bioihbjkbjnl/mcl2 huggingface dataset:
Salt Loading and Thiazide Intervention Study
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Salt loading; Hydrochlorothiazide (HCTZ)
Intervention description: Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 liters (L) of 0.9% sodium chloride (NaCl) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.; We will perform short-term HCTZ intervention on the same 120 subjects. After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ.
Intervention MeSH terms: Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hypertension; hydrochlorothiazide; HCTZ; Salt sensitivity; Hydrochlorothiazide induced hyperglycemia

Summary:

      The investigators of this study propose to examine the relationships between STK39 (Serine
      Threonine Kinase 39) genotypes and responses to salt loading and to thiazide diuretics,
      hydrochlorothiazide. The investigators hypothesize that STK39 genotypes will be associated
      with the outcome of both interventions and can contribute to personalized care for
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Old Order Amish

          -  Age 18 to 65

          -  Have systolic blood pressure between 120 and 160 and diastolic blood pressure between
             80 and 100

        Exclusion Criteria:

          -  History of myocardial infarction, stroke, congestive heart failure, liver disease

          -  Known cause of secondary hypertension

          -  Diabetes or Fasting glucose > 100 mg/dL

          -  Women who are pregnant, on oral contraceptives, or menstruating

          -  Used hydrochlorothiazide (HCTZ) in the last 8 weeks or known allergy to HCTZ

          -  Taking non-steroidal anti-inflammatory drugs

          -  Estimated glomerular filtration rate < 80 mL/m

          -  Intention to alter dietary habit during the study

          -  Abuse of alcohol or drug
Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Anesthetic Topical Adhesive Synera
Intervention description: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.
For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week
Intervention MeSH terms: Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will
      reduce the injection pain. Relieving injection site pain may improve the tolerability of
      Multiple Sclerosis medications.

      Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings
      as measured by the visual analog scale and Local injection site reaction scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Multiple Sclerosis based on McDonald or Poser criteria (no
             sub-type restrictions)

          -  Aged >18

          -  Regular use of one of the follow Multiple Sclerosis medication treatments: interferon
             beta subcutaneous (15 subjects, Betaseron, Extavia or Rebif), or glatiramer acetate
             subcutaneous (15 subjects, Copaxone).

          -  No change in disease modifying therapy in 60 days.

          -  Mean score of ≥1.0 on Local Injection Site Reaction scale and Mean Pain Upon Injection
             score ≥4.0 during baseline period.

          -  At least 4 valid diary entries over screening period.

          -  No Multiple Sclerosis exacerbation for 60 days prior to screening.

          -  Written informed consent

        Exclusion Criteria:

          -  Females who are breast-feeding, pregnant or have potential to become pregnant during
             the course of the study (fertile and unwilling/unable to use effective contraceptive
             measures).

          -  Cognitive deficits that would interfere with the subject's ability to give informed
             consent or perform study testing.

          -  Concurrent application of any topical medication to treat injection site reactions
             from screening through final visit.

          -  History of allergy to lidocaine, tetracaine or PABA (para-amino benzoic acid)
             containing products.

          -  Patients receiving class 1 antiarrhythmic agents (i.e. tocainide, mexiletine)

          -  Any other serious and/or unstable medical condition
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
Condition: Liver Cirrhosis; Portal Vein Thrombosis
MeSH terms: Liver Cirrhosis; Thrombosis; Venous Thrombosis
Intervention: Nadroparin calcium, warfarin
Intervention description: Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
Intervention MeSH terms: Nadroparin; Warfarin; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Portal vein thrombosis; Nadroparin calcium; Warfarin; Anticoagulation

Summary:

      The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with
      nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 75 years

          -  Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT
             diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI,
             or portal angiography

        Exclusion Criteria:

          -  Cavernous transformation of the portal vein

          -  Uncontrolled active bleeding

          -  Platelet count lower than 10*10^9/L

          -  Creatinine more than 170 mmol/L

          -  Ongoing or received antithrombotic/thrombolytic treatment

          -  Primary thrombophilia

          -  Budd-Chiari syndrome

          -  Pregnancy or breast-feeding period

          -  Severe cardiopulmonary diseases

          -  Severe systemic infection or sepsis

          -  Inability to sign informed consent
Nasal Decolonization for Orthopedic Trauma Patients
Condition: Surgical Site Infection
MeSH terms: Infections; Surgical Wound Infection
Intervention: intranasal povidone-iodine
Intervention description: povidone-iodine USP, 10% w/w antiseptic
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: 50 patients will receive PROFEND intranasal povidone-iodine prior to surgery and after surgery. The study aims to evaluate the real-world effectiveness of PROFEND® in reducing S. aureus colonization and surgical site infections (SSIs).
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nasal decolonization; Orthopedic trauma surgery

Summary:

      Many surgical site infections are caused by bacteria that is transferred from a patient's
      nose to their open surgical wound. Some small studies have shown that putting povidone-iodine
      in a patient's nose reduces this risk. This study aims to evaluate the real-world
      effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University
      of Iowa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing operative fixation of lower extremity fractures at the University
             of Iowa during the study period.

        Exclusion Criteria:

          -  Patients unable to provide informed consent due to head trauma or dementia.
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Condition: Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome; Premenstrual Dysphoric Disorder
Intervention: Flutamide; Placebo
Intervention description: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.; Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
Intervention MeSH terms: Flutamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 115.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Premenstrual Dysphoric Disorder; PMDD; PMS

Summary:

      This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual
      dysphoric disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for PMDD by history

          -  Regular menstrual cycles that are 25 to 35 days in length during the year prior to
             study entry

          -  Willing to use barrier methods of birth control during the study if sexually active

          -  If engaged in psychotherapy for at least 3 months before study entry, participation
             will be allowed if the intensity of psychotherapy remains the same during the study

          -  Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study
             entry

        Exclusion Criteria:

          -  Use of oral contraceptives or other exogenous hormone preparations within the 3 months
             prior to study entry

          -  Suicide attempt or severe suicidal ideation within the 2 years prior to study entry

          -  History of any psychotic disorder or bipolar disorder

          -  Substance abuse, except nicotine, within the 6 months prior to study entry

          -  Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones,
             gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations,
             diuretics) within the 3 months prior to study entry

          -  Daily use of psychotropic or anticonvulsant medications within the 3 months prior to
             study entry

          -  Use of sleeping pills more than once per week

          -  Consumption of more than 50 ounces of alcohol per week

          -  Pregnant or breastfeeding

          -  Hepatic, renal, autoimmune, or chronic inflammatory disease

          -  Seizure disorder

          -  Inability to read or follow instructions in English
Pre-emptive Analgesics in Orthodontic Treatment
Condition: NSAID; Pain Management
Intervention: Acetaminophen; Ibuprofen
Intervention description: Acetaminophen gel capsule; Ibuprofen gel capsule
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients of the University of Washington Graduate Orthodontics Clinic
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The medications were prepared by the Kelley-Ross Compounding Group (Seattle, WA) and were identical in appearance. The bottles were labeled as "A", "B", or "C" and the identity of the medications were not revealed until after the data analysis was completed.
Enrollment: 73.0
Sex: All
Minimum age: 12 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pre-emptive analgesics; Acetaminophen; Ibuprofen

Summary:

      This study is designed to determine if the preemptive use of a combination of acetaminophen
      and ibuprofen is more effective in reducing pain following orthodontic tooth movement when
      compared to the use of acetaminophen and ibuprofen alone.
    

