bioihbjkbjnl/mcl2 huggingface dataset:
Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain
Condition: Low Back Pain; Low Back Sprain; Low Back Pain, Recurrent
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Ten patients with acute or chronic low back pain will be invited to try a multimodal device
      for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will
      be elicited.
    

Detailed description: 
      To facilitate data collection of a short-term intervention, the investigators chose to enroll
      patients from a mixed physical therapy/chiropractic practice with demographic and economic
      diversity in the metro Washington area. The neuromodulatory device will have patient
      controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate
      ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on
      both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay
      pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute
      thermal capacity. A convenience sample of 10 patients at the clinic was invited to give
      feedback on the prototype device after informed consent. Changes suggested were incorporated
      and after informed consent a second group of ten gave will give feedback with the
      production-ready device.
    

Intervention name(s): Duotherm VibraCool Back Device
Intervention type(s): Device
Intervention description(s): Low back plate belt with mechanicothermal and pressure intervention options.
Intervention model: Single Group Assignment
Intervention model description: Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Medical Device; Buzzy; Vibration; thermomechanical
Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
Condition: Atopic Dermatitis (Eczema)
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study where all subjects will receive study medication to understand how
      the body processes the study medication, and to determine the PK, safety and efficacy of
      ARQ-151 cream 0.15% or 0.05% in adolescent and pediatric subjects with mild to moderate AD.
      At entry, subjects in Cohorts 1-3 will have 1.5-35% Body Surface Area involvement (excluding
      the scalp, palms, soles) and mild or moderate atopic dermatitis (AD) based on vIGA-AD. Cohort
      2 and Cohort 3 will be performed in parallel and may commence after results are available
      from ARQ-151-212, a Phase 2 study evaluating ARQ-151 cream 0.05% and 0.15% administered once
      a day for 4 weeks in adolescents and adults with mild to moderate AD affecting 1.5% to 35%
      BSA.

      For the maximal usage PK study (Cohorts 4-8), subjects will have BSA involvement (excluding
      the scalp, palms, soles) of ≥ 35% in subjects 3 months old to 11 years old (inclusive) or
      ≥25% in subjects 12 to <17 years old with mild or moderate AD .

      Seven groups will be evaluated, including:

        -  Cohort 1: ARQ-151 cream 0.15% in adolescents (12-17 years old; inclusive)

        -  Cohort 2: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)

        -  Cohort 3: ARQ-151 cream 0.15% in children 2-5 years old (inclusive; will be performed in
           parallel with Cohort 2)

        -  Cohort 4: ARQ-151 cream 0.15% in adolescents 12 to <17 years old

        -  Cohort 5: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)

        -  Cohort 6: ARQ-151 cream 0.15% in children 2-5 years old (inclusive)

        -  Cohort 7: ARQ-151 cream 0.05% in children 2-5 years old (inclusive)

        -  Cohort 8: ARQ-151 cream 0.05% in children 3 months old to less than 2 years old

      Subjects will apply ARQ-151 cream 0.15% or 0.05% once a day for 28 days to all AD affected
      areas and any newly appearing AD lesions that arise during the study, except on the scalp.
    


Intervention name(s): ARQ-151 cream 0.15%; ARQ-151 cream 0.05%
Intervention type(s): Drug; Drug
Intervention description(s): ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days; ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure.
Condition: Obesity, Morbid; Postoperative Pain; Postoperative Nausea and Vomiting
MeSH terms: Obesity, Morbid; Pain, Postoperative; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Sleeve gastrectomy is the most performed bariatric procedure worldwide. Postoperative pain
      management is a challenging issue. In this trial, the investigators aimed to explore the
      effects of laparoscopic guided transversus abdominis plane (TAP) block on postoperative pain
      management in patient those were performed laparoscopic sleeve gastrectomy.
    

Detailed description: 
      TAP block is a regional anesthesia technique which could be performed easily especially by
      laparoscopy and are used in various surgical procedures. In that technique, blockade of the
      plane between internal oblique muscle and transversus abdominis muscle is performed by
      infiltration of local anesthesics drugs. Therefore , reduction of postoperative pain could be
      lead to decrease in postoperative complications.
    

Intervention name(s): Transversus abdominis plane block; Placebo
Intervention type(s): Procedure; Drug
Intervention description(s): TAP block will be performed by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.; 20 ml saline solution will be injected by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty patients had divided into two groups; TAP block group (TAP-B) and placebo (P) group. Every group contained 20 patients and randomization was performed by sealed envelope method. Patient and the data collector resident didn't know the which procedure was done thus single-blinded randomization were provided.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleeve gastrectomy; Transversus abdominis plane block; Postoperative pain management
Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)
Condition: Polycystic Kidney Disease
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to observe the effects of niacinamide on markers of kidney
      injury, inflammation, kidney cyst growth and kidney function.
    

