TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Music Therapy in Methodist Homes: a Cluster Randomised Controlled Trial Including Mixed Methods Analysis Investigating the Efficacy of the Impact of a Music Therapy Programme on Caring for People With Dementia Who Have Behavioural Symptoms.
Brief Summary: The study is a cluster randomised control trial, which aims to investigate the effectiveness of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in older adults with dementia. In particular, the study aims to identify the main components of music therapy that are key in achieving this. The study will also explore carers' perceptions of music therapy, and investigate whether carers become more attentive to patients' needs and more able to manage patients' BPSD as a result of the music therapy programme.


Options:
A: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
B: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
C: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
D: Neuropsychiatric Inventory (At baseline in the 2 weeks prior to the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at week 27-28.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
Brief Summary: An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion


Options:
A: Progression-Free Survival (PFS) (Up to 84 months)
B: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC) (From the randomization date up to 60 months post the randomization date.)
C: Overall Response Rate (The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months)
D: Time to Progression (At least 24 months following completion of therapy, an average of 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
Brief Summary: The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.


Options:
A: Child Urine Cotinine (up to 12 months); Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources (up to 12 months)
B: N/A
C: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
D: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
Brief Summary: The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.


Options:
A: Proportion of patients screened for alcohol (One year); Proportion receiving Brief Intervention among those who screen positive to screener. (One year.); Proportion of patients referred to treatment (one year)
B: Child Urine Cotinine (up to 12 months); Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources (up to 12 months)
C: Medication Appropriateness Index (MAI)-Score (6 months from baseline)
D: Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
Brief Summary: The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.


Options:
A: Child Urine Cotinine (up to 12 months); Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources (up to 12 months)
B: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)
C: The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis. (6 months at the beginning of intervention)
D: The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up. (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Clinical Trial of Adjunctive Mechanical Thrombectomy Compared With Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke Due to an Occluded Major Intracranial Vessel.
Brief Summary: Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. PISTE is a randomised, controlled trial to test whether additional mechanical thrombectomy device treatment improves functional outcome in patients with large artery occlusion who are given IV thrombolytic drug treatment as standard care.


Options:
A: Distribution of the modified Rankin Scale scores (shift analysis) (90 days)
B: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
C: Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis) (90 days after enrollment)
D: modified Rankin Scale (Day 90 +/-7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized Clinical Trial to Assess the Efficacy and Safety of Tenofovir in Hepatitis B Virus Infected, s and e Antigen Positive, Pregnant Women to Prevent Perinatal Transmission Despite Infant Passive-active HBV Immunization.
Brief Summary: Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma, even if her infant receive specific immunoglobulin and vaccine.

The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant women participating in this study will receive tenofovir or placebo during the last trimester of pregnancy and two months postpartum. The risk of perinatal transmission will be compared between the two groups.

The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.


Options:
A: Percentage of Infants With Hepatitis B Infection at 6 Months of Age (6 months of age)
B: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (Week 48)
C: Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm (Week 48)
D: Antepartum Component: Number of Confirmed Infant HIV Infections (Measured at birth or Week 1 study visit); Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Obstetrical Complications (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) (Measured at birth); Postpartum Component: Incidence of Confirmed Infant HIV Infection (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death (From study entry until July 7, 2015, an average of 94 weeks of follow-up.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial On The Effects Of Parenteral Fish Oil Emulsion In Patients With Severe Acute Pancreatitis
Brief Summary: The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this figure is more than double the highest previous estimated incidence. In the majority of patients the condition is mild, but about 25% of patients suffer a severe attack and between 30 and 50% of these patients dies. The usual cause of death is multiple organ failure secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic inflammatory response syndrome (SIRS).

Studies with omega-3 fish oil have shown to control inflammatory process and improve the outcome especially in hyperinflammatory conditions.

This research will look at the effects of supplementing omega-3 fish oil to patients with severe acute pancreatitis (severe inflammation of the pancreas).

Patients with severe acute pancreatitis will be prospectively and blindly randomised into either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical care will be provided to all patients as per the national management guidelines. Each patient will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for discharge by their own medical team or for a maximum of SEVEN days.

The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish oil could improve the clinical outcome in patients with severe acute pancreatitis.


Options:
A: Reduction of the CRP by 20% from the control group (Day 7 post infusion)
B: Post-ERCP Pancreatitis (5 days)
C: Change in C-Reactive Protein (CRP) (baseline, Day 1, Day 3); Change in Tumor Necrosis Factor (TNF)-Alpha (baseline, Day 1, Day 3); Change in Interleukin (IL) IL-6 (baseline, Day 1, Day 3); Changes in Interleukin (IL) IL-8 (baseline, Day 1, Day 3)
D: The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5. (0-60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.
Brief Summary: Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone receptors(ER and/or PR) breast cancer (HEr2+/HR+).

A new high potential trastuzumab conjugate T-DM1(trastuzumab was linked with the cytotoxic agent mertansine DM1)was tested with endocrine therapy and without against a standard arm with trastuzumab and endocrine therapy.


Options:
A: Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks); Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks)
B: Comparison of the pCR rates in patients with HER2+/HR+ breast cancer treated by preoperative T-DM1 with or without standard endocrine therapy or trastuzumab with endocrine therapy. (After 12 weeks); Evaluation of dynamic testing (based on proliferation/apoptosis changes in serial biopsy and imaging by MRI) after three weeks of treatment as a surrogate parameter for response. (after 3 weeks of treamtment)
C: Disease Free Survival (DFS) of 3 years (3 years after mastectomy)
D: Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine (After 12 weeks of therapy); Comparison: pCR in responders vs. non-responders (After 12 weeks of therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Online Social Networks for Dissemination of Smoking Cessation Interventions
Brief Summary: Effective evidence-based interventions exist for smoking cessation delivered over the Internet, but consumer acceptance and adherence remains low. Scalable and efficient mechanisms to disseminate these interventions online are needed, and existing online social networks provide a potential mechanism. This is a proposal for a randomized, factorial trial of the dissemination of an evidence-based intervention through the massive Facebook social network, with the goal of determining intervention characteristics that drive viral spread.


Options:
A: Smoking abstinence (6 months)
B: Smoking Abstinence (12 months); Treatment Utilization for Smoking Cessation (12 months)
C: Reproductive rate (30 days)
D: Point Prevalence Abstinence (5 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy
Brief Summary: To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).


Options:
A: Pain recorded using a Visual Analog Scale (15 minutes after the procedure)
B: Macular Evaluation (6 Months)
C: Mean Change in Visual Acuity From Baseline (2-years)
D: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of N6022 to Evaluate Safety and Pharmacokinetics in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation (SNO1)
Brief Summary: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation.


Options:
A: Treatment Period 1 (Treatment Cohorts): Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Safety and tolerability as assessed by adverse events (AEs) and serious adverse events (SAEs) (From Baseline up to Week 196)
D: Safety and Tolerability (Over 7 treatment days and 7 days of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of N6022 to Evaluate Safety and Pharmacokinetics in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation (SNO1)
Brief Summary: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation.


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: Safety and Tolerability (Over 7 treatment days and 7 days of follow-up)
C: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
D: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Transcranial Direct Current Stimulation and Electro Acupuncture in Pain, Functional Capability and Cortical Excitability in Patients With Osteoarthritis.
Brief Summary: The objective of this study is to evaluate the efficacy of transcranial direct current stimulation (tDCS) and electro acupuncture (EAC) compared to sham treatment in reducing pain, improving functional capacity and functioning of the neuro-immune-endocrine system in patients with chronic pain due to knee osteoarthritis.


Options:
A: Recruitment Rate (Baseline); Feasibility of Assessment Procedures: completion rate (Through study completion (16 weeks)); Retention Rate (Through study completion (16 weeks)); Feasibility of Research Assistant (RA) Training: rating (Baseline); Monitoring Treatment Fidelity (Through study completion (16 weeks))
B: Change in knee pain intensity from baseline at 4 weeks (4 weeks)
C: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Change from baseline at 9 weeks, 1 year and 2 years)
D: Change in the intensity of daily pain. (The treatment will be 5 daily sessions.The pain level will be assessed before treatment, after each session and at the end of treatment.Totaling six days.); Change in the pressure pain threshold. (The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.)

Answer: D