bioihbjkbjnl/mcl2 huggingface dataset:
Altered Drug Disposition and Biomarkers for Diagnosis of Chronic Inflammatory Liver Disease
Condition: Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD).
      NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people
      have this disease, the change in how the liver handles drugs and compounds in the body has
      not been studied. The purpose of this study is to investigate how advanced NAFLD changes the
      ability of the liver to handle both endogenous and exogenous compounds.
    


Intervention name(s): High fat meal; Morphine
Intervention type(s): Other; Drug
Intervention description(s): A high fat breakfast will be administered to induce gall bladder emptying.; Five milligrams of intravenous morphine will be administered.
Intervention MeSH terms: Morphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Bile acids; Pharmacokinetics
Intensive Glycemic Control and Skeletal Health Study
Condition: Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus; Coronary Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Coronary Disease; Diabetes Mellitus; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic
      control for type 2 diabetes (in ACCORD participants) on factors related to bone health,
      including, fractures, falls, and bone mineral density.
    

Detailed description: 
      Recent studies have established that type 2 diabetes is a risk factor for fractures,
      particularly of the hip, shoulder and foot. Additionally, type 2 diabetes is associated with
      a 50-60% increase in the risk of falling. The higher risk of fracture associated with type 2
      diabetes is an important health burden for these patients. More frequent falls and perhaps
      reduced bone strength in those with diabetes are thought to be key contributing factors. The
      best approach to preventing fractures in type 2 diabetes is not yet understood. There is
      observational evidence to support our hypothesis that better glycemic control will preserve
      bone and reduce falls and fractures. The ACCORD-BONE study provides a unique opportunity to
      determine whether intensive glycemic control will prevent fractures, falls, and bone loss in
      older diabetic adults, which may lead to improved treatment and prevention in the future.
    

Intervention name(s): hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
Intervention type(s): Drug
Intervention description(s): type 2 diabetes treatments, per standard of care
Intervention MeSH terms: Hypoglycemic Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Diabetes Mellitus; Fracture; Falls; Height Loss
Reference Nurse Program for Pressure Ulcers in Primary Care
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care
      in health centers. The chronic wound care by skilled personnel is key to healing and
      management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC)
      can improve the effectiveness of interventions and cost savings.

      Objective: To evaluate the effectiveness and costs reduction after the implementation in PC
      setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses
      for the management of PU in patients in home care setting.

      Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza
      will be randomly assigned to two parallel groups: experimental group and control group. Each
      nurse will recruit at least 1 new patient in home care with PU in stage II-III. The
      intervention will consist of a telematic advice from the reference nurse regarding chronic
      wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a
      minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of
      the intervention, multilevel models or linear mixed models to take into account the
      auto-correlation at the individual level and nurse, will be used
    


Intervention name(s): Tele-assistance; Active comparator
Intervention type(s): Procedure; Procedure
Intervention description(s): Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application; Usual care as specified in the PU practice guideline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel
      group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and
      immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma
      on standard of care (SOC). Up to approximately 80 sites globally will participate in this
      study.

      Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to
      receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.
    


Intervention name(s): MEDI3506; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2; Participants will receive multiple doses of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI3506; lung function; IL-33; inflammation
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in
      Japan. The objective of the study was to compare the efficacy and safety of cetirizine
      hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial
      allergic rhinitis.
    


Intervention name(s): Ketotifen; Cetirizine
Intervention type(s): Drug; Drug
Intervention description(s): Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks; Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
Intervention MeSH terms: Cetirizine; Ketotifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cetirizine; Zyrtec
Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea; Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional

Summary: 
      The aim of the present study is to compare the effects of different types of antihypertensive
      drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients
      with hypertension and obstructive sleep apnea who are not controlled well with their
      hypertension after continuous positive airway pressure therapy.
    

Detailed description: 
      Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both
      disorders are well known risk factors for cardiovascular diseases (CVD). Treating them
      appropriately may improve the prognosis of the patients. Presently, continuous positive
      airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor
      blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in
      the present study, we wanted to compare the effects of these different types of
      antihypertensive drugs on the control of blood pressure in patients with OSA whose
      hypertension is not controlled well after CPAP therapy.
    

