bioihbjkbjnl/mcl2 huggingface dataset:
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Bosentan; Placebo; Bosentan; Sildenafil Citrate
Intervention description: Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil); Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil); Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase; Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Intervention MeSH terms: Bosentan; Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of sildenafil when added to patients with PAH who are
      taking bosentan as all or part of their background therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated
             according to national license

          -  Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge
             pressure of <15mmHg at rest via right heart catheterization within 3 years prior to
             randomization.

          -  Subjects whose baseline 6 Minute Walk Test distance is >100m and < 450m.

        Exclusion Criteria:

          -  PAH secondary to any aetiology including congenital heart disease other than those
             specified in the inclusion criteria

          -  Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related
             dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Condition: Cough
MeSH terms: Cough; Hypersensitivity
Intervention: electronic cigarette exposure
Intervention description: 30 puffs of a disposable electronic cigarette, 30 seconds apart.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cough; cough reflex sensitivity; electronic cigarette; capsaicin

Summary:

      Although electronic cigarettes (e-cigs) are now widely used, very little information exists
      regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim
      of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30
      seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy adults (age18 years and above)

          -  nonsmokers

        Exclusion Criteria:

          -  previous smoker

          -  asthma/other respiratory illness

          -  acute viral upper respiratory tract infection (common cold) in previous 4 weeks
Enterra Therapy Gastric Stimulation System
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Enterra Therapy Gastric Stimulator
Intervention description: The intramuscular stomach leads, implanted in a minimally invasive surgical procedure lasting 1-3 hours, are placed on the greater curvature of the stomach. The implanted pulse generator (IPG) is about 2 1/2" x 2" x 1/2" and is implanted in a subcutaneous pocket, generally created in the abdominal area, and is then connected to the leads. The IPG provides the energy source that delivers the electrical pulse to the stomach muscle through the stomach leads to improve the symptoms of gastroparesis.
The doctor will use an external programmer to change the settings of the neurostimulator and control the neurostimulator after implantation. Part of the programmer is held outside the body over the implant site and can adjust or change the settings of the neurostimulator using radio remote control.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Enterra therapy; Gastric Simulation System

Summary:

      Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of
      patients with long term, uncontrolled (not helped by medication) nausea and vomiting from
      gastroparesis of diabetic or idiopathic origin.

      In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device
      Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical
      (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy
      System probably helps patients, symptoms, the FDA's HDE approval indicates that the
      helpfulness of this therapy has not been proven. Physicians at Columbia University Medical
      Center hope to prove the helpfulness of this device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic(long term, lasting greater than 3 months)

          -  Intractable (drug refractory, failed medical management with prokinetic and antiemetic
             drugs

          -  Failed dietary modifications, and/or requiring enteral feeding) nausea and vomiting
             secondary to gastroparesis of diabetic or idiopathic etiology

        Exclusion Criteria:

          -  Only patients whom the physician determines are not a candidate for surgical
             procedures and/or anesthesia due to physical or mental conditions will be excluded.
             This includes pregnant women, anyone unable to tolerate general anesthesia, and
             uncorrectable coagulopathy.
Research Evaluating the Value of Augmenting Medication With Psychotherapy
Condition: Depression; Depressive Disorder
MeSH terms: Depression; Depressive Disorder
Intervention: Brief Supportive Psychotherapy; CBASP; Medication Only
Intervention description: brief supportive psychotherapy; psychotherapy developed for chronic depression; antidepressant medication
Intervention MeSH terms: Antidepressive Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 491.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 24-week study, with a 12-month follow up period, will compare the effectiveness of
      antidepressant medication alone to the combination of psychotherapy and antidepressant
      medication in patients with chronic depression.
    

