TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Sickle Cell-Related Pain Crises
Brief Summary: The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the drug and how long it stayed in the blood stream.

Funding Source - FDA Office of Orphan Products Development (OOPD)


Options:
A: Incidence rate of clinical stroke or TIA (3 Years)
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: Number of Malaria Episodes (12 months)
D: Annual Rate of Sickle Cell-related Pain Crises (SCPC) Per Hodges-Lehmann Median (One year); Annual Rate of Sickle Cell-related Pain Crises (SCPC) - Per Standard Median (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age
Brief Summary: The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.


Options:
A: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)
B: Composite Primary Endpoint (From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.)
C: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
D: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age
Brief Summary: The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.


Options:
A: Recurrent deep venous thrombosis or venous thromboembolism (6 months); Occurrence of fatal or major bleeding (6 months); Mortality related to massive pulmonary embolism (6 months)
B: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
C: Composite Primary Endpoint (From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The present research aims at examining the effectiveness of a specific set of therapist relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients diagnosed with Borderline Personality Disorder.

The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne, Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition (General Psychiatric Management; Gunderson \& Links, 2008) and 2) MOTR-condition. The investigators hypothesize better results in the MOTR-condition, as compared to the control condition in terms of symptom reduction pre-post.

The conduct of the study represents a significant contribution to the understanding and enhancement of relationship aspects in the treatment of patients diagnosed with Borderline Personality Disorder which may be of potential benefit for these patients.


Options:
A: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)
B: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)
C: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
D: Symptom Checklist 90

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The present research aims at examining the effectiveness of a specific set of therapist relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients diagnosed with Borderline Personality Disorder.

The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne, Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition (General Psychiatric Management; Gunderson \& Links, 2008) and 2) MOTR-condition. The investigators hypothesize better results in the MOTR-condition, as compared to the control condition in terms of symptom reduction pre-post.

The conduct of the study represents a significant contribution to the understanding and enhancement of relationship aspects in the treatment of patients diagnosed with Borderline Personality Disorder which may be of potential benefit for these patients.


Options:
A: Job satisfaction (baseline to 3 month)
B: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))
C: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
D: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The present research aims at examining the effectiveness of a specific set of therapist relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients diagnosed with Borderline Personality Disorder.

The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne, Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition (General Psychiatric Management; Gunderson \& Links, 2008) and 2) MOTR-condition. The investigators hypothesize better results in the MOTR-condition, as compared to the control condition in terms of symptom reduction pre-post.

The conduct of the study represents a significant contribution to the understanding and enhancement of relationship aspects in the treatment of patients diagnosed with Borderline Personality Disorder which may be of potential benefit for these patients.


Options:
A: Self-harm Ideation (pre-treatment (week 0) to post-treatment (end of week 8))
B: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)
C: Suicide Attempts (Assessed bimonthly)
D: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression
Brief Summary: The purpose of this study is to determine whether combination of antidepressant drugs plus interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant depression.


Options:
A: Hamilton Depression Scale (HAM-D) - continuous (End point week 19 and Week 24)
B: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
C: Hamilton Depression Rating Scale - Grid version (6 months)
D: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Brief Summary: The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial


Options:
A: Corticosteroid-free remission (At the end of the study treatment)
B: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
C: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)
D: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Brief Summary: The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial


Options:
A: Safety (up to 6 mo post FMT)
B: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
C: diversity and steady state of the stool (6 months)
D: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Brief Summary: The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial


Options:
A: Safety (up to 6 mo post FMT)
B: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)
C: co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score (at 12 weeks after treatment.)
D: clinical remission (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation - a Feasibility Study
Brief Summary: Stroke is the most common cause of adult disability. Current treatments for functional loss of the upper extremity post-stroke remain limited in efficacy, particularly for those with moderate to severe impairment.

Previous studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is effective to enhance motor recovery, with activation of neural pathways similar to that of motor execution. This treatment is accessible to more severely impaired stroke survivors. Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is detected by surface EEG and translated to execution of the target movement with the aid of an arm robot (MIT-Manus).

In this study, we investigate the feasibility of combining robot-assisted MI-BCI training, with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI. Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic stimulation (TMS).

We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI) vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each session. Primary outcome will be functional ability measured by upper extremity component of the Fugl-Meyer Assessment. Secondary outcome measures will be the Box \& Block Test, Modified Ashworth Score (measuring spasticity), grip strength and measures of brain activity including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures including functional MRI and diffusion tensor imaging (DTI).

This study will be important to develop a new and effective treatment (tDCS-BCI) for post-stroke motor impairment.


Options:
A: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
B: Change in Behavioural Inattention Test (BIT) (6 months post intervention)
C: Fatigue relief (assessed by the Fatigue Severity Scale) (4 months after the stroke)
D: Behavioural Inattention Test (BIT) (Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)); Neglect Test Battery (Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation - a Feasibility Study
Brief Summary: Stroke is the most common cause of adult disability. Current treatments for functional loss of the upper extremity post-stroke remain limited in efficacy, particularly for those with moderate to severe impairment.

Previous studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is effective to enhance motor recovery, with activation of neural pathways similar to that of motor execution. This treatment is accessible to more severely impaired stroke survivors. Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is detected by surface EEG and translated to execution of the target movement with the aid of an arm robot (MIT-Manus).

In this study, we investigate the feasibility of combining robot-assisted MI-BCI training, with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI. Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic stimulation (TMS).

We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI) vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each session. Primary outcome will be functional ability measured by upper extremity component of the Fugl-Meyer Assessment. Secondary outcome measures will be the Box \& Block Test, Modified Ashworth Score (measuring spasticity), grip strength and measures of brain activity including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures including functional MRI and diffusion tensor imaging (DTI).

This study will be important to develop a new and effective treatment (tDCS-BCI) for post-stroke motor impairment.


Options:
A: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
B: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
C: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
D: Fugl-Meyer Upper Extremity (FM-UE) (from baseline to day 3 post-training)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
Brief Summary: The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and neurocognitive functioning including memory, attention, the ability to plan activities, and learn new information. Participants will be assigned by chance to receive regular care or exercise sessions in addition to regular care. This study will allow determining the potential positive influence of AE on cognitive and daily functioning in individuals with schizophrenia.


Options:
A: Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks (Baseline and after 12 weeks.); Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks (Baseline and after 12 weeks); Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks (Baseline and after 12 weeks); Change from Baseline in Daily Functioning Assessments at 12 weeks (Baseline and after 12 weeks)
B: Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score) (At 6 weeks and At 12 weeks); Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure) (At 6 weeks and At 12 weeks)
C: Cognitive performance, as measured by a neuropsychological battery (Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up)
D: Cognitive Function Measured by MCCB Composite Score (4-6 month period); Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale (4-6 month period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.


Options:
A: Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1 (4 hours post-morning dose on Day 1); Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14 (4 hours post-morning dose on Day 14); Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA) (Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)); Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 26)
B: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)

Answer: A