bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of JNJ-61393215
      versus placebo after single oral dose administration under fasted (ascending dose levels) and
      fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal
      fluid (CSF) and urine after single oral dose administration and to investigate the effect of
      food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral
      dose administration.
    


Intervention name(s): JNJ-61393215; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.; Matching placebo will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of Fenofibrate for Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with
      primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
    

Detailed description: 
      This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20
      patients with PBC treated for 1 year. A randomized design would not be feasible at this stage
      of the research. Two sites are enrolling patients: University of Florida, Gainesville, and
      Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients
      to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease
      activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic
      index -Mayo risk score and 3) the NIDDK quality of life questionnaire.
    

Intervention name(s): Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
Intervention type(s): Drug
Intervention description(s): 160 mg per day for 1 year
Other intervention name(s): Triglide-Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)
Intervention MeSH terms: Fenofibrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PBC; Primary Biliary Cirrhosis; Fenofibrate; Triglide
Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection
Condition: HIV Prevention
MeSH terms: Infections; Acquired Immunodeficiency Syndrome; HIV Infections; Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and effectiveness of intravaginal 1%
      tenofovir gel in preventing Human Immunodeficiency Virus (HIV-1) infection and Herpes Simplex
      Virus (HSV-2) infection in sexually active women.
    

Detailed description: 
      This is a phase III, multicenter trial to assess the safety and effectiveness of 1% tenofovir
      gel, administered vaginally by approximately 2900 sexually active women at high risk for
      sexually transmitted HIV. Approximately 2600 women aged 18-30 years old will be enrolled to
      achieve the required number of endpoints to show an effect on HIV-1 infection, while up to
      300 additional women aged 31-40 years old will be enrolled to collect more safety information
      in this age group.

      This is an event driven study that plans to randomize seronegative women. Participants will
      be randomized to a 1:1 ratio to receive 1% tenofovir gel or placebo gel. Each will be asked
      to insert a dose of the assigned study product within 12 hours prior to a coital event and
      another dose as soon as possible within 12 hours after a coital event. Participants will be
      advised to use only two doses of gel in a 24 hour period.

      All women will be evaluated for the rates of adverse events and the rate of HIV
      seroconversion. In addition, the study will evaluate several secondary endpoints that bear
      directly on potential risks and benefits of vaginal tenofovir gel use.
    

Intervention name(s): Tenofovir gel; Universal placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): Tenofovir gel is a clear, transparent, viscous gel at concentrations of 1% formulated in purified water with edentate disodium, citric acid, glycerin, methylparaben, propylparaben, HEC, and pH adjusted to 4-5. Tenofovir gel will be supplies in a 4 ml single use applicator containing approximately 4 grams of gel, equivalent to approximately 40mg of tenofovir.; The placebo gel is an inert gel containing HEC as the gelling agent, purified water, sodium chloride, sorbic acid and sodium hydroxide. Each applicator contains approximately 4ml of placebo gel
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Condition: Breast Cancer
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Exercise training has beneficial effects in cancer survivors to minimize some of the side
      effects of cancer and its treatment and improve long-term prognosis, but there are numerous
      hurdles for individuals diagnosed with, and being treated for, cancer to participate in
      exercise programs. The goal of this research study is to begin to evaluate whether exercise
      training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal
      muscle size and function in cancer survivors.
    


Intervention name(s): Neuromuscular electrical stimulation
Intervention type(s): Device
Intervention description(s): Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer
Condition: Breast Cancer Metastatic
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objectives:

        -  To assess the safety for each cohort of patients on a fixed-dose combination pill of
           capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule
           (defined as continuous daily treatment without interruption) in patients with metastatic
           breast cancer.

        -  To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination
           pill of capecitabine and cyclophosphamide administered at different doses/regimens by
           metronomic schedule in patients with metastatic breast cancer.

      Secondary Objectives:

        -  To assess antitumor activity of the fixed-dose combination pill of capecitabine and
           cyclophosphamide administered at different doses/regimens by metronomic schedule in
           patients with metastatic breast cancer given at 3 different doses and schedules (regimen
           1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low
           dose [OD])

        -  Disease Control Rate (DCR)

        -  Overall Response Rate (ORR)

        -  Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors
           (RECIST) criteria (version 1.1).

        -  To evaluate the compliance under treatment.

        -  To describe evolution of toxicities.

        -  To assess safety all along patient's treatment.
    

