TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
Brief Summary: The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis.

The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications.

The patients will be randomized to conservative treatment with and without antibiotic therapy.


Options:
A: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)
B: Treatment Failure (4-6 weeks)
C: Readmission ratio (3 months)
D: Time-to-full-recovery (6 months follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dynamics of Human Atrial Fibrillation
Brief Summary: The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.


Options:
A: Composite of all-cause mortality and heart failure events (Baseline to a minimum of 24 months)
B: Survival Free of Atrial Fibrillation (6 -12 months)
C: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
D: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% (baseline and 6 months); Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) (Baseline); Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Effectiveness of Potassium Diclofenac for Retinal Photocoagulation in Patients With High-risk Proliferative Diabetic Retinopathy
Brief Summary: The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation.

Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure.


Options:
A: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
B: N/A
C: Pain recorded using a Visual Analog Scale (15 minutes after the procedure)
D: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Effectiveness of Potassium Diclofenac for Retinal Photocoagulation in Patients With High-risk Proliferative Diabetic Retinopathy
Brief Summary: The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation.

Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure.


Options:
A: Functional Macular Evaluation (24 weeks)
B: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
C: Pain recorded using a Visual Analog Scale (15 minutes after the procedure)
D: total area of fluorescein leakage from active new vessels (baseline, weeks 1,6,12,24,36,48); Best corrected Visual Acuity (BCVA) (Baseline, weeks 1,6,12,24,36,48); central macular thickness (baseline, weeks 1,6,12,24,36,48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Dynamic Hyperinflation Through Breathing Retraining
Brief Summary: This study will compare the effects of exercise training and breathing retraining (using metronome tones) to exercise training only. Exercise training lasts 12 weeks.


Options:
A: The number of ED presentations (1 year after randomization.)
B: Asthma composite score (During first year of follow-up); COPD composite score (During first year of follow-up); Asthma-or-COPD diagnosis rate (During first year of follow-up)
C: Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) (baseline and 12 weeks)
D: Clinical COPD Questionnaire (CCQ) (Up to 3 weeks); Timed Up & Go test (TUG) (Up to 3 weeks); The five time sit to stand test (FTSST) (Up to 3 weeks); Patients' falls during training (Up to 3 weeks); Need for acute contact to the general practitioner (Up to 3 weeks); Patient subjective perception (Up to 3 weeks); Costs per patient participating in the telemedicine rehabilitation (Up to 3 weeks); Reimbursement to the hospital (Up to 3 weeks); Focus Group interview (Up to 3 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression
Brief Summary: This work is supported by the "Kompetenznetz Diabetes mellitus (Competence Network for Diabetes mellitus)" funded by the Federal Ministry of Education and Research (FKZ 01GI0809).

Approximately one third of diabetic patients has elevated depressive symptoms. The majority of these patients are suffering from a subthreshold depression. In spite of the fact that subthreshold depression has an equivalent negative impact on the prognosis of diabetes as clinical depression, there is no specific intervention tool. The main objective of this project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to standard diabetes education. A total of 188 diabetic patients will be recruited and randomly assigned to the two treatment conditions. The expected main outcome is the reduction of subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are improvement of glycaemic control, quality of life, diabetes self-management as well as reduction of health care costs and modification of inflammatory parameters.


Options:
A: N/A
B: Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease. (12 months)
C: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
D: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression
Brief Summary: This work is supported by the "Kompetenznetz Diabetes mellitus (Competence Network for Diabetes mellitus)" funded by the Federal Ministry of Education and Research (FKZ 01GI0809).

Approximately one third of diabetic patients has elevated depressive symptoms. The majority of these patients are suffering from a subthreshold depression. In spite of the fact that subthreshold depression has an equivalent negative impact on the prognosis of diabetes as clinical depression, there is no specific intervention tool. The main objective of this project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to standard diabetes education. A total of 188 diabetic patients will be recruited and randomly assigned to the two treatment conditions. The expected main outcome is the reduction of subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are improvement of glycaemic control, quality of life, diabetes self-management as well as reduction of health care costs and modification of inflammatory parameters.


Options:
A: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
B: Severity of depressive symptoms (7 Days)
C: Quick Inventory of Depressive Symptoms (Measured at Month 7)
D: Change in patient perception of personal self-efficacy at 6 months (6 months); Change in patient perception of self-management practice at 6 months (6 months); Change in patient perception of health behaviours at 6 months (6 months); Change in patient perception of activation at 6 month (6 months); Change in patient perception of psychological distress at 6 months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression
Brief Summary: This work is supported by the "Kompetenznetz Diabetes mellitus (Competence Network for Diabetes mellitus)" funded by the Federal Ministry of Education and Research (FKZ 01GI0809).

