bioihbjkbjnl/mcl2 huggingface dataset:
Reduced Intensity Double Umbilical Cord Blood Transplantation
Condition: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia; Acute Myelogenous Leukemia
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Fludarabine; Melphalan; Total Body Radiation; Cord Blood
Intervention description: 30 mg/m2/day IV x 6 days; 100 mg/m2/day IV x 1 day; 200 cGy on Day 0; 2 cord blood units IV
Intervention MeSH terms: Fludarabine; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: NHL; lymphoma; leukemia; myelodysplastic disorder; aplastic anemia

Summary:

      This trial will use two cord blood units for transplantation using a reduced intensity
      regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood
      units (double cord blood) are being used, as the numbers of blood cells in one unit are too
      few to allow successful growth of these cells.

      Because the risk of infection, particularly virus infection, is high after double cord blood
      transplant, this study seeks to reduce the rise of virus infection by using a reduced
      intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior
      cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and
      fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The
      number of patients with virus infections in this study will be compared to our prior
      experience using the ATG.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hematologic malignancy for whom allogeneic stem cell transplantation is deemed
             clinically appropriate

          -  Appropriate candidate for reduced intensity regimen, according to the treating
             physician

          -  Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or
             unrelated donor not available with a time frame necessary to perform a potentially
             curative stem cell transplant

          -  Able to comply with the requirements for care after allogeneic stem cell
             transplantation

        Exclusion Criteria:

          -  Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular
             dysfunction

          -  Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic
             restrictive lung disease

          -  Renal disease

          -  Hepatic disease

          -  Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
             neuropsychiatric abnormalities believed to preclude transplantation

          -  HIV-positive

          -  Uncontrolled infection

          -  Pregnant or breast-feeding
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Factor XIIa antagonist monoclonal antibody; Placebo
Intervention description: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use; Buffer without active ingredient
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are assigned to 1 of 2 or more groups in parallel for the duration of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to
      investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to
      prevent attacks in subjects with HAE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Aged ≥ 18 to ≤ 65 years

          -  A diagnosis of C1-INH HAE or FXII/PLG HAE;

          -  For subjects with C1-INH HAE: ≥ 4 HAE attacks over a consecutive 2-month period during
             the 3 months before Screening, as documented in the subject's medical record.

        Exclusion Criteria:

          -  History of clinically significant arterial or venous thrombosis, or current clinically
             significant prothrombotic risk

          -  History of an uncontrolled, abnormal bleeding event due to a coagulopathy, or a
             current clinically significant coagulopathy or clinically significant risks for
             bleeding events

          -  Known incurable malignancies
68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer
Condition: Prostate Carcinoma
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-DOTA-Bombesin; Magnetic Resonance Imaging (MRI) scan; Positron Emission Tomography (PET) scan
Intervention description: 68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is [4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl]-acetyl.
68Ga-DOTA-Bombesin is administered intravenously (IV)
Intervention MeSH terms: Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent
      for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively
      PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called
      68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces.
      The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and
      attaching to tumor cells, which may help doctors recognize differences between tumor and
      healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside
      the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow
      doctors to identify smaller tumors than standard imaging.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Provides written informed consent

          -  Known diagnosis of prostate cancer

          -  Patient has suspected recurrence based on biochemical data [prostate-specific antigen
             (PSA) > 2 ng/mL]

          -  Able to remain still for duration of each imaging procedure (about one hour)

        EXCLUSION CRITERIA

          -  Unable to provide informed consent

          -  Inability to lie still for the entire imaging time

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance

          -  Metallic implants
Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Antidepressants through Texas Medication Algorithm (TMA); Brief Interpersonal Psychotherapy (IPT-B)
Intervention description: Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.; IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
Intervention MeSH terms: Antidepressive Agents; Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Mood Disorders; Hispanic

Summary:

      This study will determine whether combination treatment driven by patient choice is better
      than standardized medication treatment at retaining and improving Hispanic patients with
      major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hispanic males and females

          -  DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate
             severity (HAM-D-17> 18)

          -  18- 79

          -  Patients with stable dosage of Benzodiazepines to treat anxiety disorders

        Exclusion Criteria:

          -  At risk of attempting suicide

          -  Unstable medical illness

          -  History of bipolar disorder, schizophrenia, or other psychotic disorder

          -  Pregnant or lactating

          -  Alcohol or substance use disorder that requires acute detoxification
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
Condition: Covid19; SARS-CoV-2 Infection
MeSH terms: Infections; COVID-19; Critical Illness
Intervention: GC4419; Placebo
Intervention description: 180 Minute IV Infusion; 180 Minute IV Infusion
Intervention MeSH terms: Avasopasem manganese
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID19; SARS-CoV-2 Infection

Summary:

      A Trial of GC4419 in Patients with Critical Illness due to COVID-19
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects at least 18 years of age.

