bioihbjkbjnl/mcl2 huggingface dataset:
Hypogonadotropic Hypogonadism in Obese Young Males
Condition: Hypogonadism, Hypogonadotropic
MeSH terms: Hypogonadism
Intervention: Clomiphene; Placebo
Intervention description: clomiphene capsule 25mg twice a week; placebo capsule 25mg twice a week
Intervention MeSH terms: Clomiphene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: Male
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity can lead to low testosterone concentrations in young men. This study will study the
      effects of low testosterone in those men and the result of treating them with clomiphene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males

          -  Age 18-30 years inclusive will be recruited.

        A total of 90 males will be recruited:-

          -  30 obese males (defined as BMI ≥30 kg/m2) with HH,

          -  30 obese males with normal FT concentrations and

          -  30 lean males (defined as BMI <25 kg/m2) with normal FT concentrations.

        Exclusion Criteria:

          -  Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health
             supplements which contain androgens currently or in the past 6 months

          -  Hematocrit > 50%

          -  Congestive heart failure

          -  currently suffering from depression

          -  type 1 diabetes

          -  Hepatic disease (transaminase > 3 times normal) or cirrhosis

          -  Renal impairment (eGFR<30 ml/min/1.73m2)

          -  HIV or Hepatitis C positive status

          -  Participation in any other concurrent clinical trial

          -  currently suffering from foot ulcer, significant periodontal disease or any other
             chronic infectious condition
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: RVT-1401; Placebo
Intervention description: Subcutaneous administration of RVT-1401; Subcutaneous administration of Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Blinded
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMVT-1401

Summary:

      The purpose of the current study is to assess safety/tolerability and key pharmacodynamic
      (PD) effects that are considered to be associated with clinical benefit (reduction of total
      IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also
      known as IMVT-1401) compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 18 years of age.

          2. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of
             a respirator for the duration of the study as judged by the Investigator.

          3. QMG score ≥12 at Screening and Baseline.

        Other, more specific inclusion criteria are defined in the protocol.

        Exclusion Criteria:

          1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody for
             immunomodulation within 6 months prior to first dosing.

          2. Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or
             plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.

          3. Thymectomy performed < 12 months prior to screening.

          4. Total IgG level <6 g/L (at screening).

          5. Absolute neutrophil count <1500 cells/mm3(at screening).

        Other, more specific exclusion criteria are defined in the protocol
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
Condition: Polymyositis; Dermatomyositis
MeSH terms: Dermatomyositis; Polymyositis
Intervention: BAF312; Placebo
Intervention MeSH terms: Siponimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Inflammatory muscle disease, Muscle weakness, Myositis, inflammatory myopathy, inclusion body myositis, skin rash, autoimmune, difficulty swallowing, dysphagia

Summary:

      This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a
      novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive
      to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12
      week, randomized, placebo controlled period, followed by another 12 weeks where all subjects
      received BAF312 treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with disease at least 3 months before study

          -  Muscle weakness

          -  Received corticosteroids with or with out disease modifying antirheumatic drugs at
             least 3 months before study however not responding to this therapy

        Exclusion Criteria:

          -  Other idiopathic inflammatory myopathies

          -  Myopathy other than polymyositis and dermatomyositis

          -  Patients with late stages of disease
Pharmacokinetic Study to Determine Time to Steady-state
Condition: Male Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to confirm how long (i.e., how many days) it takes to reach
      steady-state when testosterone undecanoate is administered twice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, age 18-75

          -  Morning serum testosterone (T) <300 ng/dL on two occasions

          -  Naive to androgen-replacement therapy or willing to wash-out from current T therapy

        Exclusion Criteria:

          -  Significant intercurrent disease

          -  Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history
             of prostate cancer.

