bioihbjkbjnl/mcl2 huggingface dataset:
Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This is a double-blind randomized controlled pilot study to test the effects of
      Remotely-Supervised (RS)-tDCS using a dorsolateral prefrontal cortex montage to ameliorate
      fatigue and cognitive slowing in PD.

      Fatigue and slowed thinking are very prevalent symptoms in people with Parkinson's disease
      (PD). To date there are no concrete effective treatment available for either symptom. This
      study will test transcranial direct current stimulation (tDCS) to ameliorate fatigue and
      slowed thinking in PD. tDCS is a noninvasive brain stimulation technique that is low-cost,
      relatively safe, and reproducible when conducted in repeat clinic visits.

      Following procedures for our validated protocol, participants will receive training on the
      use of study tDCS device and pre configured laptop computer. The device will be programmed to
      deliver either active or sham tDCS (all study personnel and participants will be blinded),
      and operated with unlock codes provided by the study technician daily to release one session.
      Once trained, and following an initial in-clinic baseline tDCS tolerability test and initial
      treatment session, participants will use the equipment to complete the remaining sessions
      from their home using our tele medicine platform. Remote supervision will be provided using
      HIPAA secure online video conference with the study technician following clearly-defined
      operational procedures. Participants will be monitored to determine if any predefined "stop"
      criteria are met using VSee software, a telemedicine software. Additionally, Team Viewer
      software will allow study technicians to troubleshoot any computer issues, to initiate the
      video conference on behalf of participants, and to remotely supervise the entire tDCS
      session.
    


Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): low amplitude direct currents to induce changes in cortical excitability. tDCS produces current intensities in the brain orders of magnitude below other stimulation techniques such as transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT); The device will be programmed to deliver either active or sham tDCS (all study personnel and participants will be blinded), and operated with unlock codes provided by the study technician daily to release one session
Other intervention name(s): Remotely Supervised Transcranial Direct Current Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
Condition: Covert Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Several studies have been showed that rifaximin can improve cognitive functions, driving
      simulator performance and health-related quality of life in patients with minimal hepatic
      encephalopathy. The aim of this prospective randomized open controlled study was to evaluate
      the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic
      encephalopathy.
    


Intervention name(s): Rifaximin
Intervention type(s): Drug
Intervention description(s): The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: covert hepatic encephalopathy; low-dose rifaximin
PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase
      3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric
      subjects between 6 to 12 years of age.
    


Intervention name(s): PRC-063 oral capsules; Placebo oral capsules
Intervention type(s): Drug; Drug
Intervention description(s): Daily dose; Daily dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
TLESR-impedance Study in Patients
Condition: Reflux Episodes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare frequency and content of reflux episodes in patients
      with gastroesophageal reflux disease.
    


Intervention name(s): AZD3355; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 65 mg capsules, oral, 3 single doses; capsules, oral, 3 single doses
Other intervention name(s): Lesogaberan
Intervention MeSH terms: Lesogaberan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GERD; transient lower esophageal sphincter relaxations (TLESRs); reflux
Dietary Intake and Nutrient Status of Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Assess the dietary intake of children aged 6-12 years by means of a 24-hour recall and 3-day
      food record and asses the nutrient status of Vitamin B6, serum ferritin, serum zinc and serum
      copper of the same children by means of standard laboratory assessments.
    

Detailed description: 
      -  To document the use of vitamin and vitamin-mineral supplements

        -  To determine the percent consumption of low nutrient density (LND) foods

        -  To compare the dietary intake of ADHD children with the established standards of the
           Dietary Reference Intakes (DRIs)

        -  To compare the dietary intake of children with ADHD to the dietary recommendations of
           Canada's Food Guide for Healthy Eating

        -  To determine whether dietary intake is moderated by drug treatment

        -  To assess the pyridoxal-5'-phosphate (PLP), serum ferritin, serum zinc, and serum copper
           status of ADHD by standard laboratory blood test

        -  to measure height and weight in ADHD children
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: observational; dietary intake; nutrient status; serum assessors; Attention-Deficit/Hyperactivity Disorder (ADHD)
A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Condition: Symptomatic Gastroesophageal Reflux Disease (sGERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Abdominal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the
      treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux
      Disease (sGERD)
    


Intervention name(s): Esomeprazole; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20mg Oral Once Daily; Oral Once Daily
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Symptomatic Gastroesophageal Reflux Disease (sGERD); Nexium; Esomeprazole
Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography
Condition: Breast Cancer; Prostate Cancer; Urinary Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for
      PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential
      of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and
      less aggressive tumors. This is a first in human study to test the radiotracer in cancer
      patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10
      minutes, 1 hour and 2 hours post injection).
    

