bioihbjkbjnl/mcl2 huggingface dataset:
Retrospective Claims Analysis of Hysterectomy After Sterilization
Condition: Contraception
Study type: Observational

Summary: 
      The research questions are:

        1. What is the proportion of women undergoing hysterectomy after hysteroscopic
           sterilization or laparoscopic tubal ligation?

        2. What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy
           after hysteroscopic sterilization or laparoscopic tubal ligation?

        3. What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic
           sterilization or laparoscopic tubal ligation?
    


Intervention name(s): Laparoscopic tubal ligation; Hysteroscopic sterilization
Intervention type(s): Procedure; Procedure
Intervention description(s): Female permanent birth control method performed via a surgical procedure; Female permanent birth control method performed via placement of a device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 18 - 49 at the time of the sterilization procedure from an administrative claims
        database
Pain, Range of Motion, Edema, Sensibility, Strength (PRESS) & Self-reported Function Create a Comprehensive Score
Condition: Hand Injuries and Disorders; Upper Extremity Problem
MeSH terms: Hand Injuries
Study type: Interventional

Summary: 
      The aim of this study is to examine the development of a conceptual framework and provide
      evidence for reliability of a comprehensive hand therapy evaluation score. This approach
      provides a new standardized tool for upper extremity (UE) evaluation. Components of Pain,
      Range of Motion (ROM), Edema, Sensibility, Strength (PRESS), and self-reported Function were
      combined to create a baseline. Each assessment tool used for the PRESS to Function Approach
      assists in determining appropriate interventions.
    

Detailed description: 
      In this study, investigators used the innovative PRESS to Function Approach and Composite
      Score to describe the development and piloting of a systematic standard for upper extremity
      evaluation. Using existing instruments with substantial evidence of validity and reliability
      is more cost-effective than starting from scratch to develop and validate an instrument. This
      Approach and Score will provide occupational therapists an accurate measure to track the
      progression of a patient. The hypothesis for this study is Press to Function components will
      demonstrate utility for measuring clinical and patient-reported function when used as a
      comprehensive assessment tool.
    

Intervention name(s): Upper Extremity Rehabilitation
Intervention type(s): Other
Intervention description(s): Pain management, ROM, Edema Management, Desensitization, Strengthening, Functional Tasks
Intervention model: Single Group Assignment
Intervention model description: Single arm clinical trial. T-test employed to compare PRESS to Function scores before and after treatment. Reliability coefficient were computed to access consistency in the measurements of the Quick DASH and the PRESS to Function Scores
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PRESS to Function; Pain; Range of Motion; Edema; Sensation; Strength; Quick DASH; Upper Extremity; Hand
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fed condition in normal,
      healthy, adult, human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India
      and the corresponding Reference Product: Zestoretic® 20/25 lisinopril/hydrochlorothiazide
      Tablets of M/s AstraZeneca Pharmaceuticals LP, USA under fed condition in normal, healthy,
      adult, human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single
      Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of either test or reference was
      administered to the subjects as per the randomization schedule in each study period with
      about 240 mL of water at ambient temperature in sitting position.

      The duration of clinical phase was 12 days, including the washout period of 7 days between
      each study period.
    

Intervention name(s): Lisinopril and Hydrochlorothiazide Tablets (20+25) mg; Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day; Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day
Other intervention name(s): Test product; Reference product
Intervention MeSH terms: Hydrochlorothiazide; Lisinopril; Hydrochlorothiazide, lisinopril drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TENS Reduces Movement-Evoked Pain in People With CLBP
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      In this cross-over study 25 patients with chronic low back pain (CLBP) were tested for pain
      relief in 2 conditions: while using the Transcutaneous Electrical Nerve Stimulation (TENS)
      application and without using it. Primary outcome: Movement-Evoked Pain (MEP). This was
      measured using the Back Performance Scale (BPS) and a 5-minute walk test (5MWT). Participants
      performed 5 functional tasks and were asked to rate their pain before, during, and after each
      movement on a numeric rating score scale. The same principle will be used for the 5MWT: for
      each walking-minute, 3 pain measurements will be assessed.
    


Intervention name(s): HeatTens (HV-F311-E)
Intervention type(s): Device
Intervention description(s): (1) 2~108 Hertz (modulation program inside); (2) 100 microseconds (pulse duration)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CCTA-based Coronary Plaque Characterization and High-sensitive Troponin T for the Prediction of Cardiovascular Outcomes
Condition: Coronary Artery Disease; Noninvasive Plaque Characterization
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      To determine the ability of semi-automated plaque assessment in cardiac computed tomography
      angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of
      patients at intermediate risk for coronary artery disease (CAD).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients scheduled to undergo CCTA
Postoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study was to evaluate and compare the postoperative pain levels after using
      EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary
      molars.
    


Intervention name(s): Irrigation Method
Intervention type(s): Other
Intervention description(s): Irrigation Method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: EndoActivator; Irrigation; Postoperative pain; Primary teeth
Comparison Between Classic Leg-press Training and Complex Leg-press Training on a Dynamic Leg-press
Condition: Healthy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A complex training on a dynamic leg-press with visual feed-back will improve coordinative
      capacity, power, sensorimotor and cognitive aspects more than a classic training on the same
      leg-press but without visual feed-back.
    

