bioihbjkbjnl/mcl2 huggingface dataset:
MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction
Condition: Acute Coronary Syndrome; ST Segment Elevation Myocardial Infarction; Stent
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter
      clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be
      followed for 5 years.

      All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to

        -  Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or

        -  Biotronik ORSIRO Sirolimus Eluting Coronary Stent System

      Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months
      angiographic follow-up (Primary endpoint).

      In a subgroup of 40 patients Optical Coherence Tomography will be performed after the
      procedure and at 12 months follow-up.

      Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months
      follow-up) will be analyzed off-line by an independent core lab.
    


Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Device
Intervention description(s): PCI + stent implantation
Other intervention name(s): stent implantation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomised to one of two groups:
MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: biodegradable stent; STEMI; Magnesium bioresorbable; Vasomotion
Evaluation of the Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this early feasibility study is to evaluate the safety and performance of
      intravascular hepatic denervation using the Metavention Integrated Radio Frequency
      Denervation System (iRF System) to improve glycemic control in type 2 diabetes subjects.
    


Intervention name(s): iRF System Hepatic Denervation
Intervention type(s): Device
Intervention description(s): The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the common hepatic artery (CHA).
Intervention model: Single Group Assignment
Intervention model description: The study is a prospective, single-arm, multi-center, non-randomized trial
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Metabolic Syndrome; NAFLD; Hypertension; High Blood Pressure; Glycemic Control; Diabetes; Denervation; Sympathetic Nervous System
Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery
Condition: Mechanical Ventilation During Anesthesia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in
      Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients
      undergoing laparoscopic gastric sleeve surgery.
    


Intervention name(s): anesthesia ventilator machine; lung ultrasound
Intervention type(s): Device; Device
Intervention description(s): dynamic lung compliance measurements will be used for detection of the optimum PEEP after alveolar recruitment; lung ultrasound views will be used for detection of the optimum PEEP after alveolar recruitment
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The study was conducted for people who suffer from excess fat mass and their age is over 18
      years will be calculated with G*power will be used body composition analyzer to calculate the
      percentage of fat.
    

Detailed description: 
      Cross-sectional study was applied. Data was collected through a questionnaire (oswestry
      disability index arabic version). Fat percentage was taken by Body composition analyzer.
    

Intervention name(s): Fat to Lean Mass Ratio
Intervention type(s): Other
Intervention description(s): The study will be conducted for people who suffer from excess fat mass and their age is over 18 years.
years will be calculated with G power
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        People who suffer from excess fat mass and their age is over 18 years.
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV
      clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).
    

Detailed description: 
      Zambia is a high burden country for both HIV and TB infection and HIV clinic enrollees are a
      high-risk group for active TB. Current Zambian Ministry of Health screening protocols are
      symptom-based even though active case-finding studies in HIV-infected populations have shown
      that symptoms are not always predictive of active TB. As a result, there may be a significant
      amount of un-diagnosed TB among HIV-infected Zambians even in the context of accessing HIV
      care. This study will examine an enhanced protocol to systematically screen a cohort of 400
      new HIV clinic enrollees for prevalence and 1-year incidence of TB using symptoms, light and
      fluorescence microscopy, chest radiography and TB culture of sputum and extra-pulmonary
      fluids (when indicated). In addition, the sensitivity, specificity and cost-effectiveness of
      each diagnostic tool will be evaluated.
    

Intervention name(s): Comprehensive TB screening
Intervention type(s): Other
Intervention description(s): All enrollees will receive a comprehensive TB screening regardless of symptom presentation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Four hundred new enrollees at the Kalingalinga HIV Care and Treatment Clinic who are not
        currently being treated for TB.
      
Biospecimen description: 
      Additional samples (10 ml blood, and 20 ml urine) will be stored in the specimen repository
      at the CIDRZ laboratory for future studies. For patients who agree to provide samples for the
      repository and are diagnosed with TB, isolates from positive cultures (blood, urine, and/or
      sputum) will also be stored in the repository.
    
Keywords: TB; HIV; Extensively resistant TB; Extra pulmonary TB
Single Dose Study of PF-05230907 in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is the following:

        -  To determine the safety and tolerability of single ascending intravenous (IV) doses of
           PF-05230907 in healthy Japanese subjects.

        -  To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy
           Japanese subjects.

        -  To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy
           Japanese subjects.

