TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)
Brief Summary: Background:

- Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There are currently no effective treatments for SP-MS. Researchers are interested in determining whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to target certain white blood cells that are thought to play a role in the progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord, participants will receive it by intravenous drip and by intrathecal injection (through a lumbar puncture into the cerebrospinal fluid).

Objectives:

- To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab in individuals with secondary-progressive multiple sclerosis.

Eligibility:

- Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have been off any form of immunosuppressive therapy for at least 3 months.

Design:

- The study will involve a 1-year pretreatment baseline series of visits, followed by a 2-year treatment period. Participants will provide blood samples throughout treatment as directed by the study researchers, and additional studies may be performed during the study period if participants consent to further investigation.


Options:
A: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
B: Neurofilament light chain in the cerebrospinal fluid (CSF) (0-48 weeks)
C: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
D: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. (Baseline up to approximately 5 years); Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) (Baseline Extension up to day 10); Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) (Baseline Extension up to day 10); Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) (Baseline Extension up to approximately 5 years); Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) (Baseline Extension up to approximately 5 years); Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) (Baseline Extension up to approximately 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
Brief Summary: Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally and Asian Indians will account for between 40-60% of the global CVD burden within the next 10-15 years. Risk factor control and preventive care are effective in reducing CVD events and mortality. The greatest gains in CVD prevention have been seen when early and target-driven interventions address multiple risk factors together. However, achieving control of even individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor, globally. Quality improvement schemes, like the proposed intervention, have shown promise in high-income countries, but are untested in South Asia; a region with a population at extraordinarily high CVD risk.

Objective: To test whether a clinic-based case management intervention (consisting of guidelines based treatment, care coordinator assistance and decision support software) to reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is more effective and sustainable compared to existing care.

Trial subjects and methods: The study will involve a total of 1120 patients attending 8 established out-patient clinics in South Asia (140 patients at each clinic). Patients enrolled in the trial will be randomly assigned to either the control (existing care) or the intervention group and will be followed up for an average of 30 months. The total trial duration is about 3.5 years, from mid-August 2010 to December 31, 2013.


Options:
A: Decisional Conflict Scale (3 months)
B: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (24 weeks)
C: Fecal Occult Blood Test (FOBT) completion rate (4 months)
D: Multiple CVD risk factor control targets (42 months after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
Brief Summary: Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally and Asian Indians will account for between 40-60% of the global CVD burden within the next 10-15 years. Risk factor control and preventive care are effective in reducing CVD events and mortality. The greatest gains in CVD prevention have been seen when early and target-driven interventions address multiple risk factors together. However, achieving control of even individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor, globally. Quality improvement schemes, like the proposed intervention, have shown promise in high-income countries, but are untested in South Asia; a region with a population at extraordinarily high CVD risk.

Objective: To test whether a clinic-based case management intervention (consisting of guidelines based treatment, care coordinator assistance and decision support software) to reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is more effective and sustainable compared to existing care.

Trial subjects and methods: The study will involve a total of 1120 patients attending 8 established out-patient clinics in South Asia (140 patients at each clinic). Patients enrolled in the trial will be randomly assigned to either the control (existing care) or the intervention group and will be followed up for an average of 30 months. The total trial duration is about 3.5 years, from mid-August 2010 to December 31, 2013.


Options:
A: %patients at ATP III goals (one year after intervention)
B: Multiple CVD risk factor control targets (42 months after randomization)
C: Main outcome variable: control of blood pressure (Baseline and 1 year)
D: Percentage (%) change from baseline to week 24 in serum LDL-C levels. (24 weeks from Baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous Thromboembolism Disease for Acutelly Ill Medical Patients Admitted to Hospital : Systematic Analysis of Thrombosis Risk Factors and Remember of Prevention Treatment Indications in Emergency Departments.
Brief Summary: The appropriate use of thromboprophylaxis in medical patients admitted to hospital can substantially reduce the overall burden of disease due to venous thromboembolism. However, the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk patients unprotected.

