TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Working Memory Deficits in Patients With Schizophrenia Using Repetitive Transcranial Magnetic Stimulation (rTMS)
Brief Summary: Deficits in working memory (WM) performance are the most significant cognitive impairments in schizophrenia (SCZ). It has also been shown that WM performance is contingent on the cortex synchronization, a process that relies on brain inhibition. Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated as an effective treatment for patients with SCZ and has been shown to increase brain inhibition and improve cognitive performance. In this study the investigators intend to:

* evaluate rTMS as a treatment for WM deficits in SCZ
* evaluate rTMS as a method to increase WM performance in healthy individuals
* determine if improvements in WM performance are related to enhanced synchronization of brain networks
* determine whether genetic polymorphisms predict cortical function and treatment response
* evaluate the influence of rTMS treatment on brain structure.


Options:
A: Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) (105 Days)
B: The primary outcome measure will be the performance on the N-back working memory task. (4 weeks)
C: 1.Auditory hallucinations Rating Scale developed by Hoffman and colleagues (2003) 2.SAPS 3.CGI 4.SANS 5.GAF (Prospective)
D: Clinical Global Impression; (November 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Escalating Dose Study to Assess the Safety, Tolerability and Dose-range Finding of a Single Intrathecal Dose of ISIS 396443 in Patients With Spinal Muscular Atrophy
Brief Summary: This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).


Options:
A: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (Up to 88 Days); Number of participants with clinically significant neurological examination abnormalities (Up to 88 Days); Number of participants with clinically significant vital sign abnormalities (Up to 88 Days); Number of participants with clinically significant physical examination abnormalities (Up to 88 Days); Number of participants with clinically significant weight abnormalities (Up to 88 Days); Number of participants with clinically significant laboratory parameters (Up to 88 Days); Number or participants with clinically significant cerbrospinal fluid (CSF) laboratory parameters (Up to 88 Days); Number of participants with clinically significant electrocardiograms (ECGs) abnormalities (Up to 88 Days); Number of participants who use concomitant medications (Up to 88 Days); PK parameters of nusinersen (ISIS 396443): Maximum observed plasma drug concentration (Cmax) (Plasma at 1, 2, 4 and 20 hours after dosing); PK parameters of nusinersen: Time to reach maximum observed concentration (Tmax) (Plasma at 1, 2, 4 and 20 hours after dosing); PK parameters of nusinersen: Area under the plasma concentrations time curve from the time of the intrathecal (IT) dose to the last collected sample (AUCinf) (Plasma at 1, 2, 4 and 20 hours after dosing); PK parameters of nusinersen (ISIS 396443): Apparent terminal elimination half-life (t1/2), if possible (Plasma at 1, 2, 4 and 20 hours after dosing)
B: Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15 (Baseline and Month 15)
C: Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit (Day 1352 or Early Termination)
D: To assess safety and tolerability of VPA in SMA patients greater than 2 years of age

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial.
Brief Summary: The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).


Options:
A: Depression (10-16 weeks); Posttraumatic Stress Symptoms (10-16 weeks)
B: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)
C: depression (pre, post and 6 months post treatment)
D: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI (Post-intervention and 3 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial.
Brief Summary: The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).


Options:
A: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI (Post-intervention and 3 month)
B: UCLA PTSD Reaction Index (Pre-treatment, post-treatment, and at 4-month follow-up); Depression Self-Rating Scale (Pre-treatment, post-treatment, and 4-month follow-up); UCLA Grief Scale (Pre-treatment, post-treatment)
C: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
D: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial.
Brief Summary: The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).


Options:
A: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)
B: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)
C: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI (Post-intervention and 3 month)
D: Depression, PTSD (Change from 0-12 weeks, 12-24 weeks and 24-36 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients
Brief Summary: Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is still a matter of debate.

Methods. Randomized, single-center trial studying single drug (nystatin) versus control in surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU admission (T0) and subsequently every 3 days (T3, T6, T9...). The primary evaluation criterion was the time course of colonization index (CI) during ICU stay.


Options:
A: Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. (Within 7 days after end of therapy)
B: Overall Recruitment Rate (32 months)
C: course of the colonization index over time. (AT 15 day from ICU admission)
D: survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion) (28 days follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Dietary modification is of great essential for the prevention and treatment of type 2 diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked oat (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.

After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes. Participants would be randomly assigned to one of the four following groups: usual care group (only basic health advice, no other interventions), diet group (systematic education, structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for years would be carried out to predict the long-term effects of ONOG plus diet intervention on patients with type 2 diabetes.

The investigators hypothesized that ONOG combined with diet would have better effects on glycaemia and insulin resistance control in addition to those yielded by diet or usual care.


