bioihbjkbjnl/mcl2 huggingface dataset:
Nitrate Effect on Exercise Capacitance
Condition: Fontan
Intervention: Isosorbide Dinitrate
Intervention description: All patients will be given a 6 week titration regimen of study medication. Patients will begin at a 5mg dosage and titrate up to 30mg three times per day if each subsequent dose is tolerated.
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The investigators will investigate the safety and preliminary efficacy of ISDN therapy to
      reduce venous congestion and improve exercise tolerance in children and adults after the
      Fontan operation. This will be accomplished by recruiting 15 Fontan physiology patients from
      the Cincinnati Children's Fontan clinic and University of Kentucky Pediatric Cardiology
      clinic for the investigation. The investigators will non-invasively measure both central
      venous pressures at rest and during graded cardiopulmonary exercise testing. In addition the
      study team will obtain a measurement of liver stiffness before and after a 4-week regimen of
      ISDN therapy. Patients will be seen twice in clinic, once before and after ISDN therapy, and
      phone calls will be made to ensure safety, compliance, and make appropriate alterations to
      medications throughout the study period. Pre- and post-intervention central venous pressure
      and exercise tolerance will be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Underlying Fontan physiology

          -  On a stable medication regimen for the past 3 months

          -  Nine years of age or older

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Prior hospitalization for heart failure in past year

          -  Presence of uncontrolled arrhythmias within the past 6 months

          -  Non-cardiac conditions which significantly limited exercise

          -  Moderate or severe ventricular dysfunction by echocardiogram or cardiac MRI

          -  Currently treated with a phosphodiesterase-5 inhibitor or organic nitrates

          -  Concurrent enrollment in other investigational drug trial

          -  End stage Liver Disease (ESLD)
Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine
Condition: Airway Remodeling
MeSH terms: Airway Remodeling
Intervention: Dexmedetomidine; propofol
Intervention description: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.; Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.
Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: upper; airway; dimensions; propofol; dexmedetomidine

Summary:

      Sedation is required in infants and children to successfully complete MRI while maintaining
      respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk
      during MRI examination. Therefore, appropriate drugs need to be selected, administered, and
      titrated to achieve these objectives. Propofol is commonly used for sedation in children in
      the MRI setting because of its predictability, rapid onset, and offset of action.
      Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and
      respiratory stability. The rationale of this research is to assess the effect of these drugs
      on the upper airway and validate their use in children with upper airway disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children undergoing MRI brain

          -  Age 2 - 5 yrs

          -  ASA I - II

        Exclusion Criteria:

          -  OSA

          -  Pathology of upper airway

          -  Craniofacial anomalies

          -  Gastroesophageal reflux

          -  Increased intracranial pressure

          -  Body weight of 20% more than ideal

          -  Contraindication to the use of either drug

          -  Failure to maintain a patent airway during the study
Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
Condition: Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: Elotuzumab (BMS-901608; HuLuc63)
Intervention MeSH terms: Elotuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether elotuzumab will improve response in
      patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the
      health of the body's immune system)
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Key Inclusion Criteria:

        Participants with a confirmed diagnosis, according to criteria of the International Myeloma
        Working Group, of smoldering multiple myeloma, considered high risk according to the
        following:

          -  Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or

          -  Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of <0.125
             or >8.0

          -  Urine M protein >200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125
             or ≥8.0

        Key Exclusion Criteria:

          -  Active multiple myeloma

          -  Monoclonal gammopathy of undetermined significance

          -  Active plasma cell leukemia

          -  Positive for hepatitis B or C virus or HIV infection
Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
Condition: Elderly
Intervention: GHRH
Intervention description: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, & 5:00 AM for 6 months.
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Growth Hormone-Releasing Hormone; Growth Hormone Insufficiency; Aging; Growth Hormone; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones

Summary:

      The purpose of the study is to evaluate the effect of a naturally occurring hormone, called
      Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body.
      GHRH stimulates the production of growth hormone (GH), which regulates the build up of many
      tissues in the body, including muscles and bones. Many elderly people have low levels of GH.
      The overall goal of this research is to determine the effectiveness of GHRH to raise levels
      of GH and improve these body tissues. The purpose of the tests is to measure how the body
      handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of low GH levels as assessed by a fasting IGF-1 level <135ng/ml.

          -  Volunteers whose BMI is above normal range and below extreme obesity (BMI 25-40
             kg/m2).

        Exclusion Criteria:

          -  Diabetes.

          -  Known coronary artery disease.

          -  Liver, peptic or inflammatory bowel disease. Renal or hematologic disease.

          -  Hematocrit <30% or >50%.

          -  Clinically significant prostate hypertrophy.

          -  Elevated Prostate specific antigen (PSA) (4ng/ml).

          -  Prostate & breast cancer.

          -  History of malignancy <5 years other than basal cell of the skin.

          -  Chronic pulmonary disease or other systemic disorders.

          -  Use of certain drugs (such as thiazide diuretics, beta-blockers, steroids (except for
             replacement doses), coumadin, and or androgen supplements).

          -  Peanut allergy.

          -  Gross physical impairment.

          -  Sleep apnea.

          -  Uncontrolled hypertension(blood pressure >160/95 and or requiring more than two
             antihypertensive medications).

          -  A clinically worrisome mammogram in women.

          -  Exercise training (>2x/wk for 20 min at a level that produces sweating) in the last 6
             months.
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
Condition: Graft Rejection
Intervention: Placebo; C1 Esterase Inhibitor (Human)
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1
      Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated
      Rejection (AMR).
    

Eligibility criteria:

        Inclusion Criteria include:

          -  ≥18 years of age.

          -  Weigh ≥50 kg.

