TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Training Dual-Task Walking After Stroke: Effects on Attentional and Locomotor Control
Brief Summary: Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Unfortunately, current rehabilitation practice for stroke fails to adequately address dual-task limitations; individuals with stroke continue to exhibit clinically significant dual-task costs on gait at discharge. As a result, many stroke survivors are living in the community with residual deficits that may increase disability in the real world and lead to falls with devastating consequences. To address this issue, the proposed study investigates the efficacy of dual-task gait training on attention allocation and locomotor performance in community-dwelling stroke survivors. Because walking in the real world often requires time-critical tasks and obstacle avoidance, the investigators will test the impact of dual-task gait training on cognitive-motor interference during walking at preferred speed and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The investigators will also evaluate the effects of the intervention on community reintegration and participation (Aim 3).


Options:
A: Dual-task cost on gait speed (4 weeks)
B: Rate of recruitment to the studies (12 weeks (pilot study))
C: Difference in the 'Graded Cycling Test with Talk Test' (at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
D: the score-change of the Functional Independence Measure (FIM) assessment for daily living function (baseline, 2-week, 4-week and three months after stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Training Dual-Task Walking After Stroke: Effects on Attentional and Locomotor Control
Brief Summary: Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Unfortunately, current rehabilitation practice for stroke fails to adequately address dual-task limitations; individuals with stroke continue to exhibit clinically significant dual-task costs on gait at discharge. As a result, many stroke survivors are living in the community with residual deficits that may increase disability in the real world and lead to falls with devastating consequences. To address this issue, the proposed study investigates the efficacy of dual-task gait training on attention allocation and locomotor performance in community-dwelling stroke survivors. Because walking in the real world often requires time-critical tasks and obstacle avoidance, the investigators will test the impact of dual-task gait training on cognitive-motor interference during walking at preferred speed and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The investigators will also evaluate the effects of the intervention on community reintegration and participation (Aim 3).


Options:
A: Dual-task cost on gait speed (4 weeks)
B: Difference in physical activity scale for the elderly (24 months)
C: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
D: Aerobic capacity (Baseline,3month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patterns of Physical Activity Levels in Patients With Bronchiectasis: Cross Sectional Study Using Quantitative Methodology
Brief Summary: The primary aim of this study is to examine the physical activity levels of patients with bronchiectasis.

Subsidiary aims are:

1. To examine whether there is a relationship between the physical activity levels of patients with bronchiectasis and clinical phenotype (disease severity, exercise capacity, quality of life or other symptoms of their disease). The investigators also want to explore the relationship between physical activity levels and readiness to change physical activity behaviour (stages of change, self-efficacy, decisional balance and processes of change).
2. To assess the feasibility and acceptability of the physical activity assessment tools: ActiGraph, ActivPAL, pedometer and the International Physical Activity Questionnaire.

Hypothesis:

Patients with bronchiectasis will have low levels of physical activity, and this is related to their clinical phenotype (disease severity, exercise capacity, quality of life and other symptoms of their disease) and also their readiness to change physical activity behaviour (stages of change, self-efficacy, processes of change and decisional balance).


Options:
A: Number of steps on the ActiGraph GT3X+ activity monitor (Seven days)
B: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
C: 6 minute walk distance (8 weeks post exacerbation)
D: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Cross Over Trial of Two Treatments for OSA in Veterans With PTSD
Brief Summary: Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in patients with PTSD compared to those without PTSD and contribute to worsening cognitive and behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general population. The proposed study aims at comparing the efficacy, tolerability, and adherence of oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would predict oral appliance response


Options:
A: Residual Apnea Hypopnea Index (up to 12 weeks)
B: Ambulatory blood pressure monitoring (Change from Baseline in Blood Pressure at 6 months)
C: Number of hours of use per day of CPAP (Six month)
D: Objective CPAP Use (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Brief Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)


Options:
A: Overall Response Rate (ORR) (Disease evaluated on Cycle 2 day 22 (Restage end of cycle 2), Cycle 10 day 1 (Final Restage 2 months after end of ofa therapy) and off treatment prior to cycle 10. Treatment duration is median 243 days with range of 9-620 days.)
B: Progression-Free Survival (PFS) (Up to 84 months)
C: Response (2 months post consolidation)
D: Progression Free Survival (PFS) (up to 50 months); Number of Participants With a Response (7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Four-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Brief Summary: The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female participants with moderate to severe pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.


Options:
A: Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI) (Baseline and 1 month)
B: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
C: Pain reduction or resolution within 10 treatment sessions, evaluated with the 0-10 Numeric Pain Rating Scale (0-10NPRS) (10 weeks or earlier on resolution)
D: Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4 (Baseline and Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis
Brief Summary: The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS).


Options:
A: Number of Disease-free Patients (Baseline through 24 months)
B: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))
C: Number of participants with adverse events (One year after completed treatment)
D: Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab (Up to 10 months); Percentage of Participants Using Rituximab Off-Label (Up to 10 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Striving to Quit: First Breath Tobacco Cessation Research
Brief Summary: This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Medicaid BadgerCare Plus pregnant smokers.


Options:
A: Smoking Status at 6 Months (6 months after enrollment)
B: Abstinence From Smoking (Measured 6 months after enrollment at follow-up assessment)
C: Biologically confirmed tobacco cessation (6 months)
D: Abstinence from smoking (Measured 6 months after births at follow-up assessment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study
Brief Summary: Background: The treatment of traumatised refugees is one of the areas within the field of psychiatry with the weakest evidence for the different types of treatment. This is a problem for both patients and doctors as well as for society.

The treatment of choice today for Post Traumatic Stress disorder (PTSD) is antidepressants from the subgroup of Selektive Serotonin Reuptake Inhibitors (SSRI), among these the drug Sertraline. The evidence for the use of these drugs as treatment for chronically complex PTSD in traumatised refugees is however very limited and a large part of the group is estimated to be insufficiently treated with this type of medicine. Venlafaxine is an antidepressant from the subgroup of dual action product which means that is works on several pathways in the brain. Among others it influences the area in the brain that is responsible for the enhanced anxiety and hyperarousal experienced by traumatised refugees and which is found to be enlarged among patients suffering from PTSD.

All together there is not sufficient evidence to conclude which type of medical and psychological treatment that is most efficient when it comes to the treatment of traumatised refugees. Also there is a lack of studies which examines social functioning and the relation between psychosocial resources and outcome from treatment. Furthermore there is a lack of knowledge of predictors of treatment outcome for the individual patients. This study seeks to produce some of this evidence.

Method: This study is expected to include approximately 150 patients randomised into two different groups. The patients are treated with Setraline or Venlafaxine depending on the group the randomised to. Patients in both groups are getting the same version of manual based Cognitive Behavioural Therapy that is specially adapted to this group of patients. The treatment period is 6-7 month. The trial endpoints are PTSD-and depression symptoms and social functioning all measured on internationally validated ratings scales.

Furthermore the study will examine the relation between expected outcome of treatment from a range of predictors and the actual treatment results for the individual patient.

Results: Altogether this study will bring forward new standards for clinical evaluation and treatment of traumatised refugees and the results are expected to be used in reference programmes/clinical guidelines.


Options:
A: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)
B: Harvard Trauma Questionnaire (HTQ) (Change from baseline after aprox. 6 months treatment)
C: Clinician Administered PTSD Scale (before treatment, 1 month after, 6 months after)
D: Severity of mental health symptoms (previous 4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Brief Summary: The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.


Options:
A: occurrence of allergic reactions (14 days)
B: The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. (4 months)
C: Total RBC glutathione (0 days, 7 days, 60 days)
D: 1. Weight of abnormal (watery/liquid) stool for each 6-hour and 24-hour (day) of the study as well as cumulative weight until resolution of diarrhoea (maximum of 5 days) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?


