TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Brief Summary: The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.


Options:
A: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
B: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
C: Clinical and Endoscopic Remission. (8 weeks)
D: Clinical and Endoscopic Remission. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Brief Summary: The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.


Options:
A: Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 (Week 8)
B: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
C: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)
D: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral and Psychosocial Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients: a Multicenter Study
Brief Summary: 5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic counseling and DNA testing are usually offered to selected patients after primary treatment has been completed (e.g. the first year after diagnosis). For women with a mutation in one of the two breast-ovarian cancer syndrome genes, chances of a second breast cancer are high, and therefore a proportion of these women may opt for preventive measures in addition to their immediate breast cancer treatment. Contralateral prophylactic mastectomy significantly reduces this risk, and is associated with a reduction in mortality.

Genetic counseling and testing for breast cancer typically takes approximately 4-6 months to complete. However, some hospitals and laboratories are now able to generate test results within 3 to 6 weeks. This technology of rapid genetic testing creates new opportunities for providing both women and their treating surgeons with information potentially relevant for deciding between available treatment options, including type of surgery and adjuvant therapy.

The study will focus on newly diagnosed breast cancer patients who, prior to receiving treatment, are identified as having at least a 10% risk of carrying a mutation in the BRCA1 or BRCA2 genes.

We will investigate whether women with a recent diagnosis of breast cancer make use of rapid genetic counseling when offered.

Furthermore, we will investigate whether the process of genetic counseling (and subsequent DNA testing) has influence on the choice of treatment, and whether and how such rapid genetic counseling and testing (RGCT) affects levels of risk perception, cancer-related worries and distress, and decisional satisfaction.


Options:
A: Decision Self Efficacy (post intervention)
B: preferences for medical care (within 48 hours of admission to the hospital)
C: The choice of primary surgical treatment (1 year)
D: Contraceptive Continuation (4 and 7 months post-enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing the Beneficial Effects of Upper Extremity Visuomotor Training With tDCS
Brief Summary: This study will determine if electrical brain stimulation during movement practice can improve the ability of stroke patients to reach for objects more than movement practice alone.

People between 18 and 85 years old who have had a stroke may be eligible for this study. Participants are randomly assigned to one of two study groups: movement training with active (tDCS) or movement training with sham (tDCS).

Participants will undergo 1-hour movement training and (tDCS) sessions twice a day, 5 days a week, for 3 weeks. For these sessions, subjects will sit in front of a computer screen that shows a target (round dots) and a cursor (a line). Participants will be instructed to move the cursor to various targets on the computer screen as fast and as accurately as possible, controlling the position of the cursor by moving their arm, which will rest on a mechanical device.

Participants will receive real or sham (tDCS) during the movement training sessions. For (tDCS), electrode sponges soaked in tap water are placed on the scalp and forehead. A small electrical current is passed between the electrodes. The stimulation lasts 20 minutes.

Patients will have the following tests four times during the study - 1) before starting movement training 2) (tDCS) during the course of training and (tDCS), 3) after completing training and (tDCS), 4) and 3 months after completing training and (tDCS):

Functional magnetic resonance imaging (fMRI)

Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to take pictures of the brain. Functional MRI (fMRI) shows what parts of the brain are used when a task is performed. For the test, the subject lies on a table that can slide in and out of the scanner. A computer screen can be seen from inside the scanner. During the scan, subjects may be asked to do the study task or to lie still for up to 20 minutes at a time.

Movement and function tests

* Measurement of arm stiffness
* Moving the arms actively and against resistance
* Picking up objects and moving them as quickly as possible
* Performing daily living tasks like buttoning, dressing and walking
* Performing tasks while wearing a glove that monitors the position of the arm
* Completing questionnaires on ability to perform daily activities or other movements and level of tiredness

Transcranial magnetic stimulation (TMS)

TMS uses a magnet to stimulate the brain in way that is different from (tDCS). This study us...


