bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Combined Hormonal Contraceptives on UPA
Condition: Contraception
Intervention: Ulipristal Acetate; Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Ulipristal acetate; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emergency contraception; Birth Control Pills

Summary:

      The purpose of this research study is to determine if taking a birth control pill effects how
      well an emergency contraceptive pill called Ulipristal acetate (UPA) works. This type of
      emergency contraceptive is the most effective oral method available. However, this medication
      is an anti-progestin and most regular forms of birth control contain progestin (a female
      hormone). It is unknown if taking the two close together may make the emergency contraceptive
      not work well. The overall goal of this research is to improve the effectiveness of
      contraception for women and to better counsel women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy women aged 18 to 35 with regular menses (every 21-35 days).

          -  Normal BMI

          -  Proven ovulation with a screening serum progesterone of >3ng/mL

          -  Willing to use condoms (if sexually active with a male partner), willing to not have
             sex with men during the study, or have had a tubal ligation (or have a partner who has
             had a vasectomy) or have a copper intrauterine device (IUD).

        Exclusion Criteria:

          -  Known intolerance or allergy to any of the study medication

          -  Known metabolic disorders including polycystic ovarian syndrome or uncontrolled
             thyroid disorder

          -  Overweight or obese BMI

          -  Any Centers for Disease Control and Prevention (CDC) Medical eligibility criteria
             category 3 or 4 for combined oral contraception (COC) use 12.

          -  Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal
             contraception

          -  Current use of drugs that interfere with metabolism of sex steroids

          -  Smokers.
Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)
Condition: Hypertension; Ischemic Heart Disease; Congestive Heart Failure; Stroke
MeSH terms: Hypertension; Heart Failure; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Intervention: Valsartan; Non-ARB
Intervention description: Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.; 'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs
Intervention MeSH terms: Valsartan; Antihypertensive Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3031.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: High risk hypertension; Ischemic heart disease; Angiotensin receptor blockers; Cardiovascular mortality- morbidity; KYOTO HEART Study

Summary:

      The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor
      Blocker, on top of the conventional treatment in high risk patients in Japan with
      hypertension in terms of the morbidity and mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of hypertension

          -  Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid
             metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular
             disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram
             (ECG) abnormality (LVH)

        Exclusion Criteria:

          -  Patients who have already been administered ARB

          -  Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and
             who are stable but are going to implement PCI or coronary artery bypass grafting(CABG)

          -  Severe/malignant/secondary hypertensive patients

          -  Pregnant women and women of childbearing potential

          -  History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within
             the preceding 6 months

          -  Arrhythmia needed to be treated or accompanied with symptoms, second or third degree
             AV block

          -  Severe renal impairment (Serum creatinine >3.0 mg/dl)

          -  Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)
Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.
Condition: Muscle Relaxation
MeSH terms: Pneumoperitoneum
Intervention: rocuronium; Sevoflurane; remifentanyl
Intervention description: measure effect on laparoscopic workspace; 1 MAC sevoflurane inhalation is given; remifentanyl is given in infusion
Intervention MeSH terms: Remifentanil; Sevoflurane; Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: pneumoperitoneum; laparoscopy

Summary:

      The objective of this study is to compare the value of deep neuromuscular block (NMB) (using
      rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 minimum
      alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon.

      The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus
      opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the
      pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points
      allow to calculate the abdominal compliance and the pressure at zero volume (PV0).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Laparoscopic bariatric surgery in a patient older than 18 years of age without previous
        laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve
        gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric
        bypass

        Exclusion Criteria:

          1. Allergies or contraindications to the use of one or more of the following drugs:
             propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane

          2. History of a laparotomy

          3. Emergency laparoscopy
Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: repaglinide; gliclazide
Intervention description: Individually adjusted dose for 16 weeks; Individually adjusted dose for 16 weeks
Intervention MeSH terms: Repaglinide; Gliclazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      glucose lowering effect and the safety profile of repaglinide given alone compared to
      gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated
      with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of
      repaglinide on the phases of insulin secretion as a subgroup study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this
             trial is allowed)

