TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
Brief Summary: This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to be used in the study, clozapine and risperidone, are fully approved for the treatment of schizophrenia.


Options:
A: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score
B: Risperidone effectiveness is measured by time to relapse within the 52 week period.
C: Brief Psychiatric Rating Scale (BPRS) (intermittent); Clinical Global Impression Scale (intermittent)
D: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Risperidone Long Acting: A Healthcare Resource Utilization Pilot Study
Brief Summary: The primary objective of this pilot study is to evaluate the impact of switching 30 subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization. The study will be a ten month open-label, 'mirror-image', pilot study. Healthcare resource utilization during the 10 months prior to starting risperidone long acting will be retrospectively collected for all subjects (period A) at the beginning of the study. The utilization of direct medical resources will also be collected for 10 months after initiation of risperidone long acting (period B). In this design the patients will serve as their own control.


Options:
A: Hospitalization-free Survival - Time to Event (From randomization until date of first re-hospitalization, assessed up to 24 months); Hazard Ratio for Hospitalization (24 months)
B: Likelihood of accepting a recommendation of long-acting atypical antipsychotic medication; Compare the time until the first episode of antipsychotic nonadherence as defined by 2 or more weeks of continuous and intentional cessation of all prescribed antipsychotic medication; Compare the total amount of outpatient days spent adherent to antipsychotic medication as a proportion of outpatient days in the study; Compare patient and family attitudes and satisfaction with antipsychotic medication given by long-acting route vs. oral route of drug delivery; 5. Modify and adapt psychoeducational material designed for multiple episode patients to better fit the needs of recently diagnosed patients with schizophrenia.
C: to evaluate the safety and tolerability of two dose ranges (6 weeks)
D: To assess the impact of switching subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization. This will be evaluated by assessing:; Direct cost of care; Frequency and duration of institutional care; Discharge; Relapse

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Nosocomial Infection in Cardiac Surgery by Decontamination of the Naso- and Oropharynx With Chlorhexidine. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Brief Summary: Does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI?


Options:
A: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)
B: Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria (21 days)
C: Nosocomial Infection
D: Development of VAP (Clinical Pulmonary Infection Score) (Baseline up to 5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Nosocomial Infection in Cardiac Surgery by Decontamination of the Naso- and Oropharynx With Chlorhexidine. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Brief Summary: Does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI?


Options:
A: Prevention of ventilator-associated pneumonia (60 days)
B: Nosocomial Infection
C: Ventilator-Associated Pneumonia (VAP) (28 days)
D: Rate of ventilator associated pneumonia (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Controlled Assessment of Once-Daily Controlled Release COREG CR vs Twice-Daily COREG Immediate Release(IR)on Measures of Compliance and Quality of Life in Patients With Heart Failure and Left Ventricular Systolic Dysfunction
Brief Summary: The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.


Options:
A: Dosing compliance: pill taking total taken vs number prescribed
B: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
C: Percentage of Participants With Depression Treatment Response (6 months)
D: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities
Brief Summary: This follow up study (\>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.


Options:
A: Total Weight Change From Baseline at 12 Weeks in kg (12 weeks)
B: BMI (5 y); Metabolic normalization (5y); Gastro-intestinal side effects (5y)
C: Improvement of co-morbidities (1-year after treatment start)
D: effectiveness in terms of weight loss, reduction in co-morbidity and quality of life (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Brief Dental Office Intervention With Tobacco Quitline
Brief Summary: The novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. Linking the patient-specific oral health information obtained during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic loop for oral health professionals and make them a focal point for the tobacco use intervention without increasing clinical burden.


Options:
A: Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.
B: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
C: Point prevalence tobacco abstinence at 3 and 6 months
D: Biomarkers (Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Management of Childhood Diabetes Study
Brief Summary: This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low intensity, multi-component behavioral intervention is effective in preventing the deterioration in glycemic control, treatment adherence, and quality of life that commonly occur during late childhood and early adolescence in youth with type 1 diabetes. The study will also examine mechanisms and processes that influence the effectiveness of family management of diabetes during this developmental period.


Options:
A: Hemoglobin A1c (0, 3, 6, 12, 18, 24, 30 months)
B: Parent Report Measures (5 years)
C: glycemic control (1/2006-3/2009); treatment adherence (1/2006-3/2009)
D: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Management of Childhood Diabetes Study
Brief Summary: This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low intensity, multi-component behavioral intervention is effective in preventing the deterioration in glycemic control, treatment adherence, and quality of life that commonly occur during late childhood and early adolescence in youth with type 1 diabetes. The study will also examine mechanisms and processes that influence the effectiveness of family management of diabetes during this developmental period.


Options:
A: ER visits (18 months)
B: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
C: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
D: glycemic control (1/2006-3/2009); treatment adherence (1/2006-3/2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
Brief Summary: The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.


Options:
A: Surgical wound infection (30 days)
B: Cumulative 24 Hour Oral Morphine Equivalent Consumption (24 hours (Day 1))
C: • Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery (1-24 hours post-operatively)
D: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair (Post-operatively (Day 1))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
Brief Summary: The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.


