TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Options:
A: Trough Forced Expiratory Volume at 1 Second (FEV1) (12 weeks)
B: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24)
C: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis) (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Options:
A: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
B: Exacerbation Rate (From randomization to the patients final study visit (up to 12 months))
C: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (up to week 12)
D: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (Measured at clinic visits: 1, 4, 8 and 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Options:
A: Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) (Change from baseline (Week 0) to Week 12); Part B: Morning Predose (Trough) FEV1 (Change from baseline (Week 0) to 52 Weeks)
B: Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. (Day 15)
C: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
D: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) (Change from Baseline to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Options:
A: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
B: Rate of moderate/severe exacerbations over a 52 week treatment period
C: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)
D: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial
Brief Summary: Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?


Options:
A: Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC). (30 days)
B: Composite of arterial access related complications (30 days)
C: Time to Hemostasis (TTH) (From when the introducer sheath was removed to the time hemostasis was first observed); Time to Ambulation (TTA) (From when the introducer sheath was removed to 30 days post-procedure); Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure (From post-procedure to 30 days follow up)
D: Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. (20 minutes, 1 hour and at discharge, pooled)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.
Brief Summary: "Fit for Delivery" is a randomized, controlled study to examine the effects of an intervention during pregnancy which consists of exercise groups and nutritional counselling. The investigators will assess the outcomes of gestational weight gain, postpartum weight retention, large newborns, glucose regulation, and the incidence of complications of pregnancy and delivery such as gestational diabetes and Cesarean section.


Options:
A: Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations (Delivery (when the baby is delivered))
B: Excessive weight gain during pregnancy (2007-2023)
C: Maternal Weight Change (baseline to 2 weeks post partum)
D: Maternal weight gain in pregnancy (Measured at the time of delivery); Weight of the newborn (Measured at the time of delivery); Maternal fasting serum glucose level (Measured at gestational week 30); Incidence of operative delivery, both cesarean section and operative vaginal delivery (Assessed following delivery); Maternal body composition (Measured at 36 weeks of gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
Brief Summary: The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese participants with active rheumatoid arthritis and inadequate response to methotrexate.


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.
C: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period (Day 169); Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period (Day 533); Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period (Baseline to Day 533); Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period (Day 533); Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period (Baseline to Day 533)
D: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
Brief Summary: The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.


Options:
A: Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure (12 Months)
B: CPAP Therapy Adherence (30 days post in-lab split night polysomnogram)
C: Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale. (Before and after 6 months of follow-up)
D: Differences in compliance among the three different strategies, measured by CPAP hours of use (six months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
Brief Summary: Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.


Options:
A: incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (5 months)
B: Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2 (1 year)
C: Change from baseline in the isotopic ratio of iron in blood at week 5 (Baseline and Week 5)
D: child nutritional status (Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
Brief Summary: Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.


Options:
A: gut microbiota composition (Fecal sample after 2 months)
B: Product sales and use (coverage) (Every 2 weeks)
C: incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (5 months)
D: Stunting-reduction in stunted children in intervention group (2 Years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
Brief Summary: Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.


Options:
A: Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9; Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9; Blood samples examined for haemoglobin level mont 0 and month 9
B: Death among children 1-36 months of age
C: incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (5 months)
D: Isotope absorption into blood stream (Day 15); Isotope absorption into blood stream (Day 43)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
Brief Summary: The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.


Options:
A: The effect of uterine size or posture on IUD insertion. (Day 1)
B: The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale (after IUD insertion)
C: Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale (assessed immediately post IUD insertion)
D: Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider. (over one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Comparison Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics With Metformin
Brief Summary: Objectives:

Primary

1. Primary prevention of new onset of hypertension

Secondary

1. Reduction of 24h BP in type II diabetics with prehypertension
2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN
3. Reduction in the total cardiovascular risk
4. 3 years morbidity and mortality rates
5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN


Options:
A: New onset of hypertension (36 months)
B: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 52 weeks)
C: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Week 24)
D: Time from randomization to the primary action point (monotherapy failure).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: How to Help When Silence is Not Golden A RCT Study of Selective Mutism
Brief Summary: Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk. SM may cause great suffering and create problems, both socially and related to learning. SM is associated with social anxiety, neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate assessment and treatment of SM is seldom provided in the mental health services. SM is considered hard to treat, and randomised treatment studies are lacking. This study will examine the effect of a manual based treatment for SM. The treatment consists of home- and kindergarten /school based interventions including behaviour techniques and psychoeducation. Defocused communication is a general treatment principle. Comorbidity, including neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot study was conducted to ensure the feasibility of the planned effectiveness study. Seven children, aged 3-5 years were included. Six has started treatment, and all talked in the kinder garden within the first 3 months. The present study will have a randomised controlled design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3 months), and then manual based intervention. The sample: Children aged 3-9 years consecutively referred to the school psychology- or the mental health services in Oslo and Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to answer our primary research question. The treatment will be given by a therapist from the research group or by a local clinician under supervision. The study can add essential knowledge on treatment of SM and make effective treatment available to clinicians in the community.


Options:
A: Change in Diagnostic severity of social anxiety disorder (ADIS CSR score) (2 week and 6-month follow-up); Change in Treatment response/non-response (a CGI-I of Improved or better, ratings of 1-3, 3 = Improved) (2 week and 6-month follow-up)
B: School version of the Selective Mutism Questionnaire (SSQ) (at 3, 6, 12 months)
C: Clinical Global Impression Scale Improvement and Severity (After 12 weeks of treatment); Pediatric Anxiety Rating Scale (After 12 weeks of treatment)
D: Clinical Global Impression - Improvement Scale (Measured at Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.


Options:
A: N/A
B: Death (Day 28)
C: 90-days mortality (90 days)
D: Ventilator-free Days (VFDs) to Study Day 28 (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.


Options:
A: N/A
B: Myocardial Infarct Size (At 72 hours post infarct)
C: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)
D: all-cause mortality (day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.


Options:
A: N/A
B: Surgical site infection (2 weeks)
C: Surgical wound infection (30 days)
D: Frequency of patients with the composite outcome measure of either a subsequent, new or recurrent, cancer registration or a new histological specimen showing any neoplasm (36-60 months after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: NAFLD in T2DM: Prevalence in Hispanics and Role of Treatment
Brief Summary: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition frequently associated with type 2 diabetes (T2DM) and characterized by insulin resistance and hepatic fat accumulation. Liver fat may range from simple steatosis to severe steatohepatitis with necroinflammation and variable degrees of fibrosis (nonalcoholic steatohepatitis or NASH). Up to 40% of patients with NAFLD develop NASH in recent series. Risk factors for progression to NASH are unclear, but appears to be more common and progress more rapidly in older individuals, and in the presence of obesity and T2DM. Because the VA population in San Antonio, Texas, frequently combine these risk factors for NASH it was felt that a study targeting this very high-risk population was needed.

This study will establish the long-term efficacy (primary endpoint: liver histology) and safety of pioglitazone for the treatment of VA patients with T2DM and NASH. All patients diagnosed with NASH will be offered lifestyle modification/weight loss (current standard of care) while being randomized to pioglitazone, vitamin E or placebo for up to 3 years. We believe that in such a high-risk population for complications from NASH, a substantial benefit may be expected from early detection and treatment.

Specifically, the arms are: a) pioglitazone + vitamin E; b) vitamin E + placebo of pioglitazone; c) placebo of both. Patients are randomized to one of these 3 arms, and followed in a double-blind fashion for up to 18 months. Patients are then offered to continue into an open-label phase with pioglitazone + vitamin E or vitamin E alone for another 18 months.


Options:
A: Biochemical: Number of Patients With Normal Transaminases at End of Treatment. (24 weeks); Physiological: Absolute Change in Liver Fat (Baseline and 24 weeks)
B: Hepatic steatosis (6 months)
C: Serum alanine transaminase level decrease min. 0.3 upper limit of normal (6 months)
D: Liver Histology (Kleiner's et al Criteria, Hepatology 2005) (18 months)

Answer: D