bioihbjkbjnl/mcl2 huggingface dataset:
Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the effects of galactooligosaccharide (GOS)
      supplementation on calcium absorption and and gut microbe profiles.
    

Detailed description: 
      Galactooligosaccharides (GOS) have been shown to have positive effects on calcium absorption
      in animals and postmenopausal women. This study aims to see whether the addition of fiber in
      the form of GOS to a calcium-containing yogurt drink will increase calcium absorption
      compared to placebo in a group of girls near menarche. Secondary outcomes are to assess
      physical fitness and determine the relationship between physical fitness and calcium
      absorption in adolescent girls as well as assess changes in gut microbiota. During this three
      phase, randomized, controlled crossover study, participants will consume yogurt drinks
      supplemented with 0, 2.5 or 5 grams of GOS twice daily for three weeks. Following each three
      week period, participants will complete a weekend clinical visit to measure calcium
      absorption. Height, weight, bone density and geometry, calcium absorption, gut microbiota and
      physical fitness will be measured. Effects of this GOS fiber intervention may help elucidate
      a mechanism of action for improving bone health with fiber supplementation.
    

Intervention name(s): Galactooligosaccharide
Intervention type(s): Dietary Supplement
Intervention description(s): Zero, 5 or 10 g/day of galactooligosaccharide will be administered in two yogurt drinks containing about 300 mg total calcium each per day for three weeks. During a clinical visit following three weeks of consumption, zero, 2.5 or 5 g of galactooligosaccharide will be administered in the same yogurt with the addition of 15 mg Ca-44 (calcium chloride). Participants will be given one of the above yogurts at breakfast in addition to intravenously receiving 3.5 mg Ca-43 (calcium chloride) in 4 ml saline one hour after breakfast consumption.
Other intervention name(s): Friesland
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Dietary Supplement: Galactooligosaccharide
Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This research is being done to study how the immune system in the small intestine improves
      after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the
      increase in the numbers of immune cells in the intestine to see if one type of HIV medication
      gives different results than other types of HIV medications.
    

Detailed description: 
      While the world-wide AIDS epidemic continues to impact millions of individuals, effective
      anti-HIV medications have substantially reduced morbidity and mortality for those patients
      able to adhere to combination regimens. Despite improved survival, durable virologic
      suppression, and increases in peripheral CD4+T-cell counts in patients receiving potent
      antiretroviral therapy (ART), immune reconstitution remains incomplete as measured by a
      number of additional surrogate markers. Perhaps critically important among areas of apparent
      incomplete immune recovery is the gastrointestinal-associated lymphoid tissue (GALT), where
      CD4+T-cells repopulate very slowly, if at all. Raltegravir is a new ART agent from a novel
      class of HIV inhibitors, integrase inhibitors, that results in rapid suppression of HIV and
      recovery of peripheral CD4+T-cells. This project proposes to examine whether volunteers
      receiving raltegravir recover GALT immune cells more completely than those taking comparator
      ART.
    

Intervention name(s): raltegravir; efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): 400mg tablet twice daily by mouth for nine months; 600mg capsule once daily by mouth without regard to food
Other intervention name(s): Isentress; Sustiva
Intervention MeSH terms: Efavirenz; Raltegravir Potassium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Positive; AIDS; Antiretroviral Therapy; Gastrointestinal-Associated Lymphoid Tissue; Immune Reconstitution; treatment experienced
Correlation Between Serum Anti-Müllerian Hormone & Müllerian Ducts Anomalies in Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric
      glycoprotein that belongs to the transforming growth factor-beta family. It is involved in
      the regression of the Müllerian ducts during male fetal development. In the female, AMH is
      solely produced by the granulosa cells of preantral and small antral follicles, and regulates
      ovarian activity and follicular steroidogenesis
    

Detailed description: 
      Following approval of the internal review board of Egyptian IVF-ET center, a retrospective
      analysis will be undertaken where a detailed review of the patients files who underwent
      intracytoplasmic sperm injection (ICSI) trials starting January 2010 till January 2015 will
      be done.

      Patients with diagnosed mullerian anomalies will have their name , age ,duration of
      infertility, serum FSH, LH ,& AMH levels recorded. The method of diagnosis (HSG,
      3D/ultrasonography, hysteroscopy, or laparoscopy) will also be documented.
    

