bioihbjkbjnl/mcl2 huggingface dataset:
Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
Condition: Obstructive Sleep Apnea; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Healthy
MeSH terms: Muscular Dystrophies; Sleep Apnea, Obstructive; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      This is a pilot study to examine the diagnostic utility of a novel transmembrane surface
      sensor, and compare signals obtained with the transmembrane sensor to conventional needle EMG
      signals from healthy volunteers to those with documented neurologic pharyngeal muscle
      dysfunction (ALS and muscular dystrophy) and to those with severe OSA.
    

Detailed description: 
      Transmembrane electromyography (TM-EMG) may be a feasible and valid non-invasive EMG
      technique for detecting neuromuscular (NM) impairment. This study will assess whether, in
      healthy volunteers and participants with known obstructive sleep apnea (OSA) and other NM
      diseases involving the oropharynx, the same characteristic motor unit potentials obtained on
      conventional needle EMG (NEMG) can be obtained using a TM-EMG sensor. The purpose of this
      study is to demonstrate whether the TM-EMG sensor can provide the same diagnostic accuracy as
      the concentric needle electrode for the diagnosis of NM diseases. Having demonstrated
      diagnostic similarity of TM-EMG to NEMG, the secondary aim of this study is to confirm that
      NM disturbance of oropharyngeal striated muscles in participants with OSA can be elicited
      with the TM-EMG sensor.
    

Intervention name(s): Transmembrane EMG Oropharynx Probe
Intervention type(s): Device
Intervention description(s): Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmembrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G).
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, cohort, pilot study with blinded data analysis and two physician testers to assess intertester reliability and device usability. Volunteers will include healthy adults, participants with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy), and participants with severe OSA. For each participant diagnostic properties of EMG studies will be assessed using a conventional needle and TM-EMG sensor in pharyngeal muscles.
Masking: None (Open Label)
Primary purpose: Diagnostic
AXOS and Microbial Metabolites in CKD
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,
      uremic retention solutes. Evidence is mounting that the colonic microbiota contributes
      substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are
      among the most extensively studied gut microbial metabolites, and are associated with
      cardiovascular disease, overall mortality and chronic kidney disease progression. The most
      important regulator of colonic bacterial metabolism is nutrient availability and especially
      the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake
      of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides
      (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing
      effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in
      general, and AXOS more specifically, can influence intestinal generation of microbial
      metabolites in predialysis patients has not been studied to date. An interventional study
      with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease
      intestinal generation and serum concentrations of microbial metabolites in patients with CKD
      not yet on dialysis.
    


Intervention name(s): Arabinoxylan-oligosaccharides; Maltodextrine
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): AXOS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Single-center Randomized Controlled Study on the Effect of Pharmacogenomics Trial on Clinical Efficacy in Patients With Depression
Condition: Depressive Disorder; Pharmacogenomic Drug Interaction
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to explore the efficacy of drug therapy under the
      guidance of pharmacogenomics test in the treatment of patients with depression. The main
      questions to be answered in this study are:

        1. Whether the drug treatment regimen under the guidance of pharmacogenomics test is
           beneficial to the rehabilitation of patients with depression.

        2. Pharmacogenomics tests whether it can reduce adverse drug reactions during treatment,
           and be evaluated by the scale before and after treatment.

      The researchers will compare the pharmacogenomics test group with the healthy control group
      to see the effect of drug therapy under the guidance of pharmacogenomics test on the efficacy
      of patients with depression.
    

Detailed description: 
      Drug treatment of mental disorders is often seriously hindered by huge differences in
      individual drug responses or drug side effects, which are closely related to genetic factors.
      Pharmacogenomics testing can help clinicians to provide better drug choices for patients. In
      this study, a single center randomized controlled design was used, including 300 cases in the
      drug gene detection group and 300 cases in the healthy control group. Hamilton Depression
      scale (HAMD) and side effects scale (TESS) were used to evaluate the efficacy of
      pharmacogenomics test in the treatment of depression before and after treatment.
    

Intervention name(s): pharmacogenomic testing
Intervention type(s): Diagnostic Test
Intervention description(s): Pharmacogenomic testing has emerged as a promising diagnostic tool, allowing clinicians to guide the selection and dosage of antidepressant medications. In theory, pharmacogenomic testing may provide improved drug selection and dosing strategies for patients with genetic alterations related to drug response
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder; Pharmacogenomic Drug Interaction
Influence of Platelet Concentrates on Wound Healing
Condition: Platelet-Rich Plasma; Wound Healing Delayed
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Chronic soft tissues defects can extend into the fat layer or even deeper and can cause
      functional disadvantages. Split-thickness skin grafts (STSGs) used to cover these wounds have
      varying success rates. To improve wound healing in chronic wounds the authors have studied
      the application of autologous platelet concentrates in a human keratinocyte culture model in
      vitro and in a combination with surgical procedures in vivo as second line therapy in
      patients with initially failed wound closure.
    

