bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Chardonnay Seed Flour on Vascular Health
Condition: 1. Endothelial Dysfunction (EndoPAT Score <=2)
Study type: Interventional

Summary: 
      This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form)
      with the purpose to test the impact of a four-month supplementation with Chardonnay Seed
      Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and
      seeds. We will examine the effect of CSF on parameters such as endothelial function (via
      EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory
      markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the
      makeup of and impact on the gut microbiome (via stool samples).
    


Intervention name(s): Chardonnay Seed Flour (CSF); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): CSF is made from wine grape skins and seeds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endothelial function
STEP: Enhanced Physical Activity in Children and Youth With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Epilepsy is common in childhood. Children with epilepsy are at increased risk of impaired
      health, functioning, psychological well-being, and quality of life. There is compelling
      evidence that physical activity improves the medical and psychosocial aspects of health in
      adults with epilepsy - but there are no such studies in children. This study is to see if
      increased levels of physical activity can influence children's functioning, psychological
      well-being, and quality of life.
    

Detailed description: 
      There are many unfounded assumptions about the dangers of exercise in children with epilepsy
      - assumptions that may be seriously detrimental to children's health, and that we have good
      reason to challenge. This project explores the innovative idea that enhancing physical
      activity in children with epilepsy will have a positive effect on medical and psychosocial
      outcomes. The primary purpose of this study is to examine whether increasing physical
      activity levels through a six-month walking program, that includes behavioral counselling and
      self-monitoring of physical activity, as compared to varied un-standardized current
      practices, positively influences health and quality of life over one year. The secondary
      purposes are to (i) determine which environmental and personal facilitators and barriers to
      physical activity are experienced when increasing physical activity levels through a
      six-month walking program; (ii) determine if physical activity levels established during the
      six-month program will be sustained over a subsequent six-month period that includes
      self-monitoring of physical activity only; (iii) identify aspects of health that are
      amendable to change with enhanced physical activity, and explore the relationships among
      physical activity and impairments, functioning, psychological well-being and quality of life;
      and (iv) assess if there is a dose-response relationship between physical activity and a
      variety of health and social factors and quality of life.
    

Intervention name(s): Physical activity behavior-change counselling
Intervention type(s): Behavioral
Intervention description(s): Participants in the experimental group will be motivated by augmented behavior modification strategies aiming to increase performance by: (i) having access to the pedometer web page that allows them to view their automatically calculated goals, and (ii) get feedback about performance toward goals.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Physical Activity; Epilepsy; Children; Motivation
A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease
Condition: Type 2 Diabetes Mellitus; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study is to assess the safety and efficacy of up to 2 injections
      of REACT given 6 months (+4 weeks) apart (maximum).
    

Detailed description: 
      All subjects enrolled will receive REACT. Subjects will receive their first REACT injection
      as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months
      (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of
      renal decline, based on adequate historical clinical data obtained 24 months prior to
      screening visit, will serve as a comparator for monitoring the rate of progression of renal
      insufficiency over time.
    

Intervention name(s): Renal Autologous Cell Therapy (REACT)
Intervention type(s): Biological
Intervention description(s): Autologous selected renal cells (SRC)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome
Condition: Advanced MDS Without Identical Sibling Donor
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Study type: Observational

Summary: 
      Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative
      treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%).
      However, many patients cannot find an HLA-matched donor. haploidentical donor is an
      alternative stem cell source.

      the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can
      improve the survival of patients with myelodysplastic syndrome
    


Intervention name(s): transplant with haploidentical donor
Intervention type(s): Procedure
Intervention description(s): patients with advanced MDS without identical sibling donor receive haploidentical transplant
Other intervention name(s): haploidentical transplant
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with MDS:1)intermediate-2 or high risk 2)low or intermediate-1 risk, drug
        resistance or disease progression
Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate if teduglutide has an effect on cardiac
      repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible
      effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration),
      pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect
      of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a
      screening and a treatment phase of four treatment periods. There is a washout period of at
      least 7 days and 4 weeks at maximum between administrations. The expected total trial
      duration for the individual subject will be about 7 weeks (maximum 17) weeks.
    


Intervention name(s): Teduglutide
Intervention type(s): Drug
Intervention description(s): subcutaneous (SC), single dose
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Thorough QTc-Study; Short Bowel Syndrome; Cardiac safety
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of escalating single- and multiple-oral
      doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of
      cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants
      will receive either cilofexor or cilofexor placebo.

      Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,
      blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to
      multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or
      pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily
      doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will
      consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated
      in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose
      already evaluated.

      This study is partially blinded (no one is blinded on Day -1).
    


Intervention name(s): Cilofexor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets administered orally; Tablets administered orally
Other intervention name(s): GS-9674
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced
      Parkinson's Disease.
    


