bioihbjkbjnl/mcl2 huggingface dataset:
Rifaximin Therapy in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Rifaximin; Placebo
Intervention description: 550mg pills; Placebo pill
Intervention MeSH terms: Rifaximin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Rifaximin decreases serum and urine levels of
      bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to
      evaluate changes in the bacterial content of the stool from these individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2

        Exclusion Criteria:

          -  Patients with normal renal function or those with less advanced kidney disease

          -  Inability or unwillingness to provide consent

          -  Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have
             undergone organ transplant

          -  Patients who may be pregnant

          -  Hemodynamically unstable patients

          -  Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease

          -  Patients with ongoing or recent infection and those with history of C-diff infection

          -  Patients with abnormal bowel structure secondary to surgical or anatomic variations

          -  Patients on certain medications including immunosuppressants, antidiarrheal agents,
             bile acid sequestrants and current or recent (within the last 3 months) use of
             antibiotics
Safety and Efficacy of the Addition of Morphine Chloride to a Low Dose of Bupivacaine as Intradural Anaesthetic for the Removal Surgery of the Hemorrhoids
Condition: Surgical Remove of Hemorrhoids
MeSH terms: Hemorrhoids
Intervention: Bupivacaine low dose; Bupivacaine standard dose; Morphine Chloride
Intervention description: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural; Single intradural standard dose of bupivacaine; A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
Intervention MeSH terms: Morphine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: hemorrhoidectomy; analgesia; anaesthetic; bupivacaine; morphine chloride

Summary:

      A single blind, randomized, with blinded evaluation by third parties clinical trial is
      carried out to assess the analgesic efficay of the addition of morphine chloride to a low
      dose solution of spinal local anaesthetic compared to a standard dose spinal anaesthetic in
      the haemorrhoid surgery.

      The objective of this clinical trial is to assess if the experimental treatment is as
      efficacy as the standard treatment in the anesthetic and analgesic effects with less side
      effects, greater and earlier mobility after surgery and shortened the hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing hemorrhoidectomy.

          -  Age between 18 and 64.

          -  Both gender

          -  ASA I to III.

          -  With indication for spinal block.

          -  People capable to grant the informed consent.

        Exclusion Criteria:

          -  Patients with allergies to the study drugs.

          -  Patients with any contraindication for performing a spinal technique (coagulation
             disorders, fever, intracraneal hypertension, abscess in the puncture site, etc..).

          -  Patients with previous neurological disorders.

          -  Pregnant women.

          -  Women who may be pregnant and do not have a negative pregnancy test.

          -  Breastfeeding women.

          -  Patients with uncapable to give informed consent.
Trial of High Dose Vitamin D in Patient's With Crohn's Disease
Condition: Crohn's Disease; Vitamin D Deficiency
MeSH terms: Crohn Disease; Vitamin D Deficiency
Intervention: Cholecalciferol 10,000 IU; Cholecalciferol 400 IU
Intervention description: Cholecalciferol 10,000 IU po daily; Cholecalciferol 400 IU po daily
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's disease; Vitamin D deficiency

Summary:

      Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is
      a major source of vitamin D. There is some research to suggest that patient's with higher
      vitamin D levels are less likely to undergo surgeries and have better control of their
      disease. We intend to study the effects of high dose vitamin D supplementation in patients
      with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses
      will have less hospitalizations, surgeries, steroid use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CD

          -  Age >= 18 and <75

          -  Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml)

        Exclusion Criteria:

          -  Corticosteroid use in the last 4 weeks

          -  CD-related surgery in the last 6 months

          -  CD-related hospitalization in the last 4 weeks

          -  Pregnancy, intended pregnancy during the study period or nursing

          -  Serum calcium >10.2 mg/dL

          -  History of primary sclerosing cholangitis

          -  History of undergoing an ileal pouch-anal anastomosis

          -  Current active perianal disease

          -  History of nephrolithiasis in the past 2 years

          -  Anticipated change in therapy in the next 30 days (steroids, biologic initiation)

          -  modified Harvey-Bradshaw Index of 10 or more

          -  History of decreased renal function (glomerular filtration rate <30ml/min based on
             MDRD) or polycystic kidney disease

          -  History of sarcoidosis

          -  History of hyperparathyroidism

          -  Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma

          -  Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or
             primidone

