bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
Condition: Acute Hypotension
MeSH terms: Hypotension
Intervention: ResQGARD ITD
Intervention description: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is attached to a comprehensive quality assurance/quality improvement (QA/QI)
      program conducted by the Office of the medical director, and is designed to contribute to
      generalizable knowledge to determine effectiveness and tolerability of an FDA approved
      Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS)
      system. The cohort will comprise a convenience sample of patients that are being treated by
      EMS for a hypotensive emergency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults between the ages of 18-120 years

          -  presenting to EMS with or development of Hypotension during EMS interaction

          -  treated by EMS with the ITD

        Exclusion Criteria:

          -  pediatric patients

          -  patients that do not present with or develop hypotension

          -  patients who the ITD will not form a secure seal due to anatomical abnormalities
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Methylnaltrexone; Placebo
Intervention MeSH terms: Methylnaltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid-induced constipation

Summary:

      This study will evaluate the safety and efficacy of methylnaltrexone administered as
      subcutaneous injections in subjects who have opioid-induced constipation and an advanced
      illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving
      opioid-induced constipation in these subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is an adult 18 years of age or older

          -  Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer
             or other end-stage disease)

          -  Has a life expectancy of at least 1 month.

          -  Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for
             the control of pain or discomfort for at least 2 weeks before the first dose of study
             drug.

          -  Has constipation that is caused by opioid medications.

        Exclusion Criteria:

          -  Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g.
             naltrexone or naloxone).

          -  Has a known or suspected mechanical gastrointestinal obstruction.

          -  Has any potential nonopioid cause of bowel dysfunction that might be a major
             contributor to the constipation.

          -  Has any other clinically important abnormalities as determined by the investigator
             that may interfere with his or her participation in or compliance with the study.

          -  Receiving opioid antagonist or partial antagonist products.
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan + HCTZ; Valsartan; HCTZ
Intervention description: At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.; At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.; At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
Intervention MeSH terms: Valsartan; Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 384.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Systolic blood pressure; Diastolic blood pressure; Valsartan; Hydrochlorothiazide

Summary:

      The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy
      with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with
      monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70
      years) with stage 1 or 2 hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 70 years or older.

          -  Patients with hypertension prior to being randomized into study.

          -  Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.

          -  Have the ability to communicate and comply with all study requirements.

          -  Provide written informed consent to participate in the study prior to any screening or
             study procedures.

        Exclusion Criteria:

          -  Use of other investigational drugs within 30 days of enrollment.

          -  History of hypersensitivity to any of the study drugs or to drugs of similar chemical
             classes.

          -  Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120
             mmHg at anytime during the screening / washout period.

          -  Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of
             Visit 1.

          -  Other protocol-defined exclusion criteria may apply
A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD
Condition: Chronic Kidney Disease; Poorly-Controlled Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Intervention: Chlorthalidone
Intervention MeSH terms: Chlorthalidone
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
Healthy volunteers: No
Keywords: hypertension; kidney disease

Summary:

      It is estimated that in the United States there are approximately 8 million individuals with
      moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an
      important role in the pathogenesis of hypertension in patients with CKD. For this pilot
      study, the investigators hypothesize that administration of chlorthalidone among patients
      with moderate to severe CKD will improve blood pressure (BP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years.

          -  Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2.

          -  Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.

          -  Treated hypertension: use of at least one antihypertensive drug. One of the drugs
             should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin
             receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is
             required.

        Exclusion Criteria:

          -  Use of thiazide or thiazide-like drugs in the previous 3 months.

          -  Use of furosemide in a dose >200 mg/d.

          -  Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP
             monitoring.

          -  Expected to receive renal replacement therapy within the next 3 months.

          -  Vascular event such as myocardial infarction, heart failure hospitalization, or stroke
             within 3 months prior to randomization.

          -  Pregnant or breastfeeding women or women who are planning to become pregnant or those
             not using a reliable form of contraception (oral contraceptives. condoms and
             diaphragms will be considered reliable).

          -  Known hypersensitivity to thiazide or sulfa drugs.

          -  Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled
             corticosteroids will be permitted.
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Gabapentin; Gabapentin; Gabapentin
Intervention description: 100-200mg once a day; 200-500mg once a day; 400-1000mg (200-500 mg twice a day)
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Gabapentin Pharmacokinetics

Summary:

      The primary objectives of this study are to evaluate the pharmacokinetics (PK) following
      administration of gabapentin in Japanese epileptic patients with renal impairment to confirm
      if there are any clinically relevant differences between the plasma gabapentin concentration
      simulated by population PK model, which was used for the evidence of the dose adjustment for
      the patients with renal impairment, and observed plasma gabapentin concentration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese epilepsy patients with renal impairment

        Exclusion Criteria:

          -  NA
Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Nasal Nicotine Spray; Nasal Normal Saline Spray
Intervention description: Single 3 mg dose of nasal nicotine spray; An isotonic solution of sodium chloride 0.65% in deionized water
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 95.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Nicotine; Postoperative pain; Bariatric surgery

Summary:

      This prospective, randomized, double-blind study will enroll nonsmoking female subjects
      undergoing laparoscopic bariatric surgery under general anesthesia. The hypothesis of this
      study is that female nonsmokers who receive nicotine via nasal spray immediately before
      waking up from anesthesia will need less pain medications 24 hours after the surgery compared
      to the subjects who receive placebo spray.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) class 2-3

          -  Non-smokers, defined as not smoking (not even a puff) for at least one year
             preoperatively, and having smoked less than 100 cigarettes throughout their life or
             remote history of smoking with complete tobacco abstinence (not even a puff) for at
             least 10 years

          -  Scheduled for elective laparoscopic bariatric surgery (other than gastric banding or
             sleeve resection bariatric surgeries as these are outpatient procedures) requiring
             general anesthesia.

