bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
Condition: Seizure Disorder; Hypogonadism; Erectile Dysfunction
MeSH terms: Epilepsy; Seizures; Erectile Dysfunction; Hypogonadism
Intervention: Anastrozole 1mg; Placebo Oral Tablet
Intervention MeSH terms: Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Seizure; Epilepsy; Testosterone; Hormone; Sexual Dysfunction; Hypogonadism; Men

Summary:

      The purpose of this study is to determine if treatment using a medication
      (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a
      tablet that does not contain any active medication, when combined with testosterone
      replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole,
      the medication that is currently under study, does not, at this time, have FDA approval for
      use for this indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be a male between the ages of 18 and 50 years.

          -  Subject must have localization-related epilepsy with complex partial and/or secondary
             generalized seizures.

          -  Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone
             levels and abnormally low scores on questionnaires of reproductive and sexual
             function).

          -  Subject will have had a normal urogenital and rectal/prostate exam during the year
             prior to entry.

          -  Subject will have had documentation of therapeutic range serum AED levels, a normal
             CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than
             twofold elevated during the 6 months prior to entry.

        Exclusion Criteria:

          -  Subject that has taken hormones, major tranquilizers or antidepressants in the three
             months prior to entry.
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; Risankizumab
Intervention description: subcutaneous (SC) injection; subcutaneous (SC) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Atopic dermatitis, Atopic dermatitis (atopic eczema)

Summary:

      The purpose of this study is to assess the safety and efficacy of risankizumab for the
      treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults who are ≥ 18 years old and, where locally permissible and approved, adolescent
             subjects who are at least 12 years old

          -  a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to
             Baseline and subject meets Hanifin and Rajka criteria

          -  moderate to severe AD at the Baseline Visit

          -  history of inadequate response to previous topical corticosteroid and/or topical
             calcineurin inhibitor treatments or a medical inability to receive these treatments

        Exclusion Criteria:

          -  prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor

          -  concurrent treatment with systemic therapy for AD (biologic or non-biologic) or
             topical and/or phototherapy treatments
Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease
Condition: Heart Disease
MeSH terms: Heart Diseases
Intervention: Motivational Interview
Intervention description: For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coronary heart disease (CHD); myocardial infarction (MI); acute coronary syndromes (ACS)

Summary:

      The purpose of this research study is to survey patients to learn about their beliefs and
      behaviors related to the management of heart disease and to discuss options for making
      healthy lifestyle changes. From the information the investigators get from patients, the
      investigators hope to develop better methods for taking care of patients who have heart
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to an inpatient medicine unit for MI, ACS, and coronary angiography

          -  Age

        Exclusion Criteria:

          -  Altered mental status

          -  Language barriers

          -  Dementia or Cognitive Impairment

          -  Diagnostic Study

          -  Resident in long-term care facility prior to the present admission

          -  Planned discharge to a skilled or intermediate care facility or hospice

          -  Lack of access to a functioning phone
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: Abatacept; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus disease 2019 (COVID-19); Coronavirus; Coronavirus infections; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Summary:

      The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept
      administered to hospitalized COVID-19 participants with respiratory compromise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2
             (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).

          -  Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)

          -  Respiratory compromise as defined by requirement of oxygen supplementation to maintain
             oxygen saturation ≥ 93% but not requiring mechanical ventilation

          -  Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical
             condition that would serve as an exclusionary criteria

          -  Women and men must agree to follow specific methods of contraception, if applicable

        Exclusion Criteria:

          -  Women who are breastfeeding

          -  Recent acute infection defined as:

             i) Any acute infection within 60 days prior to randomization that required
             hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii)
             Any acute infection within 30 days prior to randomization that required oral
             antimicrobial or antiviral therapy

          -  History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,
             osteomyelitis, bronchiectasis)

          -  Prior exposure to BMS-188667 (abatacept)

        Other protocol-defined inclusion/exclusion criteria apply
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
Condition: Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer
MeSH terms: Graft vs Host Disease
Intervention: fludarabine phosphate; busulfan; cyclophosphamide; allogeneic hematopoietic stem cell transplantation; tacrolimus; mycophenolate mofetil
Intervention description: Given IV; Given IV; Given IV; Undergo myeloablative or reduced intensity allogeneic stem cell transplant
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Busulfan; Fludarabine; Fludarabine phosphate; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in
      treating patients with hematological diseases. Giving chemotherapy before a donor stem cell
      transplant helps stop the growth of cells in the bone marrow, including normal blood-forming
      cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused
      into the patient they may help the patient's bone marrow make stem cells, red blood cells,
      white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an
      immune response against the body's normal cells (called graft-versus-host disease). Giving
      cyclophosphamide after the transplant may stop this from happening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a hematological malignancy requiring an allogeneic stem cell transplant
             consistent with the standard of care

          -  Remission of any acute hematologic malignancy or adequate disease control for chronic
             malignancies.

          -  Ages 18-69 years old.

          -  Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor

        Exclusion Criteria:

          -  Significant organ dysfunction defined as: LV EF < 50% (evaluated by echocardiogram or
             MRI), DLCO or FEV1 < 65% predicted, AST/ALT > 2.5 x ULN, Bilirubin > 1.5 x ULN, Serum
             creatinine > 2mg/dL, dialysis, or prior renal transplant

          -  HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or
             human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation)

          -  Positive pregnancy test for women of childbearing age.

          -  Major anticipated illness or organ failure incompatible with survival form transplant.

