bioihbjkbjnl/mcl2 huggingface dataset:
AROPE : Early Ovarian Reserve Decreased : Impact of Exposure to Persistent Endocrine Disruptors and Organic Solvents
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Early ovarian reserve decreased is one of the main causes of infertility for women after 35
      years. The relationship between this decreased and exposure to chemicals, including
      persistent endocrine disruptors or organic solvents, has been little studied. However,
      several in vivo or in vitro experimental studies suggested that these chemicals may impaired
      ovarian function.

      The main objective is to study the relationship between early ovarian reserve decreased and
      exposure to persistent organic pollutants.

      The secondary objectives are to study the relationship between early ovarian reserve
      decreased and exposure to organic solvents and heavy metals.

      Multicenter case-control study. This project will permit to increase the knowledge concerning
      the etiology of early decreased ovarian reserve. Considering that exposure of interest are
      frequent, the results may be important in a public health perspective. If associations are
      observed in this study, the results may encouraged prevention strategy.
    

Detailed description: 
      Cases and controls will benefit, as usual in France concerning infertility etiology
      examinations, of a follicle antral count by transvaginal ultrasound and AMH measurement.

      At baseline, physicians will complete a short questionnaire to check the inclusion criterion,
      the results of the measurement of follicle count and hormone measurement (including AMH).
      Cases and controls will respond to self-administered questionnaire at inclusion with
      information about their medical history, their demographics, their tobacco and alcohol
      consumption, their occupation and products handled in the workplace. Blood samples (for
      measure of persistent organic pollutants and heavy metals) and urine (for measure of
      metabolites of glycol ethers) will be collect at baseline. Occupational exposures to solvents
      will be defined using job exposures matrices. The risk of decreased ovarian reserve will be
      analyzed using logistic regressions for each exposure of interest adjusting for potential
      confounders.
    

Intervention name(s): Self-administered questionnaire and blood and urine samples
Intervention type(s): Other
Intervention description(s): Self-administered questionnaire and blood and urine samples
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Early ovarian reserve decreased
Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Condition: Arthritis; Rheumatoid; High Dose
MeSH terms: Arthritis
Study type: Observational

Summary: 
      This Investigation is to be performed for the purpose of assessing the following information
      in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX
      2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher than 8
      mg/week.

        1. Condition of occurrence of ADRs

        2. Factors considered to affect safety

        3. Verification of efficacy
    

Detailed description: 
      Implemented as a Special Investigation by Central Registration System
    

Intervention name(s): Methotrexate (MTX)
Intervention type(s): Drug
Intervention description(s): Methotrexate should be administered at the weekly dose of 6 mg orally once a week or twice or three times a week by subdividing the weekly dose into the relevant number of portions. When administering the subdivided doses, MTX should be administered at the interval of 12 hours on Day 1 to Day 2. When the weekly dose is subdivided into two portions, suspend the administration for the remaining 6 days. When the weekly dose is subdivided into three portions, suspend the administration on the remaining 5 days. Repeat this weekly cycle. The dose should be adjusted as appropriate depending on the age, symptom, tolerability, and response to the MTX Preparation in individual patients. The weekly dose should not be higher than 16 mg.
Other intervention name(s): Rheumatrex
Intervention MeSH terms: Methotrexate
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the
        treatment of Rheumatoid Arthritis.
      
Keywords: Rheumatrex; High Dose
REduction of Physical Inactivity Facing the CAncer
Condition: Breast Cancer
Study type: Interventional

Summary: 
      Study 1:

      The investigator hypothesizes that the level of knowledge about the benefits of physical
      activity, physical activity level and physical fatigue level observed in cancer patients,
      would influence their beliefs about physical activity and their intention to engage in AP.
    

Detailed description: 
      Study 2:

      Because of a recent research, it is shown that a narrative message from a peer generates an
      identification, a sense of self-efficacy and intention to practice in sedentary patients with
      breast cancer.