We aim to analyse the incidence of symptomatic thromboembolic disease following hospitalisation in medical setting and the efficacy of a multicomponent prevention approach in emergency department including systematic evaluation of thrombosis risk factors and remembers of thrombophylaxis indications and modalities for acutely ill medical patients.

Design: cluster randomized interventional study - Observational study at patient level

Setting: 30 French emergency departments

Patients: Patients over 40 years old admitted in participating emergency departments and hospitalized for acute medical reasons.

Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.


Options:
A: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
B: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
C: N/A
D: Symptomatic venous thromboembolic events and severe haemorrhage (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous Thromboembolism Disease for Acutelly Ill Medical Patients Admitted to Hospital : Systematic Analysis of Thrombosis Risk Factors and Remember of Prevention Treatment Indications in Emergency Departments.
Brief Summary: The appropriate use of thromboprophylaxis in medical patients admitted to hospital can substantially reduce the overall burden of disease due to venous thromboembolism. However, the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk patients unprotected.

We aim to analyse the incidence of symptomatic thromboembolic disease following hospitalisation in medical setting and the efficacy of a multicomponent prevention approach in emergency department including systematic evaluation of thrombosis risk factors and remembers of thrombophylaxis indications and modalities for acutely ill medical patients.

Design: cluster randomized interventional study - Observational study at patient level

Setting: 30 French emergency departments

Patients: Patients over 40 years old admitted in participating emergency departments and hospitalized for acute medical reasons.

Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.


Options:
A: Cardiac Medication Use (3 and 12 months)
B: Number of LTC residents on vitamin D (16 months)
C: Short-term adherence to CRC screening (From randomization to the end of 2 years); Long-term adherence to CRC screening (From randomization to the end of 9 years)
D: Symptomatic venous thromboembolic events and severe haemorrhage (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery
Brief Summary: The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.


Options:
A: Quadriceps muscle strength (MVIC) difference between the ACB and FNB after total knee arthroplasty. (Baseline, 6, 24, 48 hours and at 6 month after nerve block performance)
B: Pain-score (VAS), patient standing (2 hours postoperative)
C: The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block (24 h postoperatively)
D: Total morphine consumption (0-24 hours postoperative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Safety and Feasibility Study of High Dose Left Prefrontal Transcranial Magnetic Stimulation (TMS) to Rapidly Stabilize Suicidal Patients With PTSD
Brief Summary: The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is effective in the treatment of suicidal thinking in individuals with a depressive episode and either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or both conditions.


Options:
A: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
B: Scale of Suicidal Ideation (baseline to Day 3 of TMS treatment)
C: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
D: Beck scale for suicidal ideation (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
Brief Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.


Options:
A: Radiographic Progression-Free Survival (PFS) (Up to 44 months); Overall Survival (OS) (Up to 66 months)
B: Overall Survival (During study period (up to 3 years)); Radiographic Progression-free Survival (rPFS) (During study period (up to 20 months))
C: Overall Survival (Event-driven timeframe. Final analysis at 331 events.)
D: Survival (7.5 years after the first inclusion); Survival (9.5 years after the first inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. The program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by the program developers showed a sustained alcohol-specific restrictivity among parents exposed to the program, and also a reduction on drinking measures among the youths of the exposed parents (Koutakis, Stattin \& Kerr, 2008). This study aims to investigate whether these effects are sustained also when the program has gone into wide dissemination in Sweden.


Options:
A: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)
B: Comparison of susceptibility rate differences between the control and intervention groups (6 Months Post Intervention)
C: Self-reported drunkenness (12 months); Self-reported drunkenness (30 months)
D: Diagnosis of mental health disorder (15 year follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study
Brief Summary: Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.

Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.