          -  Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is
             allowed)

          -  Lipid-lowing agent naïve

          -  HbA1c: 6.5-8.5%

          -  Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)

          -  Body Mass Index (BMI): 20-35 kg/m^2

          -  Be able and willing to perform self-monitored plasma glucose (SMPG)

          -  Be able and willing to eat 3 main meals per day

          -  Only applicable to subjects who will participate in the subgroup study: Be able and
             willing to perform and complete IVGTT (intravenous glucose tolerance test) at
             additional visits

        Exclusion Criteria:

          -  Known or suspected allergy to repaglinide, gliclazide, or related products (for
             example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the
             study drugs

          -  Previous participation in this study

          -  Participation in a study of another investigational drug within 1 month prior to study
             start
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: Garamycin Sponge (Gentamicin-Collagen sponge); Systemic Antibiotic
Intervention description: Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base); Antibiotics options per protocol:
Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
Intervention MeSH terms: Anti-Bacterial Agents; Gentamicins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen
      sponge) in combination with antibiotics is safe and effective in treating moderate and severe
      diabetic foot infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is aged ≥ 18.

          -  Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.

          -  Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located
             on or below the malleolus that presents with the following clinical manifestations of
             a moderate or severe infection based on the Infectious Disease Society of America
             (IDSA).

          -  Has received appropriate surgical intervention to remove all necrotic and infected
             bone if diagnosed with osteomyelitis

          -  Meets certain minimal laboratory criteria.

        Exclusion Criteria:

          -  Has an ulcer infection which, based upon the patient's known history of
             hypersensitivity cannot be appropriately treated with at least one of the empiric
             systemic antibiotic regimens per protocol.

          -  Has received > 48 hours of potentially effective antibiotic therapy and the wounds are
             clinically improving. If a patient has received an antibiotic within 72 hours, but is
             not improving or deep-tissue culture results indicate that the infecting pathogen is
             not susceptible to that antibiotic, the patient may be enrolled.

          -  Requires or is likely to require treatment with any concomitant topical product or
             wound therapy during the study period.
Brain Effects of Escitalopram and Citalopram Using fMRI
Condition: Antidepressant Activity in Healthy Volunteers
Intervention: Escitalopram; Citalopram; Placebo
Intervention description: One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily.; One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily.; Two weeks of placebo taken orally.
Intervention MeSH terms: Citalopram; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: Male
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Citalopram; Escitalopram; Celexa; Lexapro; fMRI; antidepressant; healthy volunteers

Summary:

      Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake
      inhibitors that alter blood flow to the amygdala and other brain structures involved in
      regulating mood. Escitalopram consists of S-citalopram while citalopram contains both
      S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may
      block the effects of S-citalopram. The hypothesis being tested is that because of the
      antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood
      circuit than racemic citalopram when equal doses of S-citalopram are administered. The study
      design consists of a two week medication period followed by blood oxygen level dependent
      (BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male aged 21 to 50 years.

          -  Capable of providing informed consent.

          -  Has an established residence and phone.

        Exclusion Criteria:

          -  Meets DSM-IV criteria for an Axis I or II disorder.

          -  History of substance dependence or abuse within the past month.

          -  Use of NSAID's, beta blockers, calcium channel blockers, antidepressants,
             antipsychotic medications, lithium or other medication which in the opinion of the
             investigator would alter vascular responsivity.

          -  Regular use of sedative hypnotic or narcotic medication, or other medication that
             might affect the individual's perception of visual stimuli.

          -  History of cataracts or significant visual impairment.

          -  A medical condition, which in the opinion of the investigator is likely to affect the
             individual's perception of the visual stimuli or vascular response.

          -  Participation in a research protocol that included administration of medication within
             the past 3 months.

          -  Cigarette smoking.
Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Intervention: Teriparatide (FORTEO); Placebos
Intervention description: Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteogenesis Imperfecta; Brittle Bone Disease; Fragility Fractures

Summary:

      The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which
      is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in
      adults affected with Osteogenesis Imperfecta (OI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous established diagnosis of Osteogenesis Imperfecta AND

          -  > 2 previous adult fractures, AND/OR

          -  BMD at lumbar spine, femoral neck or total hip T score < -2.0

        Exclusion Criteria:

          -  Open epiphyses.

