bioihbjkbjnl/mcl2 huggingface dataset:
Insulin Action During Pregnancy in Woman at High Risk for Gestational Diabetes
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      The project objective is to validate a new indirect estimate of insulin status in both
      pregnant African-American women and Caucasian women in southern Louisiana who are at risk for
      gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that
      are potentially linked to complications during pregnancy and to increased risks of obesity
      and diabetes in later life. The investigators will explore the use of indexes of insulin
      status to identify the metabolic risk profile of pregnant women which may vary by race.
      Understanding whether there are differences which vary by race may influence clinical
      screening and treatment of pregnant women.
    

Detailed description: 
      The major goal of our proposed study is to validate a new approach to estimating insulin
      sensitivity and ß-cell function in African-American women compared to non-Hispanic white
      women in southern Louisiana who are at a high risk for gestational diabetes mellitus (GDM).
      We will determine whether the whole body insulin sensitivity index (WBISI) and insulinogenic
      index (IGI) [derived from an oral glucose tolerance test (OGTT)] can be used during 24-28
      weeks of pregnancy to accurately estimate the degree of insulin resistance relative to ß-cell
      function in women with GDM in those with impaired glucose tolerance (IGT) as well as those
      who are glucose tolerant. Fasting values will also be assessed using the homeostasis model
      assessment (HOMA-IR and HOMA-%B) to evaluate insulin resistance and ß-cell function. We will
      explore the potential use of these measures to define the metabolic risk profile of these
      pregnant women and compare them with obstetric outcomes. We will determine if there are
      differences in risk that vary by race. Second, given the high likelihood that women who
      manifest GDM will develop type 2 diabetes mellitus (DM), identification of these patients by
      ethnic group or other independent determinants will permit intervention after delivery that
      might delay or prevent the onset of type 2 DM.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy, nondiabetic pregnant African-American and Caucasian women who have been scheduled
        for a standard 3-hour glucose tolerance test at 24-28 weeks in the Woman's Hospital
        Pathology laboratory.
      
Biospecimen description: 
      Blood samples for insulin measurements
    
Keywords: insulin sensitivity; insulin secretion; infant outcome
Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis; Psoriatic Arthritis; Periodontal Disease
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Periodontal Diseases
Study type: Interventional

Summary: 
      Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and
      damage. RA attacks the lining of the joints (synovium), causing swelling that can result in
      aching and throbbing, and eventually deformity. Even though there have been many advances in
      the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors
      still do not know what causes this inflammation in joints. It is likely that RA occurs as a
      result of a complex combination of factors, including a person's genes; lifestyle choices,
      such as smoking and diet; and things in a person's environment, including bacteria or
      viruses. This study investigates the hypothesis that bacteria living in a person's mouth
      and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid
      Arthritis. The investigators believe that by killing those bacteria with antibiotics, they
      might be able to understand how the immune system works and, maybe, what causes RA.
    

Detailed description: 
      If you would like to participate in this study, we will first ask you several questions
      regarding the status of your arthritis, the medications you use or have used in the recent
      past, your social and dietary habits, and your medical and surgical history. If your answers
      tell us that you are the right patient for our study, we will go over a consent form which
      describes in more detail how we will study your intestinal and mouth bacteria, the immune
      cells in your blood and other genes, enzymes and proteins that tell us about your disease
      status.

      If you have Psoriatic Arthritis (PsA) or are healthy with no history of arthritis, and would
      like to participate in this study, your participation would involve only one or two visits,
      and no treatment.

      If you have Rheumatoid Arthritis (RA), your participation would involve six visits, and you
      would be randomly assigned to receive treatment with the antibiotic doxycycline, or the
      antibiotic vancomycin, or no antibiotic treatment.
    

Intervention name(s): doxycycline; vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): doxycycline - 100 mg twice per day, for 2 months; vancomycin, 250 mg four times a day, for 2 weeks
Other intervention name(s): Vibramycin; Vancocin
Intervention MeSH terms: Vancomycin; Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: rheumatoid arthritis; psoriatic arthritis; periodontitis; microbiota; microbiome; vancomycin; doxycycline; T cell; Th17
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects
      on craving and efficacy.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel group inpatient study of
      clavulanic acid for 10 days in adults (18-65) seeking treatment for cocaine use disorder. For
      those subjects who can tolerate 500 mg/day for 3 days (or matched placebo), there will be a
      forced dose escalation to 750 mg/day for 3 days. Subjects who can tolerate 750 mg/day for
      three days will have a forced dose escalation to 1000 mg/day for 4 days until the study ends.

      Thus, there are 3 Periods for each participant:

      Period 1: 500 mg CLAV per day for days 1-3; Period 2: 750 mg per day for days 4-6; Period 3:
      1000 mg/day for days 7-10.

      Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be
      performed daily. Structural MRI, resting state MRI (rs-fMRI), functional MRI (fMRI) and
      Magnetic Resonance Spectroscopy (MRS) scans will be done at baseline and on Days 3, 6 and 10
      of the study. At the time of each scan, safety of the subject to complete the scan will be
      re-assessed. fMRI was not done at baseline.
    

Intervention name(s): Clavulanic Acid; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Drug will be given in 250mg capsules.; Placebo
Other intervention name(s): microcrystalline cellulose
Intervention MeSH terms: Clavulanic Acids; Clavulanic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel group inpatient study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
Condition: Cervical Ripening; Labor Induction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy for cervical ripening in labor induction
      between titrated and conventional oral misoprostol
    


Intervention name(s): misoprostol; misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm; misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
Other intervention name(s): cytotec; cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Efficacy; Cervical ripening/Labor induction; Titrated oral misoprostol/Conventional oral misoprostol; Term pregnancy
Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind, randomized, placebo-controlled, three treatment parallel study in
      which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the
      face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals
      (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be
      counted at the baseline visit and at the visit four weeks following cessation of treatment.
    

Detailed description: 
      actinic keratosis
    

Intervention name(s): Brand Carac; Generic 0.5% 5-fluorouracil cream; Placebo cream
Intervention type(s): Drug; Drug; Other
Intervention description(s): treatment of actinic keratosis; treatment of actinic keratosis; treatment of actinic keratosis
Other intervention name(s): 5-fu; 5-fu
Intervention MeSH terms: Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of TAK-438 in Healthy Male Participants
Condition: Ascending Single Dose Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study was to evaluate the single dose safety and pharmacokinetics
      of TAK-438 in healthy Japanese men.
    

Detailed description: 
      The drug being tested in this study is called TAK-438. TAK-438 is being tested to find a safe
      and well-tolerated dose and to assess how TAK-438 moves throughout the body. This study will
      look at lab results and side effects in people who took TAK-438. This study consisted of 2
      sequential studies: a single rising dose study (Steps 1 to 7) and a food-effect study (Steps
      8 and 9).

      The study population for Steps 1 to 7 consisted of 12 participants; with 9 participants
      randomized to receive a single dose of TAK-438, and 3 participants to receive placebo.
      Participants in Steps 1 to 7 received a single dose of study drug after a 10-hour fast. The
      starting dose was 1 mg followed by administrations of 5, 10, 20, 40, 80, and 120 mg. Steps 8
      and 9 consisted of 12 participants in a 2-sequence, 2-period crossover design. Four
      participants were to receive a single dose of TAK-438 and 2 participants were to receive a
      single dose of placebo on Day 1, in the fasted state, and 4 participants were to receive a
      single dose of TAK-438 and 2 participants were to receive a single dose of placebo on Day 1
      in the fed state, followed by a second single dose of TAK-438 or placebo in the alternative
      fed state after a 13 day minimum washout period. Participants in Steps 8 randomized to
      receive TAK-438 will receive 10 mg and participants in Step 9 will receive 40 mg.

      This single-centre trial was conducted in Japan. The overall time to participate in this
      study was up to 32 days depending on the Step assignment. Participants made 3 to 5 visits to
      the clinic, including one or two 8-day periods of confinement to the clinic, also depending
      on Step assignment. All participants made a final visit 15 days after last dose of study drug
      for a follow-up assessment.
    

Intervention name(s): TAK-438; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-438 tablets; TAK-438 placebo-matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Effect of Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers
Condition: Oxidative Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is determine whether daily consumption of frozen red raspberries
      can improve the antioxidant capacity of the blood and reduce the effects of oxidative stress,
      dose-dependently, in a healthy adult population.
    

Detailed description: 
      Red raspberries are an excellent source of numerous polyphenolic antioxidants. The
      bioactivity of these compounds have been implicated in many biological pathways and may
      function to reduce the risk of numerous chronic diseases. We are conducting an intervention
      study with frozen red raspberries on a healthy adult population in order to determine if
      raspberry polyphenols are bioavailable and bioactive in vivo. Twenty-four subjects (12 male
      and 12 female) will be recruited to participate and consume one-cup frozen red raspberries
      daily for two weeks, they then will randomly be assigned to consume either one, two or four
      cups of raspberries for another two weeks, this will be followed by four weeks of
      non-treatment. Blood samples and 12-hour urine collections will be taken in order to measure
      the concentration of raspberry polyphenols in response to treatment dose. Dose-dependent
      treatment effects on blood biomarkers for antioxidant capacity, oxidative stress,
      inflammation and other chronic disease risk factors will also be measured.
    