      The investigator hypothesize that a promotional message about physical activity, issued by a
      self-determined peer (intrinsic motivation), compared to a non-self-determined peer
      (extrinsic motivation), generate higher scores of positive beliefs about physical activity
      and intention to engage in a physical activity program for sedentary patients.

      These promotional messages will be delivered through two videos, one featuring the
      self-determined pair, the other featuring the non-self-determined pair.
    

Intervention name(s): Physical activity motivation
Intervention type(s): Other
Intervention description(s): Physical activity motivation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      This study is being conducted to determine the percentage of patients with solid spinal
      fusions after being treated with Osteocel Plus in a TLIF procedure. Due to the unique
      processing conditions, Osteocel Plus retains a high concentration of stem cells in
      conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with
      Osteocel Plus will be comparable to published data for autograft. The Osteocel product family
      has already been used in approximately 15,000 cases worldwide.
    

Detailed description: 
      This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus
      in subjects who receive TLIF surgery at one or two levels. These subjects will present with
      degenerative conditions in the lumbar spine that are amenable to surgical treatment and will
      be screened prior to study enrollment. Subjects will receive Osteocel Plus during their TLIF
      operation. Subjects will be followed for 24-months following surgery to determine the number
      of study subjects that are solidly fused at or before 24 months postoperatively, and to
      determine the mean time to fusion. This data will be compared to published and/or
      retrospective data for autograft, synthetic ceramics and BMP.
    

Intervention name(s): Osteocel Plus
Intervention type(s): Biological
Intervention description(s): biologic
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Existing clinic patients
      
Keywords: fusion rates; TLIF; Osteocel Plus; biologics; lumbar fusion
Effects of Sulforaphane on Normal Prostate Tissue
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators proposed to identify the biological effects of a high-sulforaphane broccoli
      sprout extract in normal prostate tissue.

      The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract
      every other day will inhibit growth of prostate cancer cells.
    


Intervention name(s): High Sulforaphane Extract (Broccoli Sprout Extract); Microcrystalline Cellulose NF (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): 100 umol sulforaphane, every other day for 5 weeks; 250 mg every other day for 6 weeks
Other intervention name(s): Broccoli Sprout Extract
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of a Multi-strain Probiotic Formulation on Immune Response to Influenza Vaccination
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Randomized clinical trial to determine whether a probiotic formulation containing 4 probiotic
      strains which belong to Lactiplantibacillus plantarum and Pediococcus acidilactici species
      can boost the immune response to influenza vaccination evaluated at 4 weeks in a population
      between 50 and 80 years of age. Secondary outcomes comprise evaluation of immune response at
      8 weeks after vaccination, percentage of patients with seroconversion, incidence and duration
      of influenza-like infections and respiratory infections throughout a 4-month period and
      safety.
    

Detailed description: 
      Double blind, randomized, placebo-controlled clinical trial to determine whether
      supplementation with a probiotic formulation containing 4 probiotic strains (L. plantarum
      CECT 30292, CECT7484, CECT7485 and P. acidilactici CECT7483) can improve immune response to
      seasonal influenza vaccination. Subjects with age comprised between 50 and 80 years who meet
      inclusion and exclusion criteria will be randomized 1:1 to one of the following study groups:
      one will receive probiotic formulation for 28 days (1 capsule/day) and the other will receive
      placebo, starting the same day of the influenza vaccination. Main study outcome will be
      immune response at 4 weeks after vaccination, which will be determined by analysis of
      specific IgG antibodies in serum against influenza A and B. Secondary outcomes comprise serum
      titers of specific IgG at 8 weeks after vaccination, percentage of patients with
      seroconversion at 4 and 8 weeks, evaluation of influenza-like infections or respiratory
      infections throughout a 4-month period and adverse events.
    