Intervention name(s): Levodopa-Carbidopa
Intervention type(s): Drug
Intervention description(s): Intestinal Gel
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Parkinson's Disease; levodopa; carbidopa; Duodopa; intestinal gel
Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series
Condition: Hemiplegia; Cerebral Palsy; Unilateral Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy; Hemiplegia
Study type: Observational

Summary: 
      This study will compare the motor outcomes for five infants with asymmetrical hand function
      (AHF) who will receive two, three week episodes of standard care separated by a three week
      episode of mCIMT paired with Neuromuscular Electrical Stimulation. The results of this study
      will inform decisions on the feasibility and efficacy of the treatment for use in a larger
      study for infants with AHF at risk for unilateral cerebral palsy.
    

Detailed description: 
      Infants with asymmetrical hand function will participate in three consecutive phases of
      treatment.

      The first and third phase will consist of three weeks of standard care for children with
      asymmetrical hand function, 1 hour/day, 1 day/week. The therapist will provide weekly
      coaching with the parents so they can carry over activities at home one hour/day, six
      days/week during this phase. In addition, a sock or mitten will be used for short term
      constraint during the hour of training both in the clinic with the therapist and at home with
      the parent.

      The second phase will consist of three weeks of modified constraint induced movement therapy,
      2 hours/day, 3 days/week paired with NMES, 15 minutes/day, 3 days/week. The infants will wear
      a soft splint on their preferred hand and forearm 24 hours/day during this phase. Parents
      will be trained by the therapist to carry over activities with their child at home, 1
      hour/day, 6 days/week.

      The children will return at chronological age of 18 months for follow up testing.
    

Intervention name(s): Neuromuscular electrical stimulation; Modified constraint induced movement therapy; Standard care for infant with asymmetrical hand function
Intervention type(s): Device; Behavioral; Behavioral
Intervention description(s): Neuromuscular Electrical Stimulation will be applied by the therapist to infant's finger flexors and extensor for 15 min./day, 3x/week.; Modified CIMT will consist of constraint 24 hours/day using a splint in addition to therapy two hours/day, 3x/week for three weeks. Parents will be trained to carry over home program activities one hour/day, 6 days/week.; Infants will receive one hour of therapy, one time/week for three weeks. Parents will be trained to carry over home program activities one hour/day, 6 days/week. In addition the infant will wear a sock on their preferred hand during the hour of therapy/home program activity.
Other intervention name(s): NMES; mCIMT
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants with asymmetrical hand function
      
Keywords: infant; constraint induced movement therapy; early intervention; cerebral palsy
GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
Condition: Postoperative Sedation; Intubation; Respiration, Artificial
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients who are in the intensive care unit after surgery and require mechanical breathing
      support (intubation and ventilation) usually require sedation to avoid agitation and
      excessive stress responses. Short-acting sedatives such as midazolam and propofol are the
      drugs typically used for this. Propofol provides for fast sedation and fast recovery from
      sedation. Midazolam is slower to sedation and slower for recovery, but may provide some
      advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This
      study will look at propofol compared to a product with fast sedation and recovery like that
      of propofol but with less of a chance for hypotension like with midazolam. Patients will be
      treated with the product for up to 8 hours and then will be monitored for 8 hours following
      treatment.
    

Detailed description: 
      Patients who are intubated and ventilated and will require up to 8 hours of sedation in the
      ICU are eligible for participation in this study. Patients will be randomized to receive 1 of
      3 treatments. One treatment is standard of care, a propofol infusion. The other two treatment
      arms are infusions of GPI 15715 (AQUAVAN), one with a bolus and one without.

      Patients will be treated for up to 8 hours and monitored for eight hours post treatment. If
      there are signs of agitation during the up to 8 hour treatment period, the infusion of the
      sedative medicine will be increased according to protocol.

      Blood samples will be obtained periodically during the course of the study for safety
      evaluation and pharmacokinetic assessments. When the patient is ready for extubation or the
      end of the 8 hour study period has been reached, the infusion of the sedative agent will be
      discontinued and the patient will be monitored for 8 hours post treatment.

      Guilford Pharmaceuticals was acquired by MGI PHARMA on October 3, 2005.
    

Intervention name(s): AQUAVAN (fospropofol disodium; GPI 15715 )
Intervention type(s): Drug
Intervention MeSH terms: Fospropofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AQUAVAN; GPI 15715; ICU; Sedation
Trial of Thiamine Supplementation in Cambodia
Condition: Thiamine Deficiency
MeSH terms: Thiamine Deficiency; Beriberi
Study type: Interventional

Summary: 
      Beriberi is a potentially fatal disease caused by vitamin B1 (thiamine) deficiency that still
      occurs in Southeast Asia despite near eradication elsewhere. Mothers with a diet low in
      thiamine produce thiamine-poor milk, putting their infants at a high risk of developing
      thiamine deficiency and beriberi. There is also a growing body of evidence suggesting
      thiamine deficiency not severe enough to cause clinical symptoms may negatively effect
      cognitive development and functioning of the infant. Since human milk should be the sole
      source of nutrition for babies during the first six months, maternal thiamine intake must be
      improved to combat this disease.

