bioihbjkbjnl/mcl2 huggingface dataset:
Patient Self-managed BCI-FES
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI
      and FES technology with a view to the inexpensive equipment eventually being used for home
      use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients
      discharged from hospital.
    

Detailed description: 
      Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body.
      People with injury around the neck, suffer from tetraplegia, which affects function of both
      upper and lower limbs. Although these patients often have a caregiver, their main priority is
      to regain some upper limb function to increase independence. About half of patients with
      tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles
      preserved. Natural recovery takes about a year and is typically accompanied by intense
      physical therapy while patients are in a hospital. Patients spend on average 4 months in
      hospital and, once they go home, there are very limited options for further therapy, in
      particular those living in rural areas.

      This study will test the feasibility of patient and caregiver self-managed hand therapy based
      on the combination of brain computer interface (BCI) and functional electrical stimulation
      (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer
      and software that can analyse EEG while it is being recorded. To ensure that the knowledge
      stays within hospital, occupational therapists will first be trained who will then train
      patients and caregivers. The BCI-FES therapy is based on a previous clinical study with
      hospitalised patients, in which a researcher administered the therapy. In this study, a
      portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for
      non-professionals. The primary objective is to assess whether it is feasible for caregivers
      and patients to learn to operate the portable BCI-FES system on their own within 5 training
      sessions. The secondary objectives are to collect feedback from patients and therapists of
      their views via semi-structured interviews and questionnaires; to assess how stable the
      system parameters (EEG parameters, electrode location, FES stimulation parameters)are over
      time; to assess whether there is any functional and neurological recovery.
    

Intervention name(s): BCI-FES hand therapy
Intervention type(s): Procedure
Intervention description(s): BCI-FES rehabilitation therapy of the upper limb
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Brain-computer interface; Functional electrical stimulation
Effects of Dietary Fiber on Gastrointestinal Function
Condition: Gastrointestinal Health
Study type: Interventional

Summary: 
      The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in
      healthy, adult volunteers.
    

Detailed description: 
      The study is a blinded, cross-over design with subjects completing three, two-week treatment
      periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two
      of the treatment periods at two dose levels. The fiber will be added to foods and dispensed
      to subjects to be consumed twice a day during each treatment period. During the control
      period, subjects will receive the same study foods, but with no added fiber. Major outcomes
      will include fecal weight, and responses to questionnaires that assess fecal characteristics,
      bowel habits and gastrointestinal tolerability.
    

Intervention name(s): Dietary fiber
Intervention type(s): Other
Intervention description(s): A proprietary fiber will be given to subjects
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Dietary fiber; Gastrointestinal toleration; Fecal weight
Efficacy of a Natural Ingredient on Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Randomized controlled trial with two parallel branches (experimental product and placebo),
      double blind and unicentric with which it is intended to evaluate the efficacy of the product
      under investigation against placebo on blood pressure of normotensive subjects or with
      hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria
      will make a total of five visits to the research laboratory and perform the tests that were
      pre-established in the protocol. Later, a statistical analysis will be carried out with the
      variables measured in the study to obtain results.
    


Intervention name(s): nutraceutical: experimental product; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 84 days of consumption; 84 days of consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled clinical trial, with two parallel branches, (experimental product and placebo), double blind and unicentric.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, placebo-controlled study of the safety and tolerability of single doses
      of MEDI0618 in healthy volunteer subjects.
    

Detailed description: 
      This is a randomised, double-blind, placebo-controlled study of the safety, tolerability and
      pharmacokinetics of single ascending doses of MEDI0618 in healthy male and female volunteers.

      This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of
      MEDI0618 or placebo by intravenous administration, 1 cohort will receive MEDI0618 or placebo
      by subcutaneous administration.All subjects will undergo scheduled safety, tolerability,
      pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients
      to the end of the follow-up period.
    

Intervention name(s): MEDI0618; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MEDI0618 A novel human immunoglobulin antibody; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Double-blind; Placebo-controlled; Safety and Tolerability Study; Healthy Volunteers
Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study
Condition: Intracranial Aneurysm
MeSH terms: Subarachnoid Hemorrhage; Intracranial Aneurysm; Aneurysm; Hemorrhage
Study type: Observational

Summary: 
      The purpose of this research study is to determine if the diameter and flow of the superior
      mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive
      therapy for cerebral artery vasospasm are effected enough to justify withholding enteral
      nutrition.
    