          -  Serum transaminases >2 times upper limit of normal

          -  Serum bilirubin >2.0 mg/dL

          -  Hematocrit <35% or >50%

          -  BMI >36

          -  Untreated, obstructive sleep apnea.
Nebulized Heparin for COVID19-associated Acute Respiratory Failure
Condition: Covid19
MeSH terms: COVID-19; Respiratory Insufficiency
Intervention: Heparin; Placebo
Intervention description: Nebulized heparin 25,000 units every 6 hours; Sodium chloride 0.9% every 6 hours
Intervention MeSH terms: Heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the utilization of nebulized heparin to
      circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic
      anticoagulation.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS
        (paO2/FiO2 ratio =300) within 48 hours

        Exclusion Criteria:

          -  Allergy to heparin

          -  Any history of heparin-induced thrombocytopenia

          -  High risk of bleeding (platelet count < 50,000/µL or international normalized ratio >
             1.5)

          -  Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)

          -  Active bleeding

          -  Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank
             bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring
             repeated suctioning, and temporally associated with acute deterioration in respiratory
             status)

          -  Neurosurgical procedures during this hospital admission or such procedures are planned

          -  Epidural catheter in place

          -  Any history of intracranial, spinal or epidural hemorrhage

          -  Tracheostomy in place

          -  Cervical spinal cord injury associated with reduced long-term ability to breathe
             independently

          -  Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to
             breathe independently

          -  Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy

          -  Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure

          -  Death is deemed imminent or inevitable or there is an underlying disease with a life
             expectancy of fewer than 90 days

          -  Pregnant or might be pregnant.

          -  Objection from the treating clinician

          -  Consent refused by the patient or substitute decision maker.

          -  History of thrombosis (VTE or cardiovascular event)
The Randomized OPTIMAL-ACT Trial
Condition: Coronary Artery Disease; Ischemic Heart Disease; Anticoagulant-induced Bleeding; Coronary Syndrome
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Hemorrhage
Intervention: Unfractionated heparin
Intervention description: Administration of unfractionated heparin will be assessed using the activated clotting time
Intervention MeSH terms: Heparin; Calcium heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: activated clotting time; outcomes; bleeding

Summary:

      The purpose of this study is to find the ideal range of the activated clotting time (ACT)
      during percutaneous coronary intervention (PCI) that is associated with lowering the rate of
      undesirable medical outcomes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age>18

          -  Referred for coronary angiography with possible coronary revascularization or
             adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)

        Exclusion Criteria:

          -  Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of
             coronary angiography

          -  Prior GP IIb/IIIa use within the previous 72 hours

          -  Use of warfarin (vitamin K antagonist) or direct oral anticoagulant

          -  Patients on LMWH bridging strategy

          -  PCI within prior 30 days

          -  Planned use of bivalirudin as the procedural anticoagulant

          -  Rotational atherectomy

          -  Excimer laser coronary angioplasty

          -  Chronic total occlusions

          -  Patients with active bleeding disorders or bleeding diathesis

          -  Patients with ST-segment elevation myocardial infarction

          -  Patient with clinical evidence of cardiogenic shock (defined as SBP<90 mmHg for ≥30
             min OR support to maintain SBP ≥90 mmHg AND evidence of end-organ hypoperfusion (urine
             output <30 mL/h or cool extremities)

          -  Chronic kidney disease stage 4/5 (GFR 30 mL/min)
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: IW-3718; Matching Placebo; PPI
Intervention description: All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the safety, efficacy, and dose-response
      relationship of IW-3718 administered orally to participants who have GERD and continue to
      experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump
      inhibitors (PPIs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is an ambulatory, community-dwelling male or nonpregnant female and is at
             least 18 years old at the Screening Visit. Lactating females must agree not to
             breastfeed.

          -  Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
             regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit
             while taking standard QD PPI therapy.

        Exclusion Criteria:

          -  Patient may not meet any of the excluded conditions specified in the protocol

          -  Patient has any alarm symptoms including but not limited to GI bleeding, anemia,
             vomiting, dysphagia, or unexpected weight loss any time during the Screening or
             Pretreatment Periods

          -  Patient has a history of clinically significant hypersensitivity or allergies to any
             of the excipients contained in the study medication (active or placebo).