Detailed description: 
      Polycystic Kidney Disease (PKD) is a genetic disease that affects about 1 in 500 people
      worldwide. It can lead to kidney failure which can lead to death. PKD causes the development
      of kidney cysts (fluid-filled balloons), which cause worsening kidney function. It is common
      for people with PKD to also have blood in the urine, kidney pain, high blood pressure, kidney
      stones, kidney infections, and cysts in the brain or other parts of the body.

      There is currently no treatment known to stop cyst growth or a cure for the disease.

      Participants in this study will be randomly assigned to one of two groups: niacinamide or
      placebo. Participants have an equal chance of being assigned to either of the groups. For
      people that qualify and decide to participate in this study, they will be asked to make five
      visits to the study clinic and complete two study related phone calls over the course of 12
      months.
    

Intervention name(s): Niacinamide; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Placebo pill that matches niacinamide pill is size, shape and color
Other intervention name(s): Nicotinamide; Vitamin B3
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: PKD; Kidney disease; Vitamin B3
Study to Investigate Benefits of Weight Loss in Young Adults and Adolescents
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the changes in subcutaneous adipocyte size,
      number and gene expression after weight loss and to assess whether those changes contribute
      to decreases in ectopic fat accumulation and insulin resistance in women between ages of
      16-32.
    

Detailed description: 
      There are no studies in young women that have prospectively studied changes in fat cell size,
      gene expression and insulin sensitivity during the transition from overweight/obese to normal
      weight. Our preliminary data suggest that the presence of ectopic fat accumulation and
      insulin resistance in obese children could be considered an "early phase" in the development
      of T2DM. We hypothesize that a 10% weight loss will restore/improve insulin sensitivity.
      Furthermore, we speculate that the decrease in subcutaneous fat mass after weight loss is due
      to a decrease in mean adipocyte cell size, but not cell number.
    

Intervention name(s): Caloric restrictive diet
Intervention type(s): Behavioral
Intervention description(s): Patients will meet weekly with a registered dietician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Obesity; Insulin Resistance; Weight loss; Women
Effects of Atx and Oros-mph on Executive Functions
Condition: Executive Dysfunction
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate and compare the effects of Atomoxetine(ATX) and osmotic
      release oral system-methylphenidate (OROS-MPH) therapies on executive functions, activities,
      treatment response time and adverse effects based on discernible clinical effects in children
      with combined type attention deficit-hyperactivity disorder (ADHD).
    

Detailed description: 
      The aim of this study was to evaluate and compare the effects of Atomoxetine(ATX) and osmotic
      release oral system-methylphenidate (OROS-MPH) therapies on executive functions, activities,
      treatment response time and adverse effects based on discernible clinical effects in children
      with combined type attention deficit-hyperactivity disorder (ADHD).

      In this study, the functional capabilities of the patients who clinically responded well to
      therapy were assessed simultaneously with clinical response that may appear at different time
      periods and the treatment groups were compared in patients who responded to therapy by
      excluding patients with insufficient clinical response.
    

Intervention name(s): Atomoxetine; methylphenidate
Intervention type(s): Drug; Drug
Intervention description(s): the drug was initiated at a dose of 0.5 mg/kg/day which was then gradually increased at 2-week intervals and it was attempted to titrate the dose to 1.2 mg/kg/day.; the drug was initiated at the lowest commercially available dose this was then increased at one-month intervals and it was attempted to titrate the dose to 1 mg/kg/day using daily doses of 36-54 mg
Other intervention name(s): STRATTERA; CONCERTA
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: attention deficit-hyperactivity disorder (ADHD).; executive functions
Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers
Condition: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to compare the diagnostic validity (sensitivity and specificity)
      and evaluate the safety of 2-min Tidal Breathing methacholine bronchial provocation tests
      with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.
    

Detailed description: 
      After screening,each asthmatic patient will visit the investigators' center 4 times.

      During the first week, the patient will be randomised to undergo methacholine bronchial
      challenge with Wright or Devilbiss 646 nebulizer on two separate days, which are at least 24
      hours but not more than 7 days apart.The above procedure will be repeated for each patient in
      one month. But the nebulizer will be selected in a reverse order.Provocative concentration
      induced a 20% decrease in forced expiratory volume in one second (PC20) will be calculated
      for each test. Record all the adverse events during the tests.
    

Intervention name(s): methacholine; Wright Nebulizer; Devilbiss646 Nebulizer
Intervention type(s): Other; Device; Device
Intervention description(s): methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada; nebulized for 2 minutes with an output of 0.13ml/min; nebulized for 2 minutes with an output of 0.13ml/min
Intervention MeSH terms: Methacholine Chloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol
Condition: Asthma, Exercise-Induced
MeSH terms: Asthma; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study.
      At each study visit a standardised treadmill test will be performed to provoke EIA. Before
      and after the challenge test pulmonary function variables (e.g. forced expiratory volume in
      one second (FEV1)) will be measured in order to assess the protective effect of the study
      medication.
    

