TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial to Evaluate the Preventive Effect on Mortality and Serious Morbidity/ Hospitalisations of Daily Vitamin D Supplements in Small for Gestational Age Term Infants
Brief Summary: The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity.


Options:
A: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
B: Percent Change in The Number of T Regulatory Cells (At 1 week (compared to baseline)); Percent Change in The Number of T Regulatory Cells (At 4 weeks (compared to baseline))
C: Mortality (weekly); Incidence of disease requiring hospitalization; Morbidity and hospitalization (weekly)
D: All-cause mortality and diarrheal morbidity (age 6 weeks to age 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology
Brief Summary: The purpose of this study is to investigate whether a physiotherapy program reduces pain and improves disability and quality-of-life in people with chronic shoulder pain.

The main study hypotheses are that (i) A 10-week physiotherapy treatment will result in significantly greater reductions in pain and disability than placebo treatment in individuals with chronic shoulder pain (ii) Improvements in pain and disability following a 10-week physiotherapy treatment will be maintained at a 3-month follow-up.


Options:
A: Constant total score as a mean and by category (at 3 months)
B: Shoulder Pain and Disability Index (1 year)
C: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)
D: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology
Brief Summary: The purpose of this study is to investigate whether a physiotherapy program reduces pain and improves disability and quality-of-life in people with chronic shoulder pain.

The main study hypotheses are that (i) A 10-week physiotherapy treatment will result in significantly greater reductions in pain and disability than placebo treatment in individuals with chronic shoulder pain (ii) Improvements in pain and disability following a 10-week physiotherapy treatment will be maintained at a 3-month follow-up.


Options:
A: Constant-Murley shoulder assessment (Baseline and change after three months of exercises, 3 month follow-up); Constant_Murley shoulder assessment (Change from baseline to the 12-month follow-up)
B: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)
C: Oxford Shoulder Score (4 months)
D: Oxford Shoulder Score (6 months post randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
Brief Summary: This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.


Options:
A: Number of Participants With Splenectomy During 52-Week Treatment Period (52 weeks); Number of Participants With Treatment Failure During 52-Week Treatment Period (52 weeks)
B: Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.
C: Number of Participants With Adverse Events (Duration of treatment plus 8 weeks (up to 285 weeks))
D: To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters (Last 8 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment.

The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice.

The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.


Options:
A: Antibiotic use; Length of stay in hospital
B: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
C: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
D: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment.

The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice.

The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.


Options:
A: Antibiotic use; Length of stay in hospital
B: N/A
C: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
D: mortality/survival (28 day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment.

The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice.

The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.


Options:
A: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
B: Antibiotic use; Length of stay in hospital
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: Mortality (28 days); Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. (Between day 1 and D28); Mortality (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment.

The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice.

The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.


Options:
A: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
B: Antibiotic Prescription Rate (at PED (Pediatric Emergency Department) presentation)
C: Antibiotic use; Length of stay in hospital
D: Proportion of Appropriateness of Antimicrobial Prescriptions in each group. (10-month period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ecological Momentary Intervention of Diet Via Mobile Technology
Brief Summary: This is a NCI funded study which will develop and evaluate a cell phone application (mDIET) that can be used as an assessment and intervention tool to improve dietary behaviors and thus reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.


Options:
A: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
B: For adults: body weight loss maintenance (6 Month)
C: Mean Weight (kg) (4 months)
D: Weight Loss (Measured at Month 18)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Caregiver Psychoeducation and Support: Improving Outcomes in AD/ADRD
Brief Summary: This study is piloting an internet-based intervention to provide support for caregivers of VA patients with Alzheimer's disease or related memory difficulties (ADRD). Veterans with a clinical diagnosis of ADRD and their caregiver/relatives will be randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly brief telephone calls with project staff for six month. It is hypothesized that participation in the intensive intervention will result in a reductions in patient problematic behavior and caregiver responses to it, reduced caregiver burden and depression, and improved medication adherence at the end of treatment, and more patients remaining at home through the 12 months post-randomization period..


Options:
A: Revised Memory and Behavior Problems Checklist (6 Months)
B: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention); Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Post-intervention, assessed 4-14 days after final intervention session.)
C: Change in Caregiver Burden From Baseline (baseline to end-of-treatment (6 months)); Change in Frequency of Patient Problematic Behavioral Patterns From Baseline (baseline to end of treatment (6 months)); Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline (baseline to end of treatment (6 months)); Change in Caregiver Depression From Baseline (baseline to end-of-treatment (6 months))
D: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study
Brief Summary: Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.


Options:
A: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
B: Lung function (FEV1, FVC, FEF25-75)
C: Computed Tomography Evidence of Less Sinus Disease (baseline and 1 year); Improvement in Appearance of Nasal Passages/Sinuses (baseline and 1 year)
D: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1/Phase 2, Single-Center, Controlled Study of the Effectiveness of Combined High Frequency Oscillation and Tracheal Gas Insufflation in Improving the Clinical Course of Patients With Severe Acute Respiratory Distress Syndrome
Brief Summary: In the past five years, there is a growing body of published evidence on the feasibility, and oxygenation and lung protection benefits of high frequency oscillation (HFO) in the acute respiratory distress syndrome (ARDS). The investigators have recently demonstrated the short term feasibility and additional benefits with respect to oxygenation of HFO combined with tracheal gas insufflation (TGI). In the present clinical trial, the investigators intend to test the hypothesis that HFO-TGI may result in improved respiratory physiology and clinical course compared to low tidal volume conventional mechanical ventilation in patients with severe ARDS.


Options:
A: Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization (8-10 days post-randomization); Survival to days 28 and 60 post-randomization and to Hospital Discharge (28 days to more than 60 days post-randomization)
B: adherence to our explicit mechanical ventilation protocols; (duration of mechanical ventilation); to measure and understand the reasons for crossovers between groups (duration of mechanical ventilation); to estimate the rate of patient recruitment, and understand barriers to recruitment; to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
C: Hospital Mortality
D: 28-day mortality from all causes (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multiple Dose, Randomized, Three-Period Crossover Study in Healthy Volunteers to Evaluate the Effect of co-Administration of Amantadine 100 mg BID and Oseltamivir 75 mg BID on the Pharmacokinetic Properties of Amantadine and Oseltamivir.
Brief Summary: This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers.


Options:
A: To characterize the pharmacokinetics of amantadine following twice daily administration alone or in combination with twice daily oseltamivir in healthy volunteers.; To characterize the pharmacokinetics of oseltamivir following twice daily administration alone or in combination with twice daily amantadine in healthy volunteers.
B: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (24 weeks)
C: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)
D: secondary influenza infection (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen
Brief Summary: This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.


Options:
A: Overall Survival (Up to 60 months)
B: Overall Survival (From the date of randomization up to 104 weeks (study cut-off))
C: Overall Survival Time (3 years)
D: Overall Survival (From randomization (Day 1) up to end of study (Month 60)); Radiographic Progression-free Survival (rPFS) (From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients
Brief Summary: The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: Development of OHSS; Ongoing pregnancy rate per embryo transfer
C: To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation. (In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum)
D: Incidence of late progesterone rise on the day of HCG triggering (Up to delivery (2010))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial)
Brief Summary: The purpose of this study is to investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure.


Options:
A: Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First (Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.)
B: A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure (by the end of the study)
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dressing: Comparison of 3-day and 7-day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-related Infection in ICU
Brief Summary: The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.


Options:
A: Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings (48 hours); Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies (48 hours)
B: Major catheter related infection
C: Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection (For the duration of catheter placement plus 2 days)
D: Prevention of catheter colonization

Answer: A