TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Strategic Family Therapy for Adolescent Drug Abusers
Brief Summary: The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent Drug Abusers to treatment as usual (TAU).

An additional follow up assessment, funded by an American Recovery \& Reinvestment Act (ARRA) grant, was completed 5 years post randomization in order to examine the long term effects of outpatient treatments for illicit drug using adolescents.


Options:
A: Increase in parental competence at nine intervals over 39 month study period (birth-3 year postpartum)
B: Evaluation of smoking cessation verified by expired air carbon monoxide (12 weeks after baseline)
C: Expired Carbon Monoxide (Baseline and treatment phases, 2-mont and 6-month follow up.)
D: Main Study, Adolescent Drug Use (Number of self reported drug use days from 28 days prior to baseline); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 1-28); Main Study, Adolescent Drug Use (Number of self reported drug use days in days 29-56); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 57-84); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 85-112); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 113-140); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 141 - 168); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 169-196); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 197-224); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 225-252); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 253-280); Main Study, Adolescent Drug Use (Number of self reported drug use from days 281-308); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 309-336); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 337-364); Follow Up Study, Drug Use (Number of self reported drug use days 90 days prior assessment); Follow Up Study, Drug Use (Number of self reported drug use days 90 days prior to assessment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer Related School Interventions in Autism
Brief Summary: This study will determine whether peer interaction training interventions are effective in enhancing the social relationships of children with autism.


Options:
A: Social network involvement of autistic children (Measured before and after treatment and at 3-month follow-up)
B: N/A
C: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
D: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Brief Summary: The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.


Options:
A: To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
B: Change from baseline to endpoint in a mania rating scale
C: Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made every 6th month till 1 year after 8th week end point. (one year); Schedule for Assessment of Negative Symptoms (SANS): Measure of efficacy will be changes in SANS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made at 6 month and 12 month after 8th week end point. (one year); Serum Prolactin Level (one year); Body Mass Index & Abdominal Circumference (one year); Lipid Panel with LDL Cholesterol (one year); FBS-PP & HbA1c (one year)
D: Percentage of Participants That Responded to Treatment (this outcome was assessed throughout the study.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
Brief Summary: The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.


Options:
A: The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.
B: Neurocognitive function (12 weeks)
C: Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
D: The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRK AD5 HIV-1 Gag/Pol/Nef) in Adults at High Risk of HIV-1 Infection
Brief Summary: This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.

On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.

Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.


Options:
A: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups
B: To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
C: Serologically confirmed HIV infection (Throughout study)
D: Number of Participants With Clinical Adverse Experiences (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)); Number of Participants With Laboratory Adverse Experiences (Day 1 to Week 208); Number of Participants With HIV-1 Infections (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)); HIV-1 Viral Load in Infected Participants (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
Brief Summary: The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.


Options:
A: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)
B: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)
C: diabetes; death
D: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
Brief Summary: The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.


Options:
A: diabetes; death
B: Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.8 years); Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.8 years)
C: All strokes (fatal and non-fatal) (Duration of trial)
D: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
Brief Summary: The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.


Options:
A: diabetes; death
B: Prevention of Type 2 Diabetes (2.4 years)
C: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
D: Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.8 years); Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.8 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.
Brief Summary: This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.


Options:
A: Change in a depression rating scale at endpoint
B: Montgomery and Asberg Scale for Depression (8 weeks)
C: MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate (12 weeks)
D: Montgomery-Åsberg Depression Rating Scale (MADRS) (Baseline and final MADRS scores during the double-blind phase.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer.


Options:
A: rate of laryngeal preservation
B: Overall Survival (3-years)
C: Overall Survival (Percentage of Participants Alive) (From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)
D: Overall Survival Time (OS) (time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer.


Options:
A: Overall Survival (3-years)
B: Tumor Responses (Baseline and 2 months)
C: overall survival (3 years)
D: Determination of progression-free survival after 2 years (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer
Brief Summary: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).


Options:
A: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)
B: Progression Free Survival (PFS) - in non-tBRCA HRD positive patients (Approximately 4 years); Progression Free Survival (PFS) - in all non-tBRCA patients (Approximately 4 years)
C: Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (after 6 weeks (2 cycles))
D: Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+） (At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer
Brief Summary: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).


Options:
A: Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (after 6 weeks (2 cycles))
B: Progression-free survival
C: Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) (3 years)
D: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
Brief Summary: The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).


Options:
A: Shorter Length Of Hospitalization (LOH) (Up to 4 weeks after surgery)
B: Disease free survival (4.5 years from surgery)
C: length of post-operative hospital stay (throughout hospitalization (up to 2 weeks)); length of clear fluid toleration (throughout hospitalization (up to 1 week)); length of solid food toleration (throughout hospitalization (up to 2 weeks))
D: Hospital Stay (1 Month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids
Brief Summary: The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.


Options:
A: Asthma Control (8 weeks (from Week 0 to Week 8))
B: FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
C: Morning peak expiratory flow
D: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (Baseline and (time weighted average over) 60 Minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.


Options:
A: Clinical and Endoscopic Remission. (8 weeks)
B: Clinical Response at Week 8 Based on Mayo Score (Eight week treatment period)
C: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
D: Safety and toleration (up to 12 weeks); Endoscopic score changes as calculated using section 3 of the Mayo Score (up to 12 weeks); Disease activity score changes as calculated using the Mayo Score (up to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.


Options:
A: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
B: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
C: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
D: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))

Answer: A