bioihbjkbjnl/mcl2 huggingface dataset:
Curcumin in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open label forced dose titration study designed to determine the
      tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This
      study will provide initial tolerability and safety data in pediatric patients with IBD.
      Twenty patients with IBD in remission or with mild disease (score <34 on PUCAI or score <30
      on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this
      study. Each patient will participate in the study for nine weeks. From this study an
      appropriate dosage will be determined to proceed with a double blinded placebo controlled
      study.
    


Intervention name(s): Curcumin
Intervention type(s): Drug
Intervention description(s): Initial dosage of 500mg twice a day for 3 weeks. Using the forced dose titration design, dose will be titrated up to 1g twice a day at Week 3 for a total of three weeks and then titrated again to 2g twice a day at Week 6 for three weeks.
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's disease; ulcerative colitis; curcumin; pediatric; inflammatory bowel disease
SISTERS: Spasticity In Stroke Study - Randomized Study
Condition: Severe Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment
      (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke
      patients with generalized spastic hypertonia who have not reached their therapy goal with
      other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score
      in the lower extremities.
    

Detailed description: 
      This is a randomized, controlled open-label parallel group study to demonstrate the efficacy
      benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not
      reached their therapy goal with other treatment interventions.

      In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a
      two-arm parallel group design will be applied. Patients will be equally randomized to one of
      two treatment arms:

        1. ITB Therapy arm; or

        2. BMT arm

      The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for
      the ITB Therapy treatment arm, followed by a 6 month active trial.

      The BMT treatment arm will receive a combination of oral antispastic medication and
      physiotherapy. Patients must be prescribed at least one or a combination of the following
      oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines)
      or dantrolene. Following the run-in phase, patients will enter the 6 month active trial.

      The ITB Therapy treatment arm will receive a combination of ITB Therapy and physiotherapy.
      During the run-in phase, a test with intrathecal baclofen will be performed to evaluate the
      response of the patient. Patients fulfilling the test success criterium will be implanted
      with a Medtronic SynchroMed®II infusion system. Following implant, patients will enter into
      the 6 month active trial, which includes a 6 week titration phase, during which time oral
      antispastic medications must be gradually reduced with complete discontinuation by the end of
      the titration period.

      During the 6 month active trial, patients will be assessed at 3 and 6 months. All primary and
      secondary endpoint assessments will be performed by a blinded assessor.

      The total study duration is expected to be 60 months, including a 39 month enrollment period.
      The total duration per patient is approximately 7 months (approximately 1 month run-in period
      followed by 6 months active treatment).
    

Intervention name(s): intrathecal baclofen
Intervention type(s): Drug
Intervention description(s): ITB test, implant, 6 months follow-up
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe spasticity in post-stroke patients
Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy
Condition: Eating Behavior
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the impact of an innovative web-based school nutrition
      intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit
      and dairy products in high school students and to identify facilitators and/or barriers
      influencing its success.
    

Detailed description: 
      Classes of first and second year secondary students (grades 9 and 10) from the Québec City
      region will be randomized into two groups. Participants in the intervention (Team
      Nutriathlon) will be asked to increase their consumption of fruits and vegetables and dairy
      products using an innovative web-based platform, developed for this study, over six weeks.
      The control group will follow the regular school curriculum. The number of servings of fruits
      and vegetables and dairy products consumed by students per day and facilitators and barriers
      influencing the success of the program will be compared between the two groups over the
      study.
    

Intervention name(s): Team Nutriathlon intervention
Intervention type(s): Behavioral
Intervention description(s): 8 wk web-based nutrition intervention program aimed at increasing the consumption of fruits, vegetables and dairy products.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Other
ExoAtlet II For SCI Patients
Condition: Spinal Cord Injuries; Paraplegia
MeSH terms: Spinal Cord Injuries; Paraplegia
Study type: Interventional

Summary: 
      This study will evaluate the ExoAtlet II exoskeleton for safety and effectiveness of
      providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited
      ambulatory function, to stand up and ambulate under a variety of conditions.
    