Eligibility criteria:

        Inclusion Criteria

          -  Major depressive episode

          -  Depressive symptoms > 2 years without remission

          -  Hamilton Depression Scale (HAM-D) score > 20

          -  Fluent in English

        Exclusion Criteria

          -  Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive
             compulsive disorder, or eating disorder

          -  Serious, unstable, or terminal medical condition

          -  Axis II diagnosis of antisocial, schizotypal, or severe borderline personality
             disorder

          -  Previous treatment with CBASP

          -  Previous ineffective treatment with 4 of the medication treatments used in the study

          -  Substance abuse

          -  Pregnancy

          -  Not willing to end other psychiatric treatment
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Dsuvia
Intervention description: Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)
Intervention MeSH terms: Dsuvia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      In this case series study, the investigators are testing the hypothesis that sublingual
      sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care
      Unit (PACU) in ambulatory surgery patients taking Suboxone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age range 18-100 years

          -  Currently taking Suboxone

          -  ASA (American Society of Anesthesiology) physical score 1-3

          -  Able to provide a signed informed consent

          -  General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC
             (monitored anesthesia care) without the use of regional anesthesia

        Exclusion Criteria:

          -  Known allergic reactions to Dsuvia and its excipients

          -  Severe respiratory illness including exacerbation of asthma attack

          -  Significant intraoperative hemodynamic instability

          -  Use of Regional anesthesia techniques
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
Condition: ALLERGIC ASTHMA
MeSH terms: Asthma
Intervention: ANTI-IGE THERAPY (XOLAIR)
Intervention description: Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The researcher proposes to assess levels of sputum inflammatory markers (eosinophils,
      eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in
      a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma
      symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).

      Associations will be assessed between the types of sputum inflammatory markers and the
      patient's atopic status and level of asthma control as indicated by the following measures:

        1. pulmonary function test (PFT)

        2. asthma symptoms based on the Asthma Control Test (ACT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe allergic asthma, uncontrolled on conventional therapy

        Exclusion Criteria:

          -  History of systemic illness, currently on other immune modulators like immunotherapy,
             IVIg

          -  Pregnancy

          -  IgE level >1300
Magnesium Sulfate in Obese Preeclamptics
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Intervention: Magnesium sulfate 4g loading dose, 1g/hr infusion; Magnesium sulfate 6g loading dose, 2g/hr infusion
Intervention MeSH terms: Magnesium Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to learn how medications participant will receive in the course
      of their delivery are metabolized (broken down by the body). The investigators hope to learn
      more about the way drugs are metabolized by pregnant women, and how those drugs are
      distributed in the blood and body compartments and cleared in the urine, and how maternal
      body weight affects the metabolism. With this information the investigators will be able to
      develop a treatment regimen considering factors in the body that affect magnesium levels so
      that the investigators can improve treatment of pregnant women. The goal of the study is to
      understand how different dosing of magnesium sulfate affects blood levels of the magnesium in
      larger women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women who are ages 18-45

          -  32-42 weeks' pregnant

          -  Prescribed magnesium sulfate for preeclampsia

          -  BMI ≥35 kg/m2

        Exclusion Criteria:

          -  Pregnant women < 32 weeks' pregnant

          -  Women who are on dialysis
A Study for Adult Patients With Fibromyalgia
Condition: Fibromyalgia, Primary; Fibromyalgia, Secondary
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Duloxetine; Placebo
Intervention description: 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks; QD po at the same time each day for 12 weeks
Intervention MeSH terms: Duloxetine 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: 308.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is
      effective in the treatment of fibromyalgia compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet study criteria for fibromyalgia diagnosis.

        Exclusion Criteria:

          -  Have previously or are currently taking duloxetine.

          -  Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder

          -  Have pain symptoms that are difficult to differentiate from fibromyalgia.

          -  Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such
             as hepatitis) or severe cirrhosis.

          -  Have had any primary Axis 1 diagnosis other than major depressive disorder or
             generalized anxiety disorder within the past year.

          -  Are pregnant or breast-feeding

          -  Have a current or previous diagnosis of rheumatoid, infectious or inflammatory
             arthritis or an autoimmune disease

          -  Have a regional pain syndrome, failed back syndrome or chronic localized pan related
             to any past surgery

          -  Have a serious unstable medical illness

          -  Have a history of substance abuse or dependence within the past year
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
Condition: Benign Breast Disease; Fibrocystic Disease of Breast; Fibroadenoma; Mastalgia
MeSH terms: Fibroadenoma; Cystic Fibrosis; Breast Diseases; Fibrocystic Breast Disease; Mastodynia
Intervention: Tamoxifen; Evening Primrose Oil
Intervention description: Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.; Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
Intervention MeSH terms: Tamoxifen; Evening primrose oil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 256.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Fibrocystic Breast Disease; Fibroadenoma; Mastalgia

Summary:

      The purpose of the study is to determine the efficacy and relapse rate of low dose, short
      duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with
      respect to etiology and estrogen receptor status and to realize its side-effects and cost of
      therapy.