Intervention name(s): individually quick frozen red raspberries; individually quick frozen red raspberries; individually quick frozen red raspberries
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.; Consumption of one-cup frozen red raspberries for two weeks, then consumption of two-cups frozen red raspberries for an additional two weeks, followed by four weeks of non-treatment.; Consumption of one-cup frozen red raspberries for two weeks, then consumption of four-cups frozen red raspberries for an addition two weeks, followed by four weeks of non-treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: raspberry; fruit; antioxidants; polyphenols; oxidative stress; dietary intervention
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Objective To evaluate change in same-day pulmonary function testing in pediatric patients
      receiving OMT compared to those receiving usual care.

      Methods For this study, we selected patients utilizing the following inclusion criteria: 1)
      ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based
      asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then
      randomized to either an OMT or a control group. We excluded patients who were experiencing an
      acute asthma exacerbation. Patients in the OMT group were treated with rib raising and
      suboccipital release, in addition to standard asthma care, while control group patients
      received standard care only. A second PFT was performed on both groups at the end of the
      visit. OMT was performed by multiple osteopathic pediatric residents who were specifically
      trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1,
      and FEF 25-75%) were then compared.
    

Detailed description: 
      Objective To evaluate change in same-day pulmonary function testing in pediatric patients
      receiving OMT compared to those receiving usual care.

      Methods For this study, we selected patients utilizing the following inclusion criteria: 1)
      ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based
      asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then
      randomized to either an OMT or a control group. We excluded patients who were experiencing an
      acute asthma exacerbation. Patients in the OMT group were treated with rib raising and
      suboccipital release, in addition to standard asthma care, while control group patients
      received standard care only. A second PFT was performed on both groups at the end of the
      visit. OMT was performed by multiple osteopathic pediatric residents who were specifically
      trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1,
      and FEF 25-75%) were then compared.

      NOTE: The OMTs were done either by our OMM attending at that time (Dr. Wolf) or by residents
      trained by her for this study (Drs. Jones, Pe, Bryant and Regan,)
    

Intervention name(s): Osteopathic Manipulative Medicine
Intervention type(s): Other
Intervention description(s): Provided 15-20 minute long OMT session for patients in the OMT arm
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients were randomized to either standard of care/teaching at our Hilltop Primary Care Center Asthma clinic OR to standard of care/teaching PLUS one time osteopathic manipulation focusing on improving lung expansion.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OMM
The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
Condition: Headache
MeSH terms: Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      To measure the cerebral hemodynamic effect of L-kynurenine.
    

Detailed description: 
      Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration
      to healthy volunteers.

      Hypothesis: L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in
      healthy individuals.

      Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the
      following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500
      microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in
      between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital
      signs, circumferences of middle cerebral artery, superficial temporalis artery and headache
      intensity and characteristics.

      The subjects will then have a questionnaire about headache for the following 24 hours.
    

Intervention name(s): L-kynurenine
Intervention type(s): Drug
Intervention description(s): intravenous infusion of L-kynurenine to healthy individuals.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Pilot, Open label
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: L-kynurenine; Cerebral hemodynamic; Headache; Mohammad Al-Mahdi Al-Karagholi
Alterations in Muscle After Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The overall goals of this work are: 1) to elucidate alterations in gene expression and
      downstream protein synthesis 2 weeks after Total Knee Arthroplasty (TKA) to better explain
      quadriceps muscle atrophy after TKA and 2) understand the mechanisms responsible for improved
      maintenance of muscle strength with Neuromuscular Electrical Stimulation (NMES) utilization.
      Furthermore, this investigation seeks to expand previous findings regarding attenuation of
      strength and functional performance deficits with NMES application to better understand how
      altered gene expression influences muscle function.
    


Intervention name(s): Neuromuscular electrical stimulation (NMES); Standard Rehabilitation Protocol
Intervention type(s): Procedure; Behavioral
Intervention description(s): 5x/week, 2x/day, for 45 minutes/session; Standard physical therapy after TKA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty (TKA); Gene Expression
Effect of Pectoralis Minor on Endurance
Condition: Pectoralis Minor Length
Study type: Observational

Summary: 
      The aim of this study evaluate the effects of dominant and non-dominant pectoralis minor (PM)
      length on scapular and core muscle endurance in the absence of scapular dyskinesia.
    


Intervention name(s): muscle length and muscle endurance assessment
Intervention type(s): Other
Intervention description(s): Pectoralis Minor Length and muscle endurance evaluation
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy adult women
      
Keywords: pectoralis minor length; scapular muscle endurance; core muscle endurance; dominant arm