Detailed description: 
      The project evaluates two different resistance training programs on a leg press. One group
      will perform a standard resistance training with the aim of muscle hypertrophia, the other
      group will perform a complex resistance training combining rate of force development
      training, power training, speed endurance as well as sensorimotor aspects (i.e. following
      visual feedback to reproduce given forces or joint angles).

      Hypotheses: Participants in the complex training group will change the relation between
      counter movement jump and squat jump, i.e. they will more improve in the counter movement
      jump because of improved sensorimotor capacity.
    

Intervention name(s): resistance training; complex resistance training
Intervention type(s): Other; Other
Intervention description(s): hypertrophic resistance training; complex resistance training with speed, excentric and power-endurance elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: resistance training; Healthy People Programs
Tracking Inflammatory Cells Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI)
Condition: Healthy
Study type: Interventional

Summary: 
      Treatment of a wide range of diseases using stem cells and other types of cell appears
      promising. Following administration of cells it is often not clear where exactly the cells
      have gone and how many of them have reached the target site. This has been one of the
      challenges of developing these treatment options further. We have developed a method of
      labelling human cells with a magnetic resonance imaging (MRI) "contrast agent" which contains
      tiny iron filings. Following intravenous administration it is possible to see where the
      iron-labelled cells have gone using MRI scanning. We would like to do is to demonstrate that
      these cells behave normally and migrate to a site of inflammation. We plan to induce an area
      of inflammation in the forearm of healthy volunteers using the Mantoux test (a test of
      immunity against tuberculosis) before giving the labelled cells intravenously. After the
      Mantoux test we will give these volunteers iron-labelled cells and do MRI scans of their
      forearm to determine whether these cells can be seen accumulating in the target site.
    


Intervention name(s): Administration of intra-dermal Endorem; Mantoux test; Autologous Endorem-labelled mononuclear cells; Administration of Endorem
Intervention type(s): Drug; Biological; Biological; Drug
Intervention description(s): single dose, intradermal; single dose, intradermal; single dose, intravenous; single dose, intravenous
Intervention MeSH terms: Dextrans
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MRI; SPIO; Healthy Volunteer
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      To describe any degree of preference for the route of administration of Fluzone influenza
      vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

      To collect safety data, injection site reactions, and systemic reactions, through Day 7
      post-vaccination; SAEs through day 28 post-vaccination
    

Detailed description: 
      The purpose of this clinical trial is to determine, in a relatively small sample of persons
      18-49 years of age, if there is a preference trend for a particular route of administration,
      ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is
      disappointingly low in this age group, and there is the perception that aversion to IM
      injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in
      this study may offer a more acceptable alternative to the standard IM injection for influenza
      immunization and thereby promote wider acceptance of influenza vaccination.
    

Intervention name(s): Fluzone: Influenza virus vaccine; Fluzone: Influenza virus vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid; 0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid
Other intervention name(s): Fluzone®; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza virus
Alpha Lipoic Acid and Polycystic Ovary Syndrome
Condition: Insulin Resistance; Oxidative Stress
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will recruit 40 subjects with Polycystic Ovary Syndrome (PCOS) as defined by the
      NIH criteria. The subjects will be pre-screened for insulin sensitivity using fasting insulin
      and glucose levels and oral glucose tolerance test. The 20 most insulin resistant subjects
      will undergo measurements of in vivo insulin action by hyperinsulinemic, euglycemic clamp.
      Body composition will be measured by dual-energy X-ray absorptiometry (DEXA). Plasma lipids
      and markers of oxidative stress will be measured. They will then receive open label
      controlled release alpha lipoic acid (CRLA) at 800 mg twice daily for 16 weeks. After
      treatment hyperinsulinemic euglycemic clamps, DEXA, plasma lipids and markers of oxidative
      stress will be repeated.

      Hypotheses: LA will improve insulin sensitivity in PCOS subjects; LA will reduce oxidative
      stress, testosterone levels and improve cardiovascular risk factors.
    

Detailed description: 
      Insulin resistance commonly occurs in patients with Polycystic Ovary Syndrome (PCOS) and may
      be responsible for many of the long term complications of PCOS. Patients with PCOS are at
      increased risk for developing type 2 diabetes and the metabolic syndrome (hypertension,
      dyslipidemia and cardiovascular disease). Data suggest that oxidative stress contributes to
      insulin resistance and thus inhibitors of oxidative stress improve insulin action. Alpha
      Lipoic Acid (LA) is synthesized in the liver and other tissues and is a key component of
      several mitochondrial enzyme complexes responsible for oxidative glucose metabolism and
      cellular energy production. When used pharmacologically, LA functions as a safe and effective
      antioxidant, recycling vitamins C and E,elevating glutathione levels,and lowering reactive
      oxygen species. Cell culture studies reveal that LA reverses the effects of oxidative stress
      and improving insulin action. Preliminary clinical data indicate that antioxidants may
      improve insulin resistance in PCOS patients. We propose, therefore, to study LA's effects on
      insulin-stimulated glucose uptake (insulin clamp) in a well characterized population of
      insulin resistant PCOS patients. Because these patients usually present in the adolescent and
      teenage years, the development of safe, long-term, treatment strategies are needed.
    

