R)
D: Child pain intensity (2 minutes after completion of the immunization series.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.


Options:
A: Hypersensitivity to pain (At 15 month vaccination (Visit 5))
B: Visual Analogue Scale (sevral minutes before and after BTX injections)
C: Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001. (At two years)
D: Analgesic utilization (Up to 6 months)

Answer: B