          -  Osteoporosis
Varenicline Effects In Schizophrenic Smokers
Condition: Schizophrenia; Tobacco Use Disorder; Nicotine Dependance
MeSH terms: Tobacco Use Disorder; Schizophrenia
Intervention: Varenicline
Intervention description: Varenicline 1-2 mg/day
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; varenicline; cognition; cigarette smoking

Summary:

      This is an open label pre-post study of the effects of clinical treatment with varenicline on
      1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in
      schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are
      assessed on subjective and objective measures of smoking, selected cognitive measures, and
      special chemical measures, during baseline testing and during 8 weeks of treatment with
      varenicline (1-2 mg/day).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis

          -  Recent History of Cigarette smoking

          -  Ages 18-65
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
Condition: Secondary Amenorrhea
MeSH terms: Neoplasm Metastasis; Amenorrhea
Intervention: PROMETRIUM® 300 mg; PROMETRIUM® 400 mg
Intervention description: 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles; 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea

Summary:

      To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in
      women of reproductive age with secondary amenorrhea
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with secondary amenorrhea

          -  Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid
             Stimulating Hormone (TSH) and thyroxine

        Exclusion Criteria:

          -  Primary amenorrhea

          -  Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)

          -  Peanut allergy

          -  Allergy to progestational steroids
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
Condition: Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State
MeSH terms: Mania; Bipolar Disorder; Psychotic Disorders; Mental Disorders; Affective Disorders, Psychotic
Intervention: Quetiapine 600mg
Intervention description: 300 mg quetiapine fumarate tablets for oral use.
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State

Summary:

      The primary purpose of the study is to assess the efficacy of Quetiapine extended release
      600mg per day either as monotherapy or combined therapy in the treatment of patients with
      mania associated to Bipolar disorder. This trial will also assess the life quality and
      productivity loss improvement for patients from baseline to day 21.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type I Bipolar Disorder in Manic phase according to standard scales and
             physician criteria.

          -  Patients of both genders, aged 18-65 years old being at the first episode

          -  Patients with chronic Bipolar Disorder with at least one previous manic episode 6
             months before inclusion, that based on the physician experience are in a manic episode
             at study entry quality

        Exclusion Criteria:

          -  Psychoactive substance or alcohol abuse or dependence, forbidden medication,
             pregnancy, rapid cycling patients, intolerance to Quetiapine, clinically severe
             disease, unstable Diabetes Mellitus, neutropenia, other laboratory abnormalities
Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
Condition: Pain
Intervention: Experimental TENS
Intervention description: Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 46.0
Sex: Female
Minimum age: 15 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pain; electric stimulation; nervous; transcutaneous; humanized childbirth

Summary:

      The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical
      Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research
      will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant
      women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be
      divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and
      will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of
      cervical dilation. The evaluation will be performed by numerical category scale, location and
      Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a
      questionnaire of customer satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primigravida

          -  literate

          -  A single fetus in vertex position

          -  Low-risk Pregnancy

          -  From 37 weeks of gestation

          -  Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage

          -  Labor in early spontaneous

          -  No use of medications during the study period

          -  Absence of cognitive or psychiatric problems

          -  Intact membranes

          -  No risk factors associated

          -  Who wish to participate and signed the informed consent

        Exclusion Criteria:

          -  TENS procedure intolerance

          -  Use of any medication or procedure that promotes pain relief

          -  Use of pacemaker
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
Condition: Renal Angiomyolipoma
MeSH terms: Tuberous Sclerosis; Angiomyolipoma; Sclerosis
Intervention: Everolimus
Intervention description: Everolimus 2.5 mg and 5 mg tablets with dosage regimen of 10 mg orally once daily.
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single arm, open label
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TSC; tuberous sclerosis complex; AML; afinitor; everolimus; RAD001; mTOR; kidney; lymphangioleiomyomatosis; renal angiomyolipoma

Summary:

      The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in
      Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex
      (TSC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible for treatment with everolimus as per the locally approved label.

          -  Presence of at least one AML ≥ 3 cm in its longest diameter using CT or MRI.

        Exclusion Criteria:

          -  AML related bleeding or embolization during the 6 months prior to enrollment.

          -  History of myocardial infarction, angina or stroke related to atherosclerosis.