Detailed description: 
      The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for
      PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential
      of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and
      less aggressive tumors. This is a first in human study to test the radiotracer in cancer
      patients. The biodistribution and tumor uptake will be evaluated by repeated PET scans (10
      minutes, 1 and 2 hours post injection). The primary end points are safety, biodistribution
      and dosimetry of 68Ga-NOTA-AE105. In addition, the quantitative uptake of 68Ga-NOTA-AE105
      will be compared to the expression of uPAR measured directly in tumor tissue obtained by
      surgery or biopsies. The project will be monitored and evaluated in accordance with the
      principles of Good Clinical Practice (GCP).
    

Intervention name(s): Injection of 68Ga-NOTA-AE105; Positron Emission Tomography scans
Intervention type(s): Drug; Device
Intervention description(s): One injection of 68Ga-NOTA-AE 105; Following injection of 68Ga-NOTA-AE105 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once
      daily for a maximum of 5 days to CHF patients with volume overload despite having received
      diuretics (injection) other than vasopressin antagonists and who have difficulty with or are
      incapable of oral intake.
    


Intervention name(s): OPC-61815 injection
Intervention type(s): Drug
Intervention description(s): Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
Condition: Spinal Cord Injury/Damage
MeSH terms: Spinal Cord Injuries; Body Weight; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this current prospective study is to assess the effects of body weight support
      treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training
      intervention aim at improving: quality of life, walking capability, spasticity, functions in
      every day life, bone mass density and related hematological factors. The examination
      consisted of (1) neurological classification by ASIA standard neurological classification of
      spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified
      Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury
      II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life-
      BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone
      mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue
      consistency by full body DXA scan, (8) skeletal system health associated blood factors
      (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid
      hormone) by hematological tests. The results will be collected and evaluated using
      statistical software (i.e. SPSS).
    


Intervention name(s): BWSTT (3 days a week for maximum of 20 minutes session)
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1/2 Lyme Vaccine Study
Condition: Prophylaxis of Lyme Borreliosis
MeSH terms: Borrelia Infections; Lyme Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Section 1:

      The purpose of the study is to obtain safety and immunogenicity data of different dose levels
      of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without
      adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the
      basis for dose/formulation selection for Section 2 of the study.

      Section 2:

      An additional purpose of the study is to evaluate the safety and immunogenicity of the
      optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative
      and seropositive healthy subjects aged 18 to 70 years.
    


Intervention name(s): Multivalent recombinant OspA Lyme Borreliosis Vaccine; Multivalent recombinant OspA Lyme Borreliosis Vaccine; Multivalent recombinant OspA Lyme Borreliosis Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Primary vaccination (6 study arms of 50 subjects each): 3 intramuscular injections containing either dose A, B or C in an adjuvanted or non-adjuvanted formulation (6 different formulations) given in monthly intervals (recruited in 3 sequential cohorts); Booster vaccination 9-12 months after first vaccination in Section 1 subjects; 3 intramuscular injections at monthly intervals (using 2 formulations selected from Section 1) in seronegative and seropositive subjects (N=350) and a booster vaccination at 6 months or at 9-12 months (Cohorts 4: seronegatives; Cohort 5: seropositives)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation
Condition: Infection
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine
      immune competence against CMV infection in stem cell transplantation.

      To determine the utility of the T-SPOT.CMV assay used before transplantation to determine
      immune competence against subsequent CMV reactivation and to determine the utility of the
      T-SPOT.CMV assay used after transplantation to determine immune competence against subsequent
      CMV reactivation.
    

Detailed description: 
      In this prospective, non-randomized, observer-blind observational study, up to 200 patients
      who meet the study's eligibility criteria will be enrolled at up to 20 study centers.
      Enrollment will be actively managed by the sponsor.

      Blood samples will be collected up to 14 days before transplantation, and then at 2-week
      intervals for the 6 months after the transplant procedure.

      Study duration: 15 months: 9 months to enroll all patients, with 6 months (182 days) of
      participation for each patient.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled in this study will be men or women aged 18 years or older with positive
        CMV serostatus (R+) who are candidates for allogeneic HSCT.

        The patients enrolled are intended to be representative of those who would be anticipated
        to have T SPOT.CMV testing when it is used in routine clinical practice. Enrollment will be
        actively managed by the sponsor.
      
