bioihbjkbjnl/mcl2 huggingface dataset:
AIDS Wasting in Women: Anabolic Effects of Testosterone
Condition: AIDS Wasting Syndrome
MeSH terms: HIV Wasting Syndrome; Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a 6 month, placebo-controlled study of transdermal testosterone for women with
      HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone
      levels. This study is designed to test the efficacy of physiologic testosterone dosing to
      improve weight, muscle mass and quality of life indices, including energy level, appetite and
      libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open
      label transdermal testosterone for an additional 6 months.
    


Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIDS; HIV; weight loss; Wasting Syndrome; testosterone; androgen levels; hormones
Effect of Dose of Buglossoides Oil on EPA Accrual and on the Inflammatory Response
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of various doses of Buglossoides oil on the accrual of eicosapentaenoic acid (EPA)
      in blood and circulating cells will be investigated.
    


Intervention name(s): Buglossoides oil; High Oleic Sunflower Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Ahiflower; HOSO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Buglossoides arvensis; vegetable oil; omega-3 fatty acids; participants
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
Condition: Small Bowel Disease
MeSH terms: Intestinal Diseases
Study type: Observational [Patient Registry]

Summary: 
      The objective of the SAMISEN study is to assess the performance and safety of diagnostic and
      therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope
      (PowerSpiral).
    

Detailed description: 
      The main objective of this registry is to collect data on the safety and performance of the
      new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that
      the new device and its safety profile is non-inferior to preceding generations of balloon
      assisted enteroscopes.

      As clinical performance and efficacy is equally important for the user this study also
      collects efficacy and handling data of the new device.
    

Intervention name(s): Deep enteroscopy
Intervention type(s): Device
Intervention description(s): A deep enteroscopy conducted with the new medical device PowerSpiral.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with an indication for direct visualization of the small bowel which fulfil all of
        these inclusion and exclusion criteria.
Diagnostic Ultrasound for Measuring Fat of the Body
Condition: Subcutaneous Fat
Study type: Interventional

Summary: 
      The purpose of this study is to provide information about human subcutaneous fat thickness at
      different anatomic sites on the body by measuring these thicknesses with a diagnostic
      ultrasound and also by correlating patient perceptions of body image with measured fat
      distribution.

      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion
      criteria will be considered for enrollment.
    


Intervention name(s): LOGIQ P6 Diagnostic Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Ultrasound measurements of subcutaneous fat thickness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the immune response to the proposed biosimilar PF-06881894 and the
      US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6
      milligrams [mg]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1
      of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose
      assessments of immunogenicity will be conducted each of the two treatment periods. In
      addition, safety assessments will be conducted throughout the study.
    


Intervention name(s): PF-06881894; US-approved Neulasta
Intervention type(s): Biological; Biological
Intervention description(s): pre-filled syringe 6 mg; pre-filled syringe 6 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets
      (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single
      tablets (10 mg empagliflozin and Glifage® 850 mg tablets) (Reference, R).
    


Intervention name(s): FDC 12.5mg empagliflozin/850mg metformin; Empagliflozin; Glifage®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): empagliflozin/metformin; empagliflozin 10mg (R1); Glifage® 850mg (R2)
Other intervention name(s): metformin
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage®
      Long Merck )
    

Detailed description: 
      Study to evaluate the bioequivalence of orally administered metformin preparations, Extended
      release tablets, 750 mg in normal healthy subjects under fasting and fed conditions
    

Intervention name(s): Metformine; Glucophage® Long; Metformin; Glucophage® Long
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): First aIntervention Period:
Single administered dose of Metformin (750 mg tablet extended-release) in a fasting condition; Second Intervention Period:
Single administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition; Third Intervention Period:
Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition; Fourth Intervention Period:
Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition
Other intervention name(s): fasting condition; fasting condition; fed condition; fed condition
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: four-way crossover
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AUC; Cmax; Pharmacokinetics; metformin; fed; fasting
A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease
Condition: Asthma; Pulmonary Disease, Chronic Obstructive
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the clinical, physiologic, and molecular
      profiles of healthy participants, participants with mild, moderate, and severe asthma; and
      participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
    