          -  Severe psychiatric illness or mental deficiency sufficiently severe as to make
             compliance with the transplant treatment unlikely and informed consent impossible.
Atovaquone for Treatment of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Experimental Group; Placebo Group
Intervention description: Continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days; Continued standard of care therapy together with matching placebo
Intervention MeSH terms: Atovaquone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the current study is to accelerate the use of a clinically available
      therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19
      addressing a serious and emergent unmet medical need.

      This is a randomized, double-blind study of atovaquone therapy in adult participants
      hospitalized with COVID-19. Approximately 60 participants who meet all eligibility criteria
      may be randomized in a 2:1 atovaquone/placebo ratio into one of the following treatment
      groups:

      Treatment Group 1: continued standard of care therapy together with an oral dose of 1500 mg
      atovaquone twice daily (administered with a meal or snack) for up to 10 days

      Treatment Group 2: continued standard of care therapy together with matching placebo
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of COVID-19 by positive RT-PCR requiring hospitalization within 72 hours

          2. Age ≥18 years old

          3. Able to provide informed consent, or (as allowed by IRB), immediate availability of
             designated legally authorized representative to provide consent by proxy

          4. Anticipated hospitalization for >48 hours

        Exclusion Criteria:

          1. Participation in any other clinical trial with antiviral activity against COVID-19

          2. Breastfeeding women

          3. Known hypersensitivity to atovaquone or formulation excipient

          4. Active treatment with rifampin

          5. HIV patients with AIDS requiring treatment for Pneumocystis jirovecii or Toxoplasma
             gondii

          6. Not expected to survive for 72 hours. 7) >14 days from symptom onset
ET-01 in Subjects With Lateral Canthal Lines, LCL-207
Condition: Lateral Canthal Lines; Crow's Feet
Intervention: Vehicle; botulinum toxin, Type A; botulinum toxin, Type A
Intervention description: Vehicle Formulation; botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline; botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel dose groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: different doses are packaged in identical containers
Enrollment: 79.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet wrinkles on contraction

          -  willingness to refrain from any product affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
Condition: Intra-dialytic Hypotension
MeSH terms: Hypotension
Intervention: Mannitol (20%); 0.9% saline
Intervention description: 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session); 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
Intervention MeSH terms: Mannitol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Kidney failure can result from a variety of conditions and can be temporary or permanent.
      Hemodialysis is available as a replacement treatment to perform the work that the kidneys
      normally do. However, the dialysis procedure can be associated with rapid changes in the
      composition of the blood - this may lead to changes in blood pressure and in turn reduced
      blood supply to important parts of the body. We aim to investigate if giving a medicine
      (called mannitol) during dialysis may be able to reduce the frequency of these low blood
      pressure events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal failure requiring intermittent hemodialysis initiation; adult patients aged over
             18 years; written informed consent

        Exclusion Criteria:

          -  Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days;
             cardiac transplant; ventricular arrhythmia; unstable angina; use of
             pressors/midodrine; enrollment in conflicting research study; institutionalized
             individuals; pregnancy; prisoners; documented allergy to mannitol
Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student
Condition: Stress; Anxiety
MeSH terms: Anxiety Disorders
Intervention: Auriculotherapy; Placebo Group
Intervention description: Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.; They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 71.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: stress disorders; anxiety disorders

Summary:

      Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing
      School students of Beneficence Portuguese Hospital and review the effectiveness of true and
      placebo auriculotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Average and high score by the List of Stress Symptoms

          -  Voluntary participation in the study

          -  Availability of time for submission to the sessions

        Exclusion Criteria:

          -  Pregnancy

          -  Medical license or vacation during the period

          -  Low score of stress
A Phase II Study of M2951 in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; M2951; M2951; M2951; M2951
Intervention description: Participants received placebo matched to M2951 orally for 52 weeks.; Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.; Participants received 75 mg of M2951 orally QD for 52 weeks.; Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.; Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 469.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus; M2951; Placebo; Dose response; Oral Corticosteroids; Safety; Efficacy; Autoimmune And Inflammatory Disorders

Summary:

      M2951 is an investigational drug under evaluation for treatment of autoimmune and
      inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of
      M2951 in participants with Systemic Lupus Erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible male and female participants, aged 18 to 75 years

          -  Must have diagnosis of SLE with either the Systemic Lupus International Collaborating
             Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of
             Rheumatology (ACR) classification criteria for SLE, of at least six months duration
             prior to Screening

          -  SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI
             greater than or equal to (>=) 4) at Screening Visit

          -  And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or
             anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith
             (anti-Sm) antibody at the time of Screening

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participants are not eligible for this study if they have active, clinically
             significant interstitial lung disease or pulmonary arterial hypertension

          -  Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)

          -  Acutely worsened renal function

          -  Central nervous system SLE

          -  Or within two weeks prior to Screening or during Screening: use of oral
             corticosteroids greater than (>) 30 mg daily prednisone equivalent

          -  Use of injectable corticosteroids, or change in dose of corticosteroids.

          -  Other protocol defined exclusion criteria could apply
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Placebo; LY3041658
Intervention description: Administered IV; Administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3041658 is effective in participants
      with moderate-to-severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of HS for at least 6 months

          -  Have HS lesions in at least 2 different anatomic areas

          -  Have inadequate response or intolerance to a 28 day course of oral antibiotics

          -  Have a total count of abscesses and inflammatory nodules greater than or equal to 4

          -  Agree to use a topical antiseptic daily

          -  Agree to stop using topical antibiotics during the study. In certain cases, oral
             antibiotics will be allowed

        Exclusion Criteria:

          -  Have more than 20 draining fistulae

          -  Have received any biologic medication (adalimumab, etc.) for the treatment of HS

          -  Plan to use oral opioids for HS-related pain during the study

          -  Uncontrolled depression or suicidal thoughts