Intervention name(s): Alpha Lipoic Acid
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Thioctic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; polycystic ovary syndrome; polycystic ovarian syndrome; alpha lipoic acid; insulin resistance; oxidative stress
The Vaginal Health Trial
Condition: Atrophy of Vagina; Menopause; Dyspareunia (Female)
MeSH terms: Dyspareunia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms
      and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter
      trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel,
      with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function,
      and to create a biorepository of specimens for future translational, mechanistic research on
      the etiology of vaginal symptoms.
    

Detailed description: 
      The Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical
      Trials network was established in 2009. By the end of 2014, the network completed 4 clinical
      trials testing 7 interventions in approximately 1000 women ages 40-62 with vasomotor (VMS)
      and other menopause symptoms.

      The current trial will evaluate a relatively understudied area of menopause - vaginal health
      and sexual function. This is a 3-arm, randomized, controlled, double-blind, clinical trial
      among postmenopausal women ages 45-70.

      Our primary aim is to evaluate the effectiveness of ultra-low dose vaginal estradiol (Vagifem
      10 mcg), non-hormonal hydrophilic non-prescriptive vaginal gel (Replens) and placebo in
      reducing the Most Bothersome Symptom (MBS) severity. Choices for MBS include vulvovaginal
      itching, pain, dryness, irritation, or pain with penetration.

      Secondary aims include an evaluation of a composite score of vaginal symptoms, sexual
      function, treatment satisfaction, menopause quality of life, and objective measures of
      genitourinary atrophy. We will also create a biorepository of vaginal and blood specimens. In
      a subset of women, we will examine whether treatment response is related to: a) the
      post-menopausal vaginal microbiome; b) vaginal mucosal inflammation; and c) reproductive
      hormone profiles. The in-depth focus on the mechanisms associated with postmenopausal vaginal
      symptoms will use state of the art microbiologic techniques on longitudinally collected
      biologic specimens and will guide future translational studies.
    

Intervention name(s): Vagifem; Replens; Placebo tablet; Placebo gel
Intervention type(s): Drug; Device; Other; Other
Intervention description(s): One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.; 2.5 gm to be applied vaginally every 3 days over 12 weeks.; Dispensed in visually identical bottle and tablet form to Vagifem.; Dispensed in visually identical tube and gel form to Replens.
Other intervention name(s): vaginal estradiol; non-hormonal hydrophilic non-prescriptive vaginal gel
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study of Transcoronary Myocardial Cooling
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Patients with heart attacks caused by blocked coronary arteries are usually treated with a
      technique called primary angioplasty. Although this treatment is very successful it can
      result in damage to the heart muscle when the artery is opened due to reperfusion injury.
      Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in
      some patients but not in others, however it is uncomfortable due to the shivering, expensive
      and can result in delays in opening the blocked artery. We are investigating a simpler way to
      cool the heart muscle directly using cooled fluid passed through the catheter without the
      shortcomings of entire body cooling. This pilot will address safety and feasibility
      considerations.
    

Detailed description: 
      The precise mechanisms involved in ischaemia/reperfusion injury is not fully understood but a
      number of factors are thought to contribute to cardiac dysfunction14, 15. These include : 1.
      reperfusion arrhythmias; 2. microvascular obstruction or no-reflow phenomenon; 3. myocardial
      stunning and 4. cardiomyocyte apoptosis. It is estimated that ischaemia/reperfusion injury
      occurs in > 30% of patients and is associated with reduced myocardial salvage and poor
      prognosis16-18. Ischaemia/reperfusion injury may account for up to 50% of the final infarct
      size9.

      Deep hypothermia (< 30 °C) has long been used in protecting the heart during coronary artery
      bypass grafting and heart transplantation. Intermittent antegrade or retrograde infusion of
      cold cardioplegia appears to reduce myocardial ischaemia and improves outcome19, 20. Deep
      hypothermia however can cause spontaneous ventricular fibrillation and impaired cardiac
      function and its application is limited to the unconscious patient.
    

Intervention name(s): Cohort A - Room temperature coronary perfusate; Cohort B - Cooled coronary perfusate
Intervention type(s): Other; Other
Intervention description(s): Patients recruited into the study will receive standard PPCI and in addition a transcoronary infusion of Hartmans solution at room temperature (Cohort A). The research intervention is the infusion of room temperature Hartmans solution.; Patients recruited into the study will receive standard PPCI and in addition a transcoronary infusion of Hartmans solution cooled at 15 degrees (Cohort B).
The research intervention is the infusion of Hartmans solution cooled to 15 degrees.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ST Elevation Myocardial Infarction; Transcoronary Cooling
Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
Condition: Gastrointestinal Microbiome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal
      intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and
      permeability, and to assess any health benefits and confirm the safety profile of HA35.
    


Intervention name(s): Hyaluronan
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science