Detailed description: 
      This is a multi-center, longitudinal (participants are followed over long period of time with
      continuous or repeated observations of health outcomes) exploratory study (biomarkers,
      clinical and physiological parameters for participants with asthma and COPD are observed for
      the first time). This study will be conducted in 2 parts. Part 1 will include healthy
      participants and participants with mild, moderate, and severe asthma. Part 2 will include
      healthy nonsmokers, healthy asymptomatic smokers, and participants with moderate and or
      severe COPD. Study participants will undergo medical tests that will include pulmonary
      function testing, assessment of airway reactivity, bronchoscopy procedure, blood samples for
      routine laboratory tests, biomarkers and DNA evaluation (for some study participants),
      induced sputum collection, and exhaled nitric oxide collection. Safety evaluations will
      includes assessment of adverse events, clinical laboratory tests, 12-lead electrocardiogram,
      vital signs, and physical examinations.
    

Intervention name(s): Medical tests
Intervention type(s): Other
Intervention description(s): All participants will undergo medical tests and will be observed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma; Pulmonary Disease, Chronic Obstructive; Healthy; Longitudinal Study; Bronchoscopy
Varied Practice on LAPSIM
Condition: Skilss Acquisition for Virtual Reality Laparoscopic Training
Study type: Interventional

Summary: 
      To investigate whether training using a random selection of exercises on a laparoscopic
      virtual reality simulator results in a stronger retention of skills when using a
      proficiency-based training program compared to conventional self-directed training.
    


Intervention name(s): Random selection of excercises
Intervention type(s): Other
Intervention description(s): Participants in the intervention group will train using a random selection of excercises and complete the profiency-based traning program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device
Condition: Hypertension; Pregnancy; Pre Eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia; Hypertension
Study type: Interventional

Summary: 
      The aim of the PRAM study was to determine whether women diagnosed with hypertension in
      pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood
      pressure is measured by either an automated device or a mercury device throughout the
      pregnancy.
    


Intervention name(s): Automated blood pressure recording device Omron HEM 705CP
Intervention type(s): Device
Intervention description(s): All subsequent blood pressure recordings done using the automated device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: pregnancy; hypertension; mercury sphygmomanometry; blood pressure; automated blood pressure; pre eclampsia; Hypertension in pregnancy
Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral
      administration in healthy Korean, Caucasian and Japanese adult volunteers
    

Detailed description: 
      This is a dose block-randomized, double-blind, placebo-controlled, single and multiple
      ascending dose study to assess the safety, tolerability and PK/PD profile by administering
      investigational product (IP) as a single dose (One time) or repeated doses (7 days, once a
      day) orally in a fasted state.
    

Intervention name(s): Study drug; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg; oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets
Other intervention name(s): JW1601
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Faecal Bacteriotherapy for Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories
      of UC pathogenesis represents a pathological response of mucosal immunity to intestinal
      microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota
      transplantation (FMT). Review of the literature on FMT suggests great potential as the
      treatment for UC, but two prospective controlled study that has been published yet are
      inconsistent.

      The first objective of the project is to compare the administration of FMT enema with
      mesalazine enema for inducing remission in patients with active left-sided UC in the form of
      a prospective, randomized, controlled study. The second objective is to observe changes in
      the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to
      identify the bacterial species which are responsible for the effect of the FMT.
    


Intervention name(s): Faecal bacterial transplantation; Mesalazine 4G Enema
Intervention type(s): Other; Drug
Intervention description(s): Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline; Standard mesalazine enema
Other intervention name(s): FMT
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Feacal bacterial transplantation; Left-sided ulcerative colitis
Effect of Electrical Stimulation at Acupoints on Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if electrical stimulation on acupoints has any effect on hypertensive subjects.
    

Detailed description: 
      All subjects will be assigned into control and experimental groups by a random table. The
      first 40 numbers in the first row will be used for the study. Subjects assigned with an odd
      number will be divided into the control group.

      ROLE OF SUBJECTS Subjects in the experimental will receive Hans treatment for hypertension.
      No invasive procedures will be used for subjects in either the control and experimental
      groups.

      This randomized controlled study will recruit hypertensive subjects into control and
      experimental groups using a random table. Only the subjects in the experimental group use
      Hans stimulation as a treatment for high blood pressure. The treatment regiment is discussed
      in the Treatment section in detail. The subjects in the control group will not
    

Intervention name(s): Hans unit
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; Hans; Electrical stimulation
Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the clinical effect of TV-1106.
    


Intervention name(s): TV-1106; Recombinant human growth hormone
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous once daily
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone deficiency; Insulin-like growth factor I (IGF-I); TV-1106
Prospective Pellevé™ Neck Wrinkle Study
Condition: Facial and Neck Rhytides
Study type: Interventional

Summary: 
      Use of RF device to treat wrinkles of the neck
    

Detailed description: 
      This is a prospective study evaluating the safety and efficacy of two treatments, spaced at
      30 day intervals, using the Surgitron® Dual RF™ S5 with the Pellevé™ wrinkle treatment
      handpiece and Pellevé™ treatment gel for the treatment of neck wrinkles.
    

Intervention name(s): Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator
Intervention type(s): Device
Intervention description(s): two treatments spaced 30 days apart
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wrinkles; rhytides
Self-estimates and Objective Blood Alcohol Concentration in Emergency Department
Condition: Alcohol Use Disorder; Blood Alcohol Content
MeSH terms: Emergencies; Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      Many patients presenting in Emergency Department (ED) present alcohol acute intoxication.
      Some previous studies in general population found that young people under- or over-estimated
      of blood alcohol concentration (BAC). The hypothesis of the study is that self-estimation of
      BAC by the patient is under-estimated. Moreover, comparing self-estimation of BAC and
      objective measure of BAC, which is routinely performed in ED, could increase in patients the
      awareness of the disorders, increase motivation to change of the patient, and increase the
      rates of seeking-treatment six months after the first evaluation, in particular in patients
      with alcohol use disorders.

      To the investigators knowledge, there is no study investigating self-estimation, compared to
      objective measurement of blood alcohol concentration in patients with alcohol intoxication
      presenting to an Emergency Department (ED). The study will assess blood alcohol concentration
      and self-estimates of BAC, using the Subjective Effects of Alcohol Scale for Measuring
      Subjective Response to Alcohol in 100 patients with or without alcohol use disorders
      according to DSM-5 classification (using MINI scale and Alcohol Use Disorders Identification
      Test (AUDIT)
    


Intervention name(s): blood alcohol concentration withdrawal
Intervention type(s): Biological
Intervention description(s): The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: blood alcohol concentration; Emergency Department; Alcohol use disorders
Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety and impact of ivermectin, administered
      as single or repeated dose, in combination with artemether-lumefantrine in reducing the
      proportion of mosquitoes that survive and become infected after feeding on a blood meal from
      a malaria-infected individual.
    


Intervention name(s): Artemether-lumefantrine combination; Artemether-lumefantrine combination + single dose Ivermectin; Artemether-lumefantrine combination + repeated dose Ivermectin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL; Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given once together with the first dose of AL. A placebo is given together with the fifth dose of AL.; Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
Intervention MeSH terms: Ivermectin; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transmission; anopheles
The Regulation of Osteoprotegerin by Mechanical Stimulation
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional
Phase: Phase 1

Summary: 
      To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone
      samples will be collected from partially impacted third molars after orthodontic uprighting
      for different period of time in volunteers. In situ hybridization and immunohistochemistry
      analysis for OPG and RANKL will reveal their roles in this physiological process.
    

Detailed description: 
      Long treatment time is a major factor causing high fee for orthodontic treatment. Patients
      would have dental caries or periodontitis resulted from improper oral hygiene care during
      this long treatment period. Therefore, how to speed up the tooth movement which determines
      the duration of orthodontic treatment, can help more people to obtain good occlusion and
      esthetics. Orthodontic force on tooth induces bone resorption on the compression side and
      bone deposition on the tension side, thus bone remodels and then tooth moves. Bone resorption
      is a complex process. Osteoblasts play an important role during initiation of bone
      resorption.

      Changes OPG expression of osteoblasts under mechanical stimulation can play a role in bone
      remodeling. In order to test this hypothesis, the following specific aims will be achieved:

        1. To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone
           samples will be collected from partially impacted third molars after orthodontic
           uprighting for different period of time in volunteers. In situ hybridization and
           immunohistochemistry analysis for OPG and RANKL will reveal their roles in this
           physiological process.

        2. To optimize the regulation by changing magnitude and frequency of pressure, and
           characterize the time table for these changes..
    

Intervention name(s): orthodontic treatment
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: orthodontic tooth movement; OPG; RANKL