bioihbjkbjnl/mcl2 huggingface dataset:
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Condition: Pelvic Organ Prolapse; Urogenital Prolapse; Vaginal Vault Prolapse; Cystocele; Uterine Prolapse; Vaginal Prolapse; Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders; Cystocele; Uterine Prolapse; Recurrence; Prolapse; Pelvic Organ Prolapse
Intervention: Conjugated Estrogens Cream; Placebo Cream
Intervention description: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.; 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: Female
Minimum age: 48 Years
Healthy volunteers: No
Keywords: Pelvic Organ Prolapse; Pelvic Floor Disorders; Therapy, Estrogen Replacement; Estrogens, Conjugated

Summary:

      This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning
      native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued
      postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic
      science investigation are designed to understand the mechanisms by which local estrogen
      treatment affects connective tissues of the pelvic floor and determine whether its use before
      and after prolapse repair will (i) improve success rates of the surgical intervention and
      minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor
      disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal: no menses for >1 year

          -  Minimum age: 48 years

          -  Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater

          -  No estrogen replacement within the last month (may come off current treatment, i.e.
             wash out, to join the study)

          -  Medically fit for elective surgery

          -  Physically able to apply/insert the study drug

          -  Available for clinic follow-up for minimum 1yr

        Exclusion Criteria:

          -  Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)

          -  BMI >35 kg/m2

          -  Recent history (within last month) of vaginal infection or vaginitis

          -  Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or
             endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)

          -  History of connective tissue disease

          -  Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu

          -  History of vaginal irradiation

          -  Allergy to Premarin or its constituents

          -  Prior apical repair or use of mesh for prolapse repair

          -  Current tobacco use
Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: apremilast
Intervention MeSH terms: Apremilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla®
      (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy
    

Eligibility criteria:

        Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:

          1. Male or female adult ≥ 18 years of age;

          2. Diagnosis of chronic plaque-type

          3. Moderate to severe plaque type psoriasis as defined at baseline by:

               -  PASI score of 12 or greater,

               -  PGA score of 3 or greater

               -  BSA affected by plaque-type psoriasis of 10% or greater,

          4. Able and willing to give written informed consent prior to performance of any
             study-related procedures

        Exclusion Criteria:

        Subjects who meet any of the following criteria will be excluded from participation in this
        study:

          1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic,
             and/or guttate psoriasis) or drug induced psoriasis

          2. Subjects with previous exposure to apremilast

          3. Malignancy or history of malignancy, except for:

               -  treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;

               -  treated [ie, cured] malignancy with no evidence of recurrence within the previous
                  5 years.
Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid; Placebo
Intervention description: Zoledronic acid per protocol; Placebo
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In a randomized, double-blind trial, BMD of the operated proximal femur after total hip
      replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two
      years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n =
      24) at two weeks and one year after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary elective total hip replacement

        Exclusion Criteria:

          -  Osteoporosis (BMD ≤-2.5)

          -  Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric
             osteotomy, inflammatory arthritis

          -  Severe renal impairment

          -  Use of any medications affecting BMD

          -  Known sensitivity to bisphosphonates

          -  Severe dental problems, and pregnancy or being able to conceive and not using reliable
             birth control methods
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
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Condition: Migraine; Migraine Disorders; Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Erenumab
Intervention description: Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.
Intervention MeSH terms: Erenumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Maximum age: 67 Years
Healthy volunteers: No
Keywords: migraine; episodic migraine; chronic migraine; headache; erenumab; AMG334; aimovig; monoclonal antibody; CGRP-receptor antibody

Summary:

      This is a 128-week open-label study to assess the long-term safety and tolerabilty of the
      monoclonal antibody erenumab in migraine patients.
    

Eligibility criteria:

        The study population consisted of patients with a documented history of episodic (4 - 14
        baseline migraine days) or chronic migraine (≥15 baseline headache days), who had been
        successfully randomized to clinical trial CAMG334ADE01.

        Key inclusion Criteria:

          -  Signed informed consent must be obtained prior to participation in the study

          -  Patient is capable of understanding the nature, significance and implications of the
             clinical trial.

          -  Adults ≥18 years of age upon entry into screening

        Key exclusion Criteria:

          -  Use of a prophylactic migraine medication within five plasma clearance half-lives, or
             a device or procedure within one month prior to the start of the Open-label Treatment
             Epoch. This exclusion criteria does not apply to erenumab or topiramate administered
             within clinical trial CAMG334ADE01

          -  Any prior exposure to (investigational) prophylactic migraine products targeting the
             CGRP pathway, other than erenumab.
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Condition: Chronic Heart Failure With Reduced Systolic Function
MeSH terms: Heart Failure
Intervention: Dapagliflozin; Dapagliflozin matching placebo
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 19 Years
Maximum age: 119 Years
Healthy volunteers: No
Keywords: heart failure; dapagliflozin; Sodium-glucose co-transporter-2 (SGLT-2) inhibitors

Summary:

      The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared
      with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and
      quality of life in patients with chronic heart failure with reduced systolic function.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart
             failure (left ventricular ejection fraction ≤40% due to either ischemic or
             non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to
             enrollment

          2. No change in diuretic management for at least 1 week prior to enrollment

          3. Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic
             peptide (NTproBNP) ≥ 400 pg/mL at enrollment

        Exclusion Criteria:

          1. History of type 1 diabetes

          2. Estimated glomerular filtration rate (eGFR) < 30 at enrollment

          3. Hospitalization for heart failure within the 30 days prior to enrollment

          4. Admission for an acute coronary syndrome (ST-elevation myocardial infarction,
             non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary
             intervention, or cardiac surgery within the 30 days prior to enrollment

          5. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the
             screening visit

          6. Planned cardiovascular revascularization (percutaneous intervention or surgical) or
             major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular
             assist device, cardiac transplantation, or any other surgery requiring thoracotomy)
             within the 90 days after enrollment

          7. Patients who are volume depleted based upon physical examination at the time of
             screening or randomization
Lidocaine Jelly for Pain Control During Mohs Surgery
Condition: Pain; Satisfaction, Consumer
Intervention: Lidocaine jelly; Surgilube
Intervention description: lidocaine 2% jelly applied during Mohs surgery; surgilube (placebo) applied during Mohs surgery
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Does the use of lidocaine jelly during Mohs surgery on the nose decrease the total amount of
      lidocaine used during surgery.

      Does patient satisfaction improve when lidocaine jelly is used during Mohs surgery of the
      nose?
    

Eligibility criteria:

        Inclusion criteria:

        Patients having Mohs surgery on the nose who are able to consent to the study >18 years old

        Exclusion criteria:

        unable to consent for themselves known allergy to lidocaine Mohs surgery in locations other
        than the nose
Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Acthar Gel; Placebo
Intervention description: 80 Units Acthar Gel per 1 mL for subcutaneous injection; Matching placebo 1 mL for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1: Single Group; Part 2: Parallel
Masking: Double (Participant, Investigator)
Masking description: Part 1: Open Label ; Part 2: Double-blind
Enrollment: 259.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Persistent disease activity

Summary:

      This is a 2-part study to examine the effect of Acthar Gel in adult participants with
      rheumatoid arthritis (RA) with persistently active disease even after receiving two other
      treatments intended to modify the disease.

      Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12
      weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for
      treatment response using the DAS28-ESR.

      Participants who have achieved low disease activity (LDA) will enter a double-blind
      randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either
      Acthar Gel or matching placebo for an additional 12 weeks.

      A single participant might be involved in the trial for as many as 32 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant, nonlactating female subjects

          -  Meets criteria for definite rheumatoid arthritis as defined by 2010 American College
             of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at
             screening

          -  Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug
             administration despite dual-DMARD treatment

          -  Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a
             stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit

          -  May also be on a stable dose of 10 mg or less of prednisone or other the dose
             equivalent of another corticosteroid for 4 weeks prior to study drug administration

        Exclusion Criteria:

          -  Has current rheumatoid disease or inflammatory joint disease other than RA

          -  Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA

          -  Has taken B-cell mediated therapies in the 6 months prior to screening

          -  Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication
             as per the United States (US) Prescribing Information for Acthar

          -  Has history of Type 1 or Type 2 diabetes

          -  Has any clinically significant infection
Clinical Trial of NAC in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: n-acetylcystine; 0.9% saline
Intervention description: NAC is a mucolytic drug.; Normal saline is a placebo agent.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma
      that is complicated by mucus in the airway, as determined by CT imaging. The study is a
      crossover design, which means that half the study participants will get 20% NAC in the first
      7-day treatment period and placebo in the next 7-day treatment period; and the other half
      will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to perform reproducible spirometry according to ATS criteria

          -  Clinical history consistent with moderate to severe asthma for 1 year or greater.

          -  Post-bronchodilator FEV1 <90% of predicted

          -  Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of
             beclomethasone or greater and a second asthma controller therapy.

          -  CT mucus score >3 (determined during the initial screening process, provided the prior
             two conditions are met)

          -  Written informed consent obtained from participant and ability for participant to
             comply with the requirements of the study.

        Exclusion Criteria:

          -  Pregnant, breastfeeding, or unwilling to practice birth control during participation
             in the study.

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data.

          -  History of intolerance to study medications.

          -  Current use of carbamazepine

          -  Angina which includes a treatment plan with PRN nitroglycerin or nitrites

          -  Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year
             smoking history

          -  Current participation in an investigational drug trial Concurrent Medications
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.
Acetaminophen's Efficacy For Post-operative Pain
Condition: Tonsillitis; Airway Obstruction; Difficulty Swallowing
MeSH terms: Tonsillitis; Deglutition Disorders; Airway Obstruction
Intervention: IV acetaminophen; PO acetaminophen
Intervention description: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .; PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 41.0
Sex: All
Minimum age: 5 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: tonsillitis; recurrent tonsillitis; obstructed air passages; swallowing difficulties

Summary:

      The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain
      control in children undergoing tonsillectomy with or without adenoidectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 5-13 years of age

          -  Surgical procedure: tonsillectomy with or without adenoidectomy

          -  American Society of Anesthesiologists physical status classification 1 and 2 (patients
             that have either no systemic illness or mild systemic disease that is well-controlled,
             e.g. mild asthma)

        Exclusion Criteria:

          -  Known allergy to study medication(s)

          -  Known genetic abnormality

          -  Known hepatitis

          -  Children with other physical, mental or medical conditions which, in the opinion of
             the PI, make study participation inadvisable or impairs pain assessment

          -  Children who have taken any analgesic within 24 hours prior to surgery

          -  Enrollment in concurrent research study

          -  Pregnant patients*

          -  Students/trainees/staff*

          -  Mentally disabled/cognitively impaired*