        NOTE: Additional inclusion/exclusion criteria may apply.
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Condition: Pouchitis; Ulcerative Colitis
MeSH terms: Pouchitis
Intervention: Fecal microbiota transplantation; Placebo
Intervention description: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.; Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: FMT

Summary:

      The aim of our study is to investigate the efficacy and safety of fecal microbiota
      transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a
      double-blinded randomized placebo controlled study. 13 patients receive a fecal
      transplantation from the healthy tested donor and 13 patients in the control group receive
      their own feces.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA)
             for ulcerative colitis

          -  Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6
             months prior to FMT

          -  Need of frequent or continuous use of antibiotics or probiotics because of the chronic
             pouchitis

          -  Availability of consecutive fecal samples during one year

          -  Compliance to attend FMT and control pouchoscopy after 52 weeks

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  Use of immunosuppressive or biological medication

          -  Use of corticosteroids

          -  Acute pouchitis

          -  Pregnancy
DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: DFD06 Cream; Clobetasol Propionate Cream 0.05%
Intervention MeSH terms: Clobetasol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA
      (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream
      when applied twice daily for 15 days.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
        psoriasis.

        Subjects with psoriasis involving 20 to 50% Body Surface Area (BSA), not including the
        face, scalp, groin, axillae and other intertriginous areas.

        Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit Subjects
        whose results from the screening Adrenocorticotropic hormone (ACTH) stimulation test are
        considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no
        other signs of abnormal HPA function or adrenal response

        Exclusion Criteria:

        Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
        exfoliative or pustular psoriasis.

        History of organ transplant requiring immunosuppression, HIV, or other immunocompromised
        state.

        Have received treatment for any type of cancer within 5 years of the Baseline Visit except
        skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the
        Baseline Visit.

        Use within 60 days prior to the baseline Visit of: 1) immunosuppressive drugs (e.g.,
        tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate,
        cyclosporine, hydroxyurea) Use within 30 days prior to the Baseline Visit of: 1) topical
        antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) psoralen and
        ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate
        mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (UVB) therapy.

        Use within 30 days prior to the Screening Visit of any product containing corticosteroids.
        Inhaled, intraocular, intranasal, etc. steroids are not allowed.

        Subjects who have an abnormal sleep schedule or work at night. Subjects with a known
        history of acute adrenal crisis, Addison's disease or decreased adrenal output, low
        pituitary function or pituitary tumors.

        Subjects who have a history of an adverse reaction to cosyntropin injection or similar test
        reagents.

        -
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Condition: Metastatic Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: Sm-EDTMP; Autologous Stem Cell Infusion; External Beam Radiotherapy
Intervention description: Subjects receive a "tracer" infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post "tracer" infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. "Tracer" activity will be applied to development of the external beam radiation (EBT) planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg.; Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.; The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.
After the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary.
Intervention MeSH terms: Samarium Sm-153 lexidronam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 10 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Osteosarcoma; Osteogenic Sarcoma; Sarcoma; Bone Cancer

Summary:

      The primary goal of this study will be to examine tumor response after radiation treatment
      via a combination of Samarium-153 EDTMP and external beam radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be between 13 and 65 years of age, inclusive

          -  Must have unresectable primary tumor or metastases

          -  Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not
             all lesions must be positive on bone scan.

          -  Creatinine clearance >70ml/min/1.73m2

          -  ANC >500/mm3

          -  Platelets >50,000/mm3

          -  Life expectancy > 8 weeks

          -  Karnofsky performance status >50%

          -  Stem cell product collected prior to the infusion of Samarium must be available,
             either by peripheral stem cell mobilization or bone marrow harvest prior to trial
             entry.

        Exclusion Criteria:

          -  Patient may not be pregnant or breastfeeding.

          -  Patients who have received prior radiotherapy to all areas of current active disease
             are not eligible.