Intervention name(s): Anti Mullerian hormone level; Mullerian duct anomaly type
Intervention type(s): Other
Intervention description(s): Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels
Intervention MeSH terms: Hormones
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        female undergoing intraCytoplasmic sperm injection for treatment of infertility
      
Keywords: anti-Müllerian hormone (AMH); Mullerian anomalies; ICSI
Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Estrogen can cause the growth of
      breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the
      amount of estrogen the body makes. Giving trastuzumab together with letrozole after disease
      progression may be an effective treatment for breast cancer.

      PURPOSE: This phase II trial is studying how well giving trastuzumab together with letrozole
      works in treating postmenopausal women with progressive advanced breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of trastuzumab (Herceptin®) monotherapy followed by trastuzumab
           and letrozole in women with progressive advanced breast cancer that is resistant to
           prior treatment with a nonsteroidal aromatase inhibitor.

      Secondary

        -  Determine the safety profile of this regimen in these patients.

        -  Correlate HER-2-extracellular domain (ECD) levels with response to treatment in these
           patients.

        -  Determine the efficacy of this regimen in these patients.

        -  Correlate response and time to tumor progression with changes in serum HER-2-ECD levels
           in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1-3 OR once in
      week 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
      toxicity. Patients experiencing disease progression after 9 weeks receive trastuzumab as
      before and oral letrozole once daily in the absence of further disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed every 12 weeks until disease
      progression and then at 6 months.

      PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study.
    

Intervention name(s): Trastuzumab + Letrozole
Intervention type(s): Drug
Intervention description(s): Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1-3 OR once in week 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression after 9 weeks receive trastuzumab as before and oral letrozole once daily in the absence of further disease progression or unacceptable toxicity.
Intervention MeSH terms: Trastuzumab; Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer
Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea
      (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to
      atomoxetine alone.
    

Detailed description: 
      The SEED study is an open-label, 4 consecutive period dose-escalation study of combinations
      of AD313 vs. atomoxetine alone in participants with moderate- to severe OSA. A screening
      polysomnogram (PSG) will be conducted to establish that each participant meets study
      enrollment criteria and to serve as baseline. Each participant will then receive escalating
      doses of AD313 with on-drug PSGs to be conducted on the final night of dosing.
    

Intervention name(s): Dosing 1: Atomoxetine; AD313
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration at bedtime; Escalating dose of AD313; Oral administration at bedtime
Other intervention name(s): 40mg or 80 mg Atomoxetine; atomoxetine dronabinol
Intervention MeSH terms: Dronabinol; Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Apnea, Obstructive Sleep; Sleep Apnea Syndromes; Upper Airway Reistance Syndrome
Bioavailability of ABT-450 and ABT-267 With Ritonavir
Condition: Absolute Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in
      combination with each other and Ritonavir(r).
    

Detailed description: 
      Absolute bioavailability of ABT-267 and ABT-450 in the body when given together
    

Intervention name(s): ABT-450/r/ABT-267
Intervention type(s): Drug
Intervention description(s): ABT-450, ABT-267 and ritonavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: absolute bioavailability; healthy volunteers
Vagal Nerve Stimulation Assessed by the Diving Reflex: An Investigation Into Mechanisms of Asthma Death
Condition: Asthma; Syncope
MeSH terms: Asthma; Syncope
Study type: Interventional

Summary: 
      The investigators' hypothesis is that dysregulation of autonomic function, as revealed during
      a simulated dive reflex, may result in an attenuation of the heart rate response to a greater
      degree in asthmatics who collapse during exacerbations of asthma than that seen in healthy
      individuals and in asthmatics without a history of syncope. The investigators will test this
      by assessing autonomic function through a dive reflex protocol.
    

Detailed description: 
      Tests of autonomic function are notoriously difficult to evaluate. Here the investigators
      required a well validated test of the dynamic cardiovascular response to an abrupt stimulus
      and considered the diving reflex the most reliable and practical. In man, the diving reflex
      acts as a vestigial reflex aimed at conserving oxygen storage during apnoeic facial
      immersion. Facial immersion activates a vagally-induced bradycardia and a sympathetically
      activated alpha-adrenergic peripheral vasoconstriction and hypertension. There are two
      triggers of the diving reflex, facial immersion in water and breath hold, both of which can
      impact on heart rate attenuation. Facial immersion can be further delineated into exposure to
      cold, wetness and pressure.
    

