bioihbjkbjnl/mcl2 huggingface dataset:
Nebivolol, Lifestyle Modification and Arterial Stiffness
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central
      arterial stiffness and these effects may contribute to improved outcomes in hypertensive
      patients. However, the results of several studies suggest that beta-blockers may actually
      increase arterial stiffness. In contrast, there is limited evidence to suggest that
      nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide,
      reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few
      studies have addressed this issue and all of these studies relied on indirect, blood pressure
      dependent measures of arterial stiffness. In addition, none of these studies focused on
      middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening
      and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a
      therapy to reduce large artery stiffness, particularly among the latter population, remains
      unclear.
    


Intervention name(s): Nebivolol; Lifestyle Modification; Nebivolol plus Lifestyle Modification
Intervention type(s): Drug; Other; Other
Other intervention name(s): Bystolic; Weight loss; Sodium restriction; Physical activity; Bsytolic; Weight Loss; Sodium restriction; Physical activity
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cognitive Rehabilitation in Pediatric Acquired Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one
      of the leading causes of death and disability for children and adolescents. Importantly,
      injuries affecting the brain in childhood or adolescence appear during a time of development
      when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not
      only impact cognitive functions at the time of injury or onset of disease, but also cognitive
      functions that are yet to develop. Changes in cognitive function, and in particular executive
      dysfunction due to acquired brain injury, cause significant real-life disability, yet solid
      evidence in support of executive functioning interventions for children and adolescents is
      lacking. In the present study different group-based cognitive rehabilitation interventions
      will be compared. The aim of the study is to investigate if a group-based "brain training"
      intervention is able to improve executive function in children and adolescents after acquired
      brain injury. Efficacy will be assessed immediately after intervention, but also six months
      after the intervention. The project is in line with international research efforts aimed at
      establishing more knowledge about how children and adolescents with brain injuries respond to
      cognitive rehabilitation.
    


Intervention name(s): Pediatric Goal Management Training; Pediatric Brain Health Workshop
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 7 GMT modules will be administered in 7x2 hours sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving. Homework assignments between sessions.; 7 pBHW modules will be administered in 7x2 hours sessions (ten groups). Psychoeducation; brain (dys)function, plasticity, memory, executive function, and attention. Stress, physical exercise, sleep, nutrition, and energy management. Homework assignments between sessions
Other intervention name(s): GMT; active control condition; pBHW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child; Rehabilitation; Psychotherapy, groups
Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The prevalence of obesity is growing in elderly with heavy consequences in term of medical
      complications and mortality, so that this is nowadays an important public health issue.

      The major therapeutic solution is dietary restrictions, but and the advantages and the
      metabolic consequences are not well known in elderly. The MONA study main aim is to assess
      the metabolic changes in this population, after dietary restrictions, compared to young
      people.
    

Detailed description: 
      Primary endpoint : Study the metabolic adaptations of the subcutaneous adipose tissue after a
      diet in elderly obese men compared to young obese men.

      Secondary endpoints : Study the metabolic adaptations of skeletal muscle, the genetic
      adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis
      modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the
      modifications on the physical composition, modifications of the energy expenditure in resting
      state and the oxidation of the substrata, study the lipoproteins metabolism and identify new
      biomarkers. All those endpoints are studied comparing elderly obese subjects versus young
      obese subjects.
    

Intervention name(s): dietary restrictions
Intervention type(s): Other
Intervention description(s): Dietary restrictions during 8 weeks
Other intervention name(s): Dietary restrictions (20 % dietary restrictions)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Obesity; dietary restrictions; metabolism; nutrition; elderly
Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the safety of intravenous autologous adipose derived
      mesenchymal stem cells transplant in spinal cord injury patients.
    

Detailed description: 
      Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell
      source for stem cell therapy.

      With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to
      cell-damaged diseases have increased.

      In a human clinical trial, eight male patients who had suffered a spinal cord injury were
      intravenously administered autologous hAdMSCs (4×10e8 cells) one time.
    

Intervention name(s): Autologous Adipose Derived Mesenchymal Stem Cells
Intervention type(s): Other
Intervention description(s): Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
Other intervention name(s): Astrostem®
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and drug levels of
      BMS-986172 and evaluate the effects of food on BMS-986172 absorption.
    