Options:
A: complete clearance of mf in 80% of the infected (At 13th week (91 days) post therapy)
B: Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) (at 36 months)
C: Number of Participants Achieving Microfilarial Clearance (12 months)
D: adverse reactions (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised Controlled Study to Investigate the Effectiveness of Using a Quality of Life Questionnaire to Target Interventions to Improve Quality of Life in Patients With Lung Cancer
Brief Summary: This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. The study will assess whether using the questionnaire will result in an improvement in QoL.


Options:
A: To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
B: Profile of Mood States (POMS) (1, 6, 12 months post randomisation)
C: Subscale quality of life of the questionnaire: EORTC QLQ C30 (After each treatment completion, during follow up; first year every 3 months, second year every 6 months)
D: The primary effect outcome measurement is the number and type of referred patients with psychosocial problems to psychosocial caregivers and type of referrals with respect to psychosocial problems. (Is measured at three (T3) and twelve (T4) months after first measurement)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised Controlled Study to Investigate the Effectiveness of Using a Quality of Life Questionnaire to Target Interventions to Improve Quality of Life in Patients With Lung Cancer
Brief Summary: This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. The study will assess whether using the questionnaire will result in an improvement in QoL.


Options:
A: Change in Depressive symptoms (3, 6 and 12 months.)
B: Speech Intelligibility Score (6 weeks)
C: To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
D: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multifaceted Nurse-based Strategy Reduces HEart FaiLure Morbidity in PatiENts Admitted for Acute Decompensated Heart Failure in Brazil
Brief Summary: The home based intervention is a multidisciplinary approach that has shown benefit in the follow-up of patients with Heart Failure (HF). It is considered one of the most effective approaches and humanized by education and care for the patient in his environment of routine. In this study the monitoring of HF patients in the home after hospital discharge will include the reinforcement, monitoring and reassessment of previously provided guidance on the disease and self-care, compliance to prescribed medications and especially the early recognition of signs and symptoms of decompensation by patients and their caregivers.


Options:
A: Hospital admissions for any cause (Twelve months)
B: The primary outcome was a composite end-point of a first visit to the emergency department (lasting less than 24 hours), or a first hospital readmission (> 24h) or all-cause death, assessed during the first 6 months of follow-up. (Up to 36 months.)
C: Adherence to exercise. (18 months)
D: Mortality rate (10-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracervical Two Percent Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial
Brief Summary: The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain


Options:
A: The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). (Time of IUD insertion)
B: Change in Pain From Baseline to IUD Insertion (change in pain score from baseline (before IUD insertion) to time of IUD insertion)
C: Pain During IUD Insertion at Various Time Points (See Description for Time Points) (During IUD insertion (see above description for which time points))
D: Mean Pain Score During IUD Insertion (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Survival Benefit of the Adjunction of Pentoxifylline to Corticosteroids in Patients Suffering From Severe Alcoholic Hepatitis
Brief Summary: The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for clinicians involved in the management of severe alcoholic liver disease. In patients with Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids improve short-term survival. However, novel strategies or molecules are required in light of the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids induce an early improvement in liver function. When considering these differences of mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is an attractive option that needs to be tested in patients with severe AH.


Options:
A: survival rate at 2 months (at 2 months)
B: Overall Survival (6 months)
C: Survival at one, three and six months (six months)
D: 30 day-survival (30 days); Malondialdehyde serum levels (14 and 30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Internet-based Interacting Together Everyday, Recovery After Childhood TBI
Brief Summary: The purpose of this study is to test two on-line interventions for families of young children who have experienced moderate or severe traumatic brain injury (TBI). This project builds upon the investigators' previous research by modifying the online intervention content to address the needs of young children with TBI. The goal of this project is to develop an intervention that will encourage positive parenting behaviors, improve child behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize that the intervention groups will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the active comparison group.


Options:
A: Change from baseline in CDRS at 3 months (Month 0, Month 3)
B: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)
C: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
D: Parent Report Measures (5 years)

Answer: D