TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Brief Summary: Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).


Options:
A: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
B: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))
C: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
D: Measles - 2 Completion (When the participants reach 2 years of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensified Insulin Treatment and Skin Microcirculation; Its Relation to Ischemic Foot Ulcer in Patients With Type 1 Diabetes Mellitus: A Long-term Follow-up Study
Brief Summary: We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).


Options:
A: Ischemic Foot Ulcer (Until hospitalization for ischemic foot ulcer or until 31 December 2011)
B: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
C: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
D: Change from baseline in postprandial glucose (baseline to 7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensified Insulin Treatment and Skin Microcirculation; Its Relation to Ischemic Foot Ulcer in Patients With Type 1 Diabetes Mellitus: A Long-term Follow-up Study
Brief Summary: We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).


Options:
A: N/A
B: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) (2014); Death from any cause (2014)
C: Ischemic Foot Ulcer (Until hospitalization for ischemic foot ulcer or until 31 December 2011)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Living in Pregnancy
Brief Summary: Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal state of Germany, targeting maternal and fetal health. The objective of this trial is to evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity and weight monitoring during pregnancy. The intervention comprises 4 individual counseling sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary outcomes are pregnancy and obstetric complications like gestational diabetes and rate of caesarean sections as well as offspring health.

The lifestyle intervention program is adapted to the German health care system to allow an immediate implementation after successful evaluation.


Options:
A: Gestational weight gain (4 years)
B: Maternal Weight Change (baseline to 2 weeks post partum)
C: Gestational Weight Gain (Delivery)
D: Weight Gain Per Week of Observation (13 weeks gestation, 35 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Living in Pregnancy
Brief Summary: Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal state of Germany, targeting maternal and fetal health. The objective of this trial is to evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity and weight monitoring during pregnancy. The intervention comprises 4 individual counseling sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary outcomes are pregnancy and obstetric complications like gestational diabetes and rate of caesarean sections as well as offspring health.

The lifestyle intervention program is adapted to the German health care system to allow an immediate implementation after successful evaluation.


Options:
A: Gestational weight gain (4 years)
B: prevention gestational diabetes (weeks 24-30)
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: Primary outcome: meeting the postpartum weight goal (through 12 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial
Brief Summary: The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth.

The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".


Options:
A: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
B: Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits) (through hospital discharge (approximately 6 months unless death occurs first))
C: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
D: 2-year survival without cerebral palsy (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS
Brief Summary: This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.


Options:
A: Total Body Weight Loss (Enrollment to 12 months)
B: Change of body mass index (Baseline, at 12 months after surgery)
C: Weight (6 months); Weight (12 months); Weight (24 months); Weight (36 months)
D: Primary Safety Endpoint (12 months); Primary Efficacy Endpoint (12 months); Co-Primary Efficacy Endpoint (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
Brief Summary: Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll and PartyPlanner among university government members at two universities in Stockholm, Sweden. The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and giving feedback of estimated blood alcohol concentration levels. Both apps inform and warn the user when the estimated alcohol level is above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally provides the possibility of simulating and planning an alcohol consumption event in advance and later on comparing it with the real time registration at the event.

Method: Participants with problematic alcohol use (AUDIT \>7 for men and \>5 for women) are randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the app assigned to them gathered after 7 weeks.

The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce their alcohol use to a larger extent than the control group at follow-up compared to the baseline level. 2. The addition of the possibility to plan events beforehand (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time use (Promillekoll).


Options:
A: proportion of negative breath samples submitted (Week 4)
B: Frequency of consumption (6 months and 12 months); Usual number of drinks per occasion (6 months and 12 months); Frequency of consuming 5 or more drinks on one occasion (6 months and 12 months); Typical weekly consumption (6 months and 12 months); Highest number of drinks on one occasion (6 months and 12 months)
C: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care (5 months); Number of brief interventions for excessive alcohol consumption delivered in primary health care settings (5 months)
D: Change in estimated Blood Alcohol Concentration (eBAC) (7 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcomes in Neonatal Abstinence Syndrome
Brief Summary: 1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied. Infants will be randomized to receive either morphine or methadone. It is hypothesized that morphine treated infants will do better and require fewer days in the hospital compared to methadone treated infants.

2. SPECIFIC Aim II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants will be evaluated with development testing at 18 months of age. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will correlate with neurodevelopmental impairment at 18 months.

3: SPECIFIC Aim III: To determine if common genetic variations in the genes involving narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all infants and analyzed for differences in 3 key genes. This will then be correlated with short-term and long-term outcomes.


Options:
A: Length of Hospital Stay (assessed at hospital discharge, approximately 7-30 days)
B: Length of Hospital Stay (LOS) (Participants will be monitored during their entire hospitalization, expected mean 22 days.)
C: Length of Treatment With Opioid Medication (Up to 12 months)
D: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcomes in Neonatal Abstinence Syndrome
Brief Summary: 1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied. Infants will be randomized to receive either morphine or methadone. It is hypothesized that morphine treated infants will do better and require fewer days in the hospital compared to methadone treated infants.

2. SPECIFIC Aim II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants will be evaluated with development testing at 18 months of age. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will correlate with neurodevelopmental impairment at 18 months.

