TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Safety and Efficacy of Galantamine in Alzheimer's Disease (Extension INT-8)
Brief Summary: The long-term safety and efficacy of galantamine (12 mg bid) will be documented during a one year open-label treatment in subjects with Alzheimer's Disease who completed the GAL-INT-8 trial (up to 400 eligible patients). Safety will be tracked by means of adverse event reports, laboratory parameters and physical exam. Long-term efficacy will be evaluated by means of a Alzheimer's Disease Assessment Scale(ADAS) and activities of daily living scale Disability Assessment for Dementia Scale(DAD)


Options:
A: The primary outcome is safety as measured by adverse events, laboratory tests, vital signs, weight, physical exam and electrocardiogram
B: Cohen-Mansfield (2 weeks)
C: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
D: Neuropsychiatric Inventory Nursing Home Version (Screening, Baseline, 1 month, 2 months, 3 months); Clinical Global Impression of Change (Baseline, 1 month, 2 months, 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion Treatment for Smokers in Recovery
Brief Summary: Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.


Options:
A: 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)
B: Biochemically verified 7 day point prevalence abstinence from smoking.
C: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
D: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion Treatment for Smokers in Recovery
Brief Summary: Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.


Options:
A: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (12 weeks following start of medication)
B: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
C: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
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: Bupropion Treatment for Smokers in Recovery
Brief Summary: Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.


Options:
A: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
B: Days of abstinence following the programmed lapse (7 days)
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion Treatment for Smokers in Recovery
Brief Summary: Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.


Options:
A: Percent Treatment Sessions Attended (52 weeks)
B: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
C: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
D: Percent Compliance With Chantix (Months 1, 2, 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion Treatment for Smokers in Recovery
Brief Summary: Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.


Options:
A: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
B: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
C: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
D: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV Translating Initiatives for Depression Into Effective Solutions
Brief Summary: This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.


Options:
A: Percentage of Participants With Depression Treatment Response (6 months)
B: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life
C: To compare processes and outcomes between CHC patients receiving practice-based collaborative care to CHC patients receiving telemedicine-based collaborative care (OUTREACH intervention). (6, 12, 18 months after baseline)
D: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment (12 months); Depression Care: Treatment Response (Baseline and 12 months); Depression Care: Depression Remission (Baseline and 12 months); Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months (From Baseline to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV Translating Initiatives for Depression Into Effective Solutions
Brief Summary: This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.


Options:
A: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
B: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
C: To determine if a culturally focused psychiatric (CFP) consultation service can improve depressive symptoms and increase diagnosis and treatment of depression in Asian American and Latino American primary care patients at MGH. (6 months after baseline assessment)
D: Percentage of Participants With Depression Treatment Response (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV Translating Initiatives for Depression Into Effective Solutions
Brief Summary: This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.


Options:
A: proportion of patients who successfully complete TB treatment and achieve cure.
B: Adherence; Self-efficacy; Quality of life
C: Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48; Safety Outcome Measures: Adverse Events, Laboratory Tests; Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms
D: Percentage of Participants With Depression Treatment Response (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia
Brief Summary: The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.


Options:
A: Prevalence of parasitaemia on day 28 post treatment.; Prevalence of parasitaemia on day 14 post treatment.
B: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
C: PCR corrected clinical and parasitological outcome at day 45
D: • Prevalence of placental malaria infection; • Prevalence of maternal peripheral parasitemia

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Brief Summary: A randomized control trial of bimanual training. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy.


Options:
A: Bruininks-Oseretsky Test of Motor Proficiency (BOTMP) (4 weeks (post-treatment), 12 week, 24 week); Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ) (4 weeks (post-treatment), 12 week, 24 week); Kinematic analysis (4 weeks (post-treatment), 12 week, 24 week)
B: Assistive Hand Assessment (after two months of treatment)
C: N/A
D: Change in Score on Assisting Hand Assessment (AHA) (Baseline, 6 months); Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF) (Baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI).
Brief Summary: The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.


Options:
A: Composite of death or myocardial infarction (at 12 months after randomization (at 24 months after ZEST enrollment))
B: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (Randomization up to 12 months); Participants With Any Major Bleeding Event (First dosing up to 12 months)
C: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
D: Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) (randomization through 48 hours after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Effects of Hydroxyurea Therapy in Children With Sickle Cell Disease
Brief Summary: The primary objectives of this prospective, observational study are (1) to describe the long-term cellular, molecular, and clinical effects of hydroxyurea therapy in sickle cell disease, and (2) to perform hydroxyurea pharmacokinetics studies.

This study will follow sickle cell patients being treated with hydroxyurea for a long period of time to evaluate the long-term cellular and molecular effects of the drug on the patients' body. This study will consist of two patient groups. One group will be made up of patients who have received hydroxyurea therapy before entering the study. The second group will be made up of patients who have not received hydroxyurea before study entry.


Options:
A: DNA damage from hydroxyurea therapy-variable-diversity-joining (VDJ) recombination events defined as the number of events per microgram of genomic DNA; (Every 3 years); DNA damage from hydroxyurea therapy-percentage of HJB in immature (CD71+) erythrocytes (Every 3 years)
B: urinary albumin excretion rate (12 months)
C: Percentage of successful treatment of each arm (at 9 months of treatment)
D: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial
Brief Summary: There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.


Options:
A: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (7 weeks)
B: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
C: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (at 16 weeks)
D: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial
Brief Summary: There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.


Options:
A: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
B: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
C: Change from baseline to endpoint in a mania rating scale
D: Scores in the Young Mania Rating Scale (BD); Scores in the SNAP-IV (ADHD); Weight

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial
Brief Summary: There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.


Options:
A: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)
B: Baseline Complex Network connectivity before treatment - using electrodes signal correlation (P-value) (0 minutes); Baseline Complex Network connectivity after treatment - using electrodes signal correlation (P-value) (90 minutes)
C: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)
D: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis
Brief Summary: Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:\>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.


Options:
A: Major amputation
B: Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
C: N/A
D: Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale. (Primary follow up in a 6 month period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis
Brief Summary: Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:\>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.


Options:
A: Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
B: Survival without major amputation (6 months after implantation)
C: Ankle brachial index (6 months)
D: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.
Brief Summary: The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Options:
A: time until the first severe asthma exacerbation occurs; number of poorly controlled asthma days.
B: PC20 AMP (Post-treatment Compared to Baseline) (Baseline and 5 weeks)
C: Change from baseline to Week 16 in FEV1
D: Change from baseline to Week 12 in FEV1

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial to Evaluate the Role of Paclitaxel Eluting Stent and Tirofiban to Improve the Results of Facilitated PCI in the Treatment of Acute ST- Segment Elevation Myocardial Infarction
Brief Summary: The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents.

The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly improves epicardial and myocardial infusion in comparison with the strategy of performing immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary angiography and adequate revascularization.


Options:
A: Ischemia Driven Target Lesion Failure (TLF) (1 year)
B: Target Lesion Failure (12 months)
C: to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis (12 months); to determine the effect of tirofiban administered prior to PCI but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI (24 hours)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years
Brief Summary: Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA) (At Month 7)
B: Cervical infection with HPV-16 and/or HPV-18 (Throughout the study)
C: Number of Subjects Seroprotected Against Diphtheria and Tetanus (One month after vaccination with Boostrix Polio); Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies (One month after vaccination with Boostrix Polio); Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3 (One month after vaccination with Boostrix Polio)
D: Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA) (Day 0, Day 45, Day 180, Day 210 and Day 365)

Answer: A