Detailed description: 
      The study will introduce the ExoAtlet II exoskeleton to SCI patients with lower extremity
      paralysis (partial or complete) and provide rehabilitative standing and walking intervention.
      The study will be conducted with a trained clinician that will fit each patient into the
      adjustable exoskeleton system and provide customized programming to meet each user's specific
      needs. The training program will be initiated based upon each patient's comfort in the
      exoskeleton and ability to stand with assistance. Each patient will be closely monitored to
      assess ongoing health as well as their individual standing and walking ability. All
      exoskeleton sessions will be performed with a trained medical professional controlling the
      exoskeleton. Patient safety is the primary concern and all adverse events will be documented
      and addressed. This study will evaluate the ExoAtlet 2.0 exoskeleton for safety and
      effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or
      have limited ambulatory function, the ability to stand up and walk in a clinical facility.
    

Intervention name(s): Gait training using ExoAtlet exoskeleton
Intervention type(s): Device
Intervention description(s): Subjects will learn to use the ExoAtlet II exoskeleton, with the assistance of a trained medical professional, to perform functional activities (including stand-up, sit-down, stepping forward, and walking).
Intervention model: Single Group Assignment
Intervention model description: SCI Level T4-L5 or, C7-T3 with ASIA D
Masking: None (Open Label)
Primary purpose: Treatment
A4250, an IBAT Inhibitor in Pediatric Cholestasis
Condition: Pediatric Cholestasis
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients
      with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus
    

Detailed description: 
      The primary aims of this Phase II exploratory study in patients treated with A4250 due to
      cholestasis induced pruritus are to:

        -  Assess the safety and tolerability of A4250, orally administered first as a single dose
           and then during a four week treatment period, as determined by the occurrence of
           treatment-emergent SAEs

        -  Explore changes in serum total bile acids after a four week treatment period

      Secondary safety aims include assessment of the safety and tolerability of A4250, orally
      administered first as a single dose and then during a four week treatment period, as
      determined by the occurrence of treatment-emergent AEs and changes in safety parameters
      including laboratory tests and vital signs

      Secondary efficacy aims are to:

        -  Demonstrate the efficacy of A4250, orally administered during a four week treatment
           period, on liver biochemistry variables and on pruritus parameters

        -  Evaluate the pharmacokinetic properties of A4250 orally administered first as a single
           dose and then after a four week treatment period

        -  Evaluate changes in VAS-itching score after a four week treatment period
    

Intervention name(s): A4250
Intervention type(s): Drug
Intervention description(s): A4250
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction of SMC021 With Concomitant Antacid (Calcium Carbonate/Magnesium Hydroxide).
Condition: Health Postmenopausal Women
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effect of concomitant antacid on the pharmacokinetics and
      pharmacodynamics of SMC021
    


Intervention name(s): SMC021
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Randomized, partially blind, placebo controlled, crossover, drug interaction with concomitant antacid, pharmacokinetics, pharmacodynamics, SMC021
Bupivacaine in Tonsillectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      A placebo-controlled and double-blind study is planned according to current legislation and
      ICH GCP guidelines with 80 patients at Nordland Hospital, Bodø. Fifty percent are randomized
      to receive bupivacaine 5 mg / ml on the gauze swabs used to stop the bleeding after
      tonsillectomy, and 50% receive 0.9% sodium chloride.

      Pain at rest and pain when swallowing according to numerical rating scale (0-10), as well as
      the presence of the following symptoms (yes / no): nausea, vomiting, food intake, bleeding,
      fever, need for extra painkillers in the form of morphine or similar will be registered 1, 2,
      3, 4, 5, 6 hours and 1, 2 4 and 6 days after the operation. Differences are analyzed with
      "mixed models" statistics and the results will be published in a peer-based journal.
    


Intervention name(s): Bupivacaine; Sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.; Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.
Other intervention name(s): Marcain; Saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans
Condition: Immunologic Deficiency Syndromes
MeSH terms: Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to test wether orally administered Beta-glucan has systemic
      effects in humans.
    

Detailed description: 
      The immunostimulatory properties of mushrooms have been recognized for centuries, and
      "medicinal" mushrooms are still widely used in alternative medicine all over the world.
      Although a number of fungal components have been implicated in these properties, Beta-glucans
      have attracted the most attention. However, although Beta-glucans are widely used as a health
      food supplement, their immunomodulatory effects after administration in humans have not yet
      been determined.
    