Options:
A: fasting glucose (16 weeks)
B: Changes in faecal bacteria population (Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days)
C: Body Composition (Week 6 and 12 - End of diet period 1 and 2)
D: change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection (baseline, 30 days, 6 months and 1 year); changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection (baseline, 30 days, 6 months and 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Glucomannn for the Treatment of Abdominal Pain-related Functional Gastrointestinal Disorders in Childhood Randomized Double Blind Placebo Controlled Trial
Brief Summary: Background: Functional abdominal pain disorders (FAPD) are common in school-aged children; however, there is no reliable treatment.

Aim: To determine the efficacy and safety of glucomannan for treating FAPD in children.

Trial Setting: Department of Pediatrics, The Medical University of Warsaw.

Intervention: Patients will be enrolled in a double-blind, randomized controlled trial in which they will receive either glucomannan (10g) or placebo for 4 weeks.


Options:
A: The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention. (12 weeks and 20 weeks)
B: Frequency and intensity of abdominal pain (Eight weeks)
C: number of patients with no abdominal pain at the end of the study (4 weeks (study period))
D: Improvement in pain and stooling symptoms (The last two weeks of treatment and up to 18 months after treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy
Brief Summary: The purpose of this study is to determine whether pharmacotherapy or epidural steroid injections are a better treatment for lumbosacral radicular pain.

142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an epidural steroid injection (ESI; group I), with an equal number allocated to receive gabapentin (group II). Patients \& evaluating physicians will be blinded. Follow-up will be through 3-months after treatment.


Options:
A: Area of pin-prick hyperalgesia (Change from baseline visit to day 14 of treatment sessions); Area of touch-evoked allodynia (Change from baseline visit to day 14 of treatment sessions)
B: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month after the start of treatment); Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment); Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month from the start of treatment); Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment)
C: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
D: Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time (Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy
Brief Summary: The purpose of this study is to determine whether pharmacotherapy or epidural steroid injections are a better treatment for lumbosacral radicular pain.

142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an epidural steroid injection (ESI; group I), with an equal number allocated to receive gabapentin (group II). Patients \& evaluating physicians will be blinded. Follow-up will be through 3-months after treatment.


Options:
A: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month after the start of treatment); Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment); Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month from the start of treatment); Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment)
B: Radicular Pain Visual Analogue Scale (VAS) Score change from baseline (Baseline, 4 weeks, 8 weeks, 12 weeks post injection)
C: To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. (Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.)
D: Roland Morris (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study
Brief Summary: Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with ulcerative colitis (UC) and Crohn's disease (CD), experience clinical, biochemical and genetical improvement in their disease.

A prospective randomised study comparing the mushroom extract with placebo.


Options:
A: Corticosteroid-free remission (At the end of the study treatment)
B: Reduction in biochemical blood parameters (pro-inflammatory cytokines) (21 days)
C: 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)
D: Fatigue score (20 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B
Brief Summary: This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.


Options:
A: N/A
B: Annualized Bleeding Rate (ABR) (9 months)
C: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings (Baseline up to Week 52); Number of Participants With Clinically Significant Change From Baseline in Vital Signs (Baseline up to Week 52); Number of Participants With Clinical Laboratory Abnormalities Reported as TEAE (Baseline up to Week 52); Number of Participants With Drug -Related TEAEs and Serious Adverse Events (SAEs) (Baseline up to Week 52); Number of Participants With Positive Immune Reponses Against Adeno-associated Virus Vector (AAV) Capsid (Baseline up to Week 52); Number of Participants Who Reached > 150% Vector-derived FIX:C Activity Level After SPK-9001 Infusion (Baseline up to Week 52); Number of Participants With FIX Inhibitor (Baseline up to Week 52); Incremental Recovery of FIX Product (Day 0 and Week 52)
D: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B
Brief Summary: This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.


Options:
A: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)
B: N/A
C: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))
D: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B
Brief Summary: This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.


Options:
A: Number of Bleeds During 6 Month Treatment Period (6 months)
B: Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027 (Pre-dose to 120 hours after the end of the infusion); Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for Adynovi (Pre-dose to 120 hours after the end of the infusion)
C: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))
D: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee
Brief Summary: This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)


Options:
A: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).
B: Visual Analogue Scale (VAS) Pain scale (14 days)
C: pain subscale of the WOMAC (week 12)
D: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.


Options:
A: Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase (9 weeks)
B: Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo (Baseline up to Week 5 postdose, up to 10 months total follow up)
C: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
D: Mean pain score

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Kaabong, Karamoja, Uganda
Brief Summary: The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.


Options:
A: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
B: "negative nutritional outcome" of a child (6 months follow-up)
C: Change from baseline in the isotopic ratio of iron in blood at week 5 (Baseline and Week 5)
D: "negative nutritional outcome" of a child (6 months follow-up)

Answer: D