TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
Brief Summary: This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.


Options:
A: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)
B: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
C: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)
D: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
Brief Summary: This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)
B: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
C: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
D: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
Brief Summary: This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.


Options:
A: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
B: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
C: N/A
D: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.
Brief Summary: Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.


Options:
A: severity of nasea (immediated postop to 48hrs after surgery)
B: Painscore during mobilization (2-24 hours after extubation time.)
C: Incidence or intensity of PONV (during postoperative hospital stays (2 days))
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.
Brief Summary: Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.


Options:
A: Pain score by numeric rating scale (At 8 hours postoperatively)
B: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
C: N/A
D: Surgical wound infection (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.
Brief Summary: Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.


Options:
A: pain during coughing (day 1)
B: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
C: Major Perioperative Morbidity (30 day after surgery)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
Brief Summary: Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease the chance that patients will experience delirium after their surgery. The investigators are also testing whether ketamine decreases postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length of stay, and adverse outcomes (e.g. hallucinations and nightmares).


Options:
A: Percentage of Participants With Delirium Using the CAM Over Time (Baseline, hospital interviews, weeks 2, 4 and 6)
B: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
C: Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 (Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients)
D: Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry (At PACU entry on Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
Brief Summary: Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease the chance that patients will experience delirium after their surgery. The investigators are also testing whether ketamine decreases postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length of stay, and adverse outcomes (e.g. hallucinations and nightmares).


Options:
A: pain score (4 hours)
B: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (24 months)
C: Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 (Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients)
D: Pain at 24 hour postoperatively (at 24 hour postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients
Brief Summary: End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.


Options:
A: Left Ventricular Mass Index (9 months)
B: CV Death or Hospitalization for Heart Failure (up to 5 years)
C: Iohexol clearance (3 months)
D: Peritoneal fibrosis (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
Brief Summary: This study will implement and test the effectiveness and cost-effectiveness of a tobacco cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for adults admitted to the hospital. The intervention will begin during the hospital stay and continue after discharge. The intervention will use resources easily available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL).

The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report and biochemical verification (exhaled carbon monoxide reading).


Options:
A: Error rate per patient treated demonstrated by deviation from the algorithms
B: Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence (12 months post enrollment)
C: poor asthma control (2006-2009)
D: Proportion of clinical failure by day 7 compared among the 3 study arms. (10 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Two Training Protocols in Physical Activity in Daily Life and Balance in Patients With COPD: Land Versus Water
Brief Summary: Introduction: There is evidence that demonstrate the beneficial effects of pulmonary rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the studies used high intensity endurance and strength exercise training on land. Exercise on water is an effective form of training that has been used for decades for rehabilitation in different chronic conditions. In addition, there are promising preliminary results on the literature regarding aquatic training in patients with COPD. However, several gaps remain.

Aim: Compare the effects of two rehabilitation programs with 6 months of duration in patients with COPD on physical activity in daily life and balance: land versus water.

Methods: The sample will consist of 36 patients with COPD diagnosed according to the GOLD criteria, 50 years old or more and clinically stable.

Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months after the end of the PR (follow up). In addition to the assessment of physical activity in daily life and balance, the investigators will also evaluate pulmonary function, peripheral and respiratory muscle strength, body composition, maximal and submaximal exercise capacity, functional status and quality of life.

Both groups (land or water) will be submitted for 3 sessions of exercise training per week, with 45 minutes of duration, during 6 months. The sessions of both groups include the same exercises sequence. Endurance exercise training will be performed on a bicycle and walking on land and strength training using free weights. Workload will be established according to the tests performance on assessment and progression will follow a predetermined schedule and adjusted according symptoms. On water the same approach will be followed.

Expected results: the investigators expect improvement in terms of symptoms, exercise capacity, muscle strength, quality of life, functional status and physical activity in daily life at the end of the two training protocols. However, it is unclear whether one training protocol will be superior than the other. Due to the characteristics involved in the aquatic training, the investigators hypothesized that this type of training can result in better results on balance.


Options:
A: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
B: Daily step count (90 days)
C: Physical activity in daily life (measuremet unit: number of steps per day) (four years)
D: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
Brief Summary: Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.


Options:
A: Change of the intestinal and urinary microbiome (3 months to 12 months)
B: Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC) (One year)
C: Occurrence of the first recurrence (12 months)
D: UTI Recurrence (Variable for each participant over course of up to one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
Brief Summary: Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.


Options:
A: Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC) (One year)
B: Rate of UTIs (6 months)
C: Time to onset of a first UTI within one year of treatment. (one year)
D: Mean number of urinary tract infections (Within a 6-month period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
Brief Summary: Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.


Options:
A: Time to onset of a first UTI within one year of treatment. (one year)
B: Number of cases of asymptomatic bacteriuria
C: Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC) (One year)
D: The primary outcome variable will be UTI incidence density, defined as the semi-annualized number of UTIs in each group, adjusted for susceptible time under observation. (six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
Brief Summary: This study will evaluate two dose regimens of mepolizumab \[75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks\] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events.

This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC.

Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.


Options:
A: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)
B: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Week 52); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Week 52)
C: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose)
D: Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24 (Baseline and Week 24)

Answer: C