TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
Brief Summary: Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. Despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania.

Research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. By contrast, randomized controlled trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral treatments such as Habit Reversal Therapy.

The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.


Options:
A: Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score (Subjects were followed for their duration of participation in the study (12-weeks))
B: Massachusetts General Hospital Hairpulling Scale (Baseline and final visit after 12 weeks)
C: Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) (Week 12)
D: National Institute of Mental Health Trichotillomania Symptom Severity Scale (This is the final score, measured at week 8 (final visit).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Trial of Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas
Brief Summary: Previous studies addressing preoperative somatostatin analogs (SSA) treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. The investigators also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.


Options:
A: Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments (12 months)
B: Cure rate at evaluation 4 months postoperatively (every 4 weeks)
C: Surgical cure by transsphenoidal surgery (Primarily 3 months postoperatively, but up to 10 years postoperatively)
D: Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC (Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)); Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. ((Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)); Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough (Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)); Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax (Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)); Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough ((Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)); Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. ((Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Multinational, Open-label, Single-dose Acute Hemodynamic Study Followed by Multi-centre, Multinational, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy (Proof-of-concept) of ACT-293987 (NS-304) in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
Brief Summary: This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.


Options:
A: Six Minute Walk Distance (6MWD) (Baseline and 16 Weeks)
B: Six-minute walk distance (Twelve Weeks)
C: Assessment of hemodynamic parameters after single oral dose of ACT-293987. (17 weeks); Proof-of-concept assessment of the efficacy of ACT-293987 in subjects with PAH by measuring the change from baseline in the PVR at Week 17 compared to placebo. (17 weeks)
D: 6-minute Walk Distance (6MWD) (Baseline and 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
Brief Summary: To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.


Options:
A: total area of fluorescein leakage from active new vessels (baseline, weeks 1,6,12,24,36,48); Best corrected Visual Acuity (BCVA) (Baseline, weeks 1,6,12,24,36,48); central macular thickness (baseline, weeks 1,6,12,24,36,48)
B: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
C: Regression of neovascularization (12-month treatment)
D: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
Brief Summary: To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.


Options:
A: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
B: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
C: total area of fluorescein leakage from active new vessels (baseline, weeks 1,6,12,24,36,48); Best corrected Visual Acuity (BCVA) (Baseline, weeks 1,6,12,24,36,48); central macular thickness (baseline, weeks 1,6,12,24,36,48)
D: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Single-blind, Placebo-controlled, Multicenter Study to Evaluate the Immunogenicity of Pneumococcal and Influenza Vaccines in Adult Subjects With Rheumatoid Arthritis Receiving Certolizumab Pegol or Placebo
Brief Summary: The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal and influenza vaccines, respectively.


Options:
A: Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6. (Baseline, End of single blind period (Week 6)); Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6. (Baseline, End of single blind period (Week 6))
B: Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)] (Baseline (Week 0) to Week 12); Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52 (Baseline (Week 0) to Week 52)
C: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
D: American college of Rheumatolofy (ACR)-20 responder rate at Week 24

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
Brief Summary: The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.

The study will also evaluate the safety of 3804-250A.


Options:
A: Reduction of rhinovirus-induced common colds. (9 weeks)
B: Secondary infection with influenza of the household members who are healthy at the start of the study
C: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
D: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
Brief Summary: The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.

The study will also evaluate the safety of 3804-250A.


Options:
A: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
B: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
C: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)
D: Reduction of rhinovirus-induced common colds. (9 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
Brief Summary: The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.

The study will also evaluate the safety of 3804-250A.


Options:
A: Reduction of rhinovirus-induced common colds. (9 weeks)
B: Incidence rate of people infected with SARS-CoV-2 (up to 8 weeks); Incidence rate of people infected with SARS-CoV-2 (up to 8 weeks)
C: To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry (Through case completion, an average a year)
D: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
Brief Summary: The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.

The study will also evaluate the safety of 3804-250A.


Options:
A: Absenteeism rate due to gastrointestinal or respiratory illness during the study period. (8 weeks)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
C: Reduction of rhinovirus-induced common colds. (9 weeks)
D: the episodes due to respiratory tract infections (8 moth); The episodes due to gastroenteritis (8 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
Brief Summary: The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.

The study will also evaluate the safety of 3804-250A.


Options:
A: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
B: Reduction of rhinovirus-induced common colds. (9 weeks)
C: Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 7); Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Haematology Change From Baseline by Maximum Grade (From Day 7 up to Day 30); Number of Subjects With Solicited Local Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Solicited General Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Unsolicited Adverse Events (AEs) (During a 30-day follow-up period (from Day 0 to Day 29) after vaccination); Number of Subjects With Serious Adverse Events (SAEs) (From vaccination (Day 0) up to study end (Day 30))
D: Frequency of vaccine-related reaction events and other adverse events in each cohort (Throughout study); Amount of vaccine virus shed by each participant (Throughout study); Amount of serum antibody and mucosal antibody induced by the vaccine in each participant (Throughout study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty
Brief Summary: The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.


Options:
A: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month (1 month after procedure); Patient's Rating of Average Pain at 1 Month (1 month)
B: Impact into quality of life with the Qualeffo-41 test (Baseline, 2 weeks, 2 months, 6 months and 1 year)
C: Back specific functional status(Roland) (12 mo); Pain (12 mo)
D: To compare the cost-effectivity in the two groups (1 month, 1 year); VAS score in time (1 month, 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty
Brief Summary: The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.


Options:
A: Back specific functional status(Roland) (12 mo); Pain (12 mo)
B: Impact into quality of life with the Qualeffo-41 test (Baseline, 2 weeks, 2 months, 6 months and 1 year)
C: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month (1 month after procedure); Patient's Rating of Average Pain at 1 Month (1 month)
D: pain relief (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Kids-Houston: An Integrated Community Program for the Prevention of Obesity Among Minority Children
Brief Summary: The collaborative study is to determine the effectiveness of an after-school community-based program to prevent obesity among minority children.


Options:
A: BMI and aerobic fitness (1 schoolyear)
B: Change in body mass index in adults and body mass index percentile in children. (Baseline to 18 months.)
C: Body mass index (One school year)
D: Insulin area under the curve (oral glucose tolerance test) (10-15 weeks); Body composition (% body fat, visceral fat) (10-15 weeks); Aerobic fitness (10-15 weeks); Cognition (Executive function) (10-15 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Kids-Houston: An Integrated Community Program for the Prevention of Obesity Among Minority Children
Brief Summary: The collaborative study is to determine the effectiveness of an after-school community-based program to prevent obesity among minority children.


Options:
A: Body mass index (One school year)
B: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption (5 weeks); Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) (5 weeks); Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans (5 weeks)
C: Insulin area under the curve (oral glucose tolerance test) (10-15 weeks); Body composition (% body fat, visceral fat) (10-15 weeks); Aerobic fitness (10-15 weeks); Cognition (Executive function) (10-15 weeks)
D: Academic performance (October 2014 - June 2015 (8 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
Brief Summary: The purpose of this study is to help us learn more about how to lower the patient's risk of the most common complications after their pancreas operation. After tumors are removed and the remaining part of the pancreas is connected to the intestine or closed, a leakage of pancreatic fluid may occur. This fluid may form an "abscess" (collection of pus) or "fistula" that would need to be drained. A fistula is a persistent leakage of pancreatic fluid that sometimes occurs after pancreatic surgery. Fistulas, leaks, and abscesses are complications that are seen in roughly every 15-20 patients out of every 100 that have pancreas surgeries. Complications like these extend the patient's stay in the hospital after surgery. These complications may require the patient's doctor to perform additional tests or procedures to treat them.

The physical and emotional burden these complications place upon patients, as well as the financial cost to the health care system, can be great. The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if a drug, SOM230, can help reduce the rate of these complications. SOM230, also known as Pasireotide, is a drug that has been observed to reduce the rate of similar complications in other studies.

The surgeon would like to compare the effects, good and/or bad, of SOM230 with "placebo" (solution without medication) to see if SOM230 reduces the rate of fistulas, leaks and abscesses.


Options:
A: Abdominal Complications (1 month)
B: 60-day ≥ Grade II Complication Rate (60 days)
C: To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo. (60 days)
D: Postoperative pancreatic fistula (30 days postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled Multi-Center and Parallel Group Study of the Safety, Tolerability and Efficacy of YM150 in Combination With Standard Treatment in Secondary Prevention of Ischemic Vascular Events in Subjects With Acute Coronary Syndromes
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.


Options:
A: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis (From 22 to 165 minutes)
B: MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT (18 months (12-30 months post-index procedure)); Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT (18 months (12-30 months post-index procedure)); GUSTO Severe or Moderate Bleeding - Randomized DES ITT (18 months (12-30 months post-index procedure))
C: Composite Safety Endpoint (one year); Primary Efficacy Endpoint (one year)
D: Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition (6 Months)

Answer: D