bioihbjkbjnl/mcl2 huggingface dataset:
The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood
Condition: Perimenopausal Disorder; Stress, Emotional
Intervention: Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release; Placebo Patch; Progesterone Capsule; Placebo Oral Capsule
Intervention description: Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).; Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).; Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week; Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week.
Intervention MeSH terms: Estradiol; Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: Female
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: perimenopause; menopause transition; estrogen; stress; mood

Summary:

      Women in the menopause transition ('perimenopause') are exposed to extreme hormone
      variability, tend to experience a unique set of severe stressors (e.g., divorce, death of
      loved ones), and are also at substantially elevated risk to suffer from mood and anxiety
      disorders. The purpose of this research is to understand the mechanisms by which variability
      in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest
      and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal
      manipulation, this research will determine the degree to which the E2 variability (or E2
      levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it
      does so by affecting biological responses to stress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Perimenopausal (either early perimenopause, defined as menstrual cycle length 7+ days
             longer or shorter than usual; or the late perimenopause, defined as ≥2 skipped cycles
             and an interval of amenorrhea ≥60 days but within one year of the last menstrual
             period)

          -  45 to 60 years of age

          -  must be medically healthy

        Exclusion Criteria:

          -  a history of cardiovascular disease (CVD) including coronary artery disease,
             arteriosclerosis, heart attack, or stroke

          -  Type I or II diabetes

          -  personal history of thrombotic events

          -  personal or family history suggesting elevated risk for E2-related cancer

          -  currently experiencing migraine headaches with aura
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Montelukast; Placebo
Intervention description: 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age; Oral granules or chewable tablet, PO QD (given oral daily)
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 1 Year
Maximum age: 8 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis (Eczema) associated with food allergies

Summary:

      AD is a disease found in children; the focus of the study is the mechanisms associated in
      children with AD induced by food allergies.

      This study will be a randomized, double-blind, placebo-controlled, parallel group trial
      conducted in participants diagnosed with atopic dermatitis and food allergies. The study
      duration for participants will be approximately 9 weeks. A total of 20 participants will be
      recruited for the entire study. Each arm will consist of 10 participants.The study will
      enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated
      with food allergens, previously documented by skin or RAST test, before enrollment. Atopic
      dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Mild to moderate atopic dermatitis involving greater than or equal to 5% of body
             surface

          2. Total severity score of 2 or greater for any 3 of the 4 signs and symptoms calculated
             by study doctor (erythema, papulation, or lichenification)

          3. Positive skin or (radioallergosorbent) RAST tests by ImmunoCap to food or
             environmental allergens

          4. GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics

        Exclusion Criteria:

          1. Participants with intolerance or allergy to montelukast.

          2. History of anaphylaxis requiring hospitalization.

          3. No underlying renal or liver disease.

          4. Participants with a diagnosis of severe asthma.

          5. Participants diagnosed with primary immune deficiency.

          6. Participants using sublingual immunotherapy.

          7. Immunotherapy must be a maintenance dose for a minimum of 30 days.

          8. If on gastrointestinal medication, 30 day stable dose before visit 1 and maintained
             throughout the study.
Beneficial Effect of Probiotics on Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Probiotics; Cornstarch
Intervention description: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations; placebo will be given in 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized double blinded placebo control studies are performed in Chronic Kidney
      Disease (CKD) patients. After informed consent, intervention group receives probiotics
      containing 109 CFU B. bifidum, B.catenulatum, B. longum, and L.plantarm), while placebo group
      receives corn starch. In the first year the investigators examine the 60 peritoneal dialysis
      (PD) patients, in the second year the investigators do the 60 hemodialysis (HD) patients, and
      in the third year the investigators do the 60 stage 3 and 4 CKD patients. Primary endpoint is
      cardiovascular event, gastrointestinal symptoms, peritonitis in PD patients, and progression
      of stage 3 and 4 CKD. Values are compared between the groups by unpaired t test. X2 testis
      used to compare proportions between the groups. Relative risk and the number needed to treat,
      both with 95% CI, are used to describe the treatment effect of probiotics. A p value less
      than 0•05 is regarded as statistically significant.
    

Eligibility criteria:

        Inclusion Criteria:

          1. receiving peritoneal dialysis for more than 3 months, at least 18 years of age, and
             GFR < 15 ml/min.

          2. receiving hemodialysis dialysis for more than 3 months, at least 18 years of age, and
             GFR < 15 ml/min.

          3. Stage 3 and 4 CKD patients

        Exclusion Criteria:

          -  active infectious conditions within the last 30 days,

          -  pregnancy for female,

          -  autoimmune disease e.g. SLE.,

          -  cardiovascular events before.
Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)
Condition: Dehydration
MeSH terms: Dehydration
Intervention: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
Intervention description: Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dehydration; fluid therapy; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20

Summary:

      The purpose is to characterize the in-line pressure profiles associated with several infusion
      technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded
      by recombinant human hyaluronidase (hylenex). The safety and tolerability of
      hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18 to 60 years, inclusive.

          -  Body mass index 19.0 to 35.0 kg/m2

          -  Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on
             the upper back in the area intended for infusion

          -  Free from any clinically significant abnormality on the basis of medical/medication
             history or physical examination

          -  Vital signs and clinical laboratory parameters within normal range or, if outside
             normal range, deemed not clinically significant

          -  Negative urine drug and alcohol screens.

        Exclusion Criteria:

          -  Upper back pathology that could interfere with study outcome.

          -  History of congestive heart failure, known coronary heart disease, active or recent
             pulmonary disease, or renal insufficiency.

          -  Rales on lung auscultation.

          -  Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex
             recombinant

          -  Treatment with furosemide, benzodiazepines, or phenytoin.

          -  Pregnancy or breastfeeding.

          -  Exposure to any experimental drug within 30 days prior to study admission, or previous
             participation in this study.

          -  Any other reason which, in the investigator's opinion, would prevent the safe
             participation in the study.
A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Interleukin 28B testing
Intervention description: Blood sampling for ILB28 genotyping
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4766.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes
      with disease characteristics and demographics in treatment-naïve and treatment-experienced
      chronic hepatitis C patients, including patients with HIV co-infection. There will be a
      single study visit for testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (according to local legislation) male or female patient

          -  Chronic hepatitis C (CHC)

          -  Patients naïve to CHC treatment or patients who received prior interferon-based
             therapy for CHC for whom data on treatment received and treatment outcome is
             available; information on fibrosis stage prior to previous treatment is also required

        Exclusion Criteria:

          -  Co-infection with hepatitis B

          -  History or evidence of decompensated liver disease

          -  History of major organ transplantation with an existing functional graft (including
             liver transplantation)

          -  End stage renal disease
TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Plain bupivacaine; Liposomal bupivacaine
Intervention description: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn; Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain, Liposomal bupivacaine, Wound infiltration

Summary:

      In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after
      ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound
      infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  ASA physical status 1-3

          -  Scheduled for open abdominal hysterectomy

          -  Age 18-80 years old

          -  Able to participate personally or by legal representative in informed consent in
             English or Spanish

        Exclusion Criteria:

          -  History of relevant drug allergy

          -  Age less than 18 or greater than 80 years

          -  Chronic opioid use or drug abuse

          -  Significant psychiatric disturbance

          -  Inability to understand the study protocol

          -  Refusal to provide written consent
Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)
Condition: Contraception
Intervention: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)
Intervention description: Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
Intervention MeSH terms: Ethinyl Estradiol; Etonogestrel; NuvaRing
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will collect information on cycle control, acceptability and tolerability of the
      vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women at risk of pregnancy and seeking contraception

        Exclusion Criteria:

        Exclusion criteria based on approved prescribing information in India:

          -  Presence or history of venous thrombosis, with or without pulmonary embolism.

          -  Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial
             infarction) or prodromi of a thrombosis (e.g. angina pectoris or

        transient ischemic attack).

          -  Known predisposition for venous or arterial thrombosis, with or without hereditary
             involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency,
             protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid
             antibodies (anticardiolipin antibodies, lupus anticoagulant).

          -  History of migraine with focal neurological symptoms.

          -  Diabetes mellitus with vascular involvement.

          -  The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
             (at the discretion of the doctors)

          -  Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.

          -  Presence or history of severe hepatic disease as long as liver function values have
             not returned to normal.

          -  Presence or history of liver tumors (benign or malignant).

          -  Known or suspected malignant conditions of the genital organs or the breasts, if sex
             steroid-influenced.

          -  Undiagnosed vaginal bleeding.

          -  Known or suspected pregnancy.

          -  Hypersensitivity to the active substances or to any of the excipients of NuvaRing.

          -  Women who are breast feeding
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Rupture
Intervention: Bupivacaine; Preservative free normal saline
Intervention description: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000; Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Anterior cruciate ligament reconstruction

Summary:

      Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide
      analgesia for the front of the knee. Postoperatively, these patients will often report pain
      in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee
      results in blockade of the genicular nerves of the posterior knee. These nerves originate off
      of the tibial and common peroneal nerves and their blockade will result in improved posterior
      knee pain relief and may decrease narcotic consumption compared to patients who receive the
      same infiltration with normal saline.
    

Eligibility criteria:

        Inclusion Criteria:

          1. patients who are presenting for ACL reconstruction

          2. candidates for peripheral nerve blocks patients

          3. ASA 1-3

        Exclusion Criteria:

          1. Patient refusal

          2. ASA Classification of 4 or higher

          3. Pre-existing neuropathy in the femoral or sciatic distribution

          4. Coagulopathy

          5. Infection at the site

          6. Non-English speaking or non-reading patients

          7. Chronic opioid use (>3months)

          8. Pregnancy

          9. Any other contra-indication to regional anesthesia

         10. Failed femoral nerve block

         11. Sciatic nerve block placed due to severe pain not managed by intravenous and oral
             agents.
Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Condition: Diabetes Mellitus
Intervention: Saxagliptin
Intervention description: 2.5-5 mg daily
Intervention MeSH terms: Saxagliptin; Dipeptidyl-Peptidase IV Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 110 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety and efficacy of a drug called
      saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized
      patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c
      ≤7.0% on ≤ 2 non-insulin agents at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0%
             on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical
             illness.

          -  Written informed consent.

        Exclusion Criteria:

          -  Admitted to or expected to require admission to ICU

          -  Patients with a history of diabetic ketoacidosis or hyperosmolar state

          -  HbA1c >7.5% at the time of admission or within 3 months before admission

          -  Insulin requiring before admission

          -  Unable to take oral food or medications

          -  Systemic steroid use

          -  Pregnancy or breastfeeding

          -  Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an
             acceptable method to avoid pregnancy for the entire study period and up to 4 weeks
             after the last dose of study drug.

          -  History of pancreatitis or active gallbladder disease

          -  End stage renal disease on dialysis

          -  Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors

          -  Subject unable to give informed consent