Detailed description: 
      For in vitro testing on keratinocytes a platelet-mediator concentrate (PMC) was processed
      with a commercially available bed-side system (ATR®, Curasan, Germany). In a clinical study
      soft tissue defects (n=5) were treated using a combination of surgical debridement and
      autologous platelet rich plasma (PRP). Time of healing as determined by epithelization as
      well as Laser Doppler Imaging to visualize blood flow were analyzed. Additionally, changes in
      "ease of surgical wound closure" were determined. Finally, the quality of life of patients
      was assessed using a validated questionnaire.
    

Intervention name(s): Platelet-Rich Plasma
Intervention type(s): Combination Product
Intervention description(s): Adding PRP to wound bed during surgical debridement
Other intervention name(s): PRP, PMC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-Rich Plasma; Laser Doppler Imaging; Growth Factors; Wound Healing; Chronic wound healing disorder; Wound quality of life
A Clinical Study to Assess the Effect of Clopidogrel on the Pharmacokinetics of Selexipag and Its Active Metabolite in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of clopidogrel on the pharmacokinetics of
      selexipag and its active metabolite (ACT-333679) in healthy male adults (by determining the
      blood concentrations of selexipag and its metabolite). Also, the safety of selexipag when
      administered alone or with clopidogrel will be assessed.
    


Intervention name(s): Selexipag; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Each film-coated tablet contains 200 microgram (mcg) of selexipag (oral use); Each film-coated tablet containing 75 mg of clopidogrel (oral use)
Other intervention name(s): ACT-293987
Intervention MeSH terms: Selexipag; Clopidogrel
Intervention model: Single Group Assignment
Intervention model description: Open-label, two-treatment, one-sequence, cross-over study
Masking: None (Open Label)
Primary purpose: Other
Keywords: selexipag; clopidogrel
Reduction of Triglycerides in Women on Hormone Replacement Therapy
Condition: Cardiovascular Diseases; Atherosclerosis; Postmenopause; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect of lifestyle intervention on subclinical
      cardiovascular disease measures in women taking hormone replacement therapy (HRT).
    

Detailed description: 
      BACKGROUND:

      Cardiovascular disease is a common cause of morbidity and mortality in older women. Better
      methods of prevention via health promotion are needed. Estrogen HRT may beneficially affect
      women's cardiovascular health, based on evidence from observational studies, but recent trial
      evidence suggests HRT may actually lead to increased risk of cardiovascular disease in new
      users. Understanding this untoward effect of HRT and how to prevent it is a significant aim.

      DESIGN NARRATIVE:

      This randomized trial of 500 women on HRT for at least two years, aged 52-60 years, and three
      or more years postmenopausal will test whether reduction in waist circumference,
      triglycerides, dense low density lipoprotein cholesterol (LDLc), number of LDL particles,
      C-reactive protein, and plasminogen activator inhibitor-I (PAI-I) by aggressive diet and
      exercise, versus a health education control, and will decrease progression or result in
      regression of measures of subclinical vascular disease. The intervention is designed to
      reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate
      activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. The primary
      endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels, a 5 cm
      decrease in waist circumference, and a 10 percent decrease in LDLc. This will result in
      changes in subclinical measurements, including carotid ultrasound, electron beam computer
      tomography of the coronary artery and aorta, pulse wave velocity, endothelial function, and
      tonometry of the radial artery. Nuclear magnetic resonance spectroscopy of lipoproteins,
      inflammatory markers, and estrogen metabolites will also be evaluated.
    

Intervention name(s): Diet, fat-restricted; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.; Rigorous, stepped care approach to reach 150 min/week of physical activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
Condition: Opioid Use Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group
      multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an
      existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
    

Detailed description: 
      This is a Phase III, randomized, double-blind, double-dummy, active-controlled, parallel
      group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an
      existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN. The
      trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits),
      and Follow-up.

      Approximately 380 subjects (190 subjects per arm) will be randomized.
    

Intervention name(s): CAM2038 SC injection; SL BPN/NX tabs; placebo SC injections; SL placebo tablets
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Buprenorphine injection; Suboxone; placebo; placebo
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Skin Refrigerant to Reduce the Pain Associated With IV Insertion
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not the pain of IV catheter insertion in
      the Emergency Department can be reduced significantly with the use of a rapid acting topical
      anesthetic spray and to determine whether or not healthcare providers who undergo such
      treatment are likely to endorse its use in their future practice.
    

