bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
Condition: Cortisol Resistance; Negative Feedback; ACTH; Mineralcorticoid; Glucocorticoid
Intervention: Mifepristone; Placebo; Spironolactone; Combined; Dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Spironolactone; Mifepristone; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cortical Resistance; ACTH; Glucocorticoid; Mifepristone; SPIRONOLACTONE; Exercise; Hypothalamic-Pituitary-Adrenal Axis; Healthy Volunteer; HV

Summary:

      This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in
      younger endurance trained and sedentary men, and in older sedentary men.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Men aged 18 to 30 years of age are required for the young endurance trained and sedentary
        groups; men aged 65-80 years for the older study group, who will meet criteria for
        sedentary men below. Women and children are excluded to enhance homogeneity of responses
        and avoid the influence of menstrual cyclicity on the HPA axis.

        Sedentary:

          -  Less than one hour physical activity per week for three years

          -  No change in exercise anticipated for 6 weeks

        Trained:

          -  Greater than 45km (28 miles) running per week for at least 3 months

          -  No change in exercise anticipated for 6 weeks

        For all participants:

          -  All races

          -  Sleep-wake cycle with sleeping at night, wakening between 5 and 8 AM

          -  BMI between 18 and 25 kg/M2

          -  Normal TSH and free T4

        EXCLUSION CRITERIA:

        For all participants:

          -  Sleep disorders as assessed by sleep apnea questionnaire

          -  Smoking

          -  No more than 2 servings of alcohol daily

          -  Medications known to affect the HPA axis or steroid metabolism, including narcotics,
             Glucocorticoids, megace or CYP3A4 modulators

          -  History of psychiatric or endocrine disorders

          -  Marijuana or other illicit drug use

          -  Recent appendicular or skeletal injury

          -  Uncontrolled hypertension

          -  Chronic pain requiring daily medication

          -  Current treatment with medications related to mineralocorticoid function such as
             potassium, ACE-inhibitors, ARBs, diuretics, spironolactone

          -  Frailty score of 4-7 on the Canadian Study of Health and Aging frailty scale (Rockman
             2005)

          -  Overtraining syndrome will be an exclusion and will be assessed by questionnaire

          -  Abnormal creatinine level (greater than 1.2 mg/dl)

          -  Liver function tests greater than two fold normal

          -  Benzodiazepine use
Image-Guided Gynecologic Brachytherapy
Condition: Cervical Cancer; Uterine Cancer; Vaginal Cancer; Carcinoma of the Vulva
MeSH terms: Vaginal Neoplasms; Uterine Neoplasms; Vulvar Neoplasms
Intervention: Image-guided brachytherapy; 3'-Deoxy-3'-18f-Fluorothymidine
Intervention description: MRI-guided application of brachytherapy; Assessing tumor proliferation in Gynecologic cancer
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brachytherapy; Gynecological cancer

Summary:

      Standard therapy for gynecologic cancers involves the use of brachytherapy, also called
      internal radiation therapy or implant radiation. The treatment being studied consists of
      standard brachytherapy with the additional use of MRI to guide the insertion of radioactive
      applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is
      practical and beneficial when compared to the standard CT-guided brachytherapy placement. The
      investigators are hoping that this MRI procedure will decrease the risk of giving too high a
      radiation dose to the bladder or bowel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA),
             carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or
             carcinoma of the vulva (stage I-IVA)

          -  Life expectancy > 6 months

          -  MRI of the pelvis and/or PET-CT within 4 months prior to entering study

        Exclusion Criteria:

          -  Uncontrolled intercurrent illness

          -  Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments
             in the eye
Dose Range Study of CD5789 in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD5789 25 µg/g cream; CD5789 50 µg/g cream; CD5789 100 µg/g cream; Tazarotene 0.1% gel; Vehicle cream
Intervention description: CD5789 25 µg/g cream applied once daily; CD5789 50 µg/g cream applied once daily; CD5789 100 µg/g cream applied once daily; Tazarotene 0.1% gel applied once daily; Vehicle cream applied once daily
Intervention MeSH terms: Tazarotene; Trifarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of different concentrations of CD5789 cream in participants
      with acne vulgaris for the purpose of dose identification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participant, 12 to 35 years old with the following characteristics:

          -  Facial acne severity grade of the following:

               -  Stratum 1: IGA score of 3 or 4

               -  Stratum 2: IGA score of 4

               -  Stratum 3: IGA score of 3 or 4

          -  A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the
             following strata:

               -  Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a
                  maximum of one nodule on the face.