Intervention name(s): Beta-glucan (Glucan #300®)
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Betaglucan, immune modulation, immunoparalysis, immune suppression
Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      The goal of the current project is to fill the unmet clinical needs around the objective
      assessment of visual function and develop outcome-oriented visual rehabilitation approach
      using the computer assisted rehabilitation environment (CAREN) system for Argus recipients.
    


Intervention name(s): CAREN system training
Intervention type(s): Device
Intervention description(s): CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Argus II Retinal Prosthesis System; Rehabilitation
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Condition: Neurodevelopmental Abnormality
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      An extension of the MINVI trial, the MINVI Follow-Up trial will evaluate the
      neurodevelopmental outcomes at 22-26 months corrected age of term/near term infants who
      received UCM or ECC.
    

Detailed description: 
      The MINVI Follow-up trial will examine the difference in early childhood neurodevelopmental
      impairment of subjects enrolled in the MINVI trial using standardized neurological and
      developmental assessments at 22-26 months corrected age.
    

Intervention name(s): Umbilical Cord Milking; Early Cord Clamping
Intervention type(s): Procedure; Procedure
Intervention description(s): At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.; The umbilical cord is clamped within 30 seconds of delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Neurodevelopmental assessments will be done at 2 years of corrected age (22-26 months) for subjects who were randomized to receive either early cord clamping or umbilical cord milking as part of the MINVI trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Neurodevelopmental impairment; Disability; Umbilical cord milking; Early Cord Clamping
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
    

Detailed description: 
      An interventional, double-blind, randomized, placebo-control design will be used to test
      safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in 70 subjects ≥ 18 and < 65
      years of age with documented cystic fibrosis. There will up a screening period of up to 28
      days, 84 days treatment period, and 28 days follow-up.
    

Intervention name(s): JBT-101 (lenabasum); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.; Subjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.
Intervention MeSH terms: Lenabasum
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: JBT-101, Lenabasum, Cystic Fibrosis
Sensory Stimulation During CIMT
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The long-term goal of this project is to assess the impact of the novel sensory stimulation
      technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children
      with cerebral palsy. This is a pilot project.
    

Detailed description: 
      The stimulation is peripheral sensory stimulation involving application of low-level,
      random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper
      extremity function will be greater for the experimental group receiving the stimulation
      during CIMT compared with the control group who will wear the device with no vibration
      (placebo). This pilot study is to assess feasibility and safety.
    

Intervention name(s): Standardized Constraint-Induced Movement Therapy; Vibration; Placebo (for vibration)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.; Vibration applied to the wrist.; No vibration applied to the wrist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; hemiplegic; hand function
Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in
      humans and will allow further development of G1T28 1 in patients with cancer to reduce
      chemotherapy-induced myelosuppression.
    


Intervention name(s): G1T28-1 (CDK 4/6 Inhibitor); Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      In addition to the typical motor and sensory impairments, individuals with multiple sclerosis
      (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive impairment
      occurs in 40 % - 70% of patients with MS. In addition, sleep problems in individuals with MS
      are very common, and approximately 50% of patients with MS have a diagnosable sleep disorder.
      The research believes that aerobic exercise improve cognitive function and improve sleep
      quality.
    


Intervention name(s): aerobic exercise; home exercise program
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Colesevelam in Fecal Incontinence
Condition: Fecal Incontinence; Bile Acid Malabsorption
MeSH terms: Fecal Incontinence; Malabsorption Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare the effects of a combination of colesevelam and clonidine to placebo on bowel
      symptoms in patients with urge or combined type of FI.
    

Detailed description: 
      Fecal incontinence (FI) is a common symptom that can significantly impair quality of life.
      There is very limited, mostly uncontrolled, evidence to support the approaches currently used
      to manage FI. The alpha-2 adrenergic agonist clonidine decreased the frequency of loose
      stools in FI patients with diarrhea. Among patients with diarrhea, clonidine decreased the
      proportion of days with FI; however results were not statistically significant. Uncontrolled
      studies suggest that the bile acid binding resin colesevelam also increased stool consistency
      in patients with functional diarrhea. In this study, the investigators propose to compare the
      effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in
      patients with urge or combined type of FI.
    

Intervention name(s): Colesevelam; Clonidine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.; Participants who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.; Placebo will be identical in appearance to the active drug.
Other intervention name(s): Welchol; Catapres
Intervention MeSH terms: Clonidine; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Incontinence; Diarrhea; Bile acid; Microbiome