          -  Donor specific antibody identified.

        Exclusion Criteria include:

          -  Any surgical or medical condition that could interfere with the administration of
             study drug or interpretation of study results.

          -  History of allergic reaction to C1 Esterase Inhibitor or other blood products.

          -  Participation in the active dosing phase of any other investigational drug study
             within 30 days prior to dosing with study drug.

          -  Pregnancy or lactation.

          -  Receipt of any experimental agents for AMR within 1 month prior to the first dose of
             study drug.

          -  Any infection that causes hemodynamic compromise.

          -  History of bleeding or clotting abnormality.
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Aprepitant injectable emulsion; Saline Placebo
Intervention description: Aprepitant injectable emulsion, once daily (QD) for 14 days.; Saline Placebo, once daily (QD) for 14 days.
Intervention MeSH terms: Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Coronavirus

Summary:

      The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to
      standard of care for hospitalized patients with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain
             reaction (PCR), antigen or immunoglobulin M (IgM) antibody test.

          -  Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen
             saturation of <94% by pulse oximetry on room air or requiring supplemental oxygen.

          -  Not anticipated to require mechanical ventilation within 48 hours.

        Exclusion Criteria:

          -  Is taking high-dose hydroxychloroquine or chloroquine.

          -  Is taking pimozide or strong or moderate CYP3A4 inhibitors.

          -  Is currently receiving treatment with products intended to modify immune response to
             COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed),
             chemotherapy or on hemodialysis or peritoneal dialysis.

          -  Has known hypersensitivity to any components of aprepitant injectable emulsion.

          -  Has evidence of ARDS.

          -  Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask,
             noninvasive positive pressure ventilation, or ECMO.

          -  Has multiple organ failure.

          -  Has current confirmed Influenza A or B infection, or a a history of organ or
             hematologic transplant, HIV, or active hepatitis B or hepatitis C infection.
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Haemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Coversin
Intervention description: Patients enrolled in this protocol will initially be treated with an ablating dose of Coversin and daily repeat maintenance doses calculated according to body weight, the ablating dose to be 0.57mg/kg. Thereafter the daily repeat dose will be titrated according to clinical response and complement inhibition determined by CH50 ELISA. The initial repeat dose will be 25% of the ablating dose and this will be adjusted up or down if necessary once steady state is reached (5 days).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to
      Eculizumab due to complement C5 polymorphisms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with known Paroxysmal Nocturnal Haemoglobinuria (PNH)

          -  LDH >=1.5 Upper Limit of Normal (ULN)

          -  Resistance to Eculizumab proven by both a recognised C5 polymorphism on genetic
             screening and complement inhibition on CH50 ELISA of <100% at concentrations of
             Eculizumab in excess of 50 μg/mL

          -  Willing to self-inject Coversin daily or to receive daily subcutaneous injections by a
             home nurse or in a doctor's office or hospital clinic

          -  Males or females taking adequate contraceptive precautions if of childbearing
             potential, 18 - 80 years of age

          -  Body weight ≥50kg and ≤ 100kg

          -  The patient has provided written informed consent.

          -  Willing to avoid prohibited medications for duration of study

          -  Must agree to take appropriate prophylactic precautions against Neisseria infection.

          -  Must be counselled regarding the possible reproductive risks of using Coversin and be
             advised to use an adequate method of contraception pending further data on
             reproductive toxicology.

        Exclusion Criteria:

          -  Body weight <50kg or>100kg

          -  Pregnancy (females)

          -  Failure to satisfy the PI of fitness to participate for any other reason

          -  Known allergy to ticks or severe reaction to arthropod venom (e.g., bee or wasp venom)
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Intervention: SGX942; 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: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment
      for the treatment of head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is
             planned to receive a standard course of concomitant CRT.

          -  Patients who have received surgery are eligible if surgery is performed within 6 weeks
             prior to study initiation.

          -  Planned to receive standard cisplatin chemotherapy administered either weekly or every
             third week.

          -  Must be able to read and understand informed consent

          -  Adequate birth control methods for the duration of the study

        Exclusion Criteria:

          -  Current mucositis.

          -  Prior radiation to the head and neck.

          -  Chemotherapy treatment within the previous 12 months.

          -  Tumors of the lips, sinuses, salivary glands or nasopharynx.

          -  Unknown primary tumor.

          -  Stage 4c metastases.

          -  Evidence of significant hepatic, hematologic, or immunologic disease.

          -  Women who are pregnant or breast-feeding.
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Condition: Tuberculosis; AIDS-related Complex
MeSH terms: Tuberculosis; AIDS-Related Complex
Intervention: Aerosol Interferon-Gamma; Subcutaneous interferon-gamma; Placebo
Intervention description: Participants will receive aerosol interferon-gamma.; Patients will receive subcutaneous interferon-gamma
Intervention MeSH terms: Interferons; Interferon-gamma
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb)
      infection and will modulate that response with interferon-gamma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization

          -  Cluster of Differentiation 4 greater than 200 if HIV positive

          -  Ability to sign consent

          -  Bilateral, cavitary pulmonary TB

        Exclusion Criteria:

          -  Multidrug-resistant (MDR) TB

          -  Extrapulmonary TB

          -  HIV positive with opportunistic infection within 30 days of study entry

          -  Cancer

          -  Asthma

          -  Pregnant or lactating women

          -  Chronic heart disease

          -  Chronic liver disease

          -  Chronic renal disease

          -  Seizure disorder

          -  Bleeding or clotting disorder

          -  Diabetes mellitus
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Apixaban; Apixaban; Warfarin sodium
Intervention description: Apixaban 5 mg tablet BID for 12 weeks; Apixaban 2.5 