TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis
Brief Summary: Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab versus azathioprine


Options:
A: Time from remission to relapse
B: Number of major relapse (BVAS>10) in each group at the end of the maintenance treatment (18 months treatment + 10 months follow-up) (28 months)
C: Proportion of patients with CMV reactivation and time to CMV reactivation (Over 12 month period)
D: Composite of i) All-cause Mortality or ii) End-stage Renal Disease (Time frame varied by subject: minimum of 1 year - maximum of 7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days
Brief Summary: Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.


Options:
A: Periodontal Pocket Depth (PPD) (30 day.)
B: Volatile sulfur compounds (VSCs) (5 weeks)
C: Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements. (4 hours)
D: Oral malodor (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ketamine as a Rapid Treatment for Post-traumatic Stress Disorder
Brief Summary: The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg) decreases symptoms of PTSD.


Options:
A: Impact of Event Scale - Revised (IES-R) (7 days after first infusion)
B: Changes in CAPS Scores. (Baseline, 8 weeks)
C: PTSD Symptoms (8 weeks)
D: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Pharmacokinetic Study In Patients With Inadequate Response To Deferasirox (Exjade)
Brief Summary: This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron overload.

The hypothesis is that patients with poor responses have physiologic barriers to deferasirox that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or genetic factors.


Options:
A: Heart Failure (1yr); Arrhythmia (1yr)
B: Efficacy of amlodipine in retarding rate of myocardial iron deposition (Assessed by change in T2* times) (At baseline, and then at 6 months and 12 months from the start of the study)
C: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks (Baseline and 96 weeks)
D: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Pharmacokinetic Study In Patients With Inadequate Response To Deferasirox (Exjade)
Brief Summary: This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron overload.

The hypothesis is that patients with poor responses have physiologic barriers to deferasirox that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or genetic factors.


Options:
A: Myocardial T2* values (msec) (6 and 12 months)
B: Efficacy of amlodipine in retarding rate of myocardial iron deposition (Assessed by change in T2* times) (At baseline, and then at 6 months and 12 months from the start of the study)
C: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
D: Heart Failure (1yr); Arrhythmia (1yr)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Pharmacokinetic Study In Patients With Inadequate Response To Deferasirox (Exjade)
Brief Summary: This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron overload.

The hypothesis is that patients with poor responses have physiologic barriers to deferasirox that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or genetic factors.


Options:
A: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
B: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
C: The primary outcome measure is to assess the safety and tolerability of combining DFO and deferasirox in thalassemia subjects with translation iron overload. (34 days)
D: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program
Brief Summary: The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.


Options:
A: Weight (baseline, 1, 2, 3 years)
B: Among patients from the targeted diseases group, we aim at improving: a)the proportion of subjects who have an initial intervention planned, according to the CCPGO; b)the proportion of subjects who lose at least 5% of their initial weight. (18 months); Among patients from the regular follow-up group, we aim at improving: a)the proportion of patients who have measured weight, BMI and waist circumference and b)the proportion of overweight or obese subjects who have an initial intervention planned. (18 months)
C: Change in BMIz score (Baseline to 6 months)
D: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
B: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
C: Reduction in bacterial load (1 year)
D: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)
B: Reduction in bacterial load (1 year)
C: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)
D: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline (End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.); Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline (End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.); 24-hour Sputum Weight(g) (Baseline and day 28); Slow Vital Capacity (SVC) (Baseline and day 28); Forced Expiratory Volume in 1 Second (FEV1) (Baseline and day 28); Forced Vital Capacity (FVC) (Baseline and day 28); Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) (Baseline and day 28); Morning Peak Expiratory Flow (PEF) (Last 7 days on treatment); Evening Peak Expiratory Flow (PEF) (Last 7 days on treatment); Bronkotest Diary Card Signs and Symptoms (Last 7 days on treatment); St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) (Baseline and day 28)
B: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
C: Reduction in bacterial load (1 year)
D: Bronchiectasis Exacerbation (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)
B: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo (Up to Week 48); Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo (Up to Week 48)
C: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)
D: Reduction in bacterial load (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
B: Number of pulmonary exacerbations (One year)
C: Reduction in bacterial load (1 year)
D: Lung function (FEV1, FVC, FEF25-75)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)
B: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
C: Reduction in bacterial load (1 year)
D: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: Time to first exacerbation (One Year)
B: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
C: Time to first pulmonary exacerbation (from baseline) (48 weeks)
D: Reduction in bacterial load (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.
Brief Summary: The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at three months.