Detailed description: 
      Study measurements of the diameter and Doppler flow velocity of the superior mesenteric
      artery (SMA) using abdominal ultrasound in order to evaluate the potential additional risk of
      non-occlusive mesenteric ischemia (NOMI) and non occlusive bowel necrosis (NOBN) in patients
      undergoing hypertensive therapy for cerebral vasospasm in Aneurysmal Subarachnoid Hemorrhage
      (aSAH), to justify the withholding of enteral nutrition.
    

Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): Study measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) for a aneurysmal subarachnoid hemorrhage using abdominal ultrasound.
Other intervention name(s): EDGE Ultrasound System
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the neurointensive care unit (NICU).Patients admitted to
        the neurointensive care unit (NICU) with a diagnosis of aSAH or are diagnosed with aSAH
        while an inpatient at the NICU at and area hospital.
      
Keywords: aSAH
Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the
      effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6
      month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as
      measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be
      invited at the time of their last study visit to participate in this extension study.
    


Intervention name(s): Meningococcal ABCWY; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1); One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery
Condition: Chronic Kidney Disease; Bariatric Surgery Candidate
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Weight Loss
Study type: Observational

Summary: 
      This study is designed as a prospective, single-center, longitudinal and analytical study on
      the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).
    

Detailed description: 
      It is expected to enroll 22 obese subjects with chronic kidney disease (decrease in
      glomerular filtration and/or albuminuria/proteinuria). After the inclusion in the study
      patients will remain for six months with a reduced calorie diet until the day of bariatric
      surgery. Time monitoring of the patient after surgery is 24 months.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obese subjects with renal pathology (decrease in glomerular filtration and/or
        albuminuria/proteinuria) who are candidates to bariatric surgery.
      
Biospecimen description: 
      In this study, blood and urine samples will be collected to determine the effect of weight
      loss in proteinuria and renal function.
    
Keywords: Chronic kidney disease; Bariatric Surgery Candidate; Caloric restriction
A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides
Condition: Facial Rhytides
MeSH terms: Facies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar
      lines and crow's feet lines).
    


Intervention name(s): onabotulinumtoxinA; Normal Saline
Intervention type(s): Biological; Drug
Intervention description(s): BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.; Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Other intervention name(s): botulinum toxin Type A; BOTOX®; BOTOX® Cosmetic
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in
      the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving
      AP, one subject will receive placebo.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled dose-escalation study to determine the
      MTD of AP in subjects with AUD. Eighteen (18) subjects will be randomized to receive either
      AP or placebo in a 2:1 ratio; ie, 12 subjects will be assigned to AP and 6 will be assigned
      to placebo. Efforts will be made to enroll all subjects in the same period of time at one
      clinical center. The expected maximum duration of participation for each subject is 11 weeks
      and will consist of up to a 3-week screening period, up to a 30-day residential (inpatient)
      treatment period, up to a 4-week non-residential (outpatient) treatment period, and an end of
      study / early termination clinic visit.
    

Intervention name(s): Arbaclofen Placarbil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Arbaclofen Placarbil; Placebo matched tablets
Other intervention name(s): Sugar Pill
Intervention MeSH terms: Arbaclofen placarbil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alcoholism; Alcohol Abuse; Alcohol Addiction; Alcohol Dependence; Alcohol Induced Disorders; Alcoholic Intoxication
GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Condition: Chronic Pain; Neuralgia; Musculoskeletal Pain; Headache
MeSH terms: Musculoskeletal Pain; Neuralgia; Chronic Pain; Headache
Study type: Interventional

Summary: 
      The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure
      Treatment (GET Living) to target elevated pain-related fears in children with chronic pain.
      Pain-related fear is an important psychological factor associated with poor outcomes in
      children suffering with chronic pain. To examine the efficacy of GET Living in addressing
      pain-related fears the investigators propose to use a sequential replicated randomized
      single-case experimental phase design with multiple measures. The specific aims are to 1)
      evaluate the effectiveness and acceptability of individually tailored GET Living for children
      with high pain-related fear and functional disability and 2) define anatomical and resting
      state connectivity patterns in the brains of children and adolescents with complex chronic
      pain prior to and after participation in GET Living.
    