Intervention name(s): BMS-986172; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Participants; BMS-986172
Treatment of Cholestatic Pruritus With Sertraline
Condition: Pruritus; Liver Cirrhosis, Biliary; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis; Liver Cirrhosis; Liver Cirrhosis, Biliary; Pruritus; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to find an effective and well-tolerated medical therapy for itching
      due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are
      currently being enrolled in the study. Persons participating in the study are given
      sertraline, a medication which is also often used for depression,to treat their itching. The
      dose is gradually increased as the effect on itching and any other potential side effects are
      carefully monitored.
    


Intervention name(s): sertraline
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholestatic; Pruritus; Sertraline; primary biliary cirrhosis; hepatitis C
The Effect of Kinesio Taping on Ankle Proprioception
Condition: Sprains and Strains
MeSH terms: Sprains and Strains
Study type: Interventional

Summary: 
      This study examines the effect of kinesiology tape on proprioception and postural control in
      subjects with sub-acute and chronic ankle sprains/strain.
    

Detailed description: 
      The a priori hypothesis of this study is that proprioception (knee repositioning error) and
      balance (sway velocity and center of pressure) will improve significantly after intervention
      (Kinesiotape) in participants with a history of acute or chronic ankle sprains/strains.
    

Intervention name(s): KinesioTape
Intervention type(s): Other
Intervention description(s): An elastic tape that will be placed on subject's ankles to determine whether ankle proprioception is improved
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of ECO Conversion System For Red Blood Cells.
Condition: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate that small amounts of a person's own red cells,
      when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused,
      repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and
      re-infused five times. Additional samples of blood will be drawn for testing and evaluation.
    

Detailed description: 
      This study will involve a statistically valid number of subjects so that firm conclusions may
      be drawn about the safety of small volumes of A-ECO cells. All participants will receive
      their own (autologous) red cells that have been either: 1) treated with an enzyme to create
      A-ECO cells (test group); or 2) washed with saline (control group). The test and control
      groups will be compared for the rate and extent any adverse reactions or unexpected
      laboratory test results.
    

Intervention name(s): A-ECO; Saline
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: transfusion; red blood cells
PET Imaging Study on Occupancy of Dopamine D2 Receptors and Genotypes After Bupropion Administration
Condition: Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      Bupropion has different effects on D2 dopamine receptors according to genotype.
    

Detailed description: 
      Open, one arm, single sequence, 2-period, study stratified into 2 DRD2 genotype groups For
      subjects who volunteer to cease smoking, genotypes are investigated. Twelve subjects are
      enrolled (6 - DRD2 Taq1A1 allele, 6 - DRD2 Taq1A2 homozygotes). Subjects receive baseline
      raclopride PET (High Specific Activity, Low Specific Activity).

        -  Period 1 Subjects receive 150 mg of bupropion SR every day. After 1 week of medication,
           pharmacokinetic and PET studies are performed.

        -  Period 2 Subjects receive 150 mg of bupropion SR twice a day. After 1 week of
           medication, pharmacokinetic and PET studies are performed.
    

Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention description(s): bupropion
Intervention MeSH terms: Bupropion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Bupropion
keePAP Device for Treatment of Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The aim of the study is to test the hypothesis that a new device would produce a significant
      decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea
      Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during
      sleep.
    

Detailed description: 
      Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of
      upper airway obstruction that occur during sleep. Associated features include loud snoring
      and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on
      the roads and at work, and on the cardiovascular and metabolic systems.

      The aim of the study is to test the hypothesis that a new device would produce a significant
      decrease in obstructive breathing events during sleep as indexed by the AHI/RDI and measures
      of oxygen saturation during sleep.
    

Intervention name(s): keePAP
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)
Condition: Alternating Hemiplegia of Childhood
MeSH terms: Hemiplegia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      WHO: The investigators are recruiting children and young adults to participate in a research
      study who:

        1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC)

        2. Are between the ages of 6 months - 25 years old

        3. Have at least three 10-minute-long AHC episodes during a typical week

        4. Can commit to 12 weeks of completing of a daily log describing AHC episodes and to a
           multi-night hospital stay at the University of Utah Center for Clinical and
           Translational Science (CCTS)

      WHY: The goal of this study is to evaluate whether the study drug can safely and effectively
      decrease AHC episodes and improve the quality of life of individuals with AHC.

