bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy and Safety of CVAA489 in Hypertensive Patients
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: amlodipine/valsartan
Intervention description: Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: essential hypertension

Summary:

      The population that will be included in this study, will be regular Turkish hypertensive
      patients who are expected to consume sodium in high amounts. It is hypothesized that, in that
      population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP)
      control rate as expected from literature.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, above 18 years of age

          -  Diagnosis of essential hypertension

          -  Newly diagnosed,

          -  Previously untreated, or Currently untreated (not on regular antihypertensive
             treatment during the previous at least 1-month period)

          -  Written informed consent

        Exclusion Criteria:

          -  Known or suspected secondary hypertension

          -  eGFR lower than 30 mL/min

          -  Use of any other hypertension treatments during the enrollment and need for using the
             related treatments during the study phase

          -  History of hypersensitivity to any of the study drugs or to drugs of similar chemical
             classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)

          -  History of malignancy of any organ system (other than localized basal cell carcinoma
             of the skin), treated or untreated, within the past 5 years, regardless of whether
             there is evidence of local recurrence or metastases.

          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30
             days until the expected PD effect has returned to baseline, whichever is
             longer.Pregnant or nursing (lactating) women

          -  Other protocol-defined inclusion/exclusion criteria may apply.
Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
Condition: Breast Cancer; Osteoporosis; Osteopenia; Fracture
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: Aromatase Inhibitor
Intervention description: Any aromatase inhibitor started as initial adjuvant therapy
Intervention MeSH terms: Aromatase Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Healthy volunteers: No

Summary:

      Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?

      Study Design: Postmenopausal women with early stage breast cancer initiating aromatase
      inhibitor adjuvant therapy will participate in this two-month study. The primary study
      outcome is the change in intestinal calcium absorption following such therapy. Secondary
      outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms
      after initiation of therapy.

      We will interview women and review their medical records to determine eligibility. Eligible
      subjects will undergo two calcium absorption studies. The first study will determine their
      baseline calcium absorption, and the second study will occur after taking an aromatase
      inhibitor daily for at least 6 weeks. Women will present to the research unit in the early
      morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the
      next 24 hours, we will collect all urine for measurement of its calcium content. During each
      inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint
      examination. Each woman will complete a four-day diet diary twice during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women at least 5 years past menopause, defined as date of last menses or bilateral
             oophorectomy

          -  Newly diagnosed breast cancer and starting an AI as initial adjuvant therapy

        Exclusion Criteria

          -  Recent, current or planned chemotherapy for breast cancer, as this may have
             independent effects on intestinal health, calcium homeostasis and bone turnover

          -  Allergy or intolerance to orange juice, as one isotope is given with orange juice

          -  Current use of over-the-counter or prescription antacids, as they may influence Ca-Ab

          -  Intestinal conditions associated with malabsorption or low gastric acid levels
             including Crohn's disease, ulcerative colitis, pernicious anemia, bacterial
             overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month

          -  Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR <30 cc/minute

          -  Use of medications known to interfere with calcium or vitamin D metabolism, including
             oral steroids or anticonvulsants

          -  Significant lymphedema precluding adequate intravenous access
POCone-UBiT-IR300 Pediatric Comparison Study
Condition: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
MeSH terms: Bacterial Infections
Intervention: Pranactin citric solution
Intervention description: All patients were required to drink the pranactic citric solution to diagnose H.pylori.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Helicobacter pylori

Summary:

      The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring
      13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath
      test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in
      pediatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject ages 3 to 1711/12 years.

          2. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal
             pain/discomfort, bloating, nausea, or vomiting, etc.)

          3. Subject and/or parent/legal guardian is capable of giving assent or consent.

          4. Subject is able to complete the urea breath test by investigator's assessment.

        Exclusion Criteria:

          1. Subject is hypersensitive to mannitol, citric acid and/or aspartame.

          2. Previous diagnosis of phenylketonuria (PKU.

          3. Subject with difficulty swallowing or who may be at high risk for aspiration due to
             medical or physical conditions.

          4. Subjects with ongoing respiratory conditions or on bronchodilators that may compromise
             the collection of breath samples.

          5. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney
             diseases, etc.)

          6. Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days
             prior to the testing.

          7. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole,
             clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the
             testing.

          8. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole,
             lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14
             days prior to the testing.