Detailed description: 
      We recruited 38 emergency department healthcare providers (doctors, physician assistants,
      nurses and medics) to receive a total of two separate IV canulations - one in one arm and the
      other in the other. One IV canulation would be pretreated with Ethyl Chloride topical
      anesthetic (the study product) and the other would be pre-treated with a placebo (sterile
      water in an aerosol can). Both the participants and the nurses, PAs and medics who placed the
      IVs were blinded as to which was the Ethyl Chloride and which was the placebo. After the IVs
      were placed the participants were asked to rate the pain of IV canulation on a scale of 1 to
      10 for each of the pre-treatments, to state which one they believed to be superior in
      reducing the pain of receiving the IV, to state whether or not they would like the
      intervention that they rated as superior to be used on themselves and finally how likely they
      were on a 5 point scale to incorporate the intervention they rated as superior into their
      future practice.
    

Intervention name(s): Ethyl Chloride Topical Aerosol Anesthetic; Nature's Tears Sterile Water
Intervention type(s): Drug; Drug
Intervention description(s): Sprayed on the skin for 5-8 seconds immediately before IV cannulation; Sprayed on the skin for 5-8 seconds immediately before IV cannulation
Other intervention name(s): Study Device or Product B; Placebo or Product A
Intervention MeSH terms: Anesthetics; Ethyl Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Topical Anesthetic; Ethyl Chloride; Pain Reduction; IV cannulation
Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, adaptive two-stage design, human
      phase 2 study, with add-on treatment arrangement of fluvoxamine or placebo on top of standard
      of care (base therapy: the actual proposed therapy of moderate SARS-CoV-2 infected patients
      according to "Hungarian Coronavirus Handbook", including antiviral and immunmodulant therapy
      and reconvalescent plasma therapy in serious cases as indicated by the investigator).
    


Intervention name(s): Placebo; Fluvoxamine
Intervention type(s): Drug; Drug
Intervention description(s): po placebo tablets; po fluvoxamine tablets
Intervention MeSH terms: Fluvoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, adaptive design add-on treatment study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate COVID-19; fluvoxamine
Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Condition: Sedentary; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Our objective in this pilot study is to test the combined effect of a) replacing office
      workers' sedentary workstations with active workstations (LifeBalance Station) and b)
      optimizing computer workstation ergonomics on daily occupational sedentary time,
      cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.
    

Detailed description: 
      Primary Aim: To compare the effects of providing sedentary employees with seated active
      workstations in combination with an ergonomic intervention and regular motivational emails
      (experimental group) against the ergonomic intervention and regular emails only (active
      control group) on occupational sedentary behavior over 16 weeks.

      Hypothesis: The addition of a seated active workstation will result in significant reductions
      in daily occupational sedentary time compared to the active control group.

      Secondary Aims: To compare the effects of the experimental group against the active control
      group on secondary measures of cardiometabolic disease risk factors, musculoskeletal
      discomfort, cognitive function and work productivity.

      Hypothesis 1: The experimental group will result in reduced cardiometabolic disease risk,
      musculoskeletal discomfort and work limitations compared to the active control group.
    

Intervention name(s): Active Workstation Intervention; Ergonomic Intervention; Email Intervention; Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.
Intervention type(s): Behavioral; Behavioral; Behavioral; Device
Intervention description(s): Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.; Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.; Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
Condition: Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to
      biochemical and histological parameters.

        -  Trial with medicinal product
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D3, 2.100 IU/d p.o.; Placebo Tbl. p.o.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of a 4% Hydroquinone Cream for the Treatment of Melasma
Condition: Facial Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce
      melasma on the face, using a split-face randomization design, evaluating the MASI Score from
      baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.

      To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the
      face.

      To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.
    


Intervention name(s): Hydroquinone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydroquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Facial Melasma
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta; Spinal Fractures
Study type: Interventional

Summary: 
      Brittle bone disease also known as osteogenesis imperfecta (OI) is characterised by a defect
      in the bone tissue that leads to recurrent fractures and significant bone deformities in
      children. These fractures include vertebral (spinal) fractures. As a result, child with OI
      require regular clinic surveillance that includes repeated xrays of the spine. in our pilot
      study the investigators plan to use a thermal imaging camera that can pick up changes in
      temperature to 0.03 degrees to determine whether the investigators can accurately identify
      vertebral fractures without the need for radiation. in the first part of the study the
      investigators will compare the thermal images from the camera with the xrays to see if the
      investigators can pick up the vertebral fractures seen on the xray picture. If this is
      possible, then the investigators will move on to phase 2 of the study which will investigate
      the ability of the thermal camera to pick up vertebral fractures without prior knowledge of
      where the fractures are located. If this approach is successful this will help us to develop
      a nonradiation, lowcost painless way of identifying vertebral fractures in children with OI.
    


Intervention name(s): Thermal imaging device
Intervention type(s): Device
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic