bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
Condition: Acute Leukemic Patients in Children
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Null hypothesis The proportions of vomiting are not different between dexamethasone and
      placebo in the patient after sedation with intravenous ketamine and lumbar puncture with
      intrathecal chemotherapy Alternative hypothesis The proportions of vomiting are different
      between dexamethasone and placebo in the patient after sedation with intravenous ketamine and
      lumbar puncture with intrathecal chemotherapy
    

Detailed description: 
      Does intravenous dexamethasone 0.25 mg/kg (8 mg/m2/dose) have an effect in the reduction of
      vomiting and retching after sedation with intravenous ketamine and lumbar puncture with
      intrathecal chemotherapy comparison with placebo?
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: crossover; double blinded; intrathecal chemotherapy; dexamethasone; ketamine;vomiting
Value of an Intervention to Enhance Adherence in Glaucoma Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      A one-year, randomized, attention placebo-controlled trial investigating the value of
      comprehensive adherence specific interventions, over the course of one year, to enhance
      adherence in both (a) newly diagnosed open-angle glaucoma, or ocular hypertension patients,
      naive to medical therapy and (b) those who have failed monotherapy with any prostaglandin
      analogue (and are therefore candidates for adjunctive therapy) who then are randomized to
      receive only travoprost monotherapy. Subjects will be randomized to two different
      interventions involving direct physician education, each of which will take approximately the
      same amount of physician time: The first will be intensive adherence education that will
      continue throughout the year. The second will be intensive eye care education, but without
      any direct adherence education. All patients participating in the study will be monitored for
      adherence by the TDA. The study will demonstrate for the first time the role of
      adherence-specific training in improving patient adherence and will validate the TDA in
      monitoring and improving adherence in glaucoma. This will correlate with prior work that has
      documented that greater adherence is associated with marked improvement in intraocular
      pressure (IOP) control. A second goal will be seeing whether improving adherence will change
      the course of glaucoma therapy by making therapeutic failures into therapeutic successes by
      reducing the need for adjunctive therapy using only monotherapy with travoprost.
    


Intervention name(s): TDA adherence monitor for travoprost therapy; TDA and travoprost monotherapy
Intervention type(s): Device; Device
Intervention description(s): monitoring adherence to travoprost therapy; Patients will be prescribed travoprost therapy and will be followed up in a standard clinical fashion with a attention placebo at both baseline and 6 months
Other intervention name(s): Adherence and IOP control after 12 months of therapy
Intervention MeSH terms: Travoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Glaucoma; Adherence; Teaching
Proof of Concept Study of PEMF (Pulsed Electromagnetic Field) Therapy in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To investigate the effect of PEMF treatment when administered twice daily over a 90-day
      period by looking at synovial fluid in subjects with osteoarthritis of the knee.
    


Intervention name(s): Provant Therapy System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine differences in drug exposure in subjects after being
      administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after
      administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.
    


Intervention name(s): sertraline hydrochloride; sertraline hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg capsule, single-dose; 50 mg tablet, single-dose
Other intervention name(s): Zoloft; Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence study; sertraline 50 mg; capsules vs tablets
Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of research to study therapeutic possibilities of navigation transcranial magnetic
      stimulation in stroke rehabilitation, finding optimal protocol.
    

Detailed description: 
      Stroke is the main cause of long-term disability among adults. Disability following stroke
      results in significant impairment of patients quality of life. There was a lot of
      investigations with using Transcranial Magnetic Stimulation (TMS) as effective additional
      therapy in stroke rehabilitation. In this researches uses different protocols and patient's
      categories: high-frequency, low-frequency, etc. Using method of navigation transcranial
      magnetic stimulation with neuroimaging could help in choosing optimal protocol, assess
      effectiveness of therapy and forming prognosis.
    

Intervention name(s): Transcranial magnetic stimulation
Intervention type(s): Procedure
Intervention description(s): Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Other intervention name(s): Transcranial magnetic stimulation, brain stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: navigation transcranial magnetic stimulation; stroke rehabilitation
A Study to Define the ECG Effects of Lixivaptan Compared to Placebo and Moxifloxacin in Healthy Adult Men and Women: A Thorough ECG Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double-blind, randomized, repeat-dose, single -dite, 4-arm parallel group
      study to define the ECG effect of lixivaptan using a therapeutic and supratherapeutic dose
      compared to placebo and moxifloxacin (a positive control in healthy adult men and women.
    


Intervention name(s): placebo; lixivaptan; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): capsules; capsules; tablets
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: To determine whether lixivaptan administration at supratherapeutic or therapeutic doses results in the prolongation of the QTc interval.
Chronic Endometritis and IVF
Condition: Chronic Endometritis; in Vitro Fertilization
MeSH terms: Endometritis
Study type: Interventional

Summary: 
      Background: Embryo quality is known to be a very important determinant to predict the
      implantation and pregnancy rate in IVF patients, however, the role of uterine integrity or
      endometrial receptivity cannot be overlooked.

