bioihbjkbjnl/mcl2 huggingface dataset:
Niacin and Endothelial Function in Early CKD
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Niacin; Active Placebo
Intervention description: 1000 mg tablets once per day; 100 mg Niacin tablets once per day
Intervention MeSH terms: Niacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Niacin; HDL; Endothelial Function

Summary:

      The purpose of this study is to obtain information on whether raising levels of
      HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney
      disease. This may help us understand the causes leading to high rates of heart disease in
      kidney disease and also ways to reduce this risk.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR
             15-30)

          -  HDL-cholesterol <50 for men and <55 for women

          -  If taking a statin, stable dose for past one month

          -  Glucose <200 mg/dL and HbA1c <9%

          -  Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had
             no rejection episodes in the 6-months prior to study entry

        Exclusion Criteria:

          -  Hospitalization within prior 3 months

          -  Any of the following conditions:

               -  uncontrolled peptic ulcer disease

               -  active liver disease OR abnormal SGOT/SGPT

               -  history of adverse reaction to niacin

               -  contra-indication to aspirin

               -  concurrent fibrate therapy

               -  history of gout

               -  serum phosphorus levels below 2.7mg/dl

          -  Nursing

          -  Pregnancy
An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Condition: Seborrheic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
Intervention: A-101 Topical Solution
Intervention description: A-101 Topical Solution applied Day 1, Day 15 and Day 29
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is an open-label study designed to evaluate subject's satisfaction after treatment
      of seborrheic keratoses with A-101 40%.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject can comprehend and is willing to sign an informed consent for participation in
             this study.

          2. Male or female between the ages of 30 and 75 years old.

          3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the
             additional 1 target SK must be on the neck or decolletage.

          4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior
             to first treatment with A-101 Topical Solution.

          5. Target and non-target SKs must not have been previously treated.

          6. Subject is in good general health and free of any known disease state or physical
             condition which, in the investigator's opinion, might impair the evaluation of any
             target or non-target SK or which exposes the subject to an unacceptable risk by study
             participation

        Exclusion Criteria:

          1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.

          2. Subject has current systemic malignancy.

          3. Subject would require the use of any topical treatment (e.g., moisturizers,
             sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.

          4. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun
             damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the
             opinion of the investigator, might put the subject at undue risk by study
             participation or interfere with the study conduct or evaluations
Lymphedema Study for Arm or Leg Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Intervention: Ketoprofen; Placebo
Intervention description: Placebo to match ketoprofen.
Intervention MeSH terms: Ketoprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Lymphedema; edema; swelling

Summary:

      This study compares the effectiveness of a study drug versus placebo in the treatment of
      lymphedema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a history of lymphedema of one or more limbs (unilateral or bilateral), with a
             duration of > 6 months.

        Exclusion Criteria:

          -  Patients with active cancer, infection or bleeding tendency will be excluded.

          -  We will also exclude patients with medical contraindications to NSAIDs, including
             history of allergies, know gastrointestinal intolerance, or other serious systemic
             illness (e.g., renal failure, hepatic dysfunction, congestive heart failure,
             neurological or psychological impairment) that would impair the patients' ability to
             participate.

          -  Minors (<18 years of age) *>90 years of age
Emergency Contraception and Body Weight: Pilot Study
Condition: Contraception; Body Weight
MeSH terms: Body Weight; Emergencies
Intervention: ECx1; ECx2
Intervention description: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.; At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emergency contraception; Obese BMI; Normal BMI

Summary:

      The purpose of this research study is to determine how body weight changes the drug level of
      an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This
      emergency contraceptive is available to women without a prescription, but has recently been
      found to not work as well to prevent pregnancies in women of higher body weight. The overall
      goal of this research is to improve the effectiveness of contraception for women, no matter
      their weight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are between the ages of 18 and 35

          -  Subjects are in good general health

          -  Subjects have regular menstrual cycles (between 21 and 35 days)

          -  Subjects are willing to use condoms (if you are sexually active with a male partner),
             subjects are willing to not have sex with men during the study, or subjects have had a
             tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper
             intrauterine device (IUD).

        Exclusion Criteria:

          -  Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian
             Syndrome

          -  Impaired liver or renal function

          -  Actively seeking or involved in a weight loss program (must be weight stable)

          -  Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal
             contraception

          -  Current use of drugs that interfere with metabolism of sex steroids

          -  Smokers.
Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Inhaled Iloprost
Intervention description: A 20 mcg dose of Iloprost will be given initially.
Intervention MeSH terms: Iloprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Healthy volunteers: No
Keywords: pulmonary hypertension

Summary:

      Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle
      (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary
      vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this
      condition. The evidence supporting INO safety and efficacy under these circumstances is
      sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary
      hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far
      from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as
      iloprost may be a favorable alternative therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed
             by the attending physician.

          2. Indwelling arterial catheter.

          3. Signed informed consent

        Exclusion Criteria:

          1. Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or
             levophed, or already meeting treatment failure criteria (see section 5.3 below)

          2. Known hypersensitivity to prostacyclin compounds

          3. Patients receiving sildenafil or bosentan

          4. Refusal by the attending physician
(mo)BETTA Trial in Transwomen for Optimization of ART
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: B/FTC/TAF; Current ART
Intervention description: B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen); Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transgender women; Bictegravir

Summary:

      The purpose of this study is to determine the safety and tolerability of a new HIV
      medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV
      medications combined into one pill) in HIV-infected transgender women (TW).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self-identified transgender woman (TW)

          -  HIV infection

          -  Undetectable HIV viral load (HIV-1 RNA <50 copies/mL) at screening and for >/=24 weeks
             prior to entry.

          -  Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.

          -  No changes in ART in the 12 weeks prior to screening.

          -  Current female hormone therapy use.

          -  Ability and willingness of subject to provide informed consent.

        Exclusion Criteria:

          -  Current or planned use of prohibited medications (Phenobarbital, Phenytoin,
             Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea,
             Dofetilide, Cisapride, Atazanavir)

          -  Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior
             to entry, or planned need for such therapy during the study period.

          -  Current use of androgen therapy.

          -  Intent to significantly modify diet or exercise habits, or to enroll in a weight loss
             intervention during the study period.

          -  Anticipated need to initiate or change doses of medications with anti-inflammatory
             properties within the study period.

          -  Screening laboratory values as follows: (ANC <500 cells/mm^3; Hemoglobin <10 gm/dL; Cr
             Cl <30 mL/min (estimated by CKD-Epi equation); AST or ALT >3x ULN)

          -  Evidence of resistance to any component of the current ART regimen (genotypic or
             phenotypic)

          -  Current use of bictegravir in another investigational setting

          -  Current use of other investigational agents that the participant could not receive
             unchanged, if needed, throughout the study period (unless approved by the study team)

          -  Any condition that the study investigator believes would make the candidate unsuitable
             for participation
UK Study Assessing Flexible Dose Fesoterodine in Adults
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine
Intervention description: Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fesoterodine; Open Label; Flexible Dose; OAB

Summary:

      To explore the effects of fesoterodine when used in a flexible dose manner
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female >18 years old

          -  OAB for >3 months

        Exclusion Criteria:

          -  Patients with conditions that would contraindicate for fesoterodine use

          -  Patients with significant hepatic and renal disease or other significant unstable
             diseases.

          -  OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
             etc.
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Intervention: esomeprazole (Nexium®); Xolaam®
Intervention description: This randomized study was conducted on parallel groups and included two phases:
One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed; This randomized study was conducted on parallel groups and included two phases:
One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3029.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease; Acid Reflux

Summary:

      To compare the efficacy of three different long-term treatment strategies of reflux disease
      in primary care setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who seek medical advice in primary care for symptoms thought to be GERD
             related (GERD is a condition which develops when the reflux of stomach content causes
             troublesome symptoms and / or complications).

        Exclusion Criteria:

          -  Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the
             last 3 months prior to Visit 1.

          -  A history of severe esophagitis or known other complications, with alarm symptoms
Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies
Condition: Pancreatectomy
Intervention: Lidocaine; Placebo D5W
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to
      pancreatectomy patients in regards to analgesia and return of bowel function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients undergoing elective open or laparoscopic total pancreatectomies and
             pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced
             Recovery Protocol (ERP) at Mayo Clinic in Florida.

          -  Age 18 - 80 years old

          -  American Society of Anesthesiologist (ASA) class I - III

          -  BMI < 40

          -  Ability to understand and read English

        Exclusion Criteria:

          -  Not able or willing to sign consent

          -  Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local
             anesthetics (i.e., lidocaine).

          -  History of epilepsy or currently receiving treatment for seizures

          -  Severe hepatic insufficiency (Child-Pugh Score C)

          -  Renal insufficiency (creatinine clearance less than 30 mL/minute)

          -  Advance heart failure (NY Heart failure stage 3 or greater; Ejection function <30%)

          -  Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic
             bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left
             bundle branch block or bifascicular block; Not to exclude patients the following
             conditions unless clinical circumstance dictate: Atrial fibrillation or atrial
             fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers

          -  Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine,
             sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol,
             etc.) unless clinical circumstance dictate

          -  Patients with active psychiatric disorders or cognitive dysfunction

          -  Pregnancy or lactating

          -  Enucleation, central, and distal pancreatectomy

          -  Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)
Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
Condition: Schizophrenia; Metabolic Syndrome X; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome; Schizophrenia
Intervention: Switch; Control
Intervention description: Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.; Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
Intervention MeSH terms: Olanzapine; Risperidone; Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ziprasidone; Olanzapine; Risperidone; Schizoaffective Disorder; Insulin Sensitivity; Visceral Adiposity; Metabolic Syndrome

Summary:

      This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a
      standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess
      abdominal fat storage in people with schizophrenia who are at risk for diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia or schizoaffective disorder

          -  Currently receiving antipsychotic therapy with risperidone or olanzapine

          -  Overweight

        Exclusion Criteria:

          -  Diagnosis of diabetes

          -  Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to
             study entry

          -  Refractory schizophrenia or schizoaffective disorder

          -  Currently receiving therapy with clozapine

          -  No stable residence and phone number for 90 days prior to study entry

          -  Prior unsuccessful treatment with ziprasidone

          -  Intolerance to ziprasidone
Interactions Between Drug Effects and Environments II
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: Paired; Stimulant or sedative; Placebo
Intervention description: Drug conditioning is assessed by pairing drug administration with a given context.; CS+ for paired, CS0 for unpaired; CS- for paired, CS0 for unpaired
Intervention MeSH terms: Hypnotics and Sedatives
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: drug cues

Summary:

      The purpose of the study is to determine how associations between drugs and the places where
      they are experienced influence drug seeking, mood and acute drug responses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  past use of stimulants

          -  bmi 19-26

          -  hormonal birth control for women

        Exclusion Criteria:

          -  current or recent (Past year) history of major axis I disorder