          9. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine,
             cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the
             testing.

         10. Treatment for eradication of H pylori within 28 days before testing or retesting.

         11. Participation in a drug or device study within 30 days of testing
Effect of Atorvastatin on Bone-vascular Axis
Condition: Osteoporosis; Hypercholesterolemia
MeSH terms: Osteoporosis; Hypercholesterolemia
Intervention: Atorvastatin
Intervention description: Atorvastatin 40mg/day for three months
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Healthy volunteers: No

Summary:

      Background: Circulating osteoprogenitors and RANKL expression in immune cells have been
      implicated in the pathogenesis of osteoporosis and vascular calcification. The role played by
      statin therapy in the bone-vascular axis is unknown.

      Methods: Twenty naïve post-menopausal osteoporotic hypercholesterolemic women will be treated
      with Atorvastatin 40 mg/day for three months. Blood samples will be collected at baseline and
      at the end of the treatment. Gene expression analysis will be performed to assess
      modification in OPG/RANK/RANKL expression in isolated T-cells and monocytes. A flow cytometry
      analysis will be used to study changes in the levels of circulating osteoprogenitor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed osteoporosis (T score ≤ -2.5 SD at either the lumbar spine or femoral
             neck)

          -  LDL-cholesterol ≥ 130 mg/dl

        Exclusion Criteria:

          -  History of bone fractures,

          -  Clinical evidence of atherosclerotic disease

          -  CKD (stage III-V),

          -  Liver disease

          -  COPD

          -  Rheumatic disorders;

          -  Current or previous treatment with statins, steroids, hormonal replacement therapies,
             and antiosteoporotic drugs (including vitamin D and calcium supplementation)
Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Condition: Anticoagulation
Intervention: Apixaban
Intervention MeSH terms: Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 557.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of
      Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip
      replacement
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Subjects undergoing elective total knee or hip replacement or a revision of at least
             one component of a total knee or hip replacement

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Known or suspected, acquired or bleeding or coagulation disorder in the subject or a
             first degree relative

          -  Active bleeding or at high risk for bleeding.

          -  Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
             other than the elective knee/hip surgery

          -  Active hepatobiliary disease

          -  Hemoglobin <9 g/dL

          -  Platelet count <100,000/mm3

          -  Creatinine clearance <30 mL/min
Multicenter Infection Surveillance Study Following Open Heart Surgery
Condition: Surgery; Pneumonia; Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Pneumonia; Surgical Wound Infection
Intervention: Continuous Sternal Block; Opioid based analgesia
Intervention description: Elastomeric Pump for Continuous Infusion of Local Anesthetic; Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Intervention MeSH terms: Analgesics, Opioid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 647.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass Graft Surgery; Pneumonia; Surgical Site Infection

Summary:

      The main goals of the study are as follows: (1) to determine the correlation between pain
      management using continuous infusion of local anesthetics and the incidence of pneumonia and
      surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between
      hospital-acquired pneumonia and surgical infection and patient outcomes, including length of
      hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, >18 years of age;

          -  Scheduled for elective cardiac surgical procedure, including coronary
             revasculari-zation or valve surgery;

          -  Provision of informed consent

        Exclusion Criteria:

          -  Patients with a prior allergic reaction or dependency to morphine, Demerol, Di-laudid,
             Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);

          -  Cardiac transplant patients

          -  Inability to perform follow-up assessments;

          -  Pre-existing infection (pneumonia or surgical site)

          -  Repeat of primary surgery
The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
Condition: Back Pain
MeSH terms: Osteoporosis; Back Pain; Spinal Fractures
Intervention: Parathyroid hormone (PTH) (1-84); Alendronate
Intervention description: 100 µg PTH(1-84) daily; 70 mg alendronate weekly
Intervention MeSH terms: Alendronate; Hormones; Parathyroid Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Postmenopausal women; Back pain; Osteoporosis related fracture

Summary:

      The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in
      reducing back pain intensity over a 24-week treatment period in postmenopausal women with an
      osteoporosis related vertebral fracture(s).

      Secondly the objectives are to investigate any differences in patient reported outcomes
      between the two treatment arms over a 24-week treatment period in postmenopausal women with
      an osteoporosis related vertebral fracture(s).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related
             vertebral fracture. Chronic back pain.

