bioihbjkbjnl/mcl2 huggingface dataset:
Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal
      women. Preliminary data are sought to estimate statistical power for more detailed studies of
      this hypothesis.
    

Detailed description: 
      The systemic availability and orderly secretion patterns of GH and sex steroids decline in
      healthy aging men and women. The combined changes have substantial clinical implications to
      aging-related physical frailty, diminished aerobic capacity, sarcopenia, osteopenia, visceral
      adiposity, glucose intolerance, and reduced psychosocial wellbeing. Whereas androgen is
      considered the main trophic (anabolic) sex steroid, recent data demonstrate that certain
      tissues respond principally to GH and testosterone-derived estradiol, Estrogen (E2) (e.g.
      bone, brain, liver and pituitary). In principle, frailty may thus be associated with dual GH
      and sex-steroid deficiencies. Additionally, young, but not older healthy women secrete
      significant amounts of progesterone for approximately 14 days during the luteal phase of
      every menstrual cycle. When GH levels rise nearly two fold, the investigators hypothesize
      that progesterone potentiates the GH response to E2. This hypothesis arises from scattered
      indirect studies often using synthetic progestins with partial androgen agonism, instead of
      progesterone per se.

      Because there is no basis for estimating statistical power for this novel paradigm, 40 women,
      10 each in 4 groups, will be studied. The pilot data will be used to calculate statistical
      power for a definitive R01-based investigation of gender-specific distinctions in
      estrogen-regulated pituitary-hormone secretion.
    

Intervention name(s): IM Saline Placebo (0.25 ml); IM Estradiol valerate (2.5 mg); IM Saline Placebo (0.5 ml); IM Estradiol valerate (5.0 mg); Oral Micronized Progesterone; Oral Placebo; Ghrelin (0.3 ug/kg); Medroxyprogesterone - Acetate; Oral Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): (in lieu of Medroxyprogesterone)
Intervention MeSH terms: Medroxyprogesterone Acetate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Normal Healthy Volunteers
Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study
Condition: Healthy
Study type: Observational

Summary: 
      The aim of the proposed research is to measure the effect of drug-induced sedation on the
      functional connectivity between brain regions as indicated by EEG signal transmission within
      the human brain. The results of this study will help to identify the neurophysiological
      correlates of changes in conscious experience that occur during drug-induced sedation.
    

Detailed description: 
      In the proposed experiments cortical areas will be stimulated using low frequency,
      low-amplitude transcranial magnetic stimulation (TMS) in healthy human subjects during
      wakefulness and during drug-induced responsive sedation and unresponsive sedation.
      Simultaneously, high-density electroencephalography (Hd-EEG) will be recorded to evaluate the
      temporal and spatial characteristics of evoked responses and induced rhythms over the cortex.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy right-handed men aged 18-35 who do not smoke or have any metallic implants may be
        eligible for this study.
      
Keywords: Cortico-cortical; connectivity; Transcranial; Magnetic; Stimulation
Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I Study to investigate the safety, tolerability & pharmacokinetics of co-administered
      single doses of OZ439 and Piperaquine to healthy subjects.
    

Detailed description: 
      Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study.

      For each subject, the study included a screening evaluation (within 21 days of the 1st dose),
      dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks
      following the final dose).

      Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1
      and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in
      Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects).

      Safety and tolerability were evaluated: Physical examination, ECG assessments including a
      full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in
      particular liver function tests and adverse events.
    

Intervention name(s): 100mg OZ439 single oral dose; Placebo; 300 mg OZ439 single oral dose; 160mg Piperaquine single oral dose; 480mg Piperaquine single oral dose; 1440mg Piperaquine single oral dose; 800 mg OZ439 single oral dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100mg OZ439 oral suspension single dose; Placebo; 300mg OZ439 oral suspension single dose; 160 mg Piperaquine tablet; 480 mg Piperaquine tablet; 1440 mg Piperaquine tablet; 800mg OZ439 oral suspension single dose
Other intervention name(s): OZ439; OZ439; Piperaquine; Piperaquine; Piperaquine; OZ439
Intervention MeSH terms: Piperaquine; Artefenomel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy; Volunteers
Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents
Condition: Intervention
Study type: Interventional

Summary: 
      A double-blind randomized controlled trial (RCT) was conducted in current human study. This
      study aims to investigate the intervention effect of AOB-w on the short-term exposure and
      toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing,
      in Chinese adolescents.
    

Detailed description: 
      In the morning of test day, participants were served with a meal of potato chips,
      corresponding to a single oral dose of 12.6 μg/kg b.w. exposure to acrylamide, and an edible
      capsule, which contains 350 mg AOB-w or the placebo with the same dose. Urine were collected
      within 48 hours thereafter. The diet was rigorously controlled within 24 hours prior to study
      till entire study finished. Four mercapturic acid metabolites have been investigated as
      urinary biomarkers for short-term internal exposure of acrylamide in human
    

Intervention name(s): Tea polyphenols; AOB-w; Placebo; Acrylamide (Potato Chips)
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule; Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule; Edible starches 0.35g, edible capsule; Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )
Other intervention name(s): TP; Water-soluble antioxidant of bamboo leaves
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Acrylamide; Tea polyphenols; Water-soluble antioxidant of bamboo leaves
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      Describe the patient population and bacterial microbiology of pediatric patients presenting
      with spontaneous draining acute otitis media
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Middle ear fluid and anasopharyngeal swab
    
Keywords: Acute Otitis Media; Serotype distribution
Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help
      doctors identify and learn more about biomarkers related to cancer.

      PURPOSE: This research study is studying biomarkers in tissue samples from young patients
      with acute myeloid leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To determine whether the pattern of global and TSG-specific promoter CpG island
           hypermethylation and gene silencing that we have shown characterizes MLL-rearranged
           (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.

      OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter
      methylation via HELP arrays, gene expression arrays, and RT-qPCR.

      PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will
      be analyzed.
    

Intervention name(s): DNA methylation analysis; gene expression analysis; microarray analysis; reverse transcriptase-polymerase chain reaction; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients With Acute Myeloid Leukemia.
      
Biospecimen description: 
      Tissue
    
Keywords: childhood acute myeloid leukemia in remission; recurrent childhood acute myeloid leukemia; untreated childhood acute myeloid leukemia and other myeloid malignancies
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Compare the safety of four oral doses of pradefovir after 48 weeks of treatment

        -  Select the dose of pradefovir for Phase 3 studies
    

Detailed description: 
      -  Compare the safety of four oral doses of pradefovir after 48 weeks of treatment

        -  Compare the antiviral activity of four oral doses of pradefovir to adefovir and
           dipivoxyl after 48 weeks of treatment

        -  Select the dose of pradefovir for Phase 3 studies

        -  Determine the pharacokinetic profiles of four oral doses of pradefovir
    

Intervention name(s): pradefovir mesylate; adefovir dipivoxyl
Intervention type(s): Drug; Drug
Intervention MeSH terms: Adefovir; Pradefovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B, Chronic; Hepatitis B Virus; Pradefovir Mesylate; Adefovir Dipivoxyl
Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Intravenous BI 836826 in combination with ibrutinib in relapsed/refractory Chronic
      Lymphocytic Leukemia (CLL) patients who have been pre-treated with at least one prior line of
      systemic therapy, and who are eligible for treatment with ibrutinib. Objectives of the trial
      are to determine the recommended Phase 2 dose of BI 836826, and to document the safety and
      tolerability of BI 836826 when given in combination with ibrutinib
    


Intervention name(s): BI 836826; Ibrutinib
Intervention type(s): Drug; Drug
Intervention description(s): Standard of Care
Intervention MeSH terms: BI 836826
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optical Coherence Tomography-based Positioning for Macular Hole Surgery
Condition: Macular Hole Surgery
MeSH terms: Retinal Perforations
Study type: Observational

Summary: 
      The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring
      the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared
      with the surgery by the surgeon's decision. The macular hole closure and visual outcome were
      compared.
    

Detailed description: 
      The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring
      the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared
      with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy,
      internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection
      of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual
      outcome were compared.
    

Intervention name(s): Macular hole surgery
Intervention type(s): Procedure
Intervention description(s): Vitrectomy with internal limiting membrane removal and gas tamponade
Other intervention name(s): Vitrectomy
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The efficacy of macular hole (MH) surgery with the halting of prone positioning by
        monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images
        in 60 eyes was compared with the 69 eyes with same surgical procedure but the prone
        position determined by the surgeon's decision.
Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of
      the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the
      exposure of mifepristone at 2 dose levels.
    


Intervention name(s): Mifepristone
Intervention type(s): Drug
Intervention description(s): Period 1: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2; then Period 2: rifampin 300 MG (2 capsules) for a total of 600 MG daily for 14 days for both cohorts; then Period 3: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2
Other intervention name(s): rifampin
Intervention MeSH terms: Rifampin; Mifepristone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Evidence-Based Nutrition Practice Guidelines of Toolkit and Preliminary Outcomes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The goal of this study is to field test ADA's Type 2 Diabetes Evidence-Based nutrition
      Practice Guidelines (EBNPG) for Adults in 2008 as a tool for registered dietitians (RDs) for
      their patients with with type 2 diabetes who have no evidence of organ damage. A six month
      pilot study will be conducted to determine the feasibility of training RDs in documenting the
      outcomes of implementing Medical Nutrition Therapy (MNT) using ADA's evidence-based GL for
      T2D.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        practitioners working with patients who have heart failure
Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is an investigator initiated, sponsored, open label, prospective randomized controlled
      trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will
      be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that
      occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary
      bypass (CPB).
    