Intervention name(s): Olmesartan and Azelnidipine
Intervention type(s): Drug
Intervention description(s): Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months
Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months
Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months
Other intervention name(s): Olmesartan (angiotensin II receptor blockers: ARB); Azelnidipine (long-acting calcium channel blockers: CCB)
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; Calcium Channel Blockers; Angiotensin II; Angiotensin Receptor Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous positive pressure ventilation; Blood pressure; Oxygen desaturation index; Endothelial dysfunction; Patient reported measurement
Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy
Condition: Gastritis; Functional Dyspepsia
MeSH terms: Gastritis; Dyspepsia
Study type: Interventional

Summary: 
      This trial aims to compare the endomicroscopic image quality and sedation efficacy of
      propofol or midazolam with fentanyl.
    


Intervention name(s): propofol; midazolam with fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): conscious sedation using propofol; conscious sedation using midazolam with fentanyl
Intervention MeSH terms: Midazolam; Fentanyl; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: normal
Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Vitamin D Deficiency
MeSH terms: Arthritis; Arthritis, Rheumatoid; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of vitamin D repletion on disease
      activity and disability in patients with rheumatoid arthritis.

      The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D
      deficiency have greater disease activity and disability, compared to RA patients with normal
      vitamin D levels. The investigators also hypothesize that vitamin D treatment in these
      deficient patients will result in a decrease in RA disease activity and disability.
    


Intervention name(s): Placebo sugar pill; Ergocalciferol
Intervention type(s): Drug; Drug
Intervention description(s): Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.; Ergocalciferol 50,000 IU per week for 16 weeks
Other intervention name(s): Placebo; Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Vitamin D deficiency; Disability
The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and
      PK of single ascending doses of inhaled TLC19 in healthy volunteer subjects.
    

Detailed description: 
      A Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability,
      and PK of single ascending doses of inhaled TLC19 (Hydroxychloroquine Liposome Inhalation
      Suspension) in healthy volunteer subjects. Three dose levels will be assessed in sequential
      cohorts, with 2 mL, 4 mL, and 6 mL. Total of approximately 30 subjects will be randomized in
      the study in 3 cohorts. Subjects will be enrolled and randomized to receiving either TLC19 or
      TLC 19 Vehicle.

      Drug Administration: Blinded study medication will be administered through inhalation via a
      portable vibration mesh nebulizer.
    

Intervention name(s): TLC19; TLC19 Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Hydroxychloroquine Liposome Inhalation Suspension; Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)
Other intervention name(s): TLC19 (Hydroxychloroquine Liposome Inhalation Suspension); TLC19 Vehicle (same formulation as TLC19 but without the active ingredient)
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hydroxychloroquine; Inhalation
Turkish Version of Revised Neurophysiology of Pain Questionnaire
Condition: Chronic Low-back Pain; Neck Pain
MeSH terms: Back Pain; Low Back Pain; Neck Pain
Study type: Observational [Patient Registry]

Summary: 
      The Neurophysiology of Pain Questionnaire was first developed in English to test whether
      healthcare staff and patients could exactly understand pain neurophysiology. This
      questionnaire which contains 19 items was developed from the exam questions of students
      interested in post-graduate pain medicine. Catley et al. (2013) investigated the psychometric
      properties of the modified Neurophysiology of Pain Questionnaire with a few word differences
      from the original version by conducting a rash analysis on 300 patients with chronic spinal
      pain. Acceptable internal consistency and test-retest reliability of the questionnaire were
      recorded. However, it was stated that 7 items negatively affect psychometric properties of
      the questionnaire. As a result, the author concluded that the questionnaire had sufficient
      psychometric properties for use in chronic spinal pain subjects, but further studies were
      needed. The Neurophysiology of Pain Questionnaire was used to measure a knowledge about pain
      in different studies. The validity and reliability studies of the Dutch, French and Brazlian
      Portuguese versions of the Neurophysiology of Pain Questionnaire were conducted in the
      literature. The aim of our study was to translate the Revised Neurophysiology of Pain
      Questionnaire into Turkish language and to investigate its psychometric properties.
    