3: SPECIFIC Aim III: To determine if common genetic variations in the genes involving narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all infants and analyzed for differences in 3 key genes. This will then be correlated with short-term and long-term outcomes.


Options:
A: Sublingual Buprenorphine safety and tolerability in the neonate (Index hospitalization)
B: Length of Treatment (Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.)
C: Duration of treatment (0 to 42 days)
D: Length of Hospital Stay (LOS) (Participants will be monitored during their entire hospitalization, expected mean 22 days.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
Brief Summary: This pilot study intends to evaluate whether stroke patients can complete ballistic strength exercises for thirty minutes, three times per week over a six week training period in addition to their existing rehabilitation program.

It will evaluate whether using ballistic training principles, is superior in improving mobility compared with usual care exercises to improve mobility and leg strength in stroke patients.

In this study there will be 15 participants per group, a total of 30 participants. The control group will receive usual care consistent with existing rehabilitation practice and literature. The experimental group will perform task specific strength training in a ballistic fashion.


Options:
A: Feasibility (6 weeks)
B: Timed "up and go" test (the day after intervention completion (max 5 weeks))
C: Glucose area under the curve (0 weeks and 2 weeks)
D: the score-change of the Functional Independence Measure (FIM) assessment for daily living function (baseline, 2-week, 4-week and three months after stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
Brief Summary: This pilot study intends to evaluate whether stroke patients can complete ballistic strength exercises for thirty minutes, three times per week over a six week training period in addition to their existing rehabilitation program.

It will evaluate whether using ballistic training principles, is superior in improving mobility compared with usual care exercises to improve mobility and leg strength in stroke patients.

In this study there will be 15 participants per group, a total of 30 participants. The control group will receive usual care consistent with existing rehabilitation practice and literature. The experimental group will perform task specific strength training in a ballistic fashion.


Options:
A: Feasibility (6 weeks)
B: Motor Assessment Scale (18 months after inclusion)
C: Systolic Blood Pressure (12 months)
D: Aerobic capacity (Baseline,3month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (n=60) that will compare BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In addition, participants' adherence rates to each of the therapies and their maintenance of clinical gains at a 1-month follow-up, will be examined.


Options:
A: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)
B: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months (6 and 12 months)
C: adherence to dietary sodium targets as assessed from 3-day food recalls (baseline and 4 months); average daily interdialytic weight gain (IDWG) (IDWG gathered with each dialysis treatment); average pulse pressure from pre-dialysis blood pressures (with each dialysis treatment)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (n=60) that will compare BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In addition, participants' adherence rates to each of the therapies and their maintenance of clinical gains at a 1-month follow-up, will be examined.


Options:
A: PHQ9 Depression Score (3 months post-partm)
B: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)
C: Recruitment and retention rates, data completion, and resource utilization. (Baseline, Week 18)
D: Patient Health Questionnaire (PHQ-9)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment); Beck Depression Inventory (BDI)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Brief Summary: The occurrence of bronchiolitis obliterans syndrome (SBO) after allogeneic hematopoietic stem cell transplantation (HSCT) is considered to be a chronic pulmonary graft versus host disease (GVHD) that is associated with significant mortality and morbidity. The reported incidence of SBO varies from 6 to 26% of allogeneic HSC recipients and is usually diagnosed within 2 years after transplantation. The diagnosis of SBO relies on the occurrence of a new airflow obstruction identified during pulmonary function testing, and the definition differs between studies. Currently, no curative immunosuppressive treatment is available, and recent data suggest that the use of these treatments, especially corticosteroids, should be limited because of their toxicity. The impairment of lung function parameters is likely caused by fibrous small airway lesions. Few data on the pathogenesis of SBO after allogeneic HSCT are available. Several hypotheses are based on the occurrence of SBO during chronic graft rejection after lung transplantation, which shares many clinical and histopathological similarities with SBO after allogeneic HSCT. One hypothesis is that the first step leading to SBO is lung epithelium injury. SBO is then identified as an alloimmune reaction with only one clearly identified risk factor: extrathoracic chronic GVHD. Due to their anti-inflammatory and immunomodulatory properties, recent data suggest that low-dose macrolides may be effective at preventing SBO after lung transplants. This well-tolerated treatment may be useful for preventing SBO after allogeneic HSCT.

The objective of this Phase 3 multicentre randomized, double-blinded, clinical trial is to evaluate the efficacy of azithromycin in preventing BO syndrome after allogeneic HSCT in patients with malignant hematological diseases.


Options:
A: Mean change in the Leicester Cough Questionnaire (LCQ) scores. (2 years)
B: The primary efficacy variable was the percentage of patients who had a 20 percent improvement according to American College of Rheumatology (ACR) criteria (an ACR 20 response) at six months.
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Airflow decline (AFD)-free survival (2 year after allogeneic HSCT)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).


Options:
A: Percentage of Participants In Remission at Week 52 (Week 52)
B: Percentage of Participants With Remission at Week 8 (Week 8)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
D: Change from baseline in the Mayo score at Week 8 (Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
Brief Summary: This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.


Options:
A: Change from baseline in postprandial glucose (baseline to 7 days)
B: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (From randomisation to individual end of trial date (maximum patient year observation: 2.75 years))
C: Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment (24 weeks)
D: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)

Answer: B