bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Condition: HIV; Contraception
Intervention: Depot medroxyprogesterone acetate (DMPA); Etonogestrel implant (Eng-Implant); Levonorgestrel intrauterine device (Lng-IUD); ParaGard® T 380A Intrauterine Copper Contraceptive
Intervention description: DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.; A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.; A standard Mirena IUD will be placed at study week 3 by a trained clinician.; A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
Intervention MeSH terms: Copper; Medroxyprogesterone Acetate; Contraceptive Agents; Levonorgestrel; Medroxyprogesterone; Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV-negative

Summary:

      This is a prospective cohort study focusing on HIV negative women. The investigators want to
      learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel
      implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A
      Intrauterine Copper Contraceptive impact the vaginal immune environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Age 18-45 years

          -  Normal menses (22-35 day intervals) for at least 3 cycles

          -  Intact uterus and cervix

          -  Interested in to DMPA, Eng-Implant or Lng-IUD or ParaGuard

          -  Willing to delay initiation of hormonal contraception for up to 1 month

          -  Willing to use condoms or abstain from sexual intercourse for at least 48 hours before
             each genital tract sampling (condoms will be made available)

          -  Able and willing to provide informed consent, and undergo serial blood and
             cervicovaginal lavage (CVL) sampling

          -  Negative HIV screening

        Exclusion Criteria:

          -  Pregnant within the last 3 months

          -  Breastfeeding

          -  History of loop electrosurgical excision procedure, conization, or cryosurgery within
             the past year

          -  Use of hormonal contraception or IUD in the past 6 months

          -  Known history of medical condition that would interfere with the conduct of the study

          -  Symptomatic vaginal infection or genital ulcer disease at screening

          -  Taking medications that interact with selected contraceptive

          -  Contraindications to selected contraceptive per the Centers for Disease Control and
             Prevention (CDC) medical eligibility criteria or judgment of clinician
Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
Condition: Retinal Degenerations
MeSH terms: Macular Edema; Retinal Degeneration
Intervention: 2% dorzolamide
Intervention description: Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)
Intervention MeSH terms: Dorzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A small percentage of patients with retinal degeneration accumulate fluid in the center of
      their retina.

      Previous studies using an oral form of treatment has been successful in decreasing this fluid
      which improves vision.

      This study will test the use of a topically applied form of this treatment to the eye to
      reduce the amount of fluid and improve or preserve vision.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of cystic macular fluid on OCT testing

        Exclusion Criteria:

          -  Allergic reaction to sulpha containing compounds

          -  Intolerance to dorzolamide (Trusopt)
Overnight Pain Treatment Investigating Opioids vs. Nonopioids
Condition: Abortion Second Trimester
Intervention: Ibuprofen 600 mg; OxyCODONE 5 Mg Oral Tablet
Intervention description: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.; Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
Intervention MeSH terms: Ibuprofen; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare maximum pain scores between patients seeking induced
      abortion and requiring cervical preparation with osmotic dilators. Patients will be
      randomized to receive prescription for ibuprofen alone or to receive prescription for
      ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic
      dilators. Data collected in-person and through a text-messaging platform.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English-speaking women

          -  18 years or older

          -  Access to cell phone with text-messaging capability/data

          -  Receiving cervical preparation for induced abortion

          -  Able to complete baseline survey on smartphone/tablet at screening visit

        Exclusion Criteria:

          -  History of opioid or alcohol abuse

          -  Contraindications or allergy to ibuprofen

          -  Contraindications or allergy opioid medications

          -  Seeking uterine evacuation for premature preterm rupture of membranes or advanced -
             cervical dilation or intrauterine fetal demise
Unicirc Adolescent 12-15 Year Old Boys
Condition: Circumcision, Male
Intervention: Unicirc circumcision
Intervention description: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Male
Minimum age: 12 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged
      12 to 15 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy boys desiring circumcision

        Exclusion Criteria:

          -  current illness

          -  bleeding disorder

          -  reaction to local anaesthetic

          -  infection

          -  any penile abnormality potentially complicating circumcision
TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Condition: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment
MeSH terms: Encephalitis, Tick-Borne; Encephalitis; Hypersensitivity
Intervention: TBE booster vaccination
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Allergic patients especially those undergoing de-sensitization treatment have an altered
      immune responsiveness. The investigators aim to find out whether this influences immune
      responses to primary and booster vaccinations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  completed primary TBE immunization + at least one booster immunization

          -  adults of both sexes between 18 and 60 years of age

          -  willingness to sign written informed consent form

        Exclusion Criteria:

          -  age < 18 and > 60 years

          -  prior TBE infection

          -  Hepatitis A vaccination

          -  pregnancy and breast feeding

          -  acute infection on day of inclusion (day 0), body temperature >37,9°C

          -  concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive
             therapy 4 weeks prior to or during study

          -  administration of other vaccines 4 weeks before/after TBE vaccination

          -  planned surgery within 2 weeks before/after TBE vaccination

          -  Start of de-sensitization and the first 4 weeks of allergen dose escalation

          -  any contraindication to administration of FSME-Immun® vaccine according to
             manufacturer's instructions

          -  history of malignant disease within the last 5 years

          -  autoimmune diseases

          -  drug addictions

          -  plasma donors

          -  receipt of blood transfusions or immuno globulins within 3 month before study entry
Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy
Condition: Pain; Quality of Life
Intervention: Meperidine; Fentanyl
Intervention description: Injection meperidine 1 mg/kg with diazepam 0.1 mg/kg.to intravenous 5 minutes before inserting the applicator and then when the patients had pain score greater or equal to 4. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.; Injection meperidine 1 mg/kg to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.
Intervention MeSH terms: Fentanyl; Meperidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Meperidine; Fentanyl; Pain management; brachytherapy

Summary:

      Purpose: To compare the pain level and quality of life of the two sedation regimens
      consisting of diazepam in combination with meperidine or fentanyl.

      Materials and methods: A total of 40 patients (160 sessions of brachytherapy), unselected
      brachytherapy out patients at Chulabhorn Hospital, Thailand were enrolled with informed
      consent and randomized to receive meperidine or fentanyl. Data of perceived pain (according
      to standard 10-cm visual analog scales [VAS]), and perceived Quality of life (EQ-5D) were
      collected. Patients and all brachytherapy staffs directly involved with the procedure were
      blinded about the drug used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 20 years old or older,

          -  Diagnosed with cervical cancer

          -  On course of external Radiation therapy

          -  Treated with brachytherapy 4 times.

        Exclusion Criteria:

          -  Pregnant

          -  Previously underwent intracavitary brachytherapy

          -  Illiterate
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone furoate Nasal Spray 110 mcg; Placebo
Intervention description: Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.; Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hay Fever; Daytime somnolence; Cognition

Summary:

      The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed
      thinking because of the hay fever will improve when treated with an effective anti-hay fever
      medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate
      better thinking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of
             study in the season of the study.

          -  Allergy skin tests positive for the airborne allergens present at the study time
             within the past 12 months.

          -  A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.

          -  Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep
             scales of drowsiness on 3 of 7 days.

          -  Ability to read, understand and give informed consent.

          -  Ability to understand and carry out responsibilities of the study

        Exclusion Criteria:

          -  Any chronic disease or other acute disease, which could influence central nervous
             system.

          -  The use of any medication, which could affect central nervous system function.

          -  Unwillingness to participate in the study.

          -  Inability to understand testing procedures or use of medication.

          -  Hypersensitivity to fluticasone or vehicle of nasal sprays.

          -  Any sleep disorders including obstructive sleep apnea.
Monoamine Contributions to Neurocircuitry in Eating Disorders
Condition: Eating Disorder
MeSH terms: Feeding and Eating Disorders
Intervention: [11C]raclopride; [11C]DASB; amphetamine
Intervention description: 1.[11C]raclopride -The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND; BPND of [11C]DASB.; The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.
Intervention MeSH terms: Raclopride; Amphetamine; Dextroamphetamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will use brain imaging technologies to measure several neurotransmitters
      (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our
      impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN)
      and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to
      use a challenge with brain imaging that will stimulate dopamine release which we hypothesize
      will generate anxiety rather than pleasure in AN, and will help explain why AN restrict
      eating in order to reduce anxiety. This study will help to understand the unique puzzling
      symptoms in eating disorders and contribute to finding better methods for identifying
      effective treatments for these often relapsing and sometimes chronic disorders.
    

