TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Adventitious Lung Sounds as Indicators of Severity and Recovery of Lung Pathology and Sputum Location
Brief Summary: This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI).

Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will be collected within 24h of the first appointment. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus respiratory physiotherapy. Conventional treatment will consist on daily medical treatment prescribed by the physician. Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.

It is expected that ALS will be responsive to changes in patients' lung function after treatment. It is also expected that, by including a respiratory physiotherapy component in the treatment of patients with LRTI, they will express more improvements in a shorter period of time.


Options:
A: treatment failure at 72h after initiation of antibiotics (Time from the first dose use of antibiotics to 72 hours); in-hospital treatment failure due to multiple causes (Time from date of admission to discharge up to 1 week)
B: Muscle strength (Participants will be followed for the duration of hospital stay, an expected average of 8 days); Exercise capacity (Participants will be followed for the duration of hospital stay, an expected average of 8 days)
C: Length of Hospital Stay (End of hospital stay); Time to Clinical Stability (Daily for the duration of the hospital stay); Symptomatic and Functional Recovery Score (14, 30, and 60 days post-admission)
D: Change in adventitious lung sounds (24 hours after hospital presentation (baseline) and 3 weeks after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section
Brief Summary: The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section


Options:
A: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)
B: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))
C: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)
D: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section
Brief Summary: The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section


Options:
A: screening of Cessation of bleeding (screening until 24 hours after placenta disconnection); time duration to stop bleeding in the case of post-cesarean section (24 hours)
B: postpartum hemorrhage-1 (after delivery of baby); postpartum hemorrhage-2 (after delivery of the baby); postpartum hemorrhage-3 (after delivery of the baby)
C: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)
D: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial
Brief Summary: Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity.

The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established TUR-P.


Options:
A: Collection of Post-treatment Catheterization for Safety (Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days); Comparison of IPSS for Efficacy (3 month); Mean UroLift Improvement in IPSS at 12 Months (12 months)
B: Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met (Month 12)
C: The prevalence of lower urinary tract symptoms using ICS 2002 symptom definition (At enrollment)
D: Changes in the International Prostate Symptom Score (Baseline and 12 weeks after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
Brief Summary: The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.


Options:
A: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
D: Time to an Exacerbation (Baseline to end of study (up to 59 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
Brief Summary: The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.


Options:
A: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
B: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) (Baseline to168 days)
C: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
Brief Summary: The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.


Options:
A: Proportion of children with radiologically-defined bronchiectasis (at three years of age); The proportion of lung tissue affected by disease (at three years of age)
B: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
C: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
D: Change in FEV1 From Baseline to End of Treatment at Day 168 (change from baseline to day 168)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
Brief Summary: The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.


Options:
A: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
B: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
C: Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle (Day 29)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
Brief Summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.


Options:
A: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
B: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
C: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
D: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
Brief Summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.


Options:
A: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)
B: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
C: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)
D: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to Week 12)); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
Brief Summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.


Options:
A: 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)
B: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
C: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
D: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
Brief Summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.


Options:
A: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
B: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
C: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
D: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations
Brief Summary: This study is a multi-site randomized, controlled trial testing the effect of a combined intervention that includes a colorectal cancer (CRC) screening decision aid plus patient navigation in a diverse, primary care patient population in clinical sites in North Carolina and New Mexico.

Our primary aim is to determine the effect of the intervention on CRC screening completion six months after the index visit among all enrolled participants and among Latinos. Secondarily, we will determine how this intervention affects screening-related knowledge, self-efficacy, intent, and clinical communication, and examine whether these factors mediate the effect of the intervention on screening test completion. Lastly, we will explore whether insurance status, ethnicity, and patient language preference moderate the effect of the intervention on screening.


Options:
A: Up to Date Well Child Care (24 months); Emergency/Urgent Care Utilization (24 months); Parent experience of care (12 months)
B: Glycemic Control (12 months.)
C: Colorectal cancer screening completion (6 months)
D: New advance care planning documentation in the medical record (15 months after study enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP Study
Brief Summary: Sirolimus (SIR) has lead to a reduction of overall kidney size, a decrease in cyst density and general tubular cell proliferation in animal models, and to a reduction of the increase in creatinine and blood urea nitrogen by 34 and 39 percent respectively, as well as a reduction of cyst proliferation, expressed by a 30 percent reduction of overall kidney enlargement, a reduction in general cyst volume, and a reduction of the cyst volume density in the renal cortex in humans.

However, despite promising data from animal- and in vivo studies, most mammalian target of rapamycin inhibitor (mTOR-I) studies in patients with autosomal-dominant polycystic kidney disease (ADPKD) produced only subtle if any clinically relevant effects on cyst growth and the preservation of renal function.

In this study we will investigate if pulsed administration of SIR in a fixed weekly oral dose of 3 mg over 24 months compared to placebo significantly reduces cyst growth and preserves excretory renal function in patients with ADPKD and an estimated glomerular filtration (eGFR) rate below 60 mL/min per 1.73m2.


Options:
A: Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion. (AEs were recorded from screening (ICF was signed) until 7-Day follow-up)
B: Total Kidney Volume (Baseline, week 24, 52, 104, and 156); Renal Function Test (eGFR) (Baseline, Week 24, 48, 104, and 156)
C: Change in kidney function from baseline to month 24 (Baseline, 24 months)
D: Liver volume (at baseline and at 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Complementary Treatments for Smoking Cessation
Brief Summary: The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control.


Options:
A: Smoking abstinence (7 days)
B: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
C: Point prevalence abstinence at 6 months (6 months after beginning treatment)
D: Smoking Abstinence (6 months post quit day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Brief Summary: To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone.


Options:
A: the change in spherical equivalent (SE) (SE measured at 3, 6, 9, 12 months.)
B: Spherical equivalent refraction determined by cycloplegic autorefraction
C: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
D: Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study (2 years)

Answer: A