Intervention name(s): Evaluation
Intervention type(s): Other
Intervention description(s): The Turkish version of the Revised Neurophysiology of Pain Questionnaire will be applied to patients with chronic spinal pain at the beginning of the study and a week later. The Visual Analogue Scale and the Short Form-36 (SF-36) questionnaire will be applied to patients only at the beginning of the stuy.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic spinal pain
      
Keywords: neurophysiology pain questionnaire; reliability; validity; pain; low back pain
A Study to Compare the Relative Bioavailability of Two Different Formulations of GSK3640254
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first time in human (FTIH), 2-period study, to assess the relative bioavailability
      of a mesylate salt capsule of GSK3640254, compared to a bis- hydrochloride salt capsule of
      GSK3640254, in healthy subjects, administered following a moderate calorie and fat meal. The
      subjects will be randomized to 2 sequences, Regimen AB or Regimen BA. For Regimen AB: The
      Regimen A, which will include oral administration of GSK3640254 bis-hydrochloride Capsule 200
      milligram (mg) (reference), which will be administered, in Period 1 and Regimen B will
      include GSK3640254 Mesylate salt capsule (test), 200 mg, which will be administered in Period
      2. For the regimen BA, the regimen B, will be administered, in Period 1 and regimen A, in
      Period 2. Each of the regimens will be given orally as 2 capsules in the morning, as per
      randomization sequence. There will be a minimum washout of 7 days between each dose of study
      treatment. A total, of 14 subjects, are planned to be enrolled in the study. The maximum
      duration of the study from screening to follow-up is approximately 7 weeks.
    


Intervention name(s): GSK3640254 bis-hydrochloride salt capsule; GSK3640254 Mesylate Salt Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally (as single dose) on morning of Day 1, as 2 capsules of 100 mg following a moderate calorie and fat meal during Period 1 and Period 2, at the specified sequence, as per study.; Administered orally (as single dose) on morning of Day 1, as 2 capsules of , 100 mg following a moderate calorie and fat meal during Period 1 and Period 2, at the specified sequence, as per study.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will receive GSK3640254 bis-hydrochloride salt capsule followed by mesylate salt capsule or vice versa in two treatment periods.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 2-period; Pharmacokinetics; FTIH; GSK3640254; healthy subject; bioavailability
Magnetic Stimulation Therapy for Treating Vascular Depression
Condition: Depressive Disorder; Depression
MeSH terms: Vascular Depression; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic
      stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of
      depression associated with small vascular lesions in the brain (vascular depression).
    

Detailed description: 
      Vascular depression is a condition that typically affects the elderly and is associated with
      small vascular lesions. It is more resistant to treatment and has a poorer outcome than
      nonvascular depression. By altering excitability in the cortical area of the brain, rTMS may
      be an effective treatment neuropsychiatric conditions, particularly depression.

      Participants in this study will be randomly assigned to 15 treatments of either rTMS or sham
      rTMS for 3 weeks. Following treatment, participants will receive citalopram for 9 weeks.
      Response rates to treatment; relapse rates; the size, number, and location of the vascular
      lesions; and the amount of regional brain atrophy will be measured. Improvements in
      activities of daily living, quality of life, and cognitive function will also be also
      measured.
    

Intervention name(s): Repetitive transcranial magnetic stimulation (rTMS); Citalopram; Sham rTMS
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Participants will receive 15 treatments of rTMS over 3 weeks.; After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.; Participants will receive 15 treatments of sham rTMS over 3 weeks.
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aged
A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the
      Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following
      Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers
    


Intervention name(s): MIV-711
Intervention type(s): Drug
Intervention description(s): MIV-711 administered as tablets and capsules at four occasions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, randomized, double-blinded, two-center trial to evaluate the
      gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T
      gel alone, for 28 days.
    

Detailed description: 
      A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment
      groups. A description of each group is as follows:

        -  Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg
           T) applied each day on the arms and shoulders

        -  Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied
           each day to the arms and shoulders

      The total duration of treatment will be 28 days followed by a 72 hour sampling period to
      assess half-life and a recovery period of at least 28 days, at which point the subjects will
      return to the clinic for an end of study visit.
    

Intervention name(s): Nestorone® /testosterone gel; Testosterone only gel
Intervention type(s): Drug; Drug
Intervention description(s): Nestorone® /testosterone combined gel; Testosterone only gel
Other intervention name(s): Androgel
Intervention MeSH terms: Methyltestosterone; ST 1435; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: spermatogenesis; androgen; male contraception
RCT to Examine the Effects of Scanning
Condition: Cancer; Breast Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of the study is to implement a randomized control trial testing effects of
      information scanning on cancer prevention and screening behaviors in a population sample of
      50-70 year olds. Participants will receive one of five versions of an e-newsletter once/month
      for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.
    


Intervention name(s): Health Newsletter
Intervention type(s): Behavioral
Intervention description(s): Participants received a health newsletter with articles about general health articles, as well as targeted health articles (differs by condition).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Exercise; Nutrition; Mammography; Colorectal screening