TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
Brief Summary: Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival.

Secondary objectives:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).


Options:
A: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
B: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
C: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)
D: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
Brief Summary: Objective:

To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.

Background:

Diabetic nephropathy is a world wide public health concern of increasing proportions. It has become the most common single cause of end-stage renal disease in the United States and in Europe. Previous studies have already found agents modifying the renin-angiotensin-system (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These agents are likely to exert multiple effects in the kidney. One of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics.

In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone. In that study, rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a reduction of urinary albumin excretion. The observed effects are potentially important in the context of renal protection, provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).

Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy.


Options:
A: Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis (From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis)
B: Plasma liraglutide concentration (pmol/L) (12 weeks)
C: N/A
D: Proteinuria (at baseline and after 6 and 12 mo of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telepsychology-Service Delivery for Depressed Elderly Veterans
Brief Summary: The purpose of this study is to see whether therapy for elderly adults with major depression can be delivered effectively using videoconferencing technology ("telepsychology"), which allows a therapist and patient who are not in the same room as one another to communicate. We are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient.


Options:
A: PHQ9 Depression Score (3 months post-partm)
B: Depression (Two months)
C: 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)
D: At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS) (8 week & 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Levosimendan in Patients With Acute Myocardial Infarction Complicated by Symptomatic Left Ventricular Failure.
Brief Summary: The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.


Options:
A: Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms. (At 5 days)
B: N/A
C: All-cause mortality in the 180 days following randomization.
D: All cause mortality at 30 days post randomization

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
Brief Summary: Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of sleep problems and their impact on the life of these individuals, there has been, until recently, little research focus on the problem. This will be a multi-site, double blind, placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks. Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three external sites) will be equally randomized to eszopiclone or placebo. The primary hypothesis is that eszopiclone will be superior to placebo for the treatment of insomnia in patients with Parkinson's disease


Options:
A: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)
B: Latency to persistent sleep measured by polysomnography (4 weeks)
C: TST (6 weeks)
D: diagnostic yield of PSG (during overnight study); total sleep time (during overnight study); wake after sleep onset (during overnight study); sleep latency (during overnight study); sleep efficiency (during overnight study); total arousal index (during overnight study); respiratory disturbance index at highest CPAP level (during overnight study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux
Brief Summary: The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.


Options:
A: The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) (12 weeks); The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase) (36 weeks)
B: Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. (Week 4); Safety Assessments (Baseline through week 8)
C: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
D: The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.; The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux
Brief Summary: The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.


Options:
A: Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. (Week 4); Safety Assessments (Baseline through week 8)
B: Maximum Observed Plasma Concentration (Cmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Time to Reach Maximum Observed Plasma Concentration (Tmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Decay Half-Life (t1/2) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Apparent Oral Clearance (CL/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Terminal-Phase Volume of Distribution (Vz/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Concentrations After Multiple Doses (Hours 2 and 4 on Day 7)
C: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
D: Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) (Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: TOMUS-Trial Of Mid-Urethral Slings
Brief Summary: The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.


Options:
A: Objective Treatment Success at 12 Months (12 months); Subjective Treatment Success at 12 Months (12 months)
B: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
C: Primary outcome (Observational)
D: success rate at improving symptom of stress urinary incontinence (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double Dummy, 3 Way Crossover Study Evaluating the Effects of a Combination of Seretide 50/500mcg Twice Daily Plus Tiotropium Bromide 18mcg Once Daily Compared With the Individual Agents (Tiotropium Bromide 18mcg Alone and Seretide50/500mcg Alone) in the Treatment of Subjects With COPD
Brief Summary: This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.


Options:
A: 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)
B: AUC (0-4hrs, sGAW after morning dose of medication at day 14)
C: The primary outcome for this study will be the proportion of subjects at risk for airway obstruction as measured by the LFQ (LFQ total score ≤ 18) and confirmed by spirometry. (4-Month)
D: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double Dummy, 3 Way Crossover Study Evaluating the Effects of a Combination of Seretide 50/500mcg Twice Daily Plus Tiotropium Bromide 18mcg Once Daily Compared With the Individual Agents (Tiotropium Bromide 18mcg Alone and Seretide50/500mcg Alone) in the Treatment of Subjects With COPD
Brief Summary: This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.


Options:
A: The primary outcome for this study will be the proportion of subjects at risk for airway obstruction as measured by the LFQ (LFQ total score ≤ 18) and confirmed by spirometry. (4-Month)
B: Percentage of Participants Who Were Able to Remain on the Randomized Treatment (24 weeks)
C: AUC (0-4hrs, sGAW after morning dose of medication at day 14)
D: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint (Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout
Brief Summary: These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.


Options:
A: Uric Acid (mg/dL) (Week 13, Week 25, Week 53, Week 101)
B: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))
C: N/A
D: Plasma Uric Acid (PUA) Responder (Months 3 and 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout
Brief Summary: These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.


Options:
A: Plasma Uric Acid (PUA) Responder (Months 3 and 6)
B: Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6 (6 months, analysis after all subjects complete 12 months)
C: Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6. (6 months)
D: Proportion of Subjects With an sUA Level That is < 6.0 mg/dL (6 Months, analysis after all subjects complete 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: It is increasingly recognised that rapid growth in infancy may be associated with a greater risk of cardiovascular disease later in life. This trial will investigate whether the use of infant feeding bottles with different designs influences the milk intake and growth of infants. We will compare the growth of bottle-fed infants with that of a breast-fed reference group.


Options:
A: Neurobehavioral Assessment of the Preterm Infant (NAPI) (Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age)
B: The Median Breast Feeding Score (36-48 hours by video recording)
C: N/A
D: Oral feeding performance (20 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Short Course Zinc Therapy (5 vs 10 d) With 20 mg Elemental Zinc Daily in the Treatment of Acute Diarrhoea: A Double-blind Individually Randomized Controlled Community Trial.
Brief Summary: Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc.

The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea.

This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area.

The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure.

Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.


Options:
A: Linear growth velocity (6 to 18 months of age)
B: proportion with treatment failures (Within 3 weeks after enrollment)
C: all cause hospitalizations in comparison to infants receiving placebo. (November 2004 to August 2007); illnesses requiring visits to healthcare providers. (November 2004 to August 2007)
D: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Short Course Zinc Therapy (5 vs 10 d) With 20 mg Elemental Zinc Daily in the Treatment of Acute Diarrhoea: A Double-blind Individually Randomized Controlled Community Trial.
Brief Summary: Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc.

The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea.

This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area.

The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure.

Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.


Options:
A: Time (hours) to resolution of clinical signs of pneumonia (31 months)
B: Reduction in duration of diarrhoea; Reeudction in total stool volume
C: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.
D: Age; Sex; Weight; Body Mass index; Duration of diarrhoea before admission; Stool volume; Dehydration status

Answer: C