               -  Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.

               -  Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions
                  and up to four nodules on the face.

                    -  Note: Participants of Japanese origin will not be included in Stratum 1 or
                       Stratum 2. Japanese origin is defined as all four grandparents were born in
                       Japan.

        Exclusion Criteria:

          -  The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary
             acne form (chloracne, drug-induced acne, etc.)

          -  Any uncontrolled or serious disease, or any medical or surgical condition, that may
             either interfere with the interpretation of the clinical trial results and/or put the
             participant at significant risk (according to the Investigator's judgment) if the
             participant participates in the clinical trial.

          -  Known or suspected allergies or sensitivities to any components of any of the study
             drugs.

          -  Current participation in any other clinical trial of a drug or device OR past
             participation within the 30 days prior to the Baseline visit.
Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MM36 topical ointment, 1%
Intervention description: Twice daily application for 28 consecutive days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the pharmacokinetic parameters and safety of topical
      MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 2 to <18 years of age

          -  Diagnosis of atopic dermatitis (AD)

          -  AD affecting ≥ 35% body surface area (BSA) if 2 to < 12 years of age or ≥ 25% if
             subject is ≥ 12 years of age (excluding scalp and venous access areas)

        Exclusion Criteria:

          -  Active or acute viral skin infection

          -  History of recurrent bacterial infection

          -  Malignancy

          -  Clinically significant history or physical findings that may pose a health risk to
             subject or may have an impact on study assessments
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Condition: IgA Nephropathy (IgAN); Berger Disease; Glomerulonephritis, IgA
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA; Glomerulonephritis
Intervention: Placebo; Cemdisiran
Intervention description: Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.; Cemdisiran was administered by SC injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults
      with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite
      standard of care, which includes treatment with angiotensin-converting enzyme (ACE)
      inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for
      progression of kidney disease, which can result in end-stage renal failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with primary IgAN

          -  Currently being treated for IgAN with stable, optimal therapy, including an ACE
             inhibitor or ARB.

          -  Has urine protein greater than or equal to 1 gram/24-hour

          -  Has hematuria (blood cells present in urine)

        Exclusion Criteria:

          -  Has renal disease other than IgAN

          -  Has a diagnosis of rapidly progressive glomerulonephritis

          -  Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis)

          -  Has poor kidney function with estimated glomerular filtration rate (eGFR) <30
             milliliters per minute per 1.73 meters square (mL/min/1.73 m^2)

          -  Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV)
             infection or hepatitis B virus (HBV) infection

          -  Has on-going high blood pressure

          -  Treated with systemic corticosteroids for more than 7 days, or other immunosuppressant
             agents in the past 6 months

          -  Received an organ transplant
Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
Condition: Postmenopausal Women
Intervention: risedronate; risedronate; risedronate; risedronate
Intervention description: 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks; 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks; 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks; 50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 181.0
Sex: Female
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after
      breakfast, to a 35 mg immediate-release tablet, administered according to labeling
      instructions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In generally good health, as determined by medical history, physical examination, and
             laboratory test results

          -  Postmenopausal greater than 2 years, naturally or surgically based on medical history.

        Exclusion Criteria:

          -  Used any of the following medications within 3 months prior to dosing or used any of
             the following medications for more than 1 month at any time within 6 months prior to
             dosing:

               -  oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)

               -  anabolic steroids

               -  estrogens (oral, skin patch, or gel), except for low dose vaginal products or
                  insertable estrogen ring, selective estrogen-receptor modulators, or
                  estrogen-related drugs

               -  progestins

               -  calcitonin

               -  vitamin D supplements

               -  calcitriol, calcidiol, or alfacalcidol at any dose

               -  any bisphosphonate

               -  fluoride

               -  strontium

               -  parathyroid hormone, including teriparatide
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ABBV-8E12; placebo for ABBV-8E12
Intervention description: ABBV-8E12 solution for IV infusion; placebo solution for intravenous (IV) infusion
Intervention MeSH terms: Tilavonemab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 453.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Early Alzheimer's Disease (AD); Mild Cognitive Impairment (MCI); Mild Alzheimer's Disease (AD); Tau; Early dementia; Tauopathies; AD; Neurodegenerative diseases; Memory loss; Nervous system diseases

Summary:

      This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early
      Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who meets the National Institute on Aging and the Alzheimer's Association
             (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

               -  Clinical Dementia Rating (CDR)-Global Score of 0.5

               -  Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive

               -  Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory
                  Index (RBANS - DMI) score of 85 or lower

          -  Subject has a positive amyloid positron emission tomography (PET) scan.