Intervention name(s): Food Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic multistrain formulation containing Lactiplantibacillus plantarum CECT30292, CECT7484, CECT7485 and P. acidilactici CECT7483 for 28 days, starting the same day of influenza vaccination; One maltodextrin-containing capsule/day for 28 days, starting the same day of influenza vaccination
Other intervention name(s): Probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, randomized controlled trial in 140 subjects 50-80 years old receiving influenza vaccination, who will be allocated to receive either an experimental product containing multi-strain probiotic formula or placebo for 28 days
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: influenza vaccination, probiotic
Lipids, Inflammation, and CV Risk in RA
Condition: Rheumatoid Arthritis; Cardiovascular Disease
MeSH terms: Arthritis; Arthritis, Rheumatoid; Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      The objective of this study is to elucidate the relationship between inflammation and
      lipoprotein atherogenicity, and to determine the relative contribution of inflammation and
      lipids to CV risk in RA. The central hypothesis of this study is that inflammation and
      lipoprotein atherogenicity is tightly linked such that both factors are important to assess
      CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by a
      consideration of routine lipids alone.
    


Intervention name(s): certolizumab; Stress myocardial perfusion PET
Intervention type(s): Drug; Radiation
Intervention description(s): Subjects who are about to start TNFi therapy as part of usual therapy will be enrolled. In this study we will provide the drug, certolizumab.; We will measure coronary flow reserve (CFR) using cardiac PET before the patients starts TNFi and 24 weeks after starting TNFi.
Other intervention name(s): Cimzia; Cardiac PET
Intervention MeSH terms: Certolizumab Pegol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1
Condition: Heroin Dependence; Opioid-Related Disorders; Substance Abuse, Intravenous
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Heroin Dependence; Substance Abuse, Intravenous
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM
      enhanced with additional education about addiction and recovery (Enhanced Medical Management,
      EMM)
    

Detailed description: 
      A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent
      subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced
      Medical Management. SMM is a brief intervention similar to that provided by primary
      practitioners to patients with chronic medical conditions such as diabetes. EMM is an
      intervention that provides education about the recovery process and advice about lifestyle
      changes and 12-step participation. Outcome measures include reduction in opioid use and
      abstinence from opioids, documented by 3x/week urine testing and self report.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): Experimental Standard Medical Management with once-weekly medication dispensing
Experimental Standard Medical Management with thrice-weekly medication dispensing
Experimental Enhanced Medical Management with thrice-weekly medication dispensing
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Opioid-Related Disorders
Treatment Outcome in CBT for Cocaine Use
Condition: Cocaine Use Disorder
Study type: Interventional

Summary: 
      Cognitive-behavioral treatments for cocaine abuse could be improved by an increased
      understanding of factors that predict treatment outcomes. The objective of this protocol is
      to conduct a study examining the impact of client characteristics on the effects of
      cognitive-behavioral therapy for cocaine abuse.
    

Detailed description: 
      Study investigators will recruit treatment-seeking cocaine users (n = 100) from a separate
      protocol (#6912) who will receive a standard 12-week course of cognitive behavioral therapy
      for relapse prevention. Using a variety of self-report questionnaires and computer-based
      tasks, three major domains will be assessed and evaluated as predictors of treatment outcome:
      (1) impulsivity, (2) motivation to change, and (3) learning style. Measures of these factors
      will have been obtained in the #6912 protocol. A better understanding of the impact of
      impulsivity, motivation to change, and learning style on treatment outcome will provide
      critical information to guide the refinement of CBT for cocaine abuse. For example, the
      results of this study may help guide the development and introduction of more targeted
      cognitive remedial strategies or behavioral training components into the framework of
      evidenced-based practices. These additions may help ameliorate the deleterious effects of
      specific participant characteristics on the acquisition and implementation of coping skills,
      which can further improve the efficacy of CBT.
    

Intervention name(s): CBT-RP
Intervention type(s): Behavioral
Intervention description(s): CBT-RP is a time-limited, manual guided intervention that aims to develop behavioral and cognitive skills needed to initiate abstinence and prevent relapse. The treatment will help individuals analyze the decision making process to minimize the influence of more immediate reinforcement, develop cognitive strategies to promote the attainment of longer-term goals, practice behavioral strategies to reduce the influence of socially mediated threats to abstinence, and outline explicit plans for managing situations that threaten their goal of abstinence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cocaine Abuse; Cocaine Use Disorder; Substance-Related Disorders
Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study assesses the pharmacokinetic profile of Ivermectin (IVM) in healthy human
      volunteers and aims to create a physiologically-based pharmacokinetic model. Planned
      indication is the prevention of malaria transmission.
    