          -  History of external beam radiation to the skeleton.

          -  Pagets disease.

          -  Bone metastases or skeletal malignancies.

          -  Total lifetime exposure to any antiresorptive medication < 90 days (Primary
             Inclusion).

          -  Treatment with any antiresorptive medication 12 months proceeding enrollment -
             (Secondary Inclusion).

          -  Women with OI who are pregnant or unwilling to use 1 form of contraception.

          -  Vitamin D insufficiency (25-hydroxyvitamin D <15ng/ml)
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
Condition: Surgery; Breast Reconstruction
Intervention: Serrato; Control
Intervention description: Serratus plane block.; Standard anesthesia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group parallel arm. With study group receiving regional anesthestic block with levobupivacaine and control group receiving standard care with intravenous analgesia only
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oncological; Surgery; Breast; Reconstruction

Summary:

      The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia
      technique ( interfascial block at the serratus muscle) performed in patient undergoing breast
      surgery and the effect of this technique on postoperative analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients older than 18 years, undergoing oncological surgery and/or breast
             reconstruction surgery whose pathology and surgical intervention supose at least a 24
             hours hospital admission

        Exclusion Criteria:

          -  ASA Physical Status Classification System- IV.- Morbid obesity (Body mass index >40).
             -Impossibility of anatomical structures ultrasound identification in a satisfactory
             way (there can be no distinction in the interfascial plane between serratus and
             pectoral muscle). -Opioids treatment before surgery. Sepsis and/or infection at the
             puncture site.

          -  Haemostasis disorders. - Allergy to any of the drugs used in the study.
Crossover Study From Macitentan or Bosentan Over to Ambrisentan
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Ambrisentan
Intervention description: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
Intervention MeSH terms: Ambrisentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn more about the safety and effects of switching
      treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24
      weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension
      (CTD-PAH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a Connective Tissue Disease (CTD)

          -  Age range: 18-80 years old

          -  Previous Right Heart Catheterization (RHC) demonstrating PAH

          -  Forced vital capacity (FVC) greater than 50%

          -  Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%

          -  World Health Organization (WHO) functional class II or III

          -  Able to perform a 6 minute walk test (6MWT)

          -  Stable dose of antihypertensive medications

          -  Non-pregnant females

          -  Have to be currently on stable dose of bosentan for at least 3 months

          -  Adequate acoustic images to allow for transthoracic echocardiography to be performed

        Exclusion Criteria:

          -  Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)

          -  Severe systemic hypertension greater than 170/95

          -  Patients with a prior history of cardiovascular disease

          -  WHO functional class IV status

          -  Patients with severe other organ disease felt by investigators to impact on survival
             during the course of the study.

          -  FVC less than 50% of predicted

          -  DLCO less than 50% of predicted
Aerosolized Beta-Agonist Isomers in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: levalbuterol; saline; levalbuterol MDI; breath actuated nebulizer; aerochamber max; ipratroprium
Intervention description: 0.5 ml. levalbuterol; 0.5ml saline
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: asthma

Summary:

      Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two
      new medications that have been approved by the United States Food and Drug Administration
      (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma
      bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There
      are also newer devices to deliver these medications into the lungs: breath actuated
      nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered
      dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new
      medications using several different devices and measuring lung function, heart rate, and
      sensations of breathlessness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  stable mild to moderate persistent asthma as defined by the National Asthma Education
             and Prevention Program

          -  greater than 18 years of age

          -  requiring bronchodilator therapy either routinely or on a as needed (PRN)basis

          -  stable with respect to respiratory disease and at least four weeks removed from the
             most recent acute exacerbation of the disease

          -  patients may or may not be on inhaled corticosteroids

        Exclusion Criteria:

          -  no unstable cardiovascular symptoms

          -  no unstable angina

          -  must be at least four weeks removed from an acute coronary syndrome