        Exclusion Criteria:

          -  Regular use of opioid medications in the past year, any prior use of sustained release
             opioid medications, or history of substance abuse with opioids

          -  History of previous psychiatric hospitalizations

          -  Allergy to nicotine

          -  Previous bariatric surgery or previous foregut surgery

          -  Pregnant or lactating female (per usual surgical routine)

          -  Contraindications for receiving ketorolac (elevated creatinine)

          -  Unstable angina, severe uncontrolled hypertension, serious cardiac dysrhythmias
             (tachyarrhythmias, atrial fibrillation), or vasospastic diseases (Buerger's disease,
             Raynaud's phenomena)

          -  Unable to provide informed consent to participate in the study

          -  Contraindication to the proposed antiemetics.
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Condition: Acne; Healthy
MeSH terms: Acne Vulgaris
Intervention: Altreno; Benzoyl peroxide
Intervention description: Acne patients will be assigned to Altreno once daily.; Acne patients will be assigned to BPO leave-on gel once daily.
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study objective is to characterize the shift in the diversity and abundance of the skin
      microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl
      peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A confirmed diagnosis of acne that warrants initiating topical medications.

          -  Denies use of any prescribed systemic acne treatments in the past 30 days.

          -  Denies use of any prescribed topical medications in the past 30 days.

          -  Denies use of any OTC topical acne medications in the past 14 days.

          -  Denies use of any emollients in the past 24 hours (if feasible).

          -  Denies bathing or facial washing in the past 12 hours (if feasible).

          -  Willingness to adhere to the recommended topical regimen during the duration of the
             study.

        Exclusion Criteria:

          -  Women who are pregnant, breastfeeding, or planning to get pregnant during the study.

          -  Use of any investigational drug(s) in the past 3 months.
The Bioseal Vascular Study
Condition: Cardiovascular Bleeding; Vascular Bleeding; Hemorrhage
MeSH terms: Hemorrhage
Intervention: Bioseal Fibrin Sealant; Manual Compression
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective
      vascular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects between 18 and 75 years of age;

          2. Undergoing elective vascular surgical procedures and with the presence of an
             appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as
             identified intra-operatively by the surgeon ;

          3. Able and willing to comply with procedures required by protocol;

          4. Signed and dated written informed consent prior to any study related procedures.

        Exclusion Criteria:

          1. Subjects with any intra-operative findings that may preclude conducting of the study
             procedures;

          2. Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than
             Bioseal on the TBS;

          3. Subjects with known intolerance to blood products or to one of the components of the
             study product or unwilling to receive blood products;

          4. Subjects with known allergies to or previously used porcine derived products;

          5. Female subjects who are known breastfeeding or pregnant or intend to become pregnant
             during the clinical study period.

          6. The subject, in the opinion of the investigator, would not be suitable for
             participation in the study.

          7. Subjects who participated in another trial within 30 days prior to the planned start
             of treatment.
A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Condition: Generalized Pustular Psoriasis; Erythrodermic Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Generalized Pustular Psoriasis (GPP); Erythrodermic Psoriasis (EP); Japan

Summary:

      The reason for this study is to see if the study drug ixekizumab is safe and effective in
      participants with generalized pustular psoriasis and erythrodermic psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with GPP or EP based on an investigator-confirmed diagnosis and meet the
             associated criteria

               -  GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare
                  (MHLW) at screening and baseline regardless of IL-36 mutation status.

               -  EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at
                  screening and baseline.

          -  Candidates for phototherapy and/or systemic therapy

          -  Men must agree to use a reliable method of birth control during the study

          -  Women must agree to use birth control or remain abstinent during the study and for at
             least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  History of drug-induced psoriasis

          -  Concurrent or recent use of any biologic agent

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to enrollment and during the study

          -  Have previously received ixekizumab

          -  Serious disorder or illness other than psoriasis

          -  Serious infection within the last 12 weeks

          -  Breastfeeding or nursing (lactating) women
Smoking Cessation Intervention: Effectiveness in Primary Care
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Intervention: nicotine patch; nicotine patch; nicotine lozenge; bupropion; patch + lozenge; bupropion + lozenge
Intervention description: Decreasing dosages from 21 to 7 mg over 12 week period; Decreasing dosage from 21 to 7 mg over 12 weeks; 4 mg nicotine lozenge: dosage according to package directions for 16 weeks; dosage according to prescription directions: 12 weeks; dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge); dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1346.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The information gathered in this study may help to develop more effective ways to help people
      quit smoking and stay quit in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm -
             Motivated to quit smoking - Able to read and write English - Willing to complete
             required study assessments, Aurora participating clinic patient

        Exclusion Criteria:

          -  Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of
             bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem
             in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of
             Alcohol Dependence in the previous 6 months by participant self-report or drinking 6
             or more drinks on six or more days a week - History of seizure and/or serious head
             injury involving loss of consciousness - Use of contraindicated medications (MAO
             inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant
             or breast-feeding - Unwilling to use effective contraception during the treatment
             phase - More than one participant from the same household - Allergic reactions to 3 or
             more classes of drugs