      To do a comparative analysis of the results with evening primrose oil which is one of the
      first line management in benign breast disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.

          -  Benign Breast disease amenable to hormonal therapy.

        Exclusion Criteria:

          -  Postmenopausal women.

          -  Premenopausal women with pregnancy or other contraindications to tamoxifen.

          -  Girls less than 16 years.

          -  Very large lesions which require surgery for cosmesis.

          -  High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on
             histopathology or susceptible lesions prone to develop malignancy.

          -  Lesions like duct ectasia where hormone therapy is not likely to be of benefit.

          -  Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for
             treatment.

          -  Patients unwilling to undergo treatment.
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
Condition: Type IIa and IIb Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Intervention: Rosuvastatin; Pravastatin; Atorvastatin
Intervention description: 5mg oral; 40mg oral; 10mg oral
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Pravastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 668.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dyslipidemia

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an
      hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and
      Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation
      after 8 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects presenting type IIa or IIb primary hypercholesterolaemia diagnosed for at
             least 3 months, in a context of primary prevention with at least two associated
             cardiovascular risk factors and: (i)either "naive" to all lipid-lowering therapy,
             (ii)or treated with a statin (treatment ongoing or stopped during the previous 8
             weeks)

        Exclusion Criteria:

          -  homozygous or heterozygous familial hypercholesterolaemia

          -  hypertriglyceridaemia (TG ≥ 4 g/l)

          -  subjects at high cardiovascular risk according to the AFSSAPS 2005 definition
             (coronary artery disease or history of documented vascular disease, high
             cardiovascular risk type 2 diabetes, subject in primary prevention with a 10-year CHD
             risk > 20%)

          -  history of adverse events or hypersensitivity to an HMG Co-A reductase inhibitor
             (particularly a history of myopathy)

          -  concomitant use of any drugs not authorized during the study

          -  active liver disease with elevation of serum transaminases (ASAT, ALAT) more than
             twice the upper limit of normal

          -  CPK more than 3 times the upper limit of normal

          -  moderate or severe renal failure (creatinine clearance < 6 ml/min)

          -  poorly controlled hypothyroidism; poorly controlled hypertension (DBP > 95 mm Hg
             and/or SBP > 180 mm Hg)
13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
Condition: Helicobacter Pylori Infection
Intervention: Lansoprazole (Lanton); Omeprezole (Losec); Pantoprazole(Controloc); Esomeprazole (Nexium)
Intervention description: Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection; Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection; Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection; Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection
Intervention MeSH terms: Esomeprazole; Pantoprazole; Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HP; UBT; PPI

Summary:

      Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test
      (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and
      after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in
      each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath
      Test). The aim of the trial is to observe the effect of different PPIs on the breath test and
      choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a
      minimal effect on the UBT while using selected PPIs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with H.pylori infection.

        Exclusion Criteria:

          -  Pregnancy,

          -  Nursing,

          -  Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,

          -  Known sensitivity to Urea or citrica.
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Intervention: Estradiol; Placebo
Intervention description: 17β-estradiol vaginal cream; Compounded placebo cream
Intervention MeSH terms: Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postpartum, local estrogen

Summary:

      Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal
      laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between
      women using vaginal estrogen in the postpartum period with those using placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females >18 years old with at least one prior prenatal care appointment affiliated
             with The Ohio State University Wexner Medical Center; nulliparous; 1-2 days status
             post >37 weeks and 0 day vaginal delivery with at least a second degree perineal
             laceration; English-speaking and able to provide informed consent.

        Exclusion Criteria:

          -  allergies to estradiol cream or its constituents; a vaginal delivery associated with a
             intrauterine fetal demise or neonatal death; inability to complete questionnaires in
             English or comply with study protocol; and inability to apply vaginal cream
             independently. The following medical conditions and diagnoses are also exempted:
             undiagnosed abnormal vaginal bleeding, known or suspected estrogen-dependent
             neoplasia, active or history of deep venous thrombosis or pulmonary embolism, active
             arterial thromboembolic disease, known liver dysfunction or disease, known protein C,
             protein S, or antithrombin deficiency, or other known thrombophilic disorders.