Detailed description: 
      Primary objective will be evaluated at 12 weeks. Patients who show evidence of efficacy will
      be treated and followed-up until progression of the disease.
    

Intervention name(s): Fixed-dose combination of capecitabine and cyclophosphamide SAR439281
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:Tablet Route of administration: Oral
Intervention MeSH terms: Cyclophosphamide; Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Triathlon on the Electrolyte Balance
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Observational

Summary: 
      Aim of the study is examining the incidence of the occurrence of hyponatremia during a
      Triathlon
    

Detailed description: 
      Studies in similar endurance sports (e.g. marathon) could already indicate a high incidence
      for the appearance of hyponatremia during competitions. The loss of sodium through sweating
      and the excessive fluid intake during the competitions is a primary risk factor for the
      development of hyponatremia.

      Based on the known occurrence of hyponatremia in marathon runners, participants of the
      Ironman European Championship between the years 2005 and 2014 were screened for the
      occurrence of hyponatremia after finishing the race for safety reasons. Subjects were
      approached at random in the athlete's garden and invited to participate. All participants
      were 18 years or older.
    

Intervention name(s): Education in nutrition
Intervention type(s): Behavioral
Intervention description(s): Athletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Participants of a long-distance triathlon
      
Keywords: Ironman; Triathlon
Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery
Condition: Postoperative Pain; Breast Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Serratus plane block (SPB) was first described in 2013 by Blanco and designed to primarily
      block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral
      anterior and posterior part of thoracic wall.Erector Spinae Plane Block (ESPB) is a newly
      described and effective interfascial plane block for thoracic and abdominal surgery. It was
      first described by Forero et al. in 2016, effectiveness being reported in four cases. The aim
      of this study is to compare Serratus plane block and erector spinae plane block on
      postoperative pain in patients undergoing modified radical mastectomy and axillary lymph node
      dissection
    


Intervention name(s): Bupivacaine Hcl 0.25% Inj; Bupivacaine HCl Inj 0.25%
Intervention type(s): Drug; Drug
Intervention description(s): 30 ml %0,25 bupivacaine; 20 ml %0,25 bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the feasibility and clinical utility of a
      continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2
      diabetes who are on non-insulin therapies.
    

Detailed description: 
      The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood
      Glucose Monitoring system.

      This investigation is a 2-phase cross-over study with patients serving as their own controls.
      The demographics, medical history, anthropometric and laboratory data are collected at
      baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM
      in blinded mode and is unaware and unable to access the data. The patient performs standard
      care, self-monitoring with twice daily glucose checks using standard finger-sticks and a
      glucometer device. During this phase, the medical providers are also blinded to the CGM data
      and continue standard care without any specific intervention.

      During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode
      and the medical providers have access to the data via Clarity and/or direct download via the
      transmitter. CGM data are collected continuously in each phase and at the end of each phase.
      Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are
      also un-blinded and adjust medical recommendations and interventions, in part based on CGM
      data, as appropriate.

      All patients will receive usual care which will include individual and virtual lifestyle
      education, virtual support group, M.D. visits, medication interventions, referrals to support
      programs outside the scope of CINEMA program and nursing support
    

Intervention name(s): Dexcom continuous glucose monitor
Intervention type(s): Device
Intervention description(s): The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose-finding study to determine if the sublingual administration of the Sufentanil
      NanoTab is safe and effective in the treatment of post-operative pain.
    


Intervention name(s): Sufentanil NanoTab 20 mcg; Sufentanil NanoTab 30 mcg; Placebo NanoTab
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Sufentanil; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      The objective of this research is to evaluate the effectiveness of an educational handbook
      for parents of children with atopic dermatitis (AD) in improving clinical outcomes for
      pediatric patients with AD and their parents. The handbook was developed by an
      interdisciplinary team of healthcare providers to facilitate therapeutic patient education as
      a routine component of care for pediatric patients with atopic dermatitis (AD). Patient
      education is an important element of practice management guidelines for AD, particularly
      given complex treatment plans and high rates of non-adherence in this population. Parents of
      children with AD will be randomized into either the handbook arm (handbook provided as an
      adjunct to standard AD management with a healthcare provider at Boston Children's Hospital)
      or the control arm (standard management alone). Participants will complete study measures at
      two time points: baseline (prior to a clinic visit appointment for AD care at Boston
      Children's Hospital), and 3-month follow-up. Data will be analyzed for change on study
      outcome measures (AD symptoms, AD severity, quality of life) and satisfaction with the
      handbook.
    