      WHAT and WHERE: This study involves at least 12 weeks of completing and submitting daily AHC
      Episode Logs and a five-day hospital stay at the University of Utah CCTS.

      There are 4 phases of the study, and they include:

        1. Six weeks of daily log completion prior to starting study drug

        2. Five day stay at the University of Utah CCTS

        3. Six additional weeks of daily log completion while using study drug at home

        4. One day clinic visit to the University of Utah for follow up

      COMPENSATION:

      There is no fee to participate. All procedures performed specifically for this study will be
      covered by the study and will not be billed to you or your insurance company.

      The study drug will be dispensed to you free of charge. Meals and lodging at the study site
      will be provided free of charge for the study participant and one care provider.
      Additionally, the research team will assist subjects with booking and obtaining free
      transportation, such as an airline tickets, to and from the study site.
    


Intervention name(s): Sodium Oxybate
Intervention type(s): Drug
Intervention description(s): dosage is by weight
Intervention MeSH terms: Sodium Oxybate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase I/II study; effects of sodium oxybate; cohort of 6 children and young adults; AHC
Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling
Condition: Diabetes Mellitus, Type 1; Self-Management
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effects of digital storytelling on the
      Self-Management behavior of adolescents with type 1 diabetes (TID).
    

Detailed description: 
      In this single-blind randomized controlled trial, 60 eligible adolescents with TID were
      selected based on a convenient sampling method. Next, the participants were randomly
      allocated into two parallel groups: intervention (training with digital storytelling method,
      n=30) or control (training with conventional) n=30) groups. Before and three months after the
      intervention the patients' levels of self-management behaviors according to Self-Management
      of TID amongst adolescents (SMOD-A); in addition to the Glycated Hemoglobin test (HbA1c) were
      measured.
    

Intervention name(s): Digital storytelling training; Routine training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The digital content in this study is called "Diabetes and Bumblebee". It features 35 minutes of animation that provides children with a brief description of the disease, its symptoms and complications, treatment methods, the type of insulin, how to preserve insulin, the importance of nutrition and exercise in treating diabetes as well as efficient communication and collaboration with parents and healthcare providers. Exciting and interactive animations were used to depict the daily life of a adolescence with diabetes.; The control group received the clinics' routine training include face to face class education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Caffeine's Effect on Attention
Condition: Attention
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether caffeine improves attention.
    

Detailed description: 
      Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with
      two treatment conditions : caffeine and placebo
    

Intervention name(s): Food; Food
Intervention type(s): Other; Other
Intervention description(s): Active group; Control group
Other intervention name(s): Caffeine; Placebo
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer
Condition: Melanoma; Ovarian Cancer; Sarcoma; Non-small Cell Lung Cancer; Breast Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung; Melanoma; Ovarian Neoplasms; Sarcoma; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical
      safety and immune response of IDC-G305 when injected intramuscularly in patients with
      unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant
      NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's
      immune system to fight the spread and growth of cancer for patients whose tumors include the
      NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer
      may be considered for the trial.
    

Detailed description: 
      This is a Phase 1, open label, multicenter, multiple ascending dose trial of IDC-G305
      administered by intramuscular injection in a 3+3 sequential dose escalation design. IDC-G305
      is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE.
      Patients with unresectable, relapsed or metastatic cancer but with low disease burden and
      indolent disease course may be considered for the trial. Tumors must express the NY-ESO-1
      gene signature and tumor types that will be studied are: melanoma, ovarian, sarcoma,non-small
      cell lung and breast cancer.

      Each of three dose level cohorts will be treated contingent upon absence of dose limiting
      toxicity (DLT) and acceptable safety data for the preceding cohort. Initially, three patients
      will be scheduled to receive IDC-G305 in each dose level cohort. Dose escalation will be
      contingent upon the assessment of safety data obtained during the initial injections.

      Patients will be evaluated at baseline and at regular intervals for safety and immune
      response. Both cellular and humoral immunogenicity will be explored.
    

Intervention name(s): IDC-G305
Intervention type(s): Biological
Intervention description(s): NY-ESO-1 recombinant protein together with GLA-SE
Intervention model: Sequential Assignment
Intervention model description: Phase 1, open label, multicenter ascending dose study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; Ovarian cancer; Sarcoma; Non-small cell lung cancer; NSCLC; Breast cancer