Detailed description: 
      Ivermectin (IVM) is a broad spectrum antiparasitic drug. Recent research indicates that IVM
      could potentially be used in malaria vector control.

      The present study assesses the pharmacokinetic profile of IVM in healthy human volunteers and
      aims to create a physiologically-based pharmacokinetic model. This model will be used to
      characterize enterohepatic circulation, serve as a basis for drug-drug and drug-disease-state
      interaction studies, and simulations of IVM disposition in different populations, with
      special regard given to adolescents and children. With this, safety in individual
      administrations can be increased, and mass drug administration programs, e.g. oral IVM as
      malaria vector control, be simulated and planned to maximize the share of a population that
      can be included. Capillary blood concentration profiles will also be determined to assess the
      amount of IVM delivered to mosquitos in malaria vector control programs. Furthermore, this
      study will validate dried blood spot analytics of IVM which will allow easier procurement of
      pharmacokinetics (PK) data in the field.
    

Intervention name(s): Ivermectin
Intervention type(s): Drug
Other intervention name(s): Stromectol
Intervention MeSH terms: Ivermectin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)
Condition: Hypogonadism; Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess if corifollitropin alfa (MK-8962), when administered in combination
      with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who
      remain azoospermic after treatment with hCG alone.

      Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in
      testicular volume from Day 1 to Week 52 is greater than one.
    


Intervention name(s): Corifollitropin alfa; hCG
Intervention type(s): Drug; Drug
Intervention description(s): Corifollitropin alfa 150 μg by SC injection, once every 2 weeks for 52 weeks; hCG 1500 or 3000 IU by SC injection twice a week; administered alone for 16 weeks (pre-treatment phase) and then in combination with corifollitropin alfa for 52 weeks (combined treatment phase)
Other intervention name(s): MK-8962
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double-blind, Placebo-controlled Study to Evaluate Very Low Dose LSD in Healthy Volunteers Aged 55-75 Years
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a Phase 1, double-blind, placebo-controlled, randomised study of very low dose
      LSD. Healthy volunteers aged 55 to 75 years with no use of LSD in the past 5 years were
      screened within 28 days of randomization. Subjects who met all inclusion and no exclusion
      criteria and provided written informed consent were randomised a 1:1:1:1 ratio to receive 6
      doses of 5 µg, 10 µg, or 20 µg LSD or placebo, at 4-day intervals for 21 days (on Study Days
      1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the
      last dose of LSD. A total of 48 subjects were enrolled.
    

Detailed description: 
      The magnitude of the effect of LSD was explored across specific PD measures.

      These included:

        -  Cognition and affect, including evaluation of memory, temporal perception, executive
           function, and learning

        -  Subjective effects

        -  Proprioception and balance
    

Intervention name(s): Lysergic acid diethylamide (LSD) 5µg; Lysergic acid diethylamide (LSD) 10µg; Lysergic acid diethylamide (LSD)20 µg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Lysergic Acid Diethylamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers
Condition: Bioequivalence; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a comparative bioavailability study performed to assess bioequivalence between
      Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC
      "Pharmaceutical firm "Darnitsa", Ukraine) and Reference medicinal product (marketed medicinal
      product INSPRA® 50 mg eplerenone film-coated tablets, Marketing Authorisation Holder: Pfizer
      Europe MA EEIG, Belgium) in healthy volunteers.
    


Intervention name(s): Efez 50 mg eplerenone film-coated tablets; INSPRA® 50 mg eplerenone film-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone; Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-period, two-sequence, two-way, crossover, single dose study
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; eplerenone; healthy subjects; pharmacokinetics