      Chronic endometritis (CE) is an inflammation of the endometrium diagnosed by the presence of
      plasma cells in the endometrial stroma. There is not only no census on the definition of CE,
      the current literature on the impact of CE on reproductive outcome is controversial and
      consists only of retrospective studies with small sample sizes. Although there is a
      presumption that CE is related to poor IVF outcome, this belief has not been proven.

      Design: Prospective cohort study

      Setting: Infertility clinics of 2 academic medical centers

      Patients: Patients between the ages of ≥ 21 and ≤ 35 years old undergoing their first IVF
      cycle will be invited to participate.

      Main Outcome Measures: The primary outcome will be ongoing pregnancy after 12 weeks estimated
      gestational age (EGA) with previously documented fetal cardiac motion. Secondary outcomes
      will include pregnancy loss rate as defined by chemical pregnancy, blighted ovum or loss of
      fetal cardiac motion before 12 weeks EGA.

      Materials and Methods: The cycle prior to IVF, patients will undergo an in-office endometrial
      biopsy on cycle days 19-24. Samples will be stained for CD138 and the number of plasma cells
      will be quantified. The number of plasma cells in a sample that yields the best sensitivity
      and specificity for pregnancy will be determined by a Receiver-Operator-Curve. This number
      will then be used as a dichotomous variable to assign categories of "positive for CE" and
      "negative for CE." Pregnancy and miscarriage rates will then be determined in the positive
      and negative CE sample with Chi Square Analysis. A secondary sub analysis will be performed
      to determine pregnancy and miscarriage rates in patients who declined to participate in the
      study.

      Expected Results: The investigators hypothesize that higher rates of CE will be found in
      women failing to conceive with IVF and with subsequent first-trimester miscarriage.
    


Intervention name(s): Endometrial biopsy
Intervention type(s): Procedure
Intervention description(s): Endometrial biopsy in women undergoing first IVF cycle
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: chronic endometritis; invitro fertilization; spontaneous abortion
Tocilizumab Treatment in Graves´ Ophthalmopathy (Graves´ Orbitopathy or Thyroid Eye Disease)
Condition: Thyroid Associated Ophthalmopathies; Graves´ Ophthalmopathy; Thyroid Eye Disease
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose is to investigate tocilizumab administration in patients with moderately to
      severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with
      corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic
      alternative.

      The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment
      in order to provide a better alternative to surgery for this patients.
    

Detailed description: 
      Thyroid orbitopathy or Graves´orbitopathy (GO) is manifested for inflammation of the orbital
      and periorbital soft tissues. Ten percent of patients with GO will have long-term serious eye
      problems.

      The cause of the GO is complex. Autoreactive T cells recognize an autoantigen, the TSH
      receptor present in the orbit and thyroid follicular cell, secrete cytokines (IL-6), which
      stimulate the fibroblasts to synthesize glycosaminoglycan, which draws liquid produce
      periorbital edema and muscle, causing exophthalmos.

      This approach suggests that inhibition of IL-6 can be an effective treatment for this problem
      on the basis that tocilizumab specifically binds to the receptors of the IL-6, both soluble
      and membrane-bound. Tocilizumab has been shown to inhibit signaling mediated for IL-6Rm
      IL-6Rs.
    

Intervention name(s): Tocilizumab (RoActemra®); Sterile 0.9% Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous infusion of tocilizumab (8 mg/kg); every 4 weeks during 16 weeks.; Single intravenous dip infusion of a sterile 0.9% sodium chloride, every four weeks during 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Graves´ orbitopathy; Graves´ ophthalmopathy; Thyroid eye disease; Thyroid-associated ophthalmopathy; Tocilizumab; EUGOGO; CAS
Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia
Condition: Postprandial Glycemia
Study type: Interventional

Summary: 
      A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects
      of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins
      extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia
      will be compared. Additionally, the postprandial metabolism and metabolites, and the
      appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine
      and feces.
    


Intervention name(s): Dietary
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of melatonin 3 mg compared to
      placebo and amitriptyline 25 mg in the preventive treatment of migraine.
    

Detailed description: 
      The investigators propose a study of patients with migraine (episodic) with or without aura,
      according to the criteria of the International Headache Society (IHS) 2004. This will be a
      randomized clinical trial, prospective, double-blind, placebo-controlled, comparing the
      efficacy of melatonin 3 mg and amitriptyline 25 mg for migraine prevention. The length of the
      inclusion of the study will be 24 months. This study's general objective is: to evaluate the
      effectiveness of melatonin in the preventive treatment of migraine and compare it to placebo
      and amitriptyline.
    

Intervention name(s): Amitriptyline; Melatonin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It will be administered Amitriptyline (25mg) once a day at bed time. Patients may keep their abortive treatment that they usually used. The drug will be encapsulated in a bottle of 30 capsules will be given to patients at every visit.; It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.; It will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time
Intervention MeSH terms: Amitriptyline; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amitriptyline; Placebo; Melatonin; Migraine; Headache; Drug therapy; Preventive treatment of migraine
Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction
Condition: Circumferential Reduction
Study type: Interventional

Summary: 
      Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential
      reduction in the abdominal region within three treatment group
    

Detailed description: 
      The study design to evaluate the safety and efficacy of the NuEra Tight for circumferential
      reduction in the abdominal region within three treatment group. each group has a different
      radio-frequency. The study hypothesis is that NuEra Tight is safe and will cause a reduction
      in abdominal circumferential after treatment and at 12 week post last treatment within each
      treatment group.
    

Intervention name(s): treatment with the study device (NuEra)
Intervention type(s): Device
Intervention description(s): Multi-arm, prospective, multi-center, baseline-controlled study:
Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Multi-arm, prospective, multi-center, baseline-controlled study, designed to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction of the abdomen area at three different frequencies.
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program (NMDP)
Condition: Healthy
Study type: Observational

Summary: 
      Individuals interested in becoming prospective bone marrow donors and joining the Registry of
      the National Marrow Donor Program (NMDP) should do so by calling 301-496-0572, the phone
      number of the NIH Marrow Donor Center. An appointment will be made to have a health history
      taken and to have a buccal swab collected for tissue (HLA) typing. The current protocol only
      involves donors already registered with the NMDP, who have been identified as "perfect
      matches" for an unrelated patient requiring a bone marrow transplant, and who require
      expedited medical evaluation prior to marrow collection.
    

Detailed description: 
      The National Marrow Donor Program (NMDP) was established in 1987 in order to (1) create a
      registry of volunteer, prospectively tissue-typed, unrelated bone marrow donors, (2)
      facilitate the performance of matched unrelated donor marrow transplants through a
      coordinated circuit of Donor Centers, Collection Centers and Transplant Centers throughout
      the United States, and (3) evaluate the outcome of such transplants and identify future areas
      of research in the field of unrelated donor marrow transplants. The NIH Marrow Donor Center,
      a participant in the NMDP, is currently the second largest hospital-based Donor Center in the
      nation, with approximately 55,900 active donors on its registry. 402 NIH unrelated donors to
      date have undergone 429 marrow or blood stem cell harvest for an NMDP recipient, and the
      current rate of such harvests is three per month. Once an HLA-matched donor in the NIH Donor
      Center registry is identified through the NMDP computer network, the donor must undergo a
      medical evaluation to determine suitability for marrow harvest. This evaluation consists of a
      medical history, a physical examination, routine blood work, EKG, chest x-ray, and
      urinalysis, and generally takes 4 to 6 weeks. A "third party" non-NIH physician usually
      performs the evaluation, with the costs reimbursed by the NMDP. Occasionally, an expedited
      evaluation of an unrelated donor must be performed, due to the urgency of the need for a
      transplant in the recipient, and there is insufficient time to accomplish this work-up using
      the routine "third-party" physician's office mechanism. This protocol shall provide a means
      by which prospective NIH unrelated marrow donors participating in the NMDP program can
      undergo an expedited medical evaluation to determine suitability for marrow donation. It is
      expected that not more than 5 to 10 donors per year shall require such expedited evaluation.
    

Keywords: Bone Marrow Transplantation; Bone Marrow Donor; Marrow Transplant; National Marrow Donor Program (NMDP); Unrelated Marrow Donor; Healthy Volunteer
Vitamin D and Microvascular Function in Postmenopausal Women
Condition: Menopause Related Conditions; Vitamin D Deficiency; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Vitamin D Deficiency
Study type: Observational

Summary: 
      Many observational studies have demonstrated links between serum levels of 25-hydroxyvitamin
      D [25(OH)D] and cardiovascular risk (CVR) factors. Microvascular dysfunction relates not only
      to CVR but also to metabolic disease. Since cardiovascular disease (CVD) is the leading cause
      of death in postmenopausal women, it would be relevant to confirm this relationship. Maybe
      further studies would show that the correction of hypovitaminosis D could minimize the CVR.
      Our objective with this clinical trail is to analyze if vitamin D status is related to
      microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal
      women. For that we enrolled, in a pilot cross-sectional study, 39 non-smokers, low CVR
      postmenopausal women, with less than 10 years of hypoestrogenism and associations of 25(OH)D
      to adiposity, blood pressure, fasting aldosterone, insulin, glucose and lipid profile,
      HOMA-IR, parathormone and microvascular function, assessed by laser-Doppler flowmetry at
      cutaneous site, were investigated.
    


Intervention name(s): Blood samples and Microvascular function assessment evaluated through laser-Doppler flowmetry by the LASER speckle contrast analysis (LASCA) device
Intervention type(s): Diagnostic Test
Intervention description(s): We enrolled 39 non-smokers, low CVR postmenopausal women, with less than 10 years of hypoestrogenism. Associations of 25(OH)D to adiposity, blood pressure, fasting aldosterone, insulin, glucose and lipid profile, HOMA-IR, parathormone and microvascular function, assessed by laser-Doppler flowmetry at cutaneous site, were investigated
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Women from the gonad outpatient clinic of the Teaching Unit Endocrinology Department at
        Pedro Ernesto University Hospital/University of State of Rio de Janeiro, which integrates
        the state network of the Unified Health System, and volunteers who may be recruited from
        other HUPE Services or externally.
      
Keywords: Menopause; Vitamin D; Microvascular Circulation; Laser Doppler Flowmetry