TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER
Brief Summary: The Emergency Department (ED) setting is a unique point of access for reaching underage drinkers (age 14-20). With the aid of computer technology, this study will screen underage drinkers in the ED and fully test promising ED-based brief intervention and 3-month follow-up brief treatment approaches for alcohol misuse. Developing methods to efficiently and effectively optimize these approaches has powerful public health implications for improving outcomes for underage drinkers.


Options:
A: Rearrest
B: Diagnosis of mental health disorder (15 year follow-up)
C: Condom use (one year)
D: alcohol use, alcohol related consequences (3 -12 month period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.


Options:
A: Forced expiratory volume in 1-second (FEV1) compared to active comparator (Year 1); Quality of Life (SGRQ) (Year 1)
B: St. George's Respiratory Questionnaire (SGRQ) (three month Follow-Up Visit)
C: Improvement in pulmonary function (FEV1) 6-minute walking test (3 months)
D: Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio (12 Weeks following final treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)
Brief Summary: Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.


Options:
A: 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)
B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs (Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)); Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab (Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose)
C: At least 1 point-reduction on Kurtzke functional scale (28 days after beginning of corticotherapy)
D: Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. (Part I (Week 24)); Incidence of treatment-emergent adverse events and serious adverse events (Part II (Up to 4.5 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet
Brief Summary: The ENGAGED study is a 12-month randomized controlled trial investigating different strategies to improve weight loss in overweight individuals. All participants will receive an effective weight loss treatment: either self-guided or group formats. All treatment will be provided in the Department of Preventive Medicine at Northwestern University. Participants who receive the self-guided weight loss treatment will be provided with a weight loss manual that contains proven behavioral weight loss strategies. Those participants who receive the group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N. Lakeshore Dr., Chicago, IL 60048. Some participants will also be assigned an individual coach, who will communicate with them regularly via phone, email, and/or text message for the duration of the study. All participants must be willing and able to record food and beverage intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive physical activity measurement device for the first six-months of the study. Additionally, all participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3, 6 and 12 after the study begins. Participants will be compensated for completing each of the 3 follow-up assessments. All participants will be part of a team weight loss competition at 3 and 6 months with financial incentive to be split evenly among the winning team.


Options:
A: Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Adjusting Amount Task) (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Monetary Choice Questionnaire) (Phase II baseline to 2 months and 4 months (end of treatment))
B: Weight loss (3 months, 6 months, 12 months)
C: Weight Change from Baseline to 24 weeks (0 and 24 weeks)
D: weight reduction (at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet
Brief Summary: The ENGAGED study is a 12-month randomized controlled trial investigating different strategies to improve weight loss in overweight individuals. All participants will receive an effective weight loss treatment: either self-guided or group formats. All treatment will be provided in the Department of Preventive Medicine at Northwestern University. Participants who receive the self-guided weight loss treatment will be provided with a weight loss manual that contains proven behavioral weight loss strategies. Those participants who receive the group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N. Lakeshore Dr., Chicago, IL 60048. Some participants will also be assigned an individual coach, who will communicate with them regularly via phone, email, and/or text message for the duration of the study. All participants must be willing and able to record food and beverage intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive physical activity measurement device for the first six-months of the study. Additionally, all participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3, 6 and 12 after the study begins. Participants will be compensated for completing each of the 3 follow-up assessments. All participants will be part of a team weight loss competition at 3 and 6 months with financial incentive to be split evenly among the winning team.


Options:
A: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)
B: Change in body mass index (BMI) (Measured at Year 2)
C: Weight loss (3 months, 6 months, 12 months)
D: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial
Brief Summary: The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).


Options:
A: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
B: placental syndrome or thromboembolic event (9 months)
C: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
D: Preterm birth (Delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial
Brief Summary: The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).


Options:
A: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
B: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
C: Venous thromboembolism (40 days after delivery)
D: placental syndrome or thromboembolic event (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial
Brief Summary: The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).


Options:
A: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
B: Live Birth (after delivery)
C: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
D: Fetal loss (From 12 weeks to 42 weeks gestational age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial
Brief Summary: The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).


Options:
A: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
B: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
C: Successful pregnancy outcome
D: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (Duration of pregnancy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
Brief Summary: The purpose of this study is to 1) develop a well-conceived and feasible protocol for hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2) compare the costs and effectiveness of this DM-specific model with those of an effective subacute care model previously developed by our research team.


Options:
A: Mortality (6 month)
B: functional recovery (baseline, end of nursing home admission)
C: Quality of life (2 years)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Open Label Study to Evaluate Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.
Brief Summary: The study will evaluate the safety, tolerability and therapeutic effects (preliminary efficacy) of injection of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), as a possible treatment for patients with Amyotrophic Lateral Sclerosis (ALS) at the early and progressive disease stages.


Options:
A: Forced vital capacity (Every 3 months)
B: Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis (One year for the first phase; 4 years for the extension phase)
C: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (At baseline and up to 6 month following treatment administration)
D: Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months); Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Open Label Study to Evaluate Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.
Brief Summary: The study will evaluate the safety, tolerability and therapeutic effects (preliminary efficacy) of injection of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), as a possible treatment for patients with Amyotrophic Lateral Sclerosis (ALS) at the early and progressive disease stages.


Options:
A: Fever (48hours); Unconsciousness (48hours); vomiting (48hours)
B: Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis (One year for the first phase; 4 years for the extension phase)
C: Forced vital capacity (Every 3 months)
D: Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months); Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
Brief Summary: To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer in a population sample of healthy postmenopausal women.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: Possible effects of B-vitamin treatment on risk of developing cancer during the trial periods (completed by 2004 and 2005) and during post-trial follow-up. (1998-2014)
C: fractures (4 years)
D: all-type cancer (excluding non-melanoma skin cancers) (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.
Brief Summary: This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.


Options:
A: Change in Depressive symptoms (3, 6 and 12 months.)
B: At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire (4 months post-randomization); Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module (4 months post-randomization)
C: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
D: Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score. (Baseline (end of week 8) to Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?
Brief Summary: It has been previously demonstrated that the risk for the development of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se, the surgery, or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.


Options:
A: International Knee Documentation Committee 'Subjective Knee Form' (3, 6, 12, 24 and 60 months)
B: Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) (2 and 10 years postoperatively)
C: the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (Primary endpoint: Change from baseline to 12 months.)
D: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Mortality (From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months)
B: Clinical Status at Day 7 (Day 7)
C: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)
D: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Death versus survival of treated patients (Up to 8 weeks)
B: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
C: Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization (1 year follow up)
D: ICU length of stay (Time from transfer into ICU to time of transfer out from ICU, Up to 12 weeks.); Safety of convalescent plasma & Serious adverse reactions. (time from signing consent to one month after transfusion, Up to 12 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Clinical Status at Day 7 (Day 7)
B: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)
C: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
D: death (within 7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
B: Lung injury (7 days); Overall survival (15-30 days)
C: Total Number of Serious Adverse Events (SAE) Through Study Day 14 (14 days); Median Time to Hospital Discharge (or Discharge Equivalent) Following First Dose of CCP (up to 28 days)
D: death (within 7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first (until hospital discharge or a maximum of 60 days whichever comes first)
B: Vital status (at day 28)
C: Category Changes in the "7-Ordinal Scale" (15 days)
D: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)

Answer: D