bioihbjkbjnl/mcl2 huggingface dataset:
Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
Condition: Endometrial Receptivity; Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Intervention: GnRH agonist; hCG
Intervention description: GnRH agonist 1mg one dose; 5,000 IU one dose
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 7.0
Sex: Female
Minimum age: 21 Years
Maximum age: 33 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GnRHa trigger; endometrial gene profile; quality of life

Summary:

      The purpose of this study is to compare gene expression profiles in endometrial biopsies
      during the window of implantation after triggers of oocyte maturation using GnRH agonist or
      hCG and compared with their natural cycles in order to identify genes that may be
      dysregulated in GnRH agonist-triggered cycles.

      The investigators also intend to evaluate patients feeling of well being and physical quality
      of life after GnRH agonist trigger compared with hCG trigger.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Oocyte donors

          -  Ages between 21 and 33

          -  Normal baseline serum FSH < 10mIU/mL

        Exclusion Criteria:

          -  Hypothalamic dysfunction

          -  Smokers

          -  Baseline serum FSH ≥ 10mIU/mL
Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Intervention: Xpert MTB/Rif; Smear microscopy
Intervention description: Automatized RT-PCR for the detection of Mycobacterium tuberculosis, the agent of TB, in sputum samples; Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining. This would be the non-intervention (control) arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34758.0
Sex: All
Healthy volunteers: No
Keywords: diagnosis; polymerase chain reaction; sputum smear; stepped-wedge design; cost-effectiveness; Xpert MTB/Rif

Summary:

      Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and
      inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of
      sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4
      to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique,
      named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in
      addition to identification of cases resistant to certain drugs used to treat TB. The test is
      expensive, but several studies have demonstrated its accuracy, and since most steps are
      automatized, savings can be expected from human resources work. The aims of our study are (1)
      to evaluate this tool as a substitute test for sputum smears in routine conditions; (2)
      evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the
      extra cost, and (3) evaluate the acceptability of the test among patients and health care
      workers.
    

Eligibility criteria:

        Inclusion Criteria:

        laboratories -and not subjects - will be randomized. All laboratories will start doing
        smears, when indicated by randomization, they will switch to Xpert MTB/Rif. There are no
        inclusion or exclusion criteria for the labs. Sputum specimens from non-diagnostic (follow
        up) patients, second samples for diagnostic tests, insufficient volume/visible blood
        specimens will be excluded from the Xpert testing.
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
Condition: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders
Intervention: Atomoxetine; Placebo
Intervention description: Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.; Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to
      compare the efficacy and safety of atomoxetine versus placebo in children and adolescents
      aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid
      oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an
      initial 3- to 28-day screening and washout phase, participants will be assigned to
      double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be
      succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will
      be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients who are at least 6 years of age, and who will not have
             reached their 18th birthday

          -  Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for
             conduct disorder not exclusionary)

          -  Normal intelligence

          -  Able to swallow capsules

        Exclusion Criteria:

          -  Weigh less than 20 kilogram (kg) or more than 90 kg at study entry

          -  Prior treatment with atomoxetine

          -  History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3
             months

          -  History of severe allergies or multiple adverse drug reactions

          -  Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT
             (measure of the time between the start of the Q wave and the end of the T wave in the
             heart's electrical cycle) prolongation , inherited cardiac disorders
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Potassium chloride powder; Potassium magnesium Citrate (KMgCit); Potassium citrate powder; Placebo
Intervention MeSH terms: Potassium Citrate; Magnesium citrate; Citric Acid; Sodium Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Potassium; Magnesium; Citrate; DASH

Summary:

      In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits,
      vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in
      controlling hypertension. Key components of such a diet are potassium, magnesium and alkali,
      each of which has been implicated in lowering blood pressure. Whether a liquid formulation of
      potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm
             and diastolic of 80-99 mm

          -  Age > 21 years of age

        Exclusion Criteria:

          -  Diabetes mellitus,

          -  Renal impairment (serum creatinine > 1.4 mg/dL),

          -  Any heart diseases such as congestive heart failure or sustained arrhythmia,

          -  Chronic NSAID use,

          -  Treatment with diuretics,

          -  Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents
             or antacid more than once a week,

          -  Esophageal-gastric ulcer,

          -  Chronic diarrhea

          -  Hyperkalemia (serum > 4.6 mmol/L for patients on Angiotensin converting enzyme (ACE)
             inhibitors or Angiotensin receptor blockers (ARB), serum K > 5.0 for patient not on
             ACE inhibitors or ARBs)

          -  Liver function test above upper limit of normal range.

          -  Subjects who require any potassium supplement on a regular basis from any reasons

          -  Pregnancy

          -  History of major depression, bipolar disorder, or schizophrenia

          -  History of substance abuse.
Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Pimecrolimus; Corticosteroid
Intervention description: Pimecrolimus cream 1 %; conventional corticosteroid-based treatment
Intervention MeSH terms: Pimecrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1091.0
Sex: All
Minimum age: 3 Months
Maximum age: 18 Months
Healthy volunteers: No
Keywords: Atopic, dermatitis, asthma, children, modification; Atopic dermatitis/atopy

Summary:

      This study consists of a 3-year double-blind phase during which patients will receive atopic
      dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or
      with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year
      open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the
      double-blind phase, the two treatment groups will be compared with respect to their efficacy
      in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years
      will be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of atopic dermatitis

          -  Family history of atopy

          -  3 to 18 months of age at baseline

          -  At least mild atopic dermatitis at baseline (investigator global assessment [IGA]
             greater or equal to 2)

          -  Clinical evidence of atopic dermatitis for no longer than 3 months

        Exclusion Criteria:

          -  Diagnosis of or substantial clinical evidence for food or other allergies at baseline

        Other protocol related criteria may apply
Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Condition: Cost Sharing, Acute Coronary Syndrome
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction
Intervention: Study voucher card
Intervention description: Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11001.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndromes, ACS, Myocardial Infarction, STEMI, NSTEMI, MI, Co-Payments, Copay, Cost Sharing

Summary:

      Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the
      impact of copayment reduction on clinician choice of medication, patient adherence, and
      clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical
      trial that will assess the impact of copayment reduction by equalizing the copayment of
      clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication
      adherence, and clinical outcomes up to one year. We hypothesize that reducing out--of--pocket
      cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment
      reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk.
      This is in part due to greater adherence to an evidence--based secondary prevention
      medication. Additionally the reduction in MACE may reflect greater selection of a more potent
      antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as
      provider choice of antiplatelet therapy will be primarily driven by risk- benefit assessment
      rather than the cost burden to the patient.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients are eligible to be included in the study if they meet all of the following
        criteria:

          -  are ≥ 18 years of age

          -  have been diagnosed with STEMI or NSTEMI during the index hospitalization

          -  be treated with a P2Y12 receptor inhibitor at the time of enrollment

          -  have U.S. based health insurance coverage with prescription drug benefit

          -  have been fully informed and are able to provide written consent for longitudinal
             follow-up

        Exclusion Criteria:

        Patients are excluded if they meet any of the following criteria:

          -  have a history of prior intracranial hemorrhage

          -  have any contraindications to P2Y12 receptor inhibitor therapy at discharge

          -  involvement in another research study that specifies the type and duration of P2Y12
             receptor inhibitor use within the next 12 months.

          -  have a life expectancy of less than one year

          -  have plans to move outside the US in the next year
Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ETN Alone; ETN+MTX
Intervention description: etanercept (25 mg, twice/week, s.c.); etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multi-center, parallel-group, randomized, open control study. All patients will be selected
      to two treatment groups.

        1. Etanercept alone treatment group (25mg, twice/week, s.c.)

        2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients had to be at least 18 years of age

          -  fulfilled the 1987 revised classification criteria for RA by in American College of
             Rheumatology (ACR)

          -  met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints
             and 6 swollen joints

          -  either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour,
             with adequate safety profiles)

          -  be ACR functional class I-III

          -  have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at
             least 4 weeks at the time of study enrollment

        Exclusion Criteria:

          -  Patients who required concurrent use of prednisone (PSL) >10 mg/day, or its
             equivalent, were excluded from study entry

          -  the start of dose increment of PSL equivalents within 3 months of the study enrollment

          -  experience of antirheumatic therapy except for MTX and PSL equivalents

          -  previous treatment with ETN or any other biological treatment
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
Condition: Cataract
MeSH terms: Cataract
Intervention: ReSTOR; Tecnis; Acri.LISA
Intervention description: Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL); Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL); Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ReSTOR

Summary:

      This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to
      subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA
      IOL
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with cataracts

        Exclusion Criteria:

          -  Preexisting condition likely to confound results; 1 D astigmatism by preoperative
             K-readings
Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
Condition: Hyperglycemia; Acute Coronary Syndromes; Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Hyperglycemia; Infarction
Intervention: Exenatide
Intervention description: 0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperglycemia; acute coronary syndromes; myocardial infarction

Summary:

      The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in
      hyperglycemic patients admitted to the coronary intensive care unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to coronary ICU

          -  Admission blood glucose 140-299 mg/dL

          -  Primary cardiovascular diagnosis by attending physician

          -  Under primary care of cardiology service

          -  Age > 18 years old

          -  Ventilator independent

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Admission blood glucose < 140 or > 300 mg/dL

          -  Ventilator dependent

          -  Unconscious sedation

          -  Type 1 diabetes

          -  Known pregnancy

          -  Admitted to coronary ICU for right heart cath to measure hemodynamics prior to
             transplant

          -  Post transplant procedure

          -  Currently enrolled in another clinical trial

          -  Unable to provide informed consent

          -  Creatinine clearance < 30 mL/min

          -  On insulin treatment except for monotherapy with long-acting basal insulin (e.g.,
             insulin glargine [Lantus®] or detemir [Levemir®])

          -  Gastroparesis
Pilot Study of Velcade® in IgA Nephropathy
Condition: Chronic Kidney Disease; IgA Nephropathy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Glomerulonephritis, IGA
Intervention: Bortezomib (Velcade®)
Intervention description: Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Intervention MeSH terms: Bortezomib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic kidney disease; IgA nephropathy; Velcade®; Proteinuria; Bortezomib; Proteasome inhibitor

Summary:

      The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to
      induce complete or partial remission in patients with severe IgA nephropathy.

      The secondary objectives are to assess clinical outcomes relating to safety and efficacy,
      such as infection, malignancy, preservation of renal function, partial responders, relapse
      rate, and to study mechanistic assays to predict remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 18 years of age or older.

          2. Must have IgA nephropathy documented by kidney biopsy.

          3. Must have greater than 1gm of proteinuria a day.

          4. Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or
             Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.

        Exclusion Criteria:

          1. Low platelet count and neutrophil count within certain limits defined for enrollment.

          2. Underlying peripheral neuropathy.

          3. Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled
             angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
             of acute ischemia or active conduction system abnormalities.

          4. Allergic to VELCADE®, boron or mannitol.

          5. Female subjects who are pregnant or breast-feeding.

          6. Recent use of investigational drug within 14 days before enrollment.

          7. Having serious medical conditions and infections (including HIV,or hepatitis B or C)
             or psychiatric illness likely to interfere with participation in the study.

          8. Diagnosed or treated for cancer within 3 years of participation in the study, with the
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
             the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.