        Exclusion Criteria:

          -  Previous/current treatment and medical history.
A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: 0.03% Bimatoprost
Intervention description: 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Intervention MeSH terms: Bimatoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Healthy volunteers: No

Summary:

      This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma
      and ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma or ocular hypertension

          -  No use of Lumigan® in the past 3 months

        Exclusion Criteria:

          -  Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery
             within the past 3 months
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
Condition: Vaccines, Combined; Hexavalent Vaccine
Intervention: Vaxelis™
Intervention description: Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 11 Months
Maximum age: 13 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objectives of this study are to evaluate the safety, tolerability, and
      immunogenicity of a booster dose of Vaxelis™ (V419) given at ~11 to 13 months of age in
      healthy participants who were previously vaccinated with a 2-dose primary infant series of
      either Vaxelis™ or Hexyon™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at
             approximately 2 and 4 months of age

        Exclusion Criteria:

          -  Has known or suspected impaired immunological function

          -  Has known or history of functional or anatomic asplenia.

          -  Has a known hypersensitivity to any component of the study vaccine.

          -  Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other
             malignant neoplasm affecting the hematopoietic and lymphatic system

          -  Has a bleeding disorder contraindicating intramuscular vaccination

          -  Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus
             infection

          -  Was born to a mother with a known history of hepatitis B infection

          -  Had a recent febrile illness (defined as rectal temperature ≥38.1°C [≥100.5°F] or
             axillary temperature ≥37.8°C [≥100.0°F]) occurring at or within 72 hours prior to
             receipt of study vaccine

          -  Has encephalopathy of unknown etiology, occurring within 7 days following prior
             vaccination with a pertussis containing vaccine

          -  Has an uncontrolled neurologic disorder or uncontrolled epilepsy.

          -  Has a health or developmental disorder that, based on the clinical judgment of the
             investigator, could affect evaluation of the vaccine

          -  Has received or is expected to receive an immunosuppressive agent

          -  Meets corticosteroid use criteria

          -  Has received any licensed, non-live vaccine within 14 days of study vaccine

          -  Has received any license live vaccine within 30 days of study vaccine

          -  Has received a blood transfusion or blood product within 6 months of study vaccine
Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Intervention: Hydrocortisone
Intervention description: Patients receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa.
Intervention MeSH terms: Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hydrocortisone; Cognition; Adrenal insufficiency; Quality of Life; Common Somatic Complaints; Cardiovascular/Metabolic Profile; Somatosensation

Summary:

      The aim of this study is to investigate whether a physiologically low hydrocortisone (HC)
      dose is better for cognition as compared to a physiologically high HC dose. In addition,
      quality of life, metabolic profile and somatosensation will be described in relation to HC
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with secondary adrenal insufficiency.

          -  Age ≥ 18 - 75 years

          -  ≥ One year after tumor treatment with surgery and/or radiotherapy

          -  On stable concomitant medications for at least six months prior to entry of study

          -  Body weight 50-100 kg

        Exclusion Criteria:

          -  Inability of legal consent

          -  Documented cognitive impairment

          -  Drug abuse/dependence

          -  History of / current psychiatric disorders

          -  Use of anti-epileptics (e.g. carbamezapine)

          -  Cushing Disease

          -  Type 1 diabetes or Type 2 diabetes with medication known to induce hypoglycemia (f.e.
             Sulfonylurea derivatives

          -  Current treatment for second malignancy

          -  Have a significant medical condition (e.g. hepatic, respiratory, or cardiovascular)
             which, in the opinion of the investigator, may interfere with the interpretation of
             results and safety or efficacy evaluations.

          -  A history of frequent hypocortisolism

          -  Hospitalization during study

          -  Work in shifts
Effect of Nicotine on Chronic Pelvic Pain
Condition: Pelvic Pain
MeSH terms: Pelvic Pain
Intervention: Placebo; Nicotine (5 mg); Nicotine (10 mg)
Intervention description: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.; Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.; Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: chronic pain; pelvic pain; nicotine patch

Summary:

      The purpose of this study is to test whether transdermal nicotine reduces pain among women
      with chronic pelvic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic pelvic pain

          -  Aged 18-60 years

          -  Female

        Exclusion Criteria:

          -  Uncontrolled hypertension

          -  Cardiovascular disease

          -  Current analgesic abuse

          -  Pregnancy

          -  Current usage of nicotine patch or gum

          -  Allergy to adhesive tape