Intervention name(s): Educational handbook
Intervention type(s): Other
Intervention description(s): The intervention being evaluated in this study is an educational handbook for parents of children with atopic dermatitis (AD). The handbook was developed and written by the interdisciplinary study team (psychologist, allergist, nurse practitioner, dermatologists, primary care physician, dietitian). Content was based on practice guidelines for AD management, consensus recommendations for therapeutic patient education for AD, and clinical experience of our study team. Content includes topics central to effective AD management, such as pathophysiology/course, elements of treatment plans, and strategies to improve quality of life, such as breaking the itch-scratch cycle, improving sleep, and coping with social-emotional issues.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is the most common cause of motor function impairment. However, the functional
      impairment is not totally irreversible. Several mechanisms may involved in both the cortical
      and motor function recovery after onset of stroke, and most of them are related to changes of
      cortical perfusion and metabolism.

      Motor function recovery after stroke (especially middle cerebral artery territory lesion)
      frequently follow stereotypic pattern (brunnström stage).

      This study is designed to investigate the relationship between motor cortex
      oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar
      stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage
      after stroke.
    

Detailed description: 
      Participants receive evaluations (1/week for 3 months period) of

        -  motor function (Include: MMSE, brunnström stage, Fugl-Meyer Assessment of Physical
           Performance, Box and Block Test of Manual Dexterity, Functional Independence Measure)

        -  cortical perfusion detection during performing limb movements (using NIRS)

      Then use path analysis to investigate the relationship between motor cortex
      oxygenation/metabolism and motor function recovery after stroke.
    

Intervention name(s): Functional Electric Stimulation; Rehabilitation programs
Intervention type(s): Procedure; Other
Intervention description(s): apply to the hemiplegia affected limbs, helping movement; include occupational therapy and physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cortical activation; motor function; activity of daily living
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of natalizumab in
      adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD).
      It is thought that natalizumab may stop the movement of certain cells, known as white blood
      cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the
      symptoms of Crohn's disease.

      Patients who complete this study may be eligible for long-term natalizumab therapy via
      extension protocol ELN100226-352.
    


Intervention name(s): natalizumab
Intervention type(s): Drug
Intervention MeSH terms: Natalizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rehabilitation Status of Children With Cerebral Palsy and Anxiety of Their Caregivers During the Covid19 Pandemic
Condition: Cerebral Palsy; Covid19; Anxiety
MeSH terms: COVID-19; Paralysis; Cerebral Palsy; Anxiety Disorders
Study type: Observational

Summary: 
      Rehabilitation status of children with cerebral palsy (CP) and anxiety of their caregivers
      during the covid19 pandemic were explored. 206 caregivers who voluntarily accepted to
      participate were administered the State-Trait Anxiety Inventory and evaluated about the
      rehabilitation status of their children.The anxiety levels of all caregivers were found high
      and the rehabilitation programmes of the children were interrupted.
    

Detailed description: 
      Investigators aimed to explore the rehabilitation status of children with CP and anxiety of
      their caregivers during the covid19 pandemic. Caregivers of children with CP who were under
      follow up in the outpatient CP clinic were called up during pandemic period. 206 caregivers
      who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory
      and evaluated about the rehabilitation status of their children. Demographic data, associated
      problems of children, Gross Motor Function Classification System (GMFCS) and Manual Ability
      Classification System (MACS) levels were recorded from their files. For the statistical
      analysis, IBM SPSS Statistics 22 (SPSS IBM, Turkey) programs were used. While evaluating the
      study data, the suitability of the parameters to the normal distribution was evaluated with
      the Shapiro Wilks test. Significance was evaluated at the p <0.05 level.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Caregivers of children with CP who were under follow up in the outpatient CP clinic.
      
Keywords: Anxiety; Cerebral Palsy; Covid19; Rehabilitation
Endoscopical Dilation of Benign Esophageal Strictures
Condition: Dysphagia
MeSH terms: Esophageal Stenosis; Constriction, Pathologic; Dilatation, Pathologic
Study type: Interventional

Summary: 
      Although balloon dilatation is the primary treatment for benign dysphagia, information about
      the optimal inflation time is lacking. The aim of the current pilot study was to compare 10
      seconds inflation time, with 2 minutes inflation time, regarding the efficacy
    


Intervention name(s): Dilation 10 sec; Dilation 2 min
Intervention type(s): Device; Device
Other intervention name(s): CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd; CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign; Esophageal strictures; Esophagus; Balloon Dilation