TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change
Brief Summary: This study will compare the effectiveness of two treatments, dialectical behavior therapy versus fluoxetine with clinical management, for reducing the risk of self-injury and suicidal behavior in people with borderline personality disorder.


Options:
A: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
B: Re-presentation to hospital with suicide attempt and/or suicidal ideations (7 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (14 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (30 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (90 days post intervention); Death by suicide rates (24 months post intervention)
C: Suicide Events (Measured after 6 months of treatment)
D: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Eptifibatide as Treatment for Acute Pain Episodes in Sickle Cell Disease
Brief Summary: This study will evaluate the safety of eptifibatide in sickle cell patients and how well it works during the course of painful crises. The overall hypothesis that we seek to test is that increased platelet activation and the resultant inflammatory responses are important contributors to the problems of sickle cell disease. Sickle cell disease has been referred to both as a condition associated with increased risk of blood clots and increased inflammation. A painful crisis represents the most common cli nical problem in sickle cell disease, but the treatment of these crises remains inadequate.


Options:
A: Patient controlled analgesia (PCA)diamorphine or morphine consumption (4 days)
B: 1) Major Bleeding Episodes (Up to 35 days); Change in Platelet Count (Up to 35 days)
C: Reduction in time to resolution of vaso-occlusive crisis (Up to 7 days or resolution)
D: To determine whether there is a difference in time to first occurrence of a large improvement in daily average pain intensity between a High Demand/Low Infusion (HDLI) dosing vs. Low Demand/High Infusion (LDHI) dosing for parenteral opioid. (Pain Intensity will be assessed 3 times a day between the hours of 7 AM and 7 PM on each day of the hospital stay)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Brief Summary: The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).


Options:
A: Postoperative Quality of Life (QoL) (one month)
B: Parietal complications after surgery (infection and hernia) (One year)
C: overall morbidity rate (at 60 days from surgery) (60 days)
D: Post-operative pain scores (visual analogue pain scale from 0-10) (Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial
Brief Summary: Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.

The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.

The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.


Options:
A: Change in disability of the arm, shoulder and hand (DASH) (DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change)
B: Constant Disability Scale (3 years)
C: Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). (12 and 24 months)
D: Shoulder function (score /100) (Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial
Brief Summary: The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.


Options:
A: Success rate of abortion (24 hours); Interval to abortion (24 hours)
B: complete abortion (14-28 days post treatment)
C: Preoperative cervical width in centimeters (intraoperative)
D: Cervical Dilation in Women Following Exposure to Either Ripening Agent (3-4 hours after placement of ripening agent)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial
Brief Summary: The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.


Options:
A: Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.) (Day 8 from first misoprostol dose)
B: doxycycline side effects (24 hours)
C: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
D: Cervical Dilation in Women Following Exposure to Either Ripening Agent (3-4 hours after placement of ripening agent)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.


Options:
A: Number of Participants With Treatment-Emergent Adverse Events (AEs) (Day 1 up to Week 561)
B: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
C: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)
D: Reduction of brain lesions in the last 4 months of the study (36 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
Brief Summary: Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.

Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.


Options:
A: Birth Weight Per Arm (delivery)
B: Glycemic Control (up to 41 weeks)
C: Percentage of fetal macrosomy
D: Blood Glucose Measurements (Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
Brief Summary: Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.

Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.


Options:
A: A composite of: pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, and NICU admission > 24 hours. (conception to 28 days after birth)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Blood Glucose Measurements (Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery)
D: Mean Fetal Weight at Birth (Immediately after delivery of fetus)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis
Brief Summary: We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.


Options:
A: all cause mortality at three months of age (3 months); incidence and severity of necrotizing enterocolitis by Bell's staging at Three months (3 months); occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months (3 months)
B: Gestational weight gain (week 36-37 of pregnancy); Change in glucose levels (Oral glucose tolerance test) (baseline (week 14-20) and 27-30 of pregnancy)
C: Prevalence of atopic disease in infant (two years)
D: Characterization of gut, oral, vaginal and human milk microbiomes (Monthly for an average of four months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
C: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)
D: Long term abstinence (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
B: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
C: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
D: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
B: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (12 weeks following start of medication)
C: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
D: Tobacco use (Six-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
C: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
D: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
D: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
B: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: Biochemically verified 7 day point prevalence abstinence from smoking.
C: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
D: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
Brief Summary: Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.


Options:
A: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
B: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
C: Overall Survival (OS) (Baseline up to Month 80)
D: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
Brief Summary: Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.


Options:
A: Progression-free Survival (Randomization until progression (up to 2 years))
B: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)
C: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
D: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))

Answer: C