Options:
A: pregnancy rate (on average 30 days if not pregnant and 12 weeks if pregnant)
B: Clinical pregnancy rate (5 weeks after intrauterine insemination)
C: ongoing pregnancy rate (12 weeks)
D: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interest of Systematic Tracking of Dementia Cases in Nursing Homes: Analysing the Contribution of MultiDisciplinary Team Meeting (MDTM) in Alzheimer's Disease and Related Diseases
Brief Summary: Introduction: Epidemiological data show that in France only half of patients with Alzheimer disease are currently diagnosed in the general population. The absence of early diagnosis of dementia reduces the opportunities of patients to receive optimal care. One of the consequences of undiagnosed dementia is inadequate use of emergency care units.

The main objective: The main aim of this study is to evaluate the impact of a systematic case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of hospitalization in emergency care units.

Secondary objectives:

To assess the impact of systematic tracking of dementia cases on the:

* Quantity and quality of drug-prescription
* Appropriateness of hospitalizations
* Prevalence of neuropsychiatric symptoms
* Dependency
* Quality of life
* Burden of nursing staff working conditions
* Planning of specific therapeutic measures
* Overall health care costs


Options:
A: Incidence of hospitalizations in emergency care units (18 months)
B: Fall Related Process Measures (6 months post intervention)
C: NPI-NH agitation/aggression (8 weeks and 12 weeks)
D: Change in knowledge of and self-efficacy concerning ACP (One questionnaire at baseline (T0), one questionnaire at follow-up (T1, 8 months after T0))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial
Brief Summary: Folic acid is the synthetic form of vitamin folate. Because of its high stability and bioavailability, it is the form of folate added to bread in Canada to reduce birth defects. There are health concerns about long-term folic acid consumption. Another form of folate, L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic acid.

The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.


Options:
A: Proportion recovered from moderate acute malnutrition (MAM) (up to 40 weeks); Maternal change in mid-upper arm circumference (MUAC) (up to 40 weeks); infant birth weight (up to 40 weeks); infant birth length (up to 40 weeks); premature delivery (up to 36 weeks)
B: Plasma zinc concentration (1 month)
C: red blood cell folate concentration at three time points (baseline, 8th week, 16th week)
D: serum B12 status; serum folate status

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"
Brief Summary: The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.


Options:
A: Change in intensity of hyper pigmentation using a scale of 0 to 10 (One week, one month and six months after surgery); Change in extension of hematoma using a scale of 0 to 10 (One week, one month and six months after surgery); Change in aesthetic results using a scale of 0 to 10 (One week, one month and six months after surgery); Change in pain levels using a scale of 0 to 10 (One week, one month and six months after surgery); Change in intensity of skin burns using a scale of 0 to 10 (One week, one month and six months after surgery); Change in presence of sensitivity alteration (One week, one month and six months after surgery); Change in presence of thrombophlebitis (One week, one month and six months after surgery); Change in presence of resection or occlusion of the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of complications (One month, six months and 12 months after surgery)
B: Comparative Duplex Ultrasound (Immediately Post-procedure)
C: long-term QoL follow-up of patients after UGFS and surgical stripping (6-10 years follow-up)
D: anatomical success rate (absence or obliteration of GSV on US examination) (3 months, 1 and 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Brief Summary: Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.


Options:
A: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)
B: objective signs of tissue or neurovascular injury (180 days after treatment); levels of plasma biomarkers (180-day)
C: changes in brain lesions (0-24 months)
D: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® NEXThaler® (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., Versus Seretide® Accuhaler® (Fluticasone 250 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., on Small Airway Derived Parameters in Patients With Asthma
Brief Summary: The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.


Options:
A: Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)]. (Baseline and 3 months)
B: FEV1, (Forced expiratory volume in the 1st second).
C: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)
D: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)

Answer: A