Intervention name(s): GET Living
Intervention type(s): Behavioral
Intervention description(s): GET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
Condition: Bipolar Disorder; Manic Depression
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a
      naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown
      preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in
      bipolar disorder in some studies, but failed to establish efficacy in subsequent
      meta-analyses. In the investigators proposed work, the investigators plan to orally
      administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to
      paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and
      who have failed an adequate course of treatment with lithium monotherapy. The investigators
      hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but
      more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15
      treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy
      and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most
      commonly used to treat bipolar disorder.
    


Intervention name(s): IP6; Lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): IP6 2,000 -3,000 mg per day given orally in two doses; Dose up to 200 mg per day over 10 weeks
Other intervention name(s): Inositol Hexaphosphate; Phytic Acid; Lamictal
Intervention MeSH terms: Inositol; Lamotrigine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Depression; Inositol; Inositol Hexaphosphate; Phytic Acid; IP6; Lithium; Lamotrigine
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Condition: Peripheral Artery Disease; Vascular Disease; Critical Limb Ischemia
MeSH terms: Vascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA)
      injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound
      complications after surgery.
    

Detailed description: 
      Patients scheduled for amputation will receive bone marrow cells concentrated via the
      MarrowStim device (cBMA) injected IM at 25 sites in the leg proximal to the amputation in the
      index limb to prevent ischemic wound complications after surgery. cBMA will be injected into
      the anterior tibialis muscle below the point of amputation in an area approximately 3cm^2 x
      2cm^2 for analytical purposes. Patients will be scheduled for amputation at Days 7, 14, or 21
      post injection. Safety will be evaluated by review of treatment related adverse events (AE)
      during the 52-week follow-up period. The investigator will compare rates of wound
      complications and amputation revisions to historical controls at the institution to assess
      trends in therapeutic efficacy.

      Patients will undergo amputation and injection sites will be harvested at that time.
      Immunohistochemical staining (IHC) will determine capillary density and local host immune
      responses. Angiogenic and inflammatory cytokines will be quantified using a multiplex array
      system and quantitative polymerase chain reaction (PCR).
    

Intervention name(s): Injection of cBMA aspirate into the index leg
Intervention type(s): Biological
Intervention description(s): Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Other intervention name(s): concentrated bone marrow; cBMA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Autologous bone marrow derived mesenchymal stromal cells will be delivered intramuscularly in the lower extremity of participants undergoing lower extremity major amputation to assess incidence of wound healing and infection prevention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BKA; amputation; MarrowStim; below knee amputation; wound complication; vascular disease; critical limb ischemia; peripheral artery disease; AKA; stem cells; bone marrow
Reliability of the Melbourne Assessment
Condition: Cerebral Palsy; Stroke; Traumatic Brain Injury; Meningomyelocele; Central Nervous System Diseases
MeSH terms: Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Nervous System Diseases; Central Nervous System Diseases; Meningomyelocele; Spina Bifida Cystica
Study type: Observational

Summary: 
      The aim of the study is to investigate the reliability of the Melbourne Assessment.
    

Detailed description: 
      Children with central motor disorders will be tested twice within one week with the Melbourne
      Assessment. The assessments will be video scored. At a later time point, different raters
      will rate the same video for inter-rater reliability, the same rater will score the same
      video for intra-rater reliability, and the same rater will score the repeated assessment
      videos for test-retest reliability.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children with central motor disorders and impaired upper limb function
      
Keywords: Children; Rehabilitation; Upper Limb; Assessments; Outcome Measures
Online Programs to Promote Colon Cancer Screening
Condition: Colon Cancer Screening
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      To evaluate online peer support and colorectal cancer screening behavior among individuals
      who are not currently meeting colorectal cancer screening guidelines. This is a randomized
      controlled trial.
    

Detailed description: 
      Participants in the control group will view standard online information about colon cancer
      screening. Participants in the intervention group will view the same information and also
      will be invited to sign on to the online website and interact with peer supporters at their
      convenience. They will have 6 months to communicate with peer supporters. Peer supporters are
      encouraged to address comments and concerns of the study participants.

      About 300 study participants, majority white, female. Inclusion criteria: age 50-75, not
      currently meeting colorectal cancer screening guidelines, no previous colorectal cancer.

      The study will also include 15 previously identified peer supporters.

      Recruitment: Administrators of the SparkPeople.com weight loss community will send study
      recruitment emails to members at least 50 years of age. Interested individuals will pass an
      eligibility screening and provide informed consent.
    

Intervention name(s): Information + Narratives + Support Group; Information Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Information from CDC website Narratives about CRCS written by others Peer social support among study participants; Information from CDC website on colon cancer screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colon cancer screening