      The investigators' recent study of thiamine-fortified fish sauce in Cambodia showed that
      fortification could increase maternal and infant thiamine status'. However, centrally
      produced fish sauce may not reach the poorest communities who make their own fish sauce, and
      fish sauce is not consumed in all regions where we find thiamine deficiency. Salt, by
      contrast, is a common condiment in most regions of the world and has proven to be a
      successful global fortification vehicle for iodine.

      Suboptimal maternal thiamine intake puts exclusively breastfed infants at risk of low
      thiamine status, impaired cognitive development, and infantile beriberi, which can be fatal.
      Thiamine fortification of salt is a potentially low-cost and sustainable means of combating
      suboptimal thiamine status; however knowledge gaps must be filled before thiamine
      fortification can proceed. In this study, mothers will consume thiamine supplements in order
      to model the thiamine dose required to optimize human milk thiamine concentrations for the
      prevention of beriberi. Other thiamine biomarkers will be assessed, and usual salt intake
      will be measured. Finally, the investigators will assess the effects of early-life thiamine
      exposure on infant neuro-cognitive development.
    

Detailed description: 
      (see full protocol)
    

Intervention name(s): thiamine (as thiamine hydrochloride)
Intervention type(s): Dietary Supplement
Intervention description(s): Opaque capsules containing varying amounts of thiamine hydrochloride and cellulose filler. All thiamine is delivered as thiamine hydrochloride, calculated using a 1.271 correction factor (ratio of molecular weights of thiamine hydrochloride and thiamine).
Intervention MeSH terms: Thiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo controlled, double-blinded, four-parallel arm, multicentre trial
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents
Condition: Posttraumatic Stress Disorder; Depression; Grief (Traumatic Grief and Existential Grief)
MeSH terms: Depression; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Context: This is the first multi-site randomized controlled study of the effectiveness of a
      group treatment for war-exposed adolescents delivered in-country within a public school
      system.

      Objective: To evaluate the effectiveness of a trauma/grief-focused group treatment program in
      reducing symptoms of posttraumatic stress disorder (PTSD), depression, and traumatic grief in
      war-exposed Bosnian youths attending 10 secondary schools located in Central Bosnia.
    

Detailed description: 
      Design: A randomized controlled trial conducted during the 2000-2001 school year, with
      4-month follow-up, compared group treatment to a psychoeducation/skill-based school milieu
      intervention.

      Setting and Participants: Students attending 10 Bosnian secondary schools exposed to severe
      trauma, traumatic loss, and severe adversity, reporting severe persisting symptoms of PTSD,
      depression, or traumatic grief, and functional impairment.

      Intervention: Students were randomly assigned to either 17-session Trauma and Grief Component
      Therapy (n=71), or a school milieu intervention (n=73), both conducted by trained school
      counselors.
    

Intervention name(s): Trauma and Grief Component Therapy for Adolescents (Group Version)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trauma; Grief; Depression; Adolescent; War; Group; Therapy; Treatment; Intervention; School; Development
Web-based vs In-person Personalized Feedback Intervention for Comorbid Substance Use and Disordered Gambling
Condition: Gambling; Alcohol Consumption; Cannabis
MeSH terms: Gambling; Alcohol Drinking
Study type: Interventional

Summary: 
      Rates of gambling and substance use behaviors are elevated among emerging adults (ages
      18-24), and these behaviors are individually and jointly associated with a host of negative
      consequences. Evidence suggests there is significant overlap between these behaviors as well
      as comorbidity of associated mental disorders (i.e., pathological gambling and substance
      abuse/dependence). Prior research suggests that a brief in-person delivered personalized
      feedback intervention (PFI) may be an effective method of reducing these behaviors and their
      associated consequences among emerging adults. Thus, the purpose of this study is to
      determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in
      reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample
      of emerging adults, as well as explore potential moderators and mediators of intervention
      efficacy and the longevity of intervention effects (over a period of 18-months).
    


Intervention name(s): Personalized Feedback Intervention
Intervention type(s): Behavioral
Intervention description(s): Printed or electronic form containing personalized information about health-relevant behaviors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Survivor mHealth: Wearable Devices in Cancer Survivors
Condition: Cancer; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The Survivor mobile health (mHealth) study is testing the use of wearable devices (Fitbits)
      and a smartphone application in cancer survivors. The goal of the program is to increase
      survivor's physical activity levels. The Fitbit will be synced to the app and participants
      will receive messages and notifications about their activity levels. Participants will also
      complete surveys through the app asking how useful it is and ways to improve it. The study
      team will conduct qualitative interviews at the completion of the 3 months to see how
      participants liked the program, and ways it can be improved and make it more specific to
      cancer survivors. The study team will also conduct interviews with providers and clinic staff
      to assess their perceptions of patient digital health programs and preferences for receiving
      patient-generated health data.
    


Intervention name(s): Wearable device deployment
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a Fitbit to be synced with a smartphone app (MyDataHelps). Participants will receive push notifications to complete surveys via the MyDataHelps app. The Fitbit will sync with the app for data collection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Physical activity; Wearable; Communication