TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Electronic Communications and Home Blood Pressure Monitoring
Brief Summary: The control of blood pressure (BP) for patients with hypertension on medications has been elusive, despite the availability of evidence-based nationally recognized guidelines for treatment and 30 years of research addressing this. At present, less than 50% of patients with known hypertension are adequately controlled. If BP control could be improved, significant decreases in cardiovascular morbidity and mortality would occur.

The purpose of this study is to conduct a randomized controlled trial of the effectiveness of the provision of home blood pressure measurement and electronic communications (secure messaging to health care providers) to improve hypertension control.


Options:
A: difference in change in systolic BP between the intervention and usual care groups (6 months)
B: *change in mean diastolic, systolic, and combined diastolic and systolic BP.; *percent of patients with adequately controlled BP.
C: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
D: Knowledge of Asthma (6 months after the first evaluation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Electronic Communications and Home Blood Pressure Monitoring
Brief Summary: The control of blood pressure (BP) for patients with hypertension on medications has been elusive, despite the availability of evidence-based nationally recognized guidelines for treatment and 30 years of research addressing this. At present, less than 50% of patients with known hypertension are adequately controlled. If BP control could be improved, significant decreases in cardiovascular morbidity and mortality would occur.

The purpose of this study is to conduct a randomized controlled trial of the effectiveness of the provision of home blood pressure measurement and electronic communications (secure messaging to health care providers) to improve hypertension control.


Options:
A: BP at 6 months (6 months)
B: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
C: Anticoagulation-related quality of life (Four months)
D: *change in mean diastolic, systolic, and combined diastolic and systolic BP.; *percent of patients with adequately controlled BP.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.
Brief Summary: The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.


Options:
A: Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose (Single measurement taken1 hour post-dose at the end of each 1-week treatment period)
B: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
C: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
D: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.
Brief Summary: The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.


Options:
A: Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose (from baseline up to 12 weeks)
B: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)
C: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
D: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.
Brief Summary: The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.


Options:
A: Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date (From the date of randomization until date of death due to any cause (average of 2 study years))
B: the frequency of exacerbations compared to a control group
C: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
D: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.
Brief Summary: The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.


Options:
A: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
B: Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date (From the date of randomization until date of death due to any cause (average of 2 study years))
C: CRP (4 weeks)
D: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.
Brief Summary: The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.


Options:
A: All cause mortality at 3 years
B: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose (Baseline to 12 weeks)
C: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.
Brief Summary: The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
C: All cause mortality at 3 years
D: CRP (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
Brief Summary: Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.


Options:
A: Rehospitalizations and psychotic relapse at two years
B: relapse rate (1 year)
C: Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.
D: relapse rate (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
Brief Summary: After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.


Options:
A: relapse rate (1 year)
B: Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.
C: Clinical Global Impression every 2 weeks; Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks; Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks; Abnormal Involuntary Movement Scale every 2 weeks; Drug Attitude Inventory every 2 weeks; Calgary Depression Scale for Schizophrenia every 2 weeks; Brief Psychiatric Rating Scale every 2 weeks
D: relapse rate (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
Brief Summary: Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index \[BMI\] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.


Options:
A: Live birth rate (End of pregnancy)
B: Rate of cancellation due to low ovarian response (one month)
C: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
D: Total number of retrieved oocytes (Two weeks Metformin treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
Brief Summary: Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index \[BMI\] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.


Options:
A: Clinical pregnancy rate (4 weeks after embryo transfer)
B: Rate of OHSS (one month)
C: Number of mature(MII) oocyte (Day1(from the day of oocyte retrieval to fertilization confirmation))
D: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
Brief Summary: Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index \[BMI\] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.


Options:
A: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
B: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)
C: Clinical pregnancy (within 6 calendar months of randomisation)
D: The main outcome was change in body weight. (Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo
Brief Summary: The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia


Options:
A: Onset meaningful pain reduction
B: Primary outcome measure is the Impairment level SumScore (ISS): pain, active range of motion and temperature, measured with VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer (t=0; t= 3 months; t= 6 months; t= 9 months)
C: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)
D: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo
Brief Summary: The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia


Options:
A: Onset meaningful pain reduction
B: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
C: Number of Participants With Loss of Therapeutic Response. (13 Weeks)
D: Daily Evening Patient Reported Pain Intensity Scores (Baseline and 6 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
Brief Summary: The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.


Options:
A: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
B: Nerve conduction measurements; Pain scores from patient diaries
C: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
D: Visual Analogue Scale (12 months); Oswestry Disability Index (12 months); Adverse Events (12 months); Number of pain medication (12months); Quality of life scale (12months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
Brief Summary: The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.


Options:
A: Nerve conduction measurements; Pain scores from patient diaries
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo (Baseline up to Week 5 postdose, up to 10 months total follow up)
D: Onset meaningful pain reduction

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.
Brief Summary: To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the combination in patients with symptomatic myocardial ischemia.

Amlodipine's use in angina has been well documented in clinical trials such as the Circadian Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical practice has not been tested. Furthermore, the potentially synergistic benefit of atorvastatin and amlodipine on inflammation ischemic activity has not been studied.


Options:
A: Effects on HDL-C and Triglycerides after 12 weeks; Safety after 12 weeks
B: From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).
C: N/A
D: Androgen secretion (0, 3, 6 months); Glucose metabolism (0, (3), 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD
Brief Summary: To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as much as possible will improve prognosis in CHD patients compared with a strategy reflecting current best clinical practice with simvastatin.


Options:
A: Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest
B: Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2. (6 weeks, 14-18 weeks, 22-24 weeks)
C: Raw Urine Osmolality value at 12 week follow-up, adjusted for baseline (UOsm in mOsm/Kg) (12 weeks follow-up)
D: Relative reduction in circulating osteoprotegerin levels (18 weeks)

Answer: A