          -  Impaired lung function.

          -  Significant hematological or hepatic abnormality.

          -  Any severe and/or uncontrolled medical conditions.
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
Condition: Stage 2 Diastolic Hypertension
MeSH terms: Hypertension
Intervention: nebivolol and lisinopril (free combination); nebivolol monotherapy; lisinopril monotherapy; placebo
Intervention description: nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks
nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks
nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks
nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks; nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks
nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)
nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks; lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks; Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks
Intervention MeSH terms: Lisinopril; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 664.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of first-line treatment with a free
      combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2
      diastolic hypertension (DBP>= 100 mmHg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and female outpatients 18 to 64 years of age

          -  Females must be post-menopausal, or not pregnant and using an approved contraceptive
             regimen

          -  stage 2 diastolic hypertension (DBP >= 100 mmHg)

        Exclusion Criteria:

          -  secondary hypertension

          -  evidence of other concurrent disease or conditions that might interfere with the
             conduct of the study

          -  participation in an investigational drug study within 30 days or 5 half-lives,
             whichever is longer, of Screening (Visit 1).

          -  have a history of hypersensitivity to nebivolol or other β-blockers, or any
             contraindication to β-blocker use
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Eisenmenger Complex
Intervention: Tracleer®
Intervention description: Patients will receive up to 125 mg b.i.d. of Tracleer.
Intervention MeSH terms: Bosentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: bosentan; PAH related to Eisenmenger physiology; Tracleer

Summary:

      This 6-month open label study will evaluate the long term safety of bosentan (via oxygen
      saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5
      study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind,
             placebo- controlled 16-week study.

          2. For female patients, only non-pregnant women who are surgically sterile,
             postmenopausal or have documented infertility (over 50 years of age and amenorrheic
             for at least 1 year), or those of childbearing potential using one of the following
             methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in
             combination with a spermicide. A double-barrier method is recommended; intrauterine
             devices (IUDs); oral or implanted contraceptives, if used in combination with a
             barrier method.

          3. Patients providing written informed consent.

        Exclusion Criteria:

          1. Patients who withdrew prematurely from BREATHE-5, AC-052-405.

          2. Patients who are pregnant or nursing.

          3. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to
             receive any of these drugs during the study.

          4. Patients with AST and/or ALT values greater than 3 times the upper limit of normal.

          5. Patients with hemoglobin or hematocrit that is more than 30% below the normal range
             (patients with secondary polycythemia are permitted in the study).

          6. Patients with systolic blood pressure < 85 mm Hg.

          7. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or
             are receiving another investigational product.

          8. Patients active on organ transplant list.

          9. Patients who are receiving or expected to receive glyburide, cyclosporin A or
             tacrolimus.

         10. Patients not able to comply with the protocol or adhere to therapy.
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: Simvastatin; Vytorin; Placebo; Ezetimibe
Intervention description: Simvastatin 20mg daily for 3 months.; Vytorin 20/10mg daily for 3 months.; Placebo one tablet daily times 3 months.; Ezetimibe 10mg daily for 3 months.
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled clinical trial with 4 arms
Masking: Double (Participant, Care Provider)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metabolic Syndrome; LDL subfraction L5; The reduction of LDL in patients with Metabolic Syndrome; The prevalence of L5 in patients with Metabolic Syndrome; The reduction of L5 in patients with Metabolic Syndrome

Summary:

      The purpose of this study is:

        -  To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.

        -  To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting
           factor and reduce L5 in Metabolic Syndrome patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines
             will be recruited.

          -  The 5 criteria are:

               1. abdominal obesity (men>40 inches, women >35 inches);

               2. TG> 150mg/dL;

               3. low HDL-C (men < 40mg/dL, women < 50 mg/dL);

               4. high blood pressure (>or=130/>or=85 mmHg);

               5. fasting glucose > or = 110mg/dL.

          -  People with different ethnic backgrounds will be included.

        Exclusion Criteria:

          -  symptomatic coronary artery disease

          -  peripheral vascular disease

          -  cerebral ischemia (stroke)

          -  smoking

          -  hypothyroidism

          -  kidney diseases

          -  consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the
             last 3 months

          -  women who are pregnant, nursing, or planning to become pregnant