TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)
Brief Summary: Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay.

Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced.

Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.


Options:
A: Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours (2 years)
B: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)
C: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)
D: compare the rate of admission to hospital between the study and control groups (1 hour after treatment ends)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)
Brief Summary: Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay.

Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced.

Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.


Options:
A: compare the rate of admission to hospital between the study and control groups (1 hour after treatment ends)
B: Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours (2 years)
C: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
D: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Pack Supply on Oral Contraception Continuation
Brief Summary: The purpose of this study is to determine whether getting more packs of birth control pills leads to improved continuation, when compared with getting the traditional supply.


Options:
A: Use of a Effective Contraceptive Method at Four-months Post-abortion (4 months)
B: contraceptive continuation (6 months)
C: N/A
D: oral contraception continuation (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients


Options:
A: 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)
B: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52); Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52)
C: Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) (10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication); Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) (Week 48); TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) (Week 48); COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) (48 weeks)
D: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 (Baseline and Day 337); Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (During actual study treatment period (planned Day 1 to Day 337))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients


Options:
A: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52); Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa
Brief Summary: The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.


Options:
A: Parasitological failure by day 28 (Within 28 days of treatment.)
B: Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42. (42 days)
C: Parasitological failure rates; Parasite clearance time; Fever clearance times; Incidence rate of adverse events
D: Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population (Day 28); Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
Brief Summary: The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.

Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?


Options:
A: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
B: Weight Change From Baseline to 12 Months (12 months)
C: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
D: To contribute to the ADDITION-Europe study, to assess screening and intensive treatment on 5 year cardiovascular outcomes (At end of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
Brief Summary: The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.

Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?


Options:
A: Primary outcome measure was step count (6-weeks)
B: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
C: Physical activity measured by accelerometry. (3 months post-randomisation)
D: Adherence to the pedometer-based physical activity regimen (24 weeks post baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
Brief Summary: The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.

Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?


Options:
A: Progression to diabetes (6 monthly intervals for 2 years)
B: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
C: Diabetes incidence (During the intervention period + after the intervention has been stopped)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study Testing the Safety and Activity of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Advanced Stage Renal Cell Carcinoma in Combination With Sunitinib
Brief Summary: Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.


Options:
A: Progression Free Survival (2 3/4 years)
B: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
C: Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met. (24 weeks)
D: Overall Survival (OS) (Baseline up to Month 80)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Combination Study of AZD2281 and Cisplatin Plus Gemcitabine in Adults With Solid Tumors
Brief Summary: Background:

* AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage; PARP inhibitors interfere with that process.
* Cisplatin and gemcitabine are approved by the United States Food and Drug Administration to treat certain cancers.

Objectives:

* To determine the optimum doses of AZD2281, cisplatin and gemcitabine in combination that can safely be given to patients with solid tumor cancers.
* To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment.

Eligibility:

-Patients 18 years or older with an advanced solid tumor cancer for whom standard treatments are not effective.

Design:

* In this dose escalation study, the first small group of patients receives the smallest study doses of the study drugs. Subsequent groups receive incrementally higher doses as long as the preceding group does not experience unacceptable side effects. When the highest safe dose is determined, additional patients entering the study receive that dose.
* Patients receive treatment in 21-day cycles as follows:
* Days 1-4: AZD2281 by mouth twice a day
* Day 3: gemcitabine thorough a vein over 1 hour; then cisplatin through a vein over 1 hour.
* Day 10: gemcitabine through a vein over 1 hour.
* Evaluations during treatment include the following:
* Physical examination, vital signs check and blood tests every 3 weeks.
* CT scans every 6 weeks to evaluate the tumor.
* Treatment may continue until it is no longer beneficial.


Options:
A: Establish the safety and tolerability of AZD2281 in combination with cisplatin and gemcitabine in patients with solid tumors. Establish the maximum tolerated dose (MTD) for the combination of AZD2281 with cisplation and gemcitabine.
B: Best Overall Response (BOR) (Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009)
C: Safety/Toxicity (End of treatment)
D: To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin (assessed at each visit)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
B: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
C: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)
D: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
B: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
C: Change in PASI score from baseline in the two groups (12 weeks)
D: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
B: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
C: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
D: Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
B: Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline (Baseline to Week 16)
C: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
D: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.


Options:
A: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)
B: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
C: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks (12 weeks); Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 (12 weeks)
D: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses
Brief Summary: This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.


Options:
A: Technical success (1 minute after the final balloon angioplasty); Primary patency (1 year)
B: N/A
C: N/A
D: Percent of Participants With Treatment Area Primary Patency (TAPP) (6 month follow-up)

Answer: D