          2. Ability to understand and the willingness to sign a written informed consent.

          3. Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test
             documented prior to randomization

          4. Requirement for intensive inpatient hospital care

          5. Acute hypoxemic respiratory failure typifying ARDS

          6. Adequate liver function

          7. Use of effective contraception

        Exclusion Criteria:

          1. Expected survival for less than 48 hours after randomization

          2. Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to
             cirrhosis

          3. Stage IV chronic kidney disease or end-stage kidney disease on maintenance
             hemodialysis

          4. Requirement for extra-corporeal membrane oxygenation (ECMO)

          5. Acute Myocardial Infarction (AMI)

          6. Active bleeding requiring transfusion

          7. Concurrent participation in another clinical trial of experimental treatment for
             SARSCoV-2

          8. Female patients who are pregnant or breastfeeding

          9. Requirement for concurrent treatment with nitrates
Vitamin C in Atrial Fibrillation Ablation
Condition: Atrial Fibrillation Ablation
MeSH terms: Atrial Fibrillation
Intervention: Vitamin C; Placebo
Intervention description: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W; 50mL infused over 30 minutes
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of
      high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered
      every six hours with a 30 minute IV infusion time per dose, compared to matched placebo
      infusion
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >/= 21 years

          2. Diagnosis of atrial fibrillation with plans for a catheter-based ablation procedure

          3. Ability to provide informed consent and willingness to be included in the study

        Exclusion Criteria:

          1. Known allergy to Vitamin C

          2. Inability to obtain informed consent

          3. Diabetes mellitus either requiring the use of insulin therapy or not requiring the use
             of insulin therapy but which is uncontrolled, defined as a glycosylated hemoglobin of
             greater than or equal to 8%

          4. Prior catheter-based ablation for atrial fibrillation

          5. Pregnancy or breast feeding

          6. Active renal calculus

          7. Active acute or chronic infection (including HIV or hepatitis C)

          8. Active or recent (within 5 years) malignancy

          9. Autoimmune or autoinflammatory disease

         10. Recent or active use of immunosuppressive medications

         11. Non-English speaking

         12. Ward of the state (inmate, other)
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: AVP-786; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Negative Symptoms; Schizophrenia; AVP-786

Summary:

      The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability
      of AVP-786 as an adjunctive treatment compared with placebo in patients with residual
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I.
             version 6.0.

          -  Patients must meet PANSS criteria

          -  Patients currently receiving atypical antipsychotics are eligible provided they are on
             a stable dose

        Exclusion Criteria:

          -  Patients with current major depressive disorder (MDD)

          -  Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic
             medication

          -  Patients currently using anticholinergic medications

          -  Recent in-patient hospitalization
Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Condition: Premature Atrial Contraction
MeSH terms: Arrhythmias, Cardiac; Atrial Premature Complexes
Intervention: Oral Magnesium Supplement; Placebo
Intervention description: 400 mg Magnesium Citrate 1x daily for 12 weeks; Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Magnesium Supplementation; Magnesium; Dietary Supplement; Arrhythmia

Summary:

      The primary objective of this research is to determine whether oral magnesium supplementation
      in healthy, community-living individuals will be associated with reductions in the burden of
      arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 55 and older

          -  Ability to speak English

          -  Availability to attend baseline and follow-up visit approximately 12 weeks after
             baseline

        Exclusion Criteria:

          -  Prior history of heart disease (coronary heart disease, heart failure, atrial
             fibrillation), stroke, severe renal disease

          -  Use of type I and III antiarrhythmics or digoxin

          -  Current use of magnesium supplements

          -  Any prior history of allergy or intolerance to magnesium

          -  Prior history of inflammatory bowel disease or any severe gastrointestinal disorder
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Lebrikizumab; Placebo
Intervention description: Sterile liquid solution administered subcutaneously.; Solution administered subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eczema

Summary:

      The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared
      with placebo in participants with moderate-to-severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years or older.

          -  Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year
             before the screening visit .

          -  Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline
             visit.

          -  Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and
             the baseline visit.

          -  ≥10% body surface area (BSA) of AD involvement at the screening and the baseline
             visit.

        Exclusion Criteria:

          -  Treatment with any of the following agents within 4 weeks prior to the baseline visit:

          -  Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
             cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,
             methotrexate, etc.)

          -  Phototherapy and photochemotherapy (PUVA) for AD.

          -  Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)
             within 1 week prior to the baseline visit.

          -  Treatment with:

          -  An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is
             longer, prior to the baseline visit.

          -  Dupilumab within 3 months prior to baseline visit.

          -  Cell-depleting biologics, including rituximab, within 6 months prior to the baseline
             visit.

          -  Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit
             (whichever is longer).

          -  Use of prescription moisturizers within 7 days of the baseline visit.
Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Condition: Bacterial Infections; Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial
Intervention: BC-3781; BC-3781; Vancomycin
Intervention description: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.; BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.; Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Intervention MeSH terms: Vancomycin; Lefamulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acute bacterial skin and skin structure infection; bacteria

Summary:

      This is a Phase II, multi-center, randomized, double-blind study comparing the safety and
      efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and
      skin structure infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients > 18

          -  Documented acute bacterial skin and skin structure infection

        Exclusion Criteria:

          -  Uncomplicated skin and skin structure infection
A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
Condition: Exudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: RBM-007
Intervention description: Intravitreal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, non-comparative
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and
      safety of additional intravitreal injections of RBM-007 in subjects with wet age-related
      macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics
             Committee (EC) approved Informed Consent Form (ICF) and provide authorization as
             appropriate for local privacy regulations.

          2. Male or female 55 years of age or older on the date of signing the ICF and able and
             willing to comply with all treatment and study procedures.

          3. Subjects must have completed all scheduled visits of previous study. Subjects can only
             enter this study after exiting previous study

          4. Subjects for which previous previous masked treatment arms with intravitreal
             anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has
             not demonstrated improvement in vision; subjects with less than 15 letter Best
             Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its
             baseline.

          5. Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as
             assessed by spectral domain optical coherence tomography (SD-OCT).

          6. Absence of central atrophy or retinal epithelial tear in the fovea or any condition
             preventing VA improvement in the study eye.

          7. BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.

          8. Reasonably clear media and some fixation in the study eye to allow for good quality
             SD-OCT and fundus photography.

        Exclusion Criteria:

          -  1. Subjects whose vision have improved >15 BCVA letters at exit visit of previous
             study over its baseline 2. Subjects who experienced any drug related serious adverse
             event during previous study