          -  Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.

          -  The subject has an identified, reliable, study partner (e.g., family member).

          -  If using medications to treat symptoms related to AD, doses must be stable for at
             least 12 weeks prior to randomization.

        Exclusion Criteria:

          -  Subject has any contraindications or inability to tolerate brain magnetic resonance
             imaging (MRI), PET scans or lumbar puncture.

          -  Subject has evidence of any other clinically significant neurological disorder other
             than early AD.

          -  In the opinion of the investigator, the subject has any clinically significant or
             uncontrolled medical or psychiatric illness, or has had an infection requiring medical
             intervention in the past 30 days.

          -  Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
             attack or required intervention for any of these conditions within 6 months of
             Screening.
Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: eteplirsen
Intervention description: Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Male
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: DMD; Duchenne muscular dystrophy; eteplirsen; Dystrophin; exon 51

Summary:

      This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics
      of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable
      to exon 51 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male 4-6 years of age.

          -  Diagnosis of DMD, genotypically confirmed.

          -  Stable dose of oral corticosteroids for at least 12 weeks or has not received
             corticosteroids for at least 12 weeks.

          -  Intact right and left biceps muscles or two alternative upper arm muscle groups.

          -  Parent that is willing to provide consent and comply with study procedures.

        Exclusion Criteria:

          -  Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that
             may have an effect on muscle strength or function (e.g., growth hormone, anabolic
             steroids).

          -  Previous or current treatment with any other experimental treatments within 12 weeks
             or participation in any other clinical trial within 6 months.

          -  Major surgery within 3 months prior to the first dose of study drug, or planned
             surgery during this study which would interfere with the ability to perform study
             activities.

          -  Presence of other clinically significant illness.
Erenumab For Treatment of Hemicrania Continua
Condition: Hemicrania Continua
MeSH terms: Anencephaly; Headache
Intervention: Erenumab
Intervention description: 140 mg of erenumab via subcutaneous injection
Intervention MeSH terms: Erenumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No

Summary:

      This research is being conducting to learn if the study drug erenumab is successful in
      treating hemicrania continua. The study is also evaluating the safety and tolerability of
      erenumab in individuals being treated for hemicrania continua.
    

Eligibility criteria:

        Inclusion Criteria

          -  Adults over the age of 18-66

          -  At least a 12 month history of hemicrania continua (unremitting subtype) according to
             International Classification of Headache Disorders, 3rd Edition (ICHD-3)1

          -  Previous or current complete response to indomethacin

          -  Stable preventive treatment for at least 2 months and no anticipated need to
             adjust/add current headache prevention treatment

        Exclusion Criteria

          -  Nonresponse to a therapeutic dose of indomethacin for hemicrania continua when used
             for at least 1 week

          -  Pregnant or lactating subjects

          -  Use of barbiturate or opioid >6 days per month; history of chronic migraine

          -  History of previous trigeminal-autonomic cephalalgia

          -  History within previous 2 months of interventional procedure for headache (occipital
             or other extracranial nerve block, sphenopalatine ganglion block, cervical facet
             block, facet rhizotomy)

          -  History of cranial nerve/rhizolysis

          -  Botulinumtoxin injection with previous 4 months

          -  Parenteral infusion of or oral corticosteroid use for more than 3 days within 4 weeks
             prior to screening phase
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Maintenance lenalidomide
Intervention description: Daily maintenance treatment, oral lenalidomide
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: chronic lymphocytic leukemia; maintenance therapy

Summary:

      This study will determine whether or not Lenalidomide improves effectiveness of treatment for
      chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the
      disease (bendamustine and rituximab).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous induction treatment with bendamustine and rituximab

          -  18 or more years of age

          -  chronic lymphocytic leukemia

          -  ECOG performance status less than or equal to 2

          -  Absolute neutrophile count more than 1,000

          -  Platelet count more than 70,000

        Exclusion Criteria:

          -  Serious medical condition that would prevent treatment with lenalidomide

          -  Evidence of tumor lysis syndrome

          -  Any prior treatment with lenalidomide