Eligibility criteria:

        Inclusion

          -  history of Diagnostic and Statistical Manual (DSM-IV) diagnosis of anorexia or
             bulimia.

          -  AN women have history of average body weight (ABW) below 85% for height.

          -  AN-BN subjects have history of ABW below 85% ABW.

          -  AN-BN subjects have history of binging/purging behaviors during a period of low
             weight.

          -  Subjects must be right-handed.

          -  Subjects have been recovered for 12 months or more.

        Exclusion

          -  Diagnosis of alcohol or drug abuse or dependence in the 3 months.

          -  Alcohol or substance use within 30 days.

          -  Current diagnosis of an Axis I disorder.

          -  Organic brain syndromes, dementia, psychotic disorders, or mental retardation.

          -  Neurological or medical disorders such as seizure disorder, renal disease, diabetes,
             thyroid disease, EKG indicative of electrolyte imbalance

          -  BN subjects whose purging methods were the use of laxatives, diuretics

          -  Use of psychoactive medication in the 3 months.

          -  Pregnancy or lactation.

          -  Tobacco use in the 3 months.
Mirabegron and Urinary Urgency Incontinence
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Mirabegron
Intervention description: Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.
Intervention MeSH terms: Mirabegron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All patients receive mirabegron daily for 12 weeks
Masking: None (Open Label)
Masking description: There is no masking scheme
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Urgency Incontinence; Mirabegron; Myrbetriq; Betmiga

Summary:

      This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive
      bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB.
      The purpose of this study is to estimate the number of women who respond to a medication
      called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A
      secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment
      and change in symptom severity over 12 weeks of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥
             5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary
             incontinence or mixed urinary incontinence-urgency predominant)

          -  No contraindications to taking mirabegron

          -  Patients on current OAB therapy will undergo a two-week drug washout period prior to
             baseline assessment

        Exclusion Criteria:

          -  Neurologic disease known to affect the lower urinary tract

          -  Systemic immunologic deficiency

          -  Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent
             culture-proven UTIs

          -  History or current pelvic malignancy or radiation

          -  Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II

          -  A contraindication to receiving mirabegron

          -  Women of childbearing potential who are pregnant or nursing or intend to become
             pregnant during the study, or who are not practicing a reliable method of
             contraception

          -  Must not have taken any antibiotics in the 4 weeks prior to enrollment
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Entresto
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study intends to measure the effects of valsartan/sacubitril compared to baseline
      standard medical heart failure therapy on reverse remodeling using echocardiographic
      endocardial surface analysis techniques to assess changes in ventricular volume, function,
      and shape.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females aged ≥18 years

          2. Congestive Heart Failure (CHF) New York Heart Association (NYHA) class II-IV with 25%≤
             Left Ventricular Ejection Fraction (LVEF) ≤40% (ECHO within last 6 months)

               -  NT-proBNP ≥ 600 pg/mL OR

               -  NT-proBNP ≥ 400 pg/mL and a hospitalization for heart failure within the last 12
                  months

          3. Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent
             to enalapril ≥ 10 twice a day (BID) for at least 4 weeks

          4. Stable and optimized on a beta-blocker for at least 4 weeks

          5. Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks

        Exclusion Criteria:

          1. History of angioedema

          2. estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 at screening

          3. Serum potassium > 5.2 mmol/L at screening

          4. Symptomatic hypotension as defined by Investigator, systolic blood pressure (SBP) <
             100 mmHg at screening

          5. Current acute decompensated heart failure

          6. History of severe pulmonary disease

          7. Active malignancy

          8. Requirement for treatment with both angiotensin-converting-enzyme inhibitor (ACEI) and
             angiotensin receptor blockers (ARB)