Intervention name(s): nitroglycerin; esmolol
Intervention type(s): Drug; Drug
Intervention description(s): nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.; esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
Intervention MeSH terms: Nitroglycerin; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Medical Marijuana Use in HIV+ Patients Prospective Cohort Study
Condition: HIV Positive; Marijuana Smoking
MeSH terms: HIV Seropositivity; Marijuana Abuse; Marijuana Use
Study type: Observational

Summary: 
      The investigators are interested in understanding personal factors such as medical conditions
      and mental health, as well as social and economic factors, that influence marijuana (and
      other substance) use in HIV-positive patients.

      Several alternative hypotheses will be evaluated in the proposed project:

        1. healthier patients may self-select marijuana use;

        2. marijuana use may be associated with consequences that create barriers to seeking
           healthcare;

        3. marijuana use may have medicinal value that reduces the need for such care.
    

Detailed description: 
      The study will involve a total of 5 interviews with clinical research staff members, the
      total involvement will be for about 1 year.

      The first interview will establish a baseline of current behaviors and health status; this
      will take about 3-4 hours. This interview will take place at the Tolan Park Medical Building,
      located at 3901 Chrysler Service Dr. The remaining 4 interviews - which will be shorter in
      length - will be conducted about 3, 6, 9, and 12 months after the baseline interview; each
      follow-up interview will take about 2 hours.The purpose of the 4 remaining interviews is to
      assess changes in behaviors and health status over time.

      We will collect urine samples at each of the 5 interview sessions to assess health and
      illicit drug use.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV positive and marijuana using volunteers
      
Keywords: HIV positive; Medical Marijuana
Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates a new drug, new enteroadsorbent polymethylsiloxane (Enterosgel) in the
      treatment of rotavirus gastroenteritis in children. Half of the participants received a new
      drug, polymethylsiloxane and half of the participants received standard treatment - probiotic
      L. reuteri (BioGaia).
    

Detailed description: 
      Polymethylsiloxane and probiotic L. reuteri both hasten symptoms of the rotavirus
      gastroenteritis but they do so by a different mode of action.

      Polymethylsiloxane is an enteroadsorbent and it possibly acts by adsorption of viruses and
      doing so it prevents binding rotaviruses for enterocytes. Another mode of action can be
      forming a thin layer over the mucosal surfaces thus protects them from various damaging
      factors.

      Probiotics help the healing of the intestinal mucosa presumably in few ways - by
      normalization of gut flora, by competition with pathogen bacteria for binding sites and
      nutrients and by stimulation of intestinal immune system.
    

Intervention name(s): Polymethylsiloxane; Lactobacillus reuteri
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Enterosgel; BioGaia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Condition: Polycystic Ovary Syndrome; Hyperandrogenism
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism
Study type: Interventional

Summary: 
      Many, but not all, girls with high levels of the male hormone testosterone go on to develop
      polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual
      periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of
      difficulty becoming pregnant. The investigators do not understand why some girls with high
      hormones develop PCOS and others do not. In a previous study by our group, some girls with
      high levels of male hormones had abnormalities in the secretion of another hormone, called
      luteinizing hormone (LH), that are often seen in women with PCOS. However, another group had
      normal LH secretion. The girls with the abnormal LH secretion had higher levels of another
      hormone, called insulin, than the girls with normal LH secretion. The investigators will test
      whether metformin, an insulin-sensitizing agent, changes the effects of high male hormone
      levels in adolescent girls, specifically by looking at their LH secretion response following
      metformin treatment.
    

Detailed description: 
      A better understanding of the factors that make adolescent girls more or less susceptible to
      the adverse neuroendocrine effects of elevated androgens will hopefully lead to improved
      prevention and treatment strategies for PCOS. In this study, we propose to explore the role
      of hyperinsulinemia on neuroendocrine function in hyperandrogenic adolescent girls by
      assessing the effect of the insulin sensitizer Metformin on hypothalamic progesterone
      sensitivity. Other differences between the progesterone sensitive and progesterone
      insensitive subgroups, including racial and ethnic differences between the two populations
      and a trend towards older gynecologic age in the progesterone insensitive population, are
      being pursued through other ongoing studies (IRB-HSR# 8588 and 12160).
    

Intervention name(s): Metformin; Progesterone; estrace
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500-2000 mg PO BID (X12 weeks); oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2); oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2
Other intervention name(s): Estrogen
Intervention MeSH terms: Metformin; Progesterone; Estradiol; Estrogens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: hyperandrogenemia