TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Life-style Intervention to Reduce Weight and Increase Workability in Health Care Workers
Brief Summary: The purpose of this study is to evaluate whether a 1 year worksite based life-style intervention can reduce body weight and increase physical capacity and subsequently reduce musculoskeletal disorders and increase workability in overweight health care workers.


Options:
A: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)
B: Change from baseline in experienced community of practice at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in well-being at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in dietary behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in exercise behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in safety behavior counts at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline safety behavior consistency at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months)
C: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)
D: weight loss (3 months); Weight loss (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Community-Based Effectiveness Trial of Selected Dietary Strategies for the Management of Young Malian Children With Moderate Acute Malnutrition (MAM) in the Context of the National Community Management of Acute Malnutrition
Brief Summary: The objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. The specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.), providing \~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children, providing \~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing \~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") for 12 weeks, as is currently recommended by the national CMAM protocol when special foods are not available.


Options:
A: weight-for-height in children 6 to 60 mo of age (8 months)
B: Change in Length for Age (Once per month for 6 months, then once after 12 months.)
C: Weight gain (3 months); Continuation in treatment (3 months)
D: Change in prevalence of growth faltering during the intervention (end of intervention (approximately 12 months of age)); Change in prevalence of growth faltering post-intervention (Six-months post-intervention (approximately 18 months of age))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial
Brief Summary: The investigators reasoned that a hypertonic saline concentration higher than 3% could be safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and preventing the need for hospitalization in some instances.


Options:
A: Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours (2 years)
B: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)
C: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
D: Admission rate (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial
Brief Summary: The investigators reasoned that a hypertonic saline concentration higher than 3% could be safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and preventing the need for hospitalization in some instances.


Options:
A: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
B: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
C: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)
D: Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Clinical Pharmacist Service on Health-related Quality of Life
Brief Summary: The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.


Options:
A: Health-related quality of life (6 months)
B: the effects of hospitalists on patient outcomes, costs, and medical education on the general medicine services (30 days after discharge)
C: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
D: Effects on hospital visits (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Clinical Pharmacist Service on Health-related Quality of Life
Brief Summary: The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.


Options:
A: Health-related quality of life (6 months)
B: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (1 year)
C: Medication Appropriateness Index (MAI)-Score (6 months from baseline)
D: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Clinical Pharmacist Service on Health-related Quality of Life
Brief Summary: The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.


Options:
A: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
B: Change in Quality of Life (one year after baseline assessment); Change in Caregiver Burden (one year after baseline assessment); Change in Behavioral and Psychological Symptoms of Dementia (one year after baseline assessment); Change in Medical Treatment With Antidementia Drugs (one year after baseline assessment); Reduction of Potential Inapropriate Medication (PIM) (one year after baseline assessment)
C: Number of unplanned hospital admissions (Recruitment - 6 months post intervention); Number of A&E attendances (Recruitment - 6 months post intervention); Number of GP consultations (Recruitment - 6 months post intervention)
D: Health-related quality of life (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Clinical Pharmacist Service on Health-related Quality of Life
Brief Summary: The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.


Options:
A: Drug-related readmission (one year after discharge from the cooperating ward)
B: Readmissions (30 days); Admissions (180 days); Emergency Department Visits (180 days); Composite Endpoint, Admissions or Emergency Department Visits (180 days)
C: Health-related quality of life (6 months)
D: Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR. (Day 14 of hospital stay or discharge, which ever comes first)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris
Brief Summary: A single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.


Options:
A: Absolute Change in Total Lesion Count From Baseline to Week 12 (Baseline (Week 0) and Week 12); Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12 (Baseline (Week 0) and Week 12); Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12 (Baseline (Week 0) and Week 12)
B: Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12)
C: Part 1: Total Atrophic Acne Scar Count Per Half-face (Week 24)
D: Success Rate (Week 12); Changes From Baseline in Inflammatory Lesion Counts (Baseline - Week12); Changes From Baseline in Non-Inflammatory Lesion Counts (Baseline - Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial
Brief Summary: Activated protein C (APC)has been shown to reduce mortality in severe sepsis(Bernard et al. 2001b). The clinical picture of severe acute pancreatitis (AP) is similar to that of sepsis. The investigators conducted a randomised double-blinded placebo-controlled pilot study in AP patients (16+16) with the same dose of APC that has been proven to be efficacious and safe in septic patients.

The aim of the study is to investigate whether the APC replacement therapy diminishes the occurrence and severity of organ dysfunction in patients with severe AP. The effect of APC on inflammatory and hemostatic parameters is also assessed.


Options:
A: Post-ERCP Pancreatitis (5 days)
B: The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5. (0-60 days)
C: Reduction of the CRP by 20% from the control group (Day 7 post infusion)
D: Change in C-Reactive Protein (CRP) (baseline, Day 1, Day 3); Change in Tumor Necrosis Factor (TNF)-Alpha (baseline, Day 1, Day 3); Change in Interleukin (IL) IL-6 (baseline, Day 1, Day 3); Changes in Interleukin (IL) IL-8 (baseline, Day 1, Day 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diabetes Outcome: The Diabetes Support Project
Brief Summary: Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. The purpose of this study is to test an intervention that helps partners and patients who have type 2 diabetes better support each other. The intervention will be delivered over the telephone to reach more people. Our hypothesis is that an intervention that targets the couple has a greater effect on health and well-being of patients than one that targets the individual patient alone.


Options:
A: Change in Dietary Intake (18 months); Change in Physical Activity (18 months)
B: the absolute change in HbA1c (baseline; 6 months and 18 months)
C: Blood glucose control (hemoglobin AIc) (Baseline, and 3 follow ups (mos 4, 8, 12))
D: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Brief Summary: The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.


Options:
A: N/A
B: Weight change (0, 3, 6 months)
C: Changes in blood pressure levels at 6 and 12 months (It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Brief Summary: The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.


Options:
A: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)
B: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)
C: LDL size (baseline and after each of 6 interventions)
D: Weight change (0, 3, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Brief Summary: The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.


Options:
A: Change of energy intake. (24 hours)
B: Body mass index percentile ranking (5 months)
C: Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months (baseline, 6-months)
D: Weight change (0, 3, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Brief Summary: The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.


Options:
A: This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. (Data will be measured at 12 weeks.)
B: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)
C: Weight change (0, 3, 6 months)
D: Initial change in weight (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Brief Summary: The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.


Options:
A: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
B: N/A
C: Weight change (0, 3, 6 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC
Brief Summary: The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).


Options:
A: Progression free survival (PFS) (2 years)
B: Progression-Free Survival (Site Read, Investigator Assessment) (Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks); Median Progression-Free Survival (Site Read, Investigator Assessment) (Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks)
C: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
D: Progression Free Survival (PFS) (Randomization to the first date of measured PD or death up to 37.32 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HZC102970: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)
B: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)
C: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)
D: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HZC102970: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)


Options:
A: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)
B: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
C: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
D: Change in trough FEV1 after 12 weeks of treatment. (week 12)

Answer: A