Approximately one third of diabetic patients has elevated depressive symptoms. The majority of these patients are suffering from a subthreshold depression. In spite of the fact that subthreshold depression has an equivalent negative impact on the prognosis of diabetes as clinical depression, there is no specific intervention tool. The main objective of this project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to standard diabetes education. A total of 188 diabetic patients will be recruited and randomly assigned to the two treatment conditions. The expected main outcome is the reduction of subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are improvement of glycaemic control, quality of life, diabetes self-management as well as reduction of health care costs and modification of inflammatory parameters.


Options:
A: Program satisfaction, behavioral and emotional outcomes. (3, 6, 9, 12 months after implementation of intervention)
B: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
C: Change in Dietary Intake (18 months); Change in Physical Activity (18 months)
D: Changes in decisional conflict (baseline and 3 month post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine
Brief Summary: The study is designed as a multicenter, double blind, parallel-group, placebo-controlled, randomized, event driven Phase II study of DTIC with or without bosentan as first-line treatment in patients with stage IV melanoma.


Options:
A: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)
B: Peak 6-minute Walk Distance (12 weeks)
C: 6 minute walk distance change from baseline to Week 16 (16 weeks)
D: Exercise Capacity; Pulmonary artery systolic pressure

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine
Brief Summary: The study is designed as a multicenter, double blind, parallel-group, placebo-controlled, randomized, event driven Phase II study of DTIC with or without bosentan as first-line treatment in patients with stage IV melanoma.


Options:
A: Disease Free Survival (Up to 2 years)
B: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)
C: Safety as measured by the frequency of grade 3/4 immune-related adverse events, using CTCAE 4.03 (During the first 12 weeks.); Response rate according to RECIST 1.1 (At 6 weeks); Pathological response according to central pathological revision, according to pathological response criteria (At 6 weeks); Pathologic response rate according to central revision of the marked index lymph node (At 6 weeks, prior surgery); RFS at 24 months in patients achieving pCR or pnCR in their marked index lymph node and did not undergo CLND. RFS will be calculated from date of resection of the marked lymph node. (24 months); RFS at 24 months in patients with pNR and being subsequently treated with adjuvant nivolumab+optional radiotherapy (or dabrafenib/trametinib if BRAFV600E pos. and treatment is approved). RFS will be calculated from day of resection of marked lymph node. (24 months)
D: Major Pathologic Response Rate (MPR) (Every 6 weeks from start of study treatment, up to 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine
Brief Summary: The study is designed as a multicenter, double blind, parallel-group, placebo-controlled, randomized, event driven Phase II study of DTIC with or without bosentan as first-line treatment in patients with stage IV melanoma.


Options:
A: Mean Pulmonary Arterial Pressure Change From Baseline (baseline, 6 months)
B: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)
C: Improvement in six minute walk distance (16 weeks)
D: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
Brief Summary: The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study.

The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.


Options:
A: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
B: The initial day and number of days there is a significant change from baseline in the mean Delirium Observation Screening (DOS) score, and/or delirium is diagnosed according to the DSM-IV criteria. (Assessed within 1 to 7 days after initiation of the study intervention.)
C: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
D: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
Brief Summary: The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study.

The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.


Options:
A: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
B: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: Instrumental and Physical Functionality (Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)); Re-Admission to Hospital (Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).); Institutionalisation (Assessed 12 months after the time of hospital discharge (T2).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
Brief Summary: The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study.

The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.


Options:
A: Montebello Rehabilitation Factor Score (MRFS) (1 day At discharge); Montebello Rehabilitation Factor Score (MRFS) (At 6 months); Montebello Rehabilitation Factor Score (MRFS) (At 1 year); Proportions of patients achieving pre-morbid ambulatory status (1 day At discharge); Proportions of patients achieving pre-morbid ambulatory status (At 6 months); Proportions of patients achieving pre-morbid ambulatory status (At 1 year); Length of stay in hospital (1 day At discharge); Percentage of patients admitted to nursing home (Up to 1 year after discharge)
B: Mortality (6 month)
C: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
D: functional recovery (baseline, end of nursing home admission)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
Brief Summary: The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study.

The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.


Options:
A: Instrumental and Physical Functionality (Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)); Re-Admission to Hospital (Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).); Institutionalisation (Assessed 12 months after the time of hospital discharge (T2).)
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
D: Postoperative delirium rate within 7 days after surgery (7 days after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Crohn's Disease
Brief Summary: This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.


Options:
A: Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 (Week(W) 24)
B: Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24 (Week 24)
C: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24 (Week 24)
D: Number of Participants With Adverse Events (From Start of the Study up to Study Termination (up to 42 Weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HZC102871: 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 blinded study medication until Visit 11 (Week 52)/Early Withdrawal)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
C: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8) (Baseline (BL) and Day 85)
D: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment); Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HZC102871: 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 blinded study medication until Visit 11 (Week 52)/Early Withdrawal)
C: Rate of moderate/severe exacerbations over a 52 week treatment period
D: AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) (after 12 weeks of treatment)

Answer: B