Options:
A: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
B: Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
C: Reaction time (millisecond) (24 hours post intervention)
D: Changes in cortical excitability measures (Measured for approximately 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Brief Summary: This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL


Options:
A: To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter (March 2012)
B: Number of Participants With Asparaginase-Related Toxicity (30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.); Induction and Post-Induction Nadir Serum Asparaginase Activity Level (Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25.)
C: Efficacy of dexamethasone vs prednisone during the induction phase (5 years); Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients (5 years); Safety and efficacy of treatment reduction during reintensification in standard-risk patients (5 years); EFS after second delayed reintensification in intermediate-risk patients (5 years); Outcome after extended reintensification therapy in high-risk patients (5 years)
D: Risk of relapse (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Arm, Multicenter Study in Subjects With End-Stage Joint Disease to Compare the Frequency of Constipation Symptoms in SubjectsTreated With Tapentadol IR and Oxycodone IR Using a Bowel Function Patient Diary
Brief Summary: The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.


Options:
A: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
B: Average Daily Pain Scores - BS11 Pain Scores. (every day over a 12 week study duration.)
C: 5-Day Sum of Pain Intensity Difference (SPID5) (Day 1 to Day 5); Spontaneous Bowel Movements Per Week (SBMs/Week) (Week 1 to Week 2)
D: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes
Brief Summary: Moderate alcohol may be beneficial for diabetics


Options:
A: Glycemic control (6 months)
B: insulin sensitivity as determined by euglycemic clamp tests (8 weeks)
C: Vascular function (Measured at weeks 4 and 12)
D: Blood Pressure (2 hours after consuming beverage)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients
Brief Summary: The purpose of this study is to define an improvement in patients:

* To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue
* To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.


Options:
A: progression-free survival (PFS) (3 year)
B: To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. (4 years)
C: 3-year progression-free survival (3 years)
D: Response (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients
Brief Summary: The purpose of this study is to define an improvement in patients:

* To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue
* To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.


Options:
A: Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD (36 Months); 36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation. (at 36 months)
B: Progression-free survival (up to 5 years after randomisation)
C: progression-free survival (PFS) (3 year)
D: To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.


Options:
A: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)
B: Rate of healthcare utilisation based exacerbations of COPD
C: All cause mortality at 3 years
D: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint (Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.


Options:
A: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose (Baseline to 12 weeks)
B: AUC (0-4hrs, sGAW after morning dose of medication at day 14)
C: Percentage of Participants Who Were Able to Remain on the Randomized Treatment (24 weeks)
D: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint (Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus
Brief Summary: Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients.

The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease, control trials are difficult to conduct. Evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against B- lymphocytes) or immunoadsorbtion.


Options:
A: Primary Safety Endpoint (1 year)
B: The cumulative total methylprednisolone doses and rate of remission.
C: Drug-related Adverse Event profile of BIVV009 (6 weeks)
D: Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion
Brief Summary: Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects.

Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.


Options:
A: complete abortion (14-28 days post treatment)
B: Complete abortion (14 days)
C: Number of surgical evacuation in each group (during de study)
D: Success rate of abortion (24 hours); Interval to abortion (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion
Brief Summary: Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects.

Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.


Options:
A: Success rate of abortion (24 hours); Interval to abortion (24 hours)
B: Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.) (Day 8 from first misoprostol dose)
C: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
D: Number of surgical evacuation in each group (during de study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial
Brief Summary: The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events.


Options:
A: Framingham Risk Score (15 months)
B: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)
C: Medication utilization; Best Practices; Recurrent stroke
D: Framingham heart risk score (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial
Brief Summary: The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)
C: Framingham heart risk score (1 year)
D: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Parallel, Time-lagged, Ascending, Multi-centre, Multiple-dose Study to Measure the Magnitude and Time Course of the Effect of FTY720 on FEV1 and Other Pulmonary Function Tests (FVC, FEF25-75%, and FEV1/FVC) in Patients With Moderate Asthma
Brief Summary: This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma


Options:
A: Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 (10 days); Safety of FTY720 (10 days)
B: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)
C: Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions (Months 6, 9, 12, 18, 24, 36, and 48)
D: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)

Answer: A