Detailed description: 
      -  Primary objective: to demonstrate superiority of the protective effect of the fixed
           combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single
           component reproterol in adults suffering from exercise induced asthma (EIA).

        -  Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus
           reproterol in comparison to the single component DSCG; to demonstrate superiority of the
           protective effect of each single component in comparison to placebo. In addition, the
           tolerability of medications will be documented.
    

Intervention name(s): Combination DSCG and Reproterol
Intervention type(s): Drug
Intervention description(s): 1:
Intervention MeSH terms: Reproterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Condition: HIV Infections; Cytopenias
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Leukopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant
      granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous
      infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In
      addition, single dose and steady state pharmacokinetics will also be determined.
    


Intervention name(s): Sargramostim
Intervention type(s): Drug
Intervention MeSH terms: Sargramostim
Primary purpose: Treatment
Keywords: Leukopenia; Drug Evaluation; Granulocyte-Macrophage Colony-Stimulating Factor
PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the present study is to establish the safety and efficacy of multiple
      administrations of Prochymal™(ex-vivo cultured human adult mesenchymal stem cells) in
      participants with moderate to severe chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      COPD is currently the fourth leading cause of death in the United States. It is clear that
      there is a significant unmet medical need for safe and effective therapies to treat moderate
      to severe COPD. This patient population has a high mortality rate and requires frequent
      hospitalizations due to disease-related exacerbations. Based on severity distribution
      estimates, approximately 70% of all current COPD patient have either moderate or severe COPD.
      COPD has no known cure, thus current therapeutic intervention is aimed at providing relief of
      symptoms. Oxygen therapy is the only treatment that has been shown to improve survival.
      Smoking cessation has been shown to slow the rate of forced expiratory volume in 1 second
      (FEV1) decline and COPD progression. In general patient are treated with bronchodilators and
      inhaled corticosteroids, but again, these measures do not provide any significant benefit
      regarding disease progression or prognosis. The characteristics and biologic activity of
      Prochymal™, along with a good safety profile in human trials to date, suggest that Prochymal™
      may be a good candidate for addressing this unmet medical need.
    

Intervention name(s): Prochymal™; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of ex- vivo cultured adult human mesenchymal stem cells.; IV infusion of excipient of Prochymal™.
Intervention MeSH terms: Remestemcel-l
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Pulmonary Emphysema; Chronic Bronchitis; Mesenchymal Stem Cells (MSCs); Adult Human Stem Cells; Osiris; Prochymal™
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)
Condition: HDL; Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the
      cholesterol ester transfer protein (CETP), in healthy male subjects with high density
      lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.
    

Detailed description: 
      This open-label Phase 1 study will be conducted in three groups of 12 subjects with HDLc
      blood concentrations equal or below 80 mg/dl at a single study center. 36 subjects will be
      enrolled.
    

Intervention name(s): ATH03
Intervention type(s): Biological
Intervention description(s): 4 vaccinations
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CETP; Vaccine; Cholesterol; Inhibition
Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
Condition: HIV Coinfection; Aids/Hiv Problem; Tuberculosis, Pulmonary; Human Immunodeficiency Virus; Lentivirus Infections; RNA Virus Infections
MeSH terms: Infections; Communicable Diseases; Tuberculosis; Acquired Immunodeficiency Syndrome; HIV Infections; Coinfection; Tuberculosis, Pulmonary; RNA Virus Infections; Lentivirus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by
      subcutaneous injection in complex treatment of patients with co-infection of HIV and
      pulmonary tuberculosis and to determine the rational of its use.
    

Detailed description: 
      Study will evaluate safety and efficacy of the investigational medical product (IMP) -
      interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.

      Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by
      NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral
      replication, viral proteins synthesis and assembly of mature viral particles. Causes
      cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright
      immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in
      patients co-infected with tuberculosis and HIV.

      The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level
      and help abacillation process. In this randomised, controlled safety and efficacy study
      interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.

      The treatment regimen in this study will also include a basic antituberculosis therapy.

      The available clinical data do not suggest a risk for serious adverse events (SAEs) from the
      IMP used in chosen doses.

      The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis.
      Participants who provide informed consent and meet study entry criteria will be randomised
      into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants
      will receive IMP in various regimens according to the group.
    

Intervention name(s): Interferon-Gamma
Intervention type(s): Drug
Intervention description(s): received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
Other intervention name(s): Ingaron; Interferon gamma human recombinant
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interferon gamma, IFN-g, HIV infection, tuberculosis