        -  To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
    


Intervention name(s): PF-05230907; PF-05230907; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single intravenous dose of 3 μg/kg; A single intravenous dose of 5 μg/kg; A single intravenous dose of matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-05230907; Pharmacokinetics; Pharmacodynamic; Immunogenicity
Auricular Stimulation vs. Expressive Writing for Exam Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Title of the study: Auricular acupuncture (AA) vs. expressive writing for pre-exam anxiety -
      a randomised crossover study

      Study period: 04 / 2014 - 07 / 2014

      Principal Investigator: Prof. Dr. T. Usichenko Department of Anaesthesiology and Intensive
      Care Medicine University Medicine of Greifswald

      Aim of the study: To investigate the anxiolytic effect of AA vs. expressive writing and vs.
      no intervention in students, passing the oral exams in anatomy at the University of
      Greifswald

      Design: Prospective randomised crossover trial

      Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Expressive
      writing

      Number of volunteers: N = 40

      Healthy medical students at the University of Greifswald Participants of the anatomy exams in
      spring/summer 2014 Without previous anxiolytic, sedative and analgesic medication No
      pregnancy or lactating Informed consent

      Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase
    


Intervention name(s): Auricular acupuncture; Expressive writing
Intervention type(s): Device; Behavioral
Intervention description(s): Auricular acupuncture with indwelling fixed auricular acupuncture needles; Expressive writing is a standard psychological method in treatment of exam anxiety
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility
Condition: Laxative Compatibility
Study type: Interventional

Summary: 
      For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol)
      has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of
      macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the
      examination). One handicap of using polyethylene glycol is the occurence of nausea and
      vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a
      pilot study the investigators have detected a high fraction of patients who consider the
      cleansing procedure wich macrogol as "very distressing". Thus patient acceptance of the
      colonoscopy procedure altogether is low.

      Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in
      Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium
      picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are
      instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study
      the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much
      more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness
      of the bowel was equal in both groups.

      The investigators believe that a new protocol which contains sodium picosulfate/magnesium
      citrate instead of macrogol will benefit the patients by fewer abdominal side effects while
      cleanness of the bowel at the same time will be warranted. This presumption is the reason for
      the present study.
    


Intervention name(s): Compatibility
Intervention type(s): Procedure
Intervention description(s): Patients asses the compatibility of the bowel cleansing procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: colonoscopy; bowel cleansing; bowel cleanness; efficiency; compatibility
Stability of Motor Output in Aging Adults
Condition: Swallowing
Study type: Observational

Summary: 
      The goal of this project is to examine the area of the brain that controls muscle movement
      for a group of muscles important for swallowing, and to see how that area changes over 2
      weeks of time.
    

Detailed description: 
      A large number of our nation's veterans develop dysphagia due to the myriad of potential
      etiological sources of swallowing disorders, including stroke and head and neck cancer. The
      Veteran's Health Administration has recently identified dysphagia as a major clinical focus
      for the VA system (Sullivan & Dennis, 2006). In order to accurately assess adaptations in
      motor cortex, it is first necessary to have a reliable tool for measuring organizational
      representation in the motor cortex. Transcranial magnetic stimulation (TMS) is a desirable
      choice for such measurement because of the ability to identify causative relationships
      between an area of motor cortex stimulated and muscle response. Therefore, the specific
      research objectives of this proposal are:

        1. To demonstrate the reproducibility of TMS mapping of the submental muscle group in
           healthy older adults between 60 and 80 years of age

        2. To determine the neural representation of submental musculature in the motor cortex of
           healthy older adults between 60 and 80 years of age.

      Twenty healthy adults, 10 men and 10 women, between the ages of 60 and 80 years will serve as
      research participants. TMS will be used to establish motor maps of the submental muscles.
      Subjects will undergo two testing sessions, on day 1 and day 14. The results from each
      session will be compared to assess excitability and representation within the motor cortex,
      and to assess stability and reliability of measurement.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults between 60 and 80 years of age
      
Keywords: Motor cortex; Motor control; Neuroplasticity; Aging; Swallowing
Gastrointestinal Motility in Patients With Neuroendocrine Tumors
Condition: Neuroendocrine Tumor
MeSH terms: Neuroendocrine Tumors
Study type: Observational

Summary: 
      We will study the total gastrointestinal transit time (GITT), gastric emptying and small
      intestine motility in NET patients before and after treated with somatostatin analogues and
      compare these to healthy subjects. For this we will use radio-opaque markers and the newly
      developed Motility Tracking System (MTS).

      Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying
      and small bowel transit time and an increase in phase III MMC activity compared to healthy
      subjects. Treatment with somatostatin analogues increase transit times and decrease phase III
      MMC activity and improves the clinical symptoms.
    


Intervention name(s): Magnetic Tracking System (MTS) and radio-opaque markers
Intervention type(s): Device
Intervention description(s): MTS: A small magnetic pill (6x15mm) is swallowed by the patient and the movement of this pill is registered by a sensor (coordinates x,y,z angles θ, φ) and depicted af graphs on a computer screen. For determination of GITT a capsule containing 10 radio-opaque markers is ingested every day for six days, on day seven an abdominal x-ray is performed.
Sampling method: Non-Probability Sample
Study population: 
        We are scheduling 12 subjects (30-80 years of age) with NET and carcinoid syndrome with
        diarrhea. Patients are recruited through the Department of Medicine V, Aarhus University
        Hospital.
      
Biospecimen description: 
      Blood samples wich are destroyed after analysis
    
Keywords: Neuroendocrine tumor; Carcinoid syndrome; Motility; Transit time
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals
Condition: Pharmacokinetics; Epinephrine; Albuterol; Asthma; Anaphylaxis
MeSH terms: Respiratory Aspiration; Anaphylaxis
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation,
      versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy
      adults.
    


Intervention name(s): Epinephrine (0.125 mg/inhalation); Epinephrine Injection Auto-Injector (0.3mg/0.3mL); Albuterol Sulfate (0.09 mg/inhalation)
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg.; Participants will receive an intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL). The 0.30 mL dose will be given perpendicularly as a single deep intramuscular injection into the anterolateral aspect of the thigh.; Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg.
Other intervention name(s): Primatene Mist; Generic of EpiPen; Albuterol HFA
Intervention MeSH terms: Epinephrine; Racepinephrine; Albuterol; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial (MTN-003)
Condition: HIV Prevention
Study type: Observational

Summary: 
      This study is primarily exploratory and is designed to both identify factors that may have
      affected participant adherence to study product in VOICE, and describe how sexual behaviors,
      such as anal sex, may have had an effect on product efficacy. As such there is no specific
      hypothesis that is being tested.
    

Detailed description: 
      MTN-003D will use qualitative in-depth interviews and/or focus group discussions with VOICE
      participants to explore study product adherence and/or anal sex behaviors in greater depth
      than was measured quantitatively during trial participation. The study approach is designed
      to encourage honesty and to minimize socially desirable responses, which may have affected
      participants' ability/willingness to accurately report during the trial. An in-depth and
      candid understanding of the various behavioral factors that contribute to the dilution of
      efficacy may assist in the interpretation of VOICE trial results and inform future studies.

      In light of VOICE's divergent results, MTN-003D will explore the potential factors that may
      have contributed to efficacy dilution in the trial. MTN-003D, was initially designed after
      the early closure of the oral and vaginal tenofovir arms, and sought to explore those factors
      contributing to the dilution of efficacy using qualitative methods (Stage 1). Given the
      subsequent release of VOICE results in February of 2013 and the availability of drug PK data,
      Stage 2 of MTN-003D has been designed to explore factors influencing adherence in greater
      depth, including HIV risk perception and motivation to join the trial.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Former VOICE (MTN-003) participants
Taste Properties of HIV Inhibitor
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the taste properties of HIV inhibitor
    


Intervention name(s): BMS-955176
Intervention type(s): Drug
Other intervention name(s): HIV Maturation Inhibitor
Intervention MeSH terms: BMS-955176
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major
      Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on
      disability and quality of life in patients with major depressive disorder.To evaluate safety
      and tolerability of 24 weeks of additional treatment in patients completing the initial
      8-week treatment period.
    


Intervention name(s): saredutant (SR48968); placebo; escitalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration (capsules); oral administration (capsules); oral administration (capsules)
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Major depressive disorders; Controlled clinical trial
Traditional Thai Massage and Brain Electrical Activity
Condition: Scapulocostal Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the immediate effect of traditional Thai massage on
      brain electrical activity in the patients with scapulocostal syndrome
    


Intervention name(s): Traditional Thai massage; Ultrasound therapy and hot pack
Intervention type(s): Other; Other
Intervention description(s): The participants will receive a thirty minutes session of traditional Thai massage onto the scapular region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment