bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Three Toothpastes Using an in Situ Caries Model
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period
      crossover, incomplete block design, in situ caries study in healthy adults who wear a
      removable bilateral mandibular partial denture. The denture will be modified to accommodate 4
      gauze-covered specimens of human dental enamel (4x3mm) that have been previously
      demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type
      will be used with each participant). After 14 days of twice daily product use off-site, the 2
      S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion
      specimens removed at the study site after a further 14 days of product use. To determine the
      remineralization ability of the treatments, all specimens will be analyzed by transverse
      microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally
      analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by
      quantitative light fluorescence (QLF).
    


Intervention name(s): 0.425 % w/w phytate,1150ppm F; 0.85 % w/w phytate,1150ppm F; 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F; 0 ppm F; 1150ppm F; 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F
Intervention type(s): Drug; Drug; Drug; Other; Drug; Drug
Intervention description(s): Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.; Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.; Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.; Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.; Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.; Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
Intervention MeSH terms: Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to determine if there is a pharmacological interaction between
      clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this
      possible interaction would change over time.
    


Intervention name(s): lansoprazole; omeprazole; esomeprazole; clopidogrel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 60 mg (2x30-mg capsule), once daily; 80 mg (2x40-mg capsule), once daily; 40 mg (1x40-mg capsule), once daily; 300 mg loading dose on Day 1 then 75 mg daily for 28 days
Intervention MeSH terms: Esomeprazole; Omeprazole; Lansoprazole; Dexlansoprazole; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: open label; randomized; 4-treatment; 3-period; crossover; interaction study; Safety; tolerability; pharmacokinetics; pharmacodynamics
Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia
Condition: Total Hip Arthroplasty
Study type: Interventional

Summary: 
      This prospective study is intended to compare the analgesic efficacy, preservation of lower
      extremity motor power and side-effect profile of L2 Paravertebral lumbar plexus approach
      compared to Posterior nerve stimulation guided lumbar plexus approach, continuous local
      anesthetic infusion postoperative analgesia of Total Hip Arthroplasty.

      The L2 Paravertebral technique of lumbar plexus block, as part of a multimodal pain
      treatment, could be a cost-effective alternative with a equal profile of analgesic efficacy
      and motor power sparing with greater promotion of early achievement of postoperative physical
      therapy goals.
    

Detailed description: 
      The nerve stimulator guided technique of continuous lumbar plexus block (LPB) is the accepted
      standard of care at University of Pittsburgh Medical Center (UPMC) for the management of
      postoperative analgesia after Total Hip Arthroplasty. Over 900 continuous lumbar plexus
      blocks were performed at UPMC Presbyterian Shadyside hospital within the last year alone.
      Continuous thoracic paravertebral block (TPVB) is also commonly performed at UPMC
      Presbyterian Shadyside . Over 2000 are performed annually for a wide variety of surgical
      procedures. Recently authors have suggested that a lumbar paravertebral block (LPVB) may
      represent an alternative approach to the lumbar plexus. Indeed the L2 paravertebral approach
      of the lumbar plexus has been described to provide adequate postoperative analgesia following
      hip arthroscopic surgery. However, to date, there is no prospective direct comparison between
      L2 Lumbar plexus approach and the posterior approach for postoperative analgesia after Total
      Hip Arthroplasty.
    

Intervention name(s): L2 Paravertebral catheter nerve block; Continuous Lumbar plexus nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): A continuous L2 paravertebral catheter will be placed according to UPMC standard of care practices.; A continuous unilateral lumbar plexus catheter will be placed according to UPMC standard of care practices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Pain; Nerve block; Total Hip Arthroplasty; Postoperative analgesia; Lumbar Plexus Catheters; L2 Paravertebral Catheters
Pasteurization of Mother's Own Milk for Preterm Infants
Condition: Sepsis
Study type: Interventional

Summary: 
      We hypothesize that short term infection-related benefits of human milk feeding are decreased
      by the process of pasteurization. Primary objective of the study is to compare the incidence
      of late-onset sepsis in very low birth weight infants assigned randomly to receive either
      pasteurized or raw expressed mothers'own milk.
    

Detailed description: 
      In this prospective, randomized, controlled trial, all patients born before 32 weeks of
      gestational age and/or with birth weight below 1500 g admitted to the tertiary neonatal
      intensive care unit(NICU) of the University Hospitals Leuven within 24 hours of birth, are
      eligible for inclusion in the study except for infants who died within the first 24 hours.
      Infants whose mothers intend to breastfeed will be randomly assigned, using a digital system,
      to receive either raw or pasteurized mother's own milk. The duration of the study is from
      birth to eight weeks of age or to discharge from the NICU, whichever occurs first. The need
      to ensure proper handling of the milk precludes true blinding of the caregivers. The
      institutional review board approved the study and written informed parental consent iss
      obtained before enrolment.
    

Intervention name(s): pasteurization of mother's own milk
Intervention type(s): Other
Intervention description(s): mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.
Other intervention name(s): pasteurization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: pasteurization; human milk; very low birth weight infants
Reproductive Health Outcomes by Method of Breast Milk Feeding
Condition: Breast Feeding; Milk Expression, Breast; Amenorrhea, Postpartum
MeSH terms: Amenorrhea
Study type: Observational

Summary: 
      The purpose of this research is to determine whether there are differences in ovarian
      suppression between women who are feeding at the breast compared with women who are pumping.

        -  In the main study, the aim is to compare reproductive health outcomes, including
           amenorrhea rates, duration of lactation, and resumption of sexual activity, between
           mothers who are exclusively breastfeeding (i.e. feeding at the breast) and those who are
           pumping after a term or preterm delivery.

        -  In the sub-study, the aim is to determine the feasibility and acceptability of using
           urinary luteinizing hormone (LH) detection kits at home to detect ovulation in
           exclusively breastmilk feeding women.
    

Detailed description: 
      Women will be recruited for this study during routine prenatal care. Interested and eligible
      participants will undergo an informed consent process. After, participants will answer
      questions regarding demographic information, medical history, obstetric and reproductive
      history, previous lactation history, and the Infant Feeding Intentions questionnaire.

      Participants who are eligible after the second eligibility verification at the time of
      delivery hospitalization will be enrolled in the study. Enrolled participants will be given
      breastmilk and infant feeding logs to complete. Study staff will contact participants at 1,
      2, 3, 4, 5, and 6 months after delivery to ask about breastmilk feeding practices in the last
      24 hours, infant feeding, vaginal bleeding, sexual activity, use of contraceptive methods,
      and repeat pregnancies. In between the monthly phone calls, study staff will ask participants
      about the occurrence of vaginal bleeding.

      For the sub-study, participants are recruited from the main study. Those who are eligible and
      interested will undergo an informed consent process. Participants will be given urinary LH
      detection kits and instructions for use at time of enrollment. Daily urine LH testing will
      start after 8 weeks postpartum. Participants will also receive monthly diaries to complete in
      addition to the breastmilk and infant feeding logs in the main study. Study staff will
      contact participants at 2, 3, 4, 5, and 6 months to review the diary information. If the
      urine LH test is positive, the participant will undergo a blood draw for serum progesterone
      levels to confirm ovulation.

      The planned enrollment is 394 participants for the main study and 40 participants in the
      sub-study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who are planning on breastmilk feeding for at least 6 months after delivery of a
        singleton.
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg
      combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin
      40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
    


Intervention name(s): Atorvastatin; Ezetimibe; Ezetimibe/atorvastatin; Placebo to atorvastatin; Placebo to ezetimibe; Placebo to ezetimibe/atorvastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 40 mg tablet administered orally once daily; 10 mg tablet administered orally once daily; Ezetimibe/atorvastatin 10 mg/40 mg combination tablet administered orally once daily; Administered orally once daily; Administered orally once daily; Administered orally once daily
Other intervention name(s): Lipitor®; Zetia®; Liptruzet®; MK-0653C
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence (comparison of the rate and
      extent of the active substance into the body following single administration of the drugs)
      between the test product V0057 and a reference product after two single oral administration
      separate by 7 days.
    


Intervention name(s): V0057 - A mg; Isotretinoin
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration; Single oral administration
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Memory in Parkinson's Disease
Condition: Memory; Prospective Memory; Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The investigators tested whether prospective memory is impaired in individuals with
      Parkinson's Disease compared to controls using reliable and validated experimental measures.
      Also, the investigators assessed the impact of Parkinson's medication on prospective memory
      performance in PD to better estimate prospective memory function in PD patients' everyday
      (chronically treated) life.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community Movement Disorder Clinic at Washington University St. Louis
      
Keywords: Prospective Memory Performance; Prospective Memory Outcome; Parkinson's Disease
Intensive Meditation and Migraines: Effects on Health and Well Being
Condition: Chronic Daily Headache
MeSH terms: Migraine Disorders; Headache Disorders; Headache
Study type: Interventional

Summary: 
      Participants completing training in intensive meditation and continuing frequent practice for
      one year would experience reduced frequency, duration and severity of headaches along with
      improved awareness of the triggers of their symptoms, improved quality of life and mental
      health, improved heart rate variability, and reduced inflammation.
    


Intervention name(s): Vipassana Meditation
Intervention type(s): Behavioral
Intervention description(s): 12 day retreat where participants learn to meditate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Headache; Vipassana; Meditation; Intensive
Cross-over Study on Effect of Lipid Lowering by Acipimox on Cardiac and Skeletal Muscle Mitochondrial Function
Condition: Diabetes Mellitus, Type 2; Cardiomyopathy, Dilated
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Accumulation of lipid in skeletal and cardiac muscle has been associated with insulin
      resistance and diabetic cardiomyopathy. In skeletal muscle, lipotoxic damage has been
      suggested to lead to dysfunction of mitochondria. It remains unknown whether lipotoxicity
      leads to mitochondrial dysfunction in heart as well, and if so, whether this also leads to
      cardiomyopathy (failure of the heart). Although it has been shown that lipid lowering agents
      can improve insulin sensitivity, the effect of lowering free fatty acids on cardiac and
      skeletal muscle mitochondrial function remains unknown. In this study the investigators want
      to investigate whether lowering cardiac and muscular lipid content will improve mitochondrial
      and cellular function in type 2 diabetic patients.

      To this end, type 2 diabetic patients and body mass index (BMI)-matched controls will be
      included in a blinded cross-over design, in which subjects will receive a lipid lowering
      agent (Acipimox) or placebo for 2 weeks in random order. During treatment, diabetes
      medication will be stopped. Baseline measurements will be performed prior to the study and
      after each treatment to assess cardiac and muscular lipid accumulation, cardiac function,
      mitochondrial function and insulin sensitivity.
    


Intervention name(s): Acipimox; Cellulosum Mycrocryst
Intervention type(s): Drug; Drug
Intervention description(s): A capsula is given with 250mg Acipimox, 3dd; 1 after each meal. This will be done during 14 days.; Capsule with cellulosum powder; this has to be taken 3 dd; 1 after each meal during 14 days.
Other intervention name(s): Olbetam; Nedios; Placebo
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Mitochondrial function; Diabetes; Cardiomyopathy; insulin resistance; lipid lowering; triglycerides; Acipimox
Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Cystocele
Study type: Interventional

Summary: 
      The goal of this interventional study is to compare the effect of Concurrent cystocele repair
      and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with
      diagnosed stress urinary incontinence and cystocele. The main questions to answer are:

      1-What are the effects of the tested Interventions on the outcomes measured by The Pelvic
      Organ Prolapse Quantification (POP-Q) System?

        1. What are the effects of the tested Interventions on the degree of pelvic organ prolapse?

        2. What are the effects of the tested Interventions on the frequency, severity, and effect
           of Stress urinary incontinence on the quality of life of the patients?

        3. What are the effects of the tested Interventions on the impact of lower urinary tract
           symptoms on the quality of the patient's life?

      Female Patients diagnosed with SUI indicated for intervention were divided into 2 groups

      Group I: (n=49) offered TOT alone

      Group II: (n=49) offered concurrent TOT and Cystocele Repair

      Patients were then followed up and evaluated using The Pelvic Organ Prolapse Quantification
      (POP-Q) System, The International Consultation on Incontinence Questionnaire-Short Form
      (ICIQ-SF), and the King Health Questionnaire (KHQ). The efficacy of both procedures and their
      impact on SUI and quality of life was measured.
    


Intervention name(s): Trans Obturator Tape Procedure (TOT); Cystocele Repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Done under Spinal anesthesia in the dorsal lithotomy position.; Done under Spinal anesthesia in the dorsal lithotomy position..
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary Incontinence, Stress; Cystocele; Trans Obturator Tape; Pelvic Organ Prolapse
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of
      erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected
      to participate for up to 30 weeks. Eligible patients will be randomised to receive either
      MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.
    


Intervention name(s): MED3000 (Male); Tadalafil 5mg (Male); MED3000 (Female); Tadalafil 5mg (Female)
Intervention type(s): Device; Drug; Device; Drug
Intervention description(s): Gel formulation; Tablets; Gel formulation; Tablets
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
Masking: None (Open Label)
Primary purpose: Treatment
A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may
      receive Venlafaxine or placebo during the course of the trial. All subjects will, in fact,
      receive placebo for the first two weeks. All subjects will then be placed on 150-225 mg per
      day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after
      placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment).

      Study Hypothesis:

      In subjects who continue to have activity-limiting osteoarthritis pain after treatment with
      acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over
      10 weeks will provide significant additional pain relief over that achieved with placebo
      (more than 30% reduction after Venlafaxine treatment).
    


Intervention name(s): Venlafaxine
Intervention type(s): Drug
Intervention description(s): Weeks 0-2: placebo. Weeks 2-3: 75 mg Venlafaxine. Weeks 3-4: 150 mg Venlafaxine. Weeks 4-12: 150-225 mg Venlafaxine.
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: osteoarthritis pain; activity limitation; antidepressant; depression; single-blind
To Determine the Minimum Amount of Alternaria Alternata Allergen Extract Producing a Positive Skin Reaction.
Condition: Allergy to Alternaria Fungus
Study type: Interventional
Phase: Phase 2

Summary: 
      The objetive of this study is to determine the minimum amount of Alternaria alternata
      allergen extract producing in a positive skin reaction.
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The primary objective is to
      assess the concentration of alternaria alternata allergen extract that elicits a wheal size
      equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
    

Intervention name(s): four differente concentrations of Alternaria alternata allergen extract, positive control and negative control
Intervention type(s): Biological
Intervention description(s): This concentrations will be tested in every patient in duplicate on the volar surface of the forearm.
Other intervention name(s): Four concentratios of Alternaria alternata together with a positive and negative control.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Immunotherapy; Skin prick test; Standardization; Alternaria alternata