Options:
A: Percent Change From Baseline Weight (Baseline, 2 years)
B: N/A
C: Change in Body Weight. (one year)
D: Bodyweight (Six Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.
Brief Summary: The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized.

Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP.

Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.


Options:
A: Subjective cure rate (compared to results of TVT)
B: Subjective Cure of Urinary Incontinence at 12 Months After Surgery (12 months)
C: A change in number of cured patients (Up to 1 year)
D: Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 2 (Mayo): Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients
Brief Summary: Specific aim: To test whether transfusion of leukoreduced red cells of lesser storage time (versus conventional storage time) reduces mild alterations in pulmonary function and immune activation in critically ill patients with mechanically ventilated lungs.

We propose to perform a prospective, randomized, double-blind clinical trial in critically ill patients whose lungs are mechanically ventilated, and who have orders to receive transfusion of at least one unit of packed red cells, comparing pulmonary function between patients randomly allocated to receive a unit of red cells stored for 5 days or less, with similar patients randomly allocated to receive a unit of red cells stored conventionally (median 21 days). We will test the hypothesis that transfusion of red cells of lesser storage age, (5 days or less) will produce the less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days).


Options:
A: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital (4hrs)
B: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. (30 days post surgery.); Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events (30 days post surgery); Effect of RBC Age on Occurrence of Neurologic Events (30 days post surgery.); Effect of RBC Age on Occurrence of Pulmonary Events. (30 days post surgery.); Effect of RBC Age on Occurrence of Renal Failure (30 days post surgery.); Effect of RBC Age on Occurrence of Infection Events (30 days post surgery.); Effect of RBC Age on Occurrence of Atrial Fibrillation (30 days post surgery.); Effect of RBC Age on Occurrence of Asystole (30 days post surgery.); Effect of RBC Age on Occurrence of Gastrointestinal Events (30 days post surgery.); Effect of RBC Age on Occurrence of Any Reoperation (30 days post surgery.); Effect of RBC Age on Occurrence of Vascular Events (30 days post surgery.)
C: Microcirculatory Flow Index (MFI) before and after blood transfusion. (One hour after the end of blood transfusion compared with before blood transfusion)
D: We will test the hypothesis that the transfusion of red cells of lesser storage age, (5 days or less) will produce less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days). (At the end of the transfusion as compared to the beginning of the transfusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 2 (Mayo): Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients
Brief Summary: Specific aim: To test whether transfusion of leukoreduced red cells of lesser storage time (versus conventional storage time) reduces mild alterations in pulmonary function and immune activation in critically ill patients with mechanically ventilated lungs.

We propose to perform a prospective, randomized, double-blind clinical trial in critically ill patients whose lungs are mechanically ventilated, and who have orders to receive transfusion of at least one unit of packed red cells, comparing pulmonary function between patients randomly allocated to receive a unit of red cells stored for 5 days or less, with similar patients randomly allocated to receive a unit of red cells stored conventionally (median 21 days). We will test the hypothesis that transfusion of red cells of lesser storage age, (5 days or less) will produce the less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days).


Options:
A: We will test the hypothesis that the transfusion of red cells of lesser storage age, (5 days or less) will produce less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days). (At the end of the transfusion as compared to the beginning of the transfusion)
B: Measure of Non-transferrin-bound Iron (four hours after transfusion)
C: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital (4hrs)
D: Glasgow Outcome Scale (at 6 months after injury)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.
Brief Summary: The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold standard therapy for SNV is currently represented by the association of Cyclophosphamide and Prednisone. The limits of this approach are the high frequency of recurrent disease and an increased incidence of malignancy and infections. The aim of the present study is to compare the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.


Options:
A: Number of relapses (at 28 months)
B: Time from remission to relapse
C: Time to First Relapse (Approximately up to 4 years)
D: Composite of i) All-cause Mortality or ii) End-stage Renal Disease (Time frame varied by subject: minimum of 1 year - maximum of 7 years)

Answer: B