Biospecimen description: 
      Blood
    
Keywords: Cytomegalovirus reactivation in stem cell transplant
A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants
Condition: Dermatitis Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the skin irritation potential of PF-07038124
      ointment and vehicle (placebo) in Part A following multiple-doses applied topically to
      healthy participants. In Part B, the safety, tolerability, pharmacokinetic (PK), and skin
      irritation potential of PF-07038124 will be evaluated. In Part A, the highest concentration
      of 0.06% PF-07038124 will be applied to normal skin with a small surface area of 20 cm2 (0.1%
      body surface area [BSA]), while Part B will evaluate application of PF-07038124 and vehicle
      (placebo) to a surface area of 2000 cm2 (10% BSA) and 4000 cm2 (20% BSA). These data will
      provide support for clinical development in participants with mild to moderate AD.
    


Intervention name(s): PF-07038124 and Vehicle; PF-07038124 or vehicle; PF-07038124 or vehicle; PF-07038124 or vehicle; PF-07038124 or vehicle; PF-07038124 or vehicle; PF-07038124 or vehicle
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA); PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA; PF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA; PF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA; PF-07038124 0.06% or vehicle ointment BID applied to 10% BSA; PF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA; PF-07038124 safe concentration or vehicle BID applied to 10% BSA
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eczema
Frequency of Hymenoptera-stings in Patients Under Allergen-Specific Immunotherapy (SIT)
Condition: Hymenoptera Sting Allergy
MeSH terms: Bites and Stings
Study type: Observational

Summary: 
      In Switzerland, 3.5% of the population are suffering from hymenoptera venom allergy. The only
      causal treatment of hymenoptera alelrty is venom specific immunotherapy. There are however
      several reasons, which question the relatively broad application of this expensive treatment.
      That's why we aim at investigating the actual risk for hymenoptera stings in patients
      undergoing allergen specific immunotherapy against hymenoptera sting allergy
    


Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Observation of sting frequency
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Hymenoptera sting allergic patients under allergen specific immunotherapy
Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the
      pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single
      dose administration of acoramidis. Blood sampling for PK assessment will include measures for
      acoramidis and its metabolite, acoramidis acyl glucuronide (acoramidis-AG).
    


Intervention name(s): Acoramidis
Intervention type(s): Drug
Intervention description(s): Film-coated immediate release oral tablet.
Other intervention name(s): ALXN2060; AG10
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a balanced, 2-period, 2-sequence, 2-way crossover study in healthy participants. All participants will receive 1 treatment in each period.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Acoramidis; ALXN2060; AG10; Pharmacokinetics; Food Effect; Crossover
Total Energy Expenditure and Fat Oxidation in 2 Year Old Children
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old
      children.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        120 toddlers born from mothers of the Glowing study (NCT01131117)
      
Biospecimen description: 
      Urine collected
The ProGirls Study
Condition: Delinquency; HIV Risk; Substance Use; Trauma Exposure
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and
      trauma are particularly at risk for engaging in risky sexual behavior and for contracting
      HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs
      for girls who have this combination of behaviors is known to exist at this time. Researchers
      are developing, assessing, and implementing a family-centered prevention program to decrease
      girls' participation in the risky behaviors associated with the spread of HIV and STIs. The
      program also includes a group-based training and support program for parents.
    

Detailed description: 
      This study aims to test an intervention to reduce HIV/STI risk behavior among girls in the
      juvenile justice system with the triple-threat risk of delinquency, drug abuse, and trauma.
      This is a competing continuation of the ProTeens study (Preventing Drug Abuse & HIV/AIDS in
      Delinquent Youths: An Integrated Intervention) which focused on testing a family-centered
      intervention for treating HIV risk, drug use, and delinquency in boys. The current study will
      adapt the ProTeens intervention for girls. Girls and their parent(s) will be randomly
      assigned to either a family-centered intervention condition (INT; n = 100) or to an active
      comparison condition (n = 100) consisting of group therapy and case management (GCM). The INT
      condition will consist of individually administered HIV preventive intervention for
      adolescent girls involved in the juvenile justice system that integrally addresses
      delinquency, drug abuse, and trauma exposure, along with group-based training and support for
      parents. The girl and parent components will run concurrently for three months. The GCM
      condition will consist of group therapy and case management for girls provided as usual by
      the juvenile justice department. We will examine intervention effects on proximal outcomes
      measured at 12 months, the effects of childhood adversity on proximal outcomes, and the
      mediation of intervention effects. Longer term outcomes will be measured at 24 months. Data
      will be collected through in-person interviews and questionnaires from focal participants and
      their parents, official arrest records, and urinary analysis.
    

Intervention name(s): Integrated intervention for parents and adolescent girls
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of individually administered preventive curriculum for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention