bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of single and
      multiple intravenous infusions of E2814 in healthy adult participants.
    

Detailed description: 
      The study is comprised of two components: a single ascending dose (SAD) component and a
      multiple ascending dose (MAD) component. The SAD component consists of 5 sequential cohorts
      and in each cohort, 8 healthy participants are randomized (3:1) to receive a single dose of
      E2814 or E2814-matched placebo. The MAD component of the study consists of 4 sequential
      cohorts and in each cohort, 8 healthy participants are randomized (3:1) to receive E2814 or
      E2814-matched placebo every 4 weeks (Q4W) on 3 occasions.
    

Intervention name(s): E2814; E2814-matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2814, intravenous infusion.; E2814-matched placebo, intravenous infusion.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: E2814; Healthy Participants; Phase 1; Pharmacokinetics; Pharmacodynamics; Immunogenicity
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Condition: Dyspepsia; Chronic Gastritis
MeSH terms: Gastritis; Gastritis, Atrophic; Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      To study the anti free radical & inflammatory effect and safety of Rebamipide in patients
      suffering of dyspepsia due to chronic gastritis.
    


Intervention name(s): Rebamipide
Intervention type(s): Drug
Intervention description(s): Rebamipide 100 mg tid for 28 days
Intervention MeSH terms: Rebamipide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patients suffering of dyspepsia due to chronic gastritis
Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics of BTDS following same-site
      patch reapplication after rest intervals.
    

Detailed description: 
      The purpose of this study is to determine the minimum application site rest period that
      ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result
      in increased absorption of drug in normal healthy subjects.
    

Intervention name(s): Buprenorphine transdermal patch
Intervention type(s): Drug
Intervention description(s): Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Other intervention name(s): Butrans™
Intervention MeSH terms: Buprenorphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid; Transdermal
Trabeculectomy With Subconjunctival Bevacizumab Injection
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the safety and efficacy of bevacizumab as an
      adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this
      new drug to the most commonly used anti-scarring agent, mitomycin C.
    

Detailed description: 
      The most common surgical technique for controlling the intraocular pressure in glaucoma
      patients is trabeculectomy.In this surgery, internal cavity of the eye is connected by a
      fistula like openings to subconjunctival space. The main cause of failure in trabeculectomy
      is excessive postoperative conjunctival scarring at the site of fistula, which is related to
      severity of conjunctival vascularization, tortuousity of vessel, and fibroblast migration and
      proliferation. At the time of surgery most surgeons use mitomycin C, which is an antimitotic
      and antifibrotic agent, to improve the results of the procedure. Although this agent is very
      effective, but is not without complication. The most significant and sight threatening
      complications are low intraocular pressure and endophthalmitis. Therefore investigations are
      going on to find a much safer and effective agents. Bevacizumab is a monoclonal antibody
      against vascular endothelial factor (VEGF). VEGF is an important vasculogenic and fibrogenic
      factor with a prominent role in wound healing.Bevacizumab is widely used in ophthalmology and
      has a promising effect in treatment of neovascularization in conjunctiva, cornea and retina.
      There are limited animal and human case series regarding the effect of this agent in
      trabeculectomy. In this study the investigators are trying, in addition to evaluating the
      efficacy and safety of this agent in result of trabeculectomy, compare this agent with
      mitomycin C.
    

Intervention name(s): Trabeculectomy
Intervention type(s): Procedure
Intervention description(s): Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intraocular pressure; Trabeculectomy; Mitomycin C; Bevacizumab
A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study investigated the bioequivalence between the new and the approved formulation for
      levothyroxine.
    


Intervention name(s): Reference Eutirox®; Test Eutirox®
Intervention type(s): Drug; Drug
Intervention description(s): Participants received single oral dose of Reference Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment period 1 or 2.; Participants received single oral dose of Test Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment 1 or 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Eutirox; Levothyroxine
ENB-GS-TBLB for the Diagnosis of PPLs
Condition: Lung Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of electromagnetic
      navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary
      lesions (PPLs) .
    

Detailed description: 
      The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and
      bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath
      (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic
      fluoroscopy.The study is designed as a two-center prospective randomized controlled trial.
      The participating centers are Department of pulmonary medicine and endoscope department,
      Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of
      pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University,
      China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray
      group.Each subject will be randomized to each group.The study is expected to enroll 60
      patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).
    

Intervention name(s): ENB; GS-TBLB-X-ray
Intervention type(s): Procedure; Procedure
Intervention description(s): ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.; A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Electromagnetic navigation bronchoscopy with a guide sheath; Transbronchial lung biopsy; Peripheral lung lesions; Solitary pulmonary nodule
Treating the Endothelium to Restore Insulin Sensitivity
Condition: Obesity; Insulin Resistance; Impaired Glucose Tolerance; Pre-diabetes
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      A study of 12 weeks' treatment with losartan or placebo, to test the hypothesis that RAS
      inhibition will improve insulin' vascular actions and therefore improve insulin sensitivity
      in skeletal muscle.
    

Detailed description: 
      Recent studies suggesting an effect of cardiovascular therapies to prevent diabetes remain
      unexplained. We hypothesize that these therapies improve vascular endothelial function
      allowing improved actions of insulin in the vasculature, which comprise a significant portion
      of insulin's metabolic action. We therefore propose to measure insulin-mediated glucose
      disposal and insulin-mediated vasodilation before and after 12 weeks' therapy with Losartan
      (an angiotensin receptor blocker) or placebo, in a randomized design. Subjects will include
      28 subjects with impaired glucose tolerance, which is generally accompanied by both insulin
      resistance and impaired vascular function. With this number of participants we have a 90%
      chance of showing a statistically significant and clinically meaningful effect of insulin on
      leg vascular resistance, and an even higher chance of showing a difference in insulin's
      metabolic effects. Exclusion criteria will include frank hypertension, diabetes, or
      hypercholesterolemia, and biochemical or other contraindications to losartan therapy. The
      primary endpoint for statistical analysis will be the invasive measure of insulin-stimulated
      endothelial function. We anticipate an improvement in both vascular and metabolic measures of
      insulin action following Losartan therapy but no change from untreated baseline following
      placebo.
    

Intervention name(s): Losartan
Intervention type(s): Drug
Intervention description(s): Tablet, 100mg, once per day for 3 months
Intervention MeSH terms: Losartan
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Insulin resistance; Impaired glucose tolerance; pre-diabetes
Yoga for Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic low back pain is the most common cause of pain in the United States. Common
      treatments such as medication, physical therapy, and surgery often do not provide adequate
      relief. Yoga has shown promise for improving low back pain in studies of predominantly middle
      class white individuals. We will assess the feasibility and collect preliminary data on yoga
      for chronic low back pain in predominantly minority individuals in a community health center
      setting in a low income neighborhood of Boston, Massachusetts. We hypothesize that offering
      yoga for this population is feasible and will show promising efficacy and safety data.
    

Detailed description: 
      Promising therapies for chronic low back pain such as yoga need to be studied because
      conventional treatments such as medication, physical therapy, and surgery frequently do not
      provide lasting relief. We will use a standardized yoga protocol, developed specifically for
      this trial by a consensus panel of yoga experts, in a pilot randomized controlled trial for
      subjects with chronic low back pain. We will recruit 30 predominantly English-speaking
      minority adults from Boston Medical Center (BMC) and its affiliated clinics with low back
      pain lasting >12 weeks and an average pain level in the previous week of 4 or more on a scale
      of 0 to 10 (0 = no pain, 10 = worst possible pain). Subjects will be randomized to a yoga
      class once per week for 12 weeks (Group 1) or a wait-list control group (Group 2). All
      subjects will receive their usual medical care and an educational booklet designed for low
      back pain patients. Primary outcomes are 12 week pain intensity and functional status
      measured by the Roland Morris Disability scale. Secondary outcomes include analgesic use,
      health-related quality of life (SF-36), global improvement, subject satisfaction, adverse
      events, compliance, work status, and health expenditures. Group 2 will be offered yoga
      classes at 26 weeks. To refine estimates of effect size and further confirm safety of the
      protocol, we will also collect data from Group 2 during their yoga classes. This pilot will
      provide preliminary feasibility and efficacy data to plan a future adequately powered
      randomized controlled trial of yoga for chronic low back pain in predominantly minority
      subjects.
    

Intervention name(s): Yoga Group
Intervention type(s): Behavioral
Intervention description(s): Reproducible standardized 12 week series of hatha yoga classes specifically developed for patients with chronic low back pain and little or no experience with yoga
Other intervention name(s): Hatha yoga classes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: yoga; complementary alternative medicine; low back pain; minority health; health care disparities; community health centers
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
Condition: ADHD; Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to
      evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a
      manipulated commercially-available d-amphetamine sulfate IR formulation administered
      intranasally in non-dependent recreational stimulant users. The study is comprised of 4
      phases: Screening, Qualification, Treatment, and Follow-up/Early Termination.
    

Detailed description: 
      VAL-103 is a phase 1, pilot, randomized, double-blind, active-controlled, 2-treatment
      crossover study. The study objectives include assessing the safety, pharmacokinetics (PK),
      and pharmacodynamics (PD) of manipulated ADAIR 30 mg compared to crushed d-amphetamine
      sulfate IR 30 mg (DEX) administered IN in non-dependent recreational stimulant users. The
      primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog
      scale.

      A total of 16 qualified subjects demonstrating a confirmed positive response to stimulants
      will enter the treatment phase. Safety will be assessed via adverse events, vital signs,
      ECGs, clinical laboratory tests, and Columbia Suicide Severity Rating Scale (C-SSRS).
    

Intervention name(s): ADAIR 10mg IR capsules; Crushed d-amphetamine sulfate IR tablets
Intervention type(s): Drug; Drug
Intervention description(s): manipulated ADAIR IR 3x10 mg capsules; crushed d-amphetamine sulfate IR 6 x 5 mg tablets
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      Given the urgency of having guidelines for the management of COVID-19 in the current epidemic
      context and the lack of specific pharmacological treatment, Military Health recommends the
      launch of a multicenter, randomized, double-blind, interventional clinical trial.

      The aim of this study is to evaluate the efficacy of a combination of two treatments,
      low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary
      prevention of COVID-19 infection in health care professionals in Tunisia compared to two
      control groups.
    


Intervention name(s): Doxycyclin
Intervention type(s): Drug
Intervention description(s): daily (100mg)
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants who meeting study entry criteria will be randomized in a 1:1 blinded comparison of daily low dose DOXY versus oral placebo for 6 weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the pharmacodynamics (course of the blood
      glucose-lowering effect and duration of effect) and pharmacokinetics (course of the
      concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg
      of insulin glulisine and insulin aspart in a direct head-to-head comparison during two
      euglycemic glucose clamps in healthy subjects.
    

Detailed description: 
      In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and
      insulin lispro it was shown that the onset of metabolic action was significantly shorter with
      insulin glulisine than with insulin lispro (while the total metabolic effect was not
      different). These results were in line with a faster early insulin exposure of insulin
      glulisine compared to insulin lispro. The primary aim of this study was to investigate
      whether or not these favorable characteristics of insulin glulisine were also evident in the
      comparison against insulin aspart. This was the first clinical study realizing a head-to-head
      comparison between these two insulin analogs.
    

Intervention name(s): insulin glulisine, insulin aspart; insulin aspart, insulin glulisine
Intervention type(s): Drug; Drug
Intervention description(s): single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during second euglycemic glucose clamp; single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during second euglycemic glucose clamp
Other intervention name(s): Apidra; NovoRapid; NovoRapid; Apidra
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: diabetes
Home Exercise Intervention in Childhood Obesity
Condition: Child Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Aim: To evaluate the impact of a physical exercise Web-based program with or without support
      on body composition, physical fitness and blood pressure values.

      Design: Randomized Controlled Trial. Population: Obese children and adolescents.
    

Detailed description: 
      In recent years there has been a decline in levels of physical activity (PA) in both children
      and adults. The promotion of PA is also a key element in the treatment of obesity, along with
      changing eating habits, but usually has very low levels of adherence. Active video games may
      be an alternative for the promotion of PA in the treatment of obesity.

      The objective of this project is to evaluate the impact of a physical exercise Web-based
      program with or without support on Body Composition, Physical Fitness and Blood Pressure
      values.
    

Intervention name(s): Web-based intervention with support; Web-based intervention without support; Traditional intervention
Intervention type(s): Other; Other; Other
Intervention description(s): Web-based combined aerobics and muscular strength exercises.; Web-based combined aerobics and muscular strength exercises.; 3 months of Printed-based combined aerobics and muscular strength exercise intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Web-based intervention
Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This 2-part study will assess the effect of formulation and food on the pharmacokinetics of
      Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of
      indoximod salt formulation to characterize the PK profile and determine the safety and
      tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized,
      3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or
      salt formulation, in the fasted or fed state.
    


Intervention name(s): Indoximod HCL (F2) tablets; Indoximod base formulation; Placebo; Indoximod HCL (F2) tablets
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): The doses will be ascending per cohort from 600 mg to 2400 mg; Single oral administration of 1200 mg; The matching placebo doses will be ascending per cohort from 1 to 4 tablets; Single oral administration of 1200 mg
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Indoximod