Options:
A: Surgical wound infection (30 days)
B: Painscore during mobilization (2-24 hours after extubation time.)
C: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
D: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
Brief Summary: The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.


Options:
A: Lung cytokines in mechanically ventilated patients (30 months)
B: invasive arterial blood pressure as a Measure of Safety (Day 1)
C: Surgical wound infection (30 days)
D: To increase the number of lungs that meet the eligibility criteria for transplantation (end of brain death diagnosis observation period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
Brief Summary: The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.


Options:
A: Surgical wound infection (30 days)
B: Painscore during mobilization (2-24 hours after extubation time.)
C: Nausea (0-72 hours postoperative)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
Brief Summary: The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.


Options:
A: 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)
B: Incisional Surgical Wound Infection (0 to 14 days after surgery)
C: Surgical wound infection (30 days)
D: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Telithromycin 800 mg (Once Daily for 10 Days) as a Supplement to the Standard of Care for Patients With Acute Exacerbations of Asthma
Brief Summary: Primary Objective:

* The primary objective is to evaluate the clinical efficacy of telithromycin versus placebo as a supplement to the usual standard of care during an acute exacerbation of asthma. Efficacy will be assessed by:

  * Changes in the diary card summary symptom score assessed daily for 6 weeks, and
  * Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral telithromycin treatment

Secondary Objectives:

The secondary objectives of the study are:

* To evaluate the microbial activity of telithromycin during an exacerbation of asthma by:

  * Assessment of the patient's clinical improvement relative to initial C. pneumoniae or M. pneumoniae status, and
  * Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae by culture and quantitative Polymerase Chain Reaction (PCR).
* To evaluate the safety of 10 days of oral telithromycin as a supplement to the standard of care for patients with acute exacerbations of asthma
* To assess additional efficacy endpoints and health outcome evaluations following 10 days of treatment with either oral telithromycin or placebo, with either treatment used as a supplement to the standard of care for patients with acute exacerbations of asthma:

  * Changes and daily variability in the PEFR during the 6 weeks of study treatment,
  * Health status at follow-up (6 weeks)
  * Pulmonary function tests:

    * Forced Expiratory Volume in 1 second (FEV1)
    * Forced Vital Capacity (FVC)
    * Forced Expiratory Flow Rate (FEF25-75%)
  * Need for additional medications (e.g., inhaled corticosteroids, oral corticosteroids, bronchodilator use),
  * Time to next acute exacerbation of asthma.


Options:
A: Diary card summary symptom score (10 days after randomisation)
B: Patient's daily diary summary symptom scores/Morning diary PEFR (During the Study Conduct)
C: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
D: Peak expiratory flow rate. (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere®) Plus Cisplatin and 5-Fluorouracil (TPF) Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil Followed by Concomitant Chemoradiotherapy to Improve the Overall Survival and Progression Free Survival in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Brief Summary: * 1.To compare overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5FU) or the control treatment (PF: cisplatin plus 5-FU) followed by chemoradiotherapy in patients with locally advanced SCCHN.
* 2.The main secondary endpoint is progression free survival (PFS). The other secondary endpoints are to evaluate and compare improvement of local symptoms; time-to-treatment failure; quality of life; clinical complete response rate (CR and CR/PR); toxicity and to evaluate the relationship of tumor markers and response to therapy.


Options:
A: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
B: Overall Survival Time (OS) (time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
C: Overall Survival (3-years)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere®) Plus Cisplatin and 5-Fluorouracil (TPF) Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil Followed by Concomitant Chemoradiotherapy to Improve the Overall Survival and Progression Free Survival in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Brief Summary: * 1.To compare overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5FU) or the control treatment (PF: cisplatin plus 5-FU) followed by chemoradiotherapy in patients with locally advanced SCCHN.
* 2.The main secondary endpoint is progression free survival (PFS). The other secondary endpoints are to evaluate and compare improvement of local symptoms; time-to-treatment failure; quality of life; clinical complete response rate (CR and CR/PR); toxicity and to evaluate the relationship of tumor markers and response to therapy.


Options:
A: overall survival (3 years)
B: Quality of Life (1-year post treatment)
C: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
D: Event free-survival (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women
Brief Summary: The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women


Options:
A: Parameters of the metabolic syndrome (At baseline, and after 6 and 12 months)
B: Framingham Risk Score (15 months)
C: weight change at 18 months (18 months)
D: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HAART Adherence Interventions in Africa: An RCT
Brief Summary: This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence.


Options:
A: Pill count (18 months)
B: N/A
C: Adherence to ART and HIV RNA suppression (6,12 months)
D: Medication adherence (At Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
Brief Summary: The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.


Options:
A: Change in trough FEV1 after 12 weeks of treatment. (week 12)
B: The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment. (week 12)
C: morning peak expiratory flow rate (PEFR) (50 weeks)
D: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
Brief Summary: The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
B: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment (23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period)
C: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
D: morning peak expiratory flow rate (PEFR) (50 weeks)

Answer: D