Intervention name(s): Simulated dive reflex
Intervention type(s): Procedure
Intervention description(s): All subjects undergo simulated dive reflex, with 30s facial immersion and continuous HR and BP monitoring with Nexfin over a period of 6 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma; Death; Mechanism; Syncope; Dive reflex
Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
Condition: Cytomegalovirus Congenital; Hearing Loss; Neurodevelopmental Disorders; Immunogenicity; Neonatal Death; Stillbirth
MeSH terms: Hearing Loss; Stillbirth; Perinatal Death; Neurodevelopmental Disorders
Study type: Observational

Summary: 
      The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV)
      infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent
      setting in Soweto, Johannesburg. A cross-sectional study will be conducted on mother-infant
      pairs, screening mothers for CMV infection and newborns for congenital CMV infection.
      Maternal CMV prevalence will be determined by testing for CMV specific antibodies in blood.
      Newborn congenital infection will be determined by polymerase chain reaction (PCR) tests on
      newborn saliva and urine within 3 weeks of birth. Various risk factors associated with
      congenital CMV such as HIV exposure, and gestational age will be assessed. The association
      between maternal vaginal CMV shedding postnatally with congenital CMV infection will be
      explored by swabbing maternal vaginal fluid and conducting quantitative CMV PCR analysis.
      Newborns confirmed with congenital CMV and a control group of uninfected newborns will form a
      cohort to be followed up until 12 months of age monitoring for various neurological sequelae
      such as hearing loss, neurodevelopmental impairment, ocular damage, cerebral damage and
      seizures.

      A comparison of vaccine immune responses between cases of congenital CMV and the CMV
      uninfected infants to the primary series of vaccines in the National Expanded Programme on
      Immunisation will be compared. The contribution of CMV infection to neonatal death and
      stillbirths will be described by minimally invasive tissue sampling (MITS) for CMV on babies
      that die during the neonatal period and stillbirths.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborns of women aged 18 years or older born at Chris Hani Baragwanath Academic hospital
        in the Johannesburg area enrolled in V98_28OBTP (NCT02215226).

        Stillbirths and Neonatal deaths at Chris Hani Baragwanath Academic hospital in the
        Johannesburg area.
Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Observational

Summary: 
      Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated
      appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in
      discriminating between perforated and simple/no appendicitis.

      Methods:

      All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to
      August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin
      levels to detect perforated appendicitis.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients undergoing appendectomy for suspected appendicitis
First-in-Human Single and Multiple Dose of GLPG1837
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to evaluate the safety and tolerability after
      single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also,
      the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy
      subjects daily for 14 days compared to placebo, will be evaluated.

      Furthermore, during the course of the study after single and multiple oral dose
      administrations, the amount of GLPG1837 and its metabolite present in the blood and urine
      (pharmacokinetics) will be characterized.

      The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be
      evaluated.

      The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will
      be explored as well.
    


Intervention name(s): GLPG1837 single ascending doses; Placebo single dose; GLPG1837 multiple ascending doses; Placebo multiple doses
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose, oral suspension; Single dose, oral suspension matching placebo; Multiple doses, daily for 14 days, oral suspension; Multiple doses, daily for 14 days, oral suspension, matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the effects of the nomegestrol
      acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
    


Intervention name(s): NOMAC-E2; DRSP-EE
Intervention type(s): Drug; Drug
Intervention description(s): Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28
for 6 consecutive 28-day menstrual cycles.; Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
Condition: Agitation
MeSH terms: Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      Excitement during the emergence from general anesthesia is a great post-operative problem. It
      may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage,
      self-extubation, and removal of catheters, and it can necessitate physically or chemically
      restraining the patient. It has been reported that the incidence of postoperative emergence
      excitement in adults after general anesthesia is 21.3% occurrence.

      Many things are mentioned as risk factors for emergence excitement. Among them, excitement
      after orthognathic surgery (two-jaw) was more common than after other types of surgery. The
      patients undergoing emergence with nasotracheal intubation after orthognathic surgery may
      have a sense of suffocation during emergence from anesthesia, which may increase the
      incidence of emergence excitement.

      Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an
      S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1)
      compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.

      To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement
      was investigated only in children.

      The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence
      and the severity of the emergence excitement in adults with nasotracheal intubation after
      orthognathic surgery (two-jaw).
    


Intervention name(s): saline; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.; We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.
Other intervention name(s): normal saline; Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy
Condition: Pregnancy
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Cardiovascular & echocardiographic assessment in pregnant women with hypertension during
      their pregnancy in comparison to Pregnant normotensive women.
    

Detailed description: 
      Cardiovascular & echocardiographic assessment in pregnant women with hypertension during
      their pregnancy in comparison to Pregnant normotensive women. Also,comparing
      echocardiographic parameters in hypertensive pregnant women being treated with either alfa
      methyl dopa or labetolol.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant Women
      
Keywords: Hypertension Pregnancy