TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
Brief Summary: This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.


Options:
A: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 (Month 6)
C: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
D: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
Brief Summary: This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 (Month 6)
B: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)
C: Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline to Week 12); Part B: Percentage of Participants Achieving ACR20 Response at Week 24 (Baseline to Week 24); Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 (Baseline, Week 16); Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 (Baseline, Week 52)
D: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study
Brief Summary: The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.


Options:
A: Number of Participants With All-cause Mortality (As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months); Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation (As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months)
B: Change in Weight From Baseline (Baseline and 52 weeks); Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline (52 weeks)
C: To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
D: Evaluate the main and interactional effects of risperidone and olanzapine on body mass index (BMI), other measures of obesity, and other health-related factors, including total cholesterol, lipid panels, blood glucose, glycohemoglobin, and prolactin (twelve months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study
Brief Summary: The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.


Options:
A: Number of Participants With All-cause Mortality (As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months); Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation (As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months)
B: Death or recurrent myocardial infarction (up to day 30); Severe hemorrhage (up to Day 9)
C: The composite of cardiovascular death, myocardial infarction (MI) and stroke
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Parallel-Group Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke
Brief Summary: The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.


Options:
A: Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2) (Day 90)
B: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)
C: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
D: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparison of Drug Eluting Balloon/Bare Metal Stent Versus Drug Eluting Stent Versus Bare Metal Stent for the Treatment of Patients With Acute ST-elevation Myocardial Infarction
Brief Summary: The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function.

The goals of this study are:

1. To compare 6-month angiographic outcome after primary angioplasty using drug eluting balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.
2. To compare stent apposition and stent endothelialization after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
3. To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.


Options:
A: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events (30 Days); Stent Arm - Ischemic Target Lesion Revascularization (1 year); Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis (1 year)
B: MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR) (2 years)
C: Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) (6 months)
D: ST segment resolution (90 min); Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up). (immediately after and at 8 month follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort
Brief Summary: The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin D to the mother during pregnancy. Participants are mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week 24 og gestation to 1 week after delivery. In addition all mothers are advised to take the recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an interventional trial with fish oil supplementation, and the vitamin D randomization is stratified by fish oil treatment group. The child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.


Options:
A: The prevalence of challenge-proven food allergy at 12 months of age (At 12 months of age); The occurrence of definite food allergy or tolerance at 6 years of age (At 6 years of age)
B: Prevalence in plasma 25OHD and parathyroid hormone at birth (at birth (baseline))
C: Persistent wheeze (0 to 3 years of age)
D: Number of Participants with D- deficiency or access (at 40 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (at 4 weeks of age); Number of Participants with D- deficiency or access (At 35 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (At 52 (+/-2 weeks) PMA (postmenstrual age))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort
Brief Summary: The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin D to the mother during pregnancy. Participants are mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week 24 og gestation to 1 week after delivery. In addition all mothers are advised to take the recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an interventional trial with fish oil supplementation, and the vitamin D randomization is stratified by fish oil treatment group. The child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.


Options:
A: Amount of calcium supplement ingested (8 weeks after ANC consultation, during which recruitment into the study occurred)
B: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
C: Persistent wheeze (0 to 3 years of age)
D: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort
Brief Summary: The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin D to the mother during pregnancy. Participants are mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week 24 og gestation to 1 week after delivery. In addition all mothers are advised to take the recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an interventional trial with fish oil supplementation, and the vitamin D randomization is stratified by fish oil treatment group. The child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.


Options:
A: 25-Hydroxyvitamin D Concentration (7 months)
B: Persistent wheeze (0 to 3 years of age)
C: Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor (18 months)
D: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
Brief Summary: A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.


Options:
A: Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS). (Baseline (Day 0) to Week 12)
B: Overall Incidence of Adverse Events (12 Months (from the 1st dose to the end of study))
C: Latency To Persistent Sleep (LPS) (10 days (5 intervals of two consecutive nights)); Sleep Latency (SL) (10 days (5 intervals of two consecutive nights))
D: TST (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy
Brief Summary: Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.


Options:
A: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
B: Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale (baseline to 6 months); Change in Hand Grip Strength (baseline to 6 months)
C: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
D: Disease free survival. (Up to end of year 2015)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy
Brief Summary: Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.


Options:
A: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)
B: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
C: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
D: Percent interlimb difference, change over 12 months. (Baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Doxycycline and Airway Inflammation in COPD: A Randomised Placebo Controlled Trial Studying the Effects of Doxycycline on Airway Inflammation in Patients With Moderate and Severe Stable COPD.
Brief Summary: COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.


Options:
A: Mean change in the Leicester Cough Questionnaire (LCQ) scores. (2 years)
B: Inflammatory markers (outcome will be assessed up to two months post initial bronchoscopy)
C: reduction of number of exacerbations; reduction of number of hospitalisations
D: myeloperoxidase in induced sputum (3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
Brief Summary: The purpose of this study is to investigate whether treatment against intestinal helminths in patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical outcome by enhancing host immunity.


Options:
A: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)
B: Change in TB-score compared to baseline (Wejse et al 2007) (2 months)
C: Change in markers of HIV-1 disease progression (12 weeks); CD4 count (12 weeks); HIV-1 RNA level (12 weeks); Genital HIV-1 RNA levels (12 weeks)
D: cure rate (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long Term, Open-Label, Safety Study of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
Brief Summary: A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.


Options:
A: Mean Subjective Sleep Diary Derived Total Sleep Time (TST) (Postnaprosyn baseline, Week 1, week 2, week 4)
B: mean subjective wake time after sleep onset (WASO) (Week 1)
C: Overall Incidence of Adverse Events (12 Months (from the 1st dose to the end of study))
D: TST (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis
Brief Summary: The purpose of this study was to investigate if adjuvant treatment with arginine (the substrate for nitric oxide production) rich food supplements could improve clinical outcome in patients with smear positive tuberculosis by affecting nitric oxide production.


Options:
A: Time to sputum culture conversion
B: Mortality
C: Time to sputum culture conversion (8 weeks of treatment)
D: Final outcome according to WHO (8 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Better Breast and Cervical Cancer Control for Korean American Women
Brief Summary: The long-term goal of this study is to build a sustainable,community-based outreach program using Korean American community health workers (CHWs) to promote breast and cervical screening among Korean American women, thereby reducing related morbidity and mortality. The study is designed to determine the effectiveness of a health literacy-focused tailored breast and cervical cancer control intervention delivered by CHWs.

The investigators hypothesized that, compared to KA women in the delayed intervention group, KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher levels of adherence to screening for breast and cervical cancer, (2) greater levels of health literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve decisional balance.


Options:
A: Change of Activities of Daily Life (ADL) (change from baseline at 6 months and 1 year); Change of Sense of Coherence (KASAM) (change from basline at 6 months and 1 year)
B: Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test) (Baseline); Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Post Test) (Up to 8-weeks post-treatment)
C: Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines (6 months)
D: Participation in cervical cancer screening (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Parallel-Group Study Examining the Efficacy and Safety of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type
Brief Summary: The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.


Options:
A: N/A
B: stride length by gait analysis with an optoelectronic system (VICON®) (3 months of treatment)
C: Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.
D: Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. (Baseline to Week 24); Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. (Baseline to Week 24)

Answer: D