Eligibility criteria:

        Inclusion Criteria:

        -Orthodontic patient presenting for orthodontic treatment

        Exclusion Criteria:

          -  History of taking an analgesic in the past six hours

          -  Hypersensitivity to ibuprofen or acetaminophen

          -  Aspirin-sensitive asthma

          -  Renal or liver impairment

          -  History of GI bleeding or ulcers

          -  Cardiovascular disease, recent myocardial infarction, heart failure, or coronary
             artery bypass graft surgery

          -  Currently taking antibiotics or other medications for a chronic systemic disease

          -  Bleeding disorder

          -  Pregnant or nursing
Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Intervention: Betamethasone; Methylprednisolone
Intervention description: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg); The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Betamethasone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses of steroid to be given will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). We will instruct patients who meet the inclusion criteria to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, immediately after the injection, five minutes after the injection, and once a day for a minimum of 7 days after the injection. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Two common corticosteroids used for trigger finger treatment are betamethasone and
      methylprednisolone. Both injections are effective in treating trigger finger and the decision
      of which to use in treatment is currently a matter of the current practice and physician
      preference. The goal through this randomized trial is to see whether there is a difference
      between these two corticosteroids in inducing flare reactions and if there are any
      differences in the peak level of pain and their duration. Findings indicating a statistically
      significant difference in the incidence and/or intensity of the flare reactions would be
      clinically significant and would be evidence supporting the switch of current practice to one
      corticosteroid over the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Single trigger injection

          -  First time for the digit

          -  No prior surgery on digit

        Exclusion Criteria:

          -  Current oral steroid use

          -  Rheumatoid arthritis

          -  More than one single digit involved

          -  Previous injection in same digit

          -  Prior surgery on same digit

          -  Other injections in the same clinic on the same day
Combined Vaginal Misoprostol and Perivascular Vasopressin
Condition: Leiomyoma; Laparoscopy; Uterine Myomectomy
MeSH terms: Leiomyoma
Intervention: Standard; Standard-vaginal misoprostol
Intervention description: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle; 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Robot-assisted; Laparoscopic; vasopressin; misoprostol; blood loss

Summary:

      Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood
      vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and
      thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at
      as an additional method to decrease operative blood loss given its ability to increase
      uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted
             laparoscopic myomectomy.

        Exclusion Criteria:

          1. History of adverse reaction or allergy to Vasopressin.

          2. History of adverse reaction or allergy to Misoprostol.

          3. Medical contraindication to use of Vasopressin or Misoprostol

          4. Suspicion of possible reproductive cancer with contraindication of morcellation of
             uterine tissue.

          5. Significant medical condition or laboratory result that in the opinion of the
             Investigator indicate an increased vulnerability to study subject which exposes the
             subject to an unreasonable risk as a result of participating.

          6. Any clinically significant even or condition uncovered during the surgery, such as
             excessive bleeding or decompensation, that might render the subject medically unstable
             to continue the study or complicate the subject's intraoperative or postoperative
             course.

          7. Pregnant women
Effect of Aldosterone on Energy Starvation in Heart Failure
Condition: Heart Failure; Nonischemic Dilated Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated; Starvation
Intervention: spironolactone
Intervention description: spironolactone 50 mg daily for 6 months
Intervention MeSH terms: Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart failure; positron emission tomography; magnetic resonance imaging; myocardial energetics; myocardial perfusion

Summary:

      We plan to study the concept of "energy starvation" in heart failure by evaluation of
      patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart
      pump function due to causes other than heart attack). We will use a combination of positron
      emission tomography and magnetic resonance imaging to study metabolism, anatomy, function,
      blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone
      which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart
      muscle).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Nonischemic dilated cardiomyopathy

          -  Left ventricular ejection fraction 35% or less

          -  Stable heart failure symptoms

          -  Able to undergo both positron emission tomography and magnetic resonance imaging with
             gadolinium

          -  Able to tolerate treatment with spironolactone

        Exclusion Criteria:

          -  Serum potassium >5.0

          -  Serum creatinine >2.5

          -  Contraindications to magnetic resonance imaging such as internal
             cardioverter-defibrillator.