bioihbjkbjnl/mcl2 huggingface dataset:
Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19
Condition: Virus Diseases; Infection Viral; Corona Virus Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Coronavirus Infections
Intervention: Azithromycin; Hydroxychloroquine; Placebo oral tablet; Placebo oral tablet
Intervention description: Azithromycin; Hydroxychloroquine; Placebo Azithromycin; Placebo Hydroxychloroquine
Intervention MeSH terms: Azithromycin; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Healthy volunteers: No

Summary:

      This study explores whether patients acutely hospitalized may have shorter hospitalization
      and fewer admittances at Intensive Care Units by treatment with azithromycin and
      hydroxychloroquine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient admitted to a Danish emergency department, lung medical department or medical
             department

          -  Age >18 years

          -  Hospitalized <48 hours

          -  Positive COVID-19 test/diagnosis during the hospitalization

          -  Signs informed consent

        Exclusion Criteria:

          -  If the patient uses > 5 LO2/min at time of recruitment

          -  Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to
             quinine or 4-aminoquinolinderivates

          -  Pregnancy

          -  Breastfeeding

          -  Neurogenic hearing loss

          -  Psoriasis

          -  Retinopathy

          -  Maculopathy

          -  Changes in vision field

          -  Severe liver disease other than amoebiases

          -  Severe gastrointestinal, neurological or haematological disorders

          -  eGFR < 45 ml/min/1.73m2

          -  Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc
             interval

          -  Myasthenia Gravis

          -  Uses Digoxin

          -  Glucose-6-phosphate dehydrogenase deficiency

          -  Porphyria

          -  Hypoglycemia at any time since hospitalization

          -  Severe mental illness which significantly impedes cooperation

          -  Severe linguistic problems that significantly impedes cooperation

          -  Treatment with sickle alkaloids
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
Condition: Genital Herpes
MeSH terms: Herpes Genitalis
Intervention: AIC316; Valacyclovir
Intervention description: 100 mg oral administration; 500 mg oral administration
Intervention MeSH terms: Valacyclovir; Pritelivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIC316; Viral shedding

Summary:

      The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg
      once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital
      shedding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, immunocompetent men and women in good health of any ethnic group

          -  Seropositive for Herpes Simplex Virus Type 2 (HSV-2)

          -  History of recurrent episodes (>=4 to <=9) of genital herpes for at least 12 months
             and willingness to obtain 4 swabs per day.

        Exclusion Criteria:

          -  Present episode of genital herpes at time of randomization

          -  Clinically relevant acute or chronic infections (excluding HSV-2)

          -  Known intolerance to valacyclovir, acyclovir, or any component of the formulation

          -  Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir
CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation for T and B Cell Depletion
Condition: Immunodeficiencies
MeSH terms: Immunologic Deficiency Syndromes
Intervention: CliniMACs
Intervention description: T and B Cell depletion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Maximum age: 22 Years
Healthy volunteers: No
Keywords: Blood and Marrow Transplant; T cell Depletion; Unrelated; Related; Donor

Summary:

      This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD)
      in patients receiving unrelated or partially matched related donor peripheral stem cells
      using the CliniMACS system to positively deplete T cells to prevent severe GVHD. Feasibility
      will be tested, focusing on engraftment, treatment-related mortality (with a specific focus
      on interstitial pneumonitis) and severe GVHD.
    

Eligibility criteria:

        Inclusion Criteria:

        As of October 2014 this study closed enrollment to malignant diseases. This study remains
        open to:

        Non-malignant diseases:

          1. Bone marrow failure, including severe aplastic anemia

          2. Immunodeficiencies

        Exclusion Criteria:

        1. Patients who have had prior stem cell transplant (SCT) and bone marrow transplant (BMT)
        are excluded for study enrollment.
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
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: zilucoplan (RA101495); Placebo
Intervention description: Daily subcutaneous (SC) injection; Daily subcutaneous (SC) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with
      generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive
      daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IVa] at
             Screening

          -  Positive serology for acetylcholine receptor (AChR) autoantibodies

          -  QMG score ≥ 12 at Screening and Randomization

          -  No change in corticosteroid dose for at least 30 days prior to Randomization or
             anticipated to occur during the 12-week Treatment Period

          -  No change in immunosuppressive therapy, including dose, for at least 30 days prior to
             Randomization or anticipated to occur during the 12-week Treatment Period

        Exclusion Criteria:

          -  Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12
             week Treatment Period

          -  History of meningococcal disease

          -  Current or recent systemic infection within 2 weeks prior to Randomization or
             infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization
Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Beraprost Sodium Modified Release
Intervention MeSH terms: Epoprostenol; Beraprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and
      have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release
      (BPS-MR) tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who remained on study drug and completed all assessments during the Treatment
             Phase of Study BPS MR PAH 203 are eligible for this study.

          -  Women of child-bearing potential (defined as less than 1 year post-menopausal or not
             surgically sterile) must be using an acceptable method of birth control or practicing
             abstinence. If sexually active, female patients must use a double barrier method of
             birth control, such as a condom and spermicidal.

        Exclusion Criteria:

          -  Patients who discontinued study drug during the previous study (BPS MR PAH 203) for
             any reason (e.g. treatment related adverse events) are not eligible for entry into
             this study.

          -  Patients who are pregnant or lactating are excluded from participation in the
             open-label extension.
Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Bromocriptine; Placebo
Intervention MeSH terms: Bromocriptine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 12 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance
      (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and
      glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)
      agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its
      recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an
      exciting development, representing a novel mechanism for improving IR. BCQR has not been
      studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data
      support the proposed study of possible benefits of BCQR on insulin action, glycemic control,
      and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR
      in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This
      is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes
      will include fasting and postprandial glucose, glycemic variability, insulin dosing,
      hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 1 Diabetes (T1D) of >1 year duration based on a clinical course consistent with
             T1D and rapid conversion to insulin requirement after diagnosis.

          2. HbA1c 6.5-10% (adults) or any HbA1c up to 12% (pediatrics)

          3. age 12-60 years of age

        Exclusion Criteria:

          1. Any comorbid condition associated with inflammation, insulin resistance, or
             dyslipidemia including cancer, heart failure, active or end stage liver disease,
             kidney disease (except microalbuminuria), inadequately treated thyroid disease, or
             rheumatologic disease;

          2. Tobacco or marijuana use;

          3. Pregnancy;

          4. Regular or frequent oral steroid use;

          5. Current use of insulin sensitizing medications, neuroleptics, ergot-related
             medications, or triptan medications for migraine,

          6. Diagnosis or history of psychosis,

          7. Diabetes of other cause such as Maturity Onset Diabetes of the Young or cystic
             fibrosis-related diabetes.
Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone nanoparticles eye drops
Intervention description: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks
Intervention MeSH terms: Dexamethasone; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of
      diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid
      and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow
      release drug capsules surgically implanted in the eyes run the risk of surgical complications
      including infections, hemorrhages and cataracts and place a huge demand on eye care resources
      significantly increase the risk of cardiovascular events and death.

      A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to
      treat DME and other retinal diseases would circumvent most of these problems.

      A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a
      drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the
      tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial
      clinical testing has shown the potential for this technology to increase the drug
      concentration in the eye tissues including the retina and therefore treat retinal diseases
      like DME.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Had DME of less than 3 years duration since diagnosis with presence of intraretinal
             and/or subretinal fluid in the study eye, with CMT of ≥ 310 µm by SD-OCT at baseline
             (Visit 2) (as measured by the Investigator).

          2. Had definite retinal thickening in the study eye due to DME involving the central
             macula based on the Investigator's clinical evaluation and by SD-OCT;

             ...

        Key Exclusion Criteria:

          1. Had macular edema considered to be due to a cause other than DME;

          2. Had a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment
             abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central
             serous retinopathy, non-retinal condition, substantial cataract, macular ischemia)
             that is likely to be decreasing BCVA by 3 lines or more (i.e., cataract would be
             reducing acuity to 20/40 or worse if eye was otherwise normal).

             ...
Resveratrol and Exercise to Treat Functional Limitations in Late Life
Condition: Aging
Intervention: Resveratrol; Placebo; Exercise
Intervention description: Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages; Vegetable-based cellulose; Multi-modal exercise regimen, 3 days/week
Intervention MeSH terms: Resveratrol
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: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to evaluate the effects of combining physical exercise
      with a resveratrol supplementation on the physical function of older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand study procedures and to comply with them for the entire length
             of the study

          -  Willingness to be randomized into either treatment group

          -  Age 65 years and older

          -  Physical limitations evidenced by >290 seconds needed to complete long-distance
             corridor walk test

          -  Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed
             by CHAMPS questionnaire

        Exclusion Criteria:

          -  Failure to provide informed consent

          -  Regular consumption of a resveratrol supplement

          -  Current involvement in supervised rehabilitation program

          -  Absolute contraindication(s) to exercise training according to American College of
             Sports Medicine guidelines

          -  Pain classification > Grade 3 on Graded Chronic Pain Scale

          -  Peripheral vascular disease; peripheral neuropathy; retinopathy

          -  Severe cardiac disease, including:

        NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis,
        history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina

          -  Myocardial infarction or stroke within past year

          -  Significant cognitive impairment, including:

        known dementia diagnosis or a Mini-Mental State Examination exam score <24

          -  Progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple
             sclerosis, ALS)

          -  Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active
             inflammatory disease)

          -  Severe pulmonary disease, requiring either steroid pills or injections or the use of
             supplemental oxygen

          -  Hip fracture, hip or knee replacement, or spinal surgery within past 4 mos.

          -  Other significant co-morbid conditions that would impair ability to participate in the
             exercise-based intervention

          -  Simultaneous participation in another intervention trial
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.; Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
Intervention description: Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.; Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 40 Months
Maximum age: 62 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Pre-school; Meningococcal disease; Prevention; Vaccination

Summary:

      The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of
      this extension study will be to explore antibody persistence at approximately 40 months of
      age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV
      NZ administered to subjects at approximately 40 months of age. Antibody persistence will be
      subsequently measured at 18-20 months after these booster doses when the subjects are 60
      months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be
      recruited in the study to serve as a baseline comparator for assessing antibody persistence
      at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.
      Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if
      they have not already received these vaccines prior to enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 40 to 44-months-old children, who participated and completed the study V72P6
             (NCT00381615; follow-on subjects)

          -  Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)

        Exclusion Criteria:

          -  Previous ascertained or suspected disease caused by N. meningitidis

          -  History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component

          -  Any serious chronic or progressive disease

          -  Known or suspected impairment/alteration of the immune system

          -  Receipt of, or intent to immunize with another vaccine, within 30 days prior and after
             vaccination with the investigational vaccines (within 14 days for licensed flu
             vaccines)