TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin-guided Algorithms of Antibiotic Stewardship in the Intensive Care Unit: Systematic Review and Meta-analysis
Brief Summary: Sepsis is common and is associated with significant mortality, morbidity and health-care costs. Unfortunately, its diagnosis is not straightforward because its signs and symptoms are neither specific nor sensitive; in addition, microbiological cultures lack specificity, sensitivity and are plagued by high turn-around times. Because the delay in the institution of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU-patients, even when they are not needed. Procalcitonin may not be the long sought for bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the administered antibiotic courses once they are started.


Options:
A: Clinical Cure Rate at the End-of-treatment (EOT) Visit (End-of-treatment (Day 10 or Day 11))
B: Duration of antibiotic treatment for the first episode of infection; Total duration of antibiotic therapy; Antibiotic-free days at 28 days after study enrollment
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: mortality/survival (28 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
Brief Summary: This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.


Options:
A: The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)
B: Number of Participants With 1 or More Severe Asthma Exacerbations (Baseline to Follow-up (up to 76 weeks of treatment))
C: Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period (Baseline; Week 1 up to Week 4)
D: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
Brief Summary: This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.


Options:
A: Number of Participants With 1 or More Severe Asthma Exacerbations (Baseline to Follow-up (up to 76 weeks of treatment))
B: FEV1, (Forced expiratory volume in the 1st second).
C: Morning Peak Expiratory Flow (AM PEF) (Baseline (run-in) and throughout 12 weeks)
D: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
Brief Summary: This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.


Options:
A: Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26 (26 weeks)
B: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24)
C: Number of Participants With 1 or More Severe Asthma Exacerbations (Baseline to Follow-up (up to 76 weeks of treatment))
D: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders
Brief Summary: The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).


Options:
A: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)
B: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
C: Change in Clinical Global Impressions (CGI) Global Improvement (Change from Baseline at 8 Weeks); Change in Clinical Global Impressions (CGI) Global Improvement (Change from Open-Label Baseline at 8 Weeks); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Baseline at 8 Weeks.); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Open-Label Baseline at 8 Weeks)
D: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders
Brief Summary: The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).


Options:
A: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
B: Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score (Baseline to Week 12)
C: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))
D: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders
Brief Summary: The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).


Options:
A: hyperactivity, impulsiveness, and distractibility
B: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
C: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
D: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders
Brief Summary: The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).


Options:
A: Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)); Expressive Vocabulary Test (EVT) (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))
B: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)
C: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
D: Clinical Global Impression-Scale(CGI-S) (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease
Brief Summary: This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease.


Options:
A: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
B: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
C: Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) (8 weeks)
D: Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment (Baseline to 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation of Cancer Survivors in Denmark: A Randomized Controlled Trial on the Effect of a Multi-focused Psychosocial Rehabilitation Course
Brief Summary: This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at a Danish rehabilitation centre for cancer survivors. The investigators hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.


Options:
A: Fatigue (immediately before and after the intervention)
B: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)
C: psychosocial well-being (as assessed by the EORTC-QLQ C30 Quality of life core questionnaire by the European Organization of Research and Treatment in Cancer (EORTC-QLQ C30) and the Profile of Mood States Short form (POMS-SF) (baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up)
D: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation of Cancer Survivors in Denmark: A Randomized Controlled Trial on the Effect of a Multi-focused Psychosocial Rehabilitation Course
Brief Summary: This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at a Danish rehabilitation centre for cancer survivors. The investigators hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.


Options:
A: psychosocial well-being (as assessed by the EORTC-QLQ C30 Quality of life core questionnaire by the European Organization of Research and Treatment in Cancer (EORTC-QLQ C30) and the Profile of Mood States Short form (POMS-SF) (baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up)
B: Feasibility of Patient Recruitment to Yoga Intervention (10 weeks)
C: Change in psychosocial status (from baseline to 24 month)
D: Physical activity (12-weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191(NCI)/IC-200403(INCIENSA)
Brief Summary: Background:

- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B.

Objectives:

* To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination.
* To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover.

Eligibility:

- Women who participated in National Cancer Institute Protocol 04-C-N191.

Design:

* All participants will be offered vaccination against hepatitis B.
* Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV.
* Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A.
* Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive.
* All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.


Options:
A: Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7)
B: Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC) (At Month 7 (i.e. one month after the last dose of study vaccine))
C: N/A
D: Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia
Brief Summary: An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.


Options:
A: A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (baseline, up to 7 weeks of treatment); A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients (baseline, up to 7 weeks of treatment)
B: PANSS-total score
C: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
D: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia
Brief Summary: An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.


Options:
A: A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (baseline, up to 7 weeks of treatment); A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients (baseline, up to 7 weeks of treatment)
B: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
C: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)
D: Clinical Utility Index (CUI) (Baseline through Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Docetaxel+Cisplatin and 5-fluorouracil (TPF) Followed by Radiotherapy+Concomitant Chemo or Cetuximab Versus Radiotherapy+Concomitant Chemo or Cetuximab in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. A Randomized Phase III Factorial Study.
Brief Summary: This is a randomized multicenter open label phase III factorial trial evaluating the 3 years OS in patients with locally advanced squamous cell carcinoma of head and neck treated with locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or without neoadjuvant chemotherapy.


Options:
A: overall survival (3 years)
B: Overall survival (5 years)
C: Disease free survival (3 years)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial
Brief Summary: Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection.

In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways.

The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.


Options:
A: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the symptom cough between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of saltiness between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of throat irritation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.)
B: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)
C: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
D: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial
Brief Summary: Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection.

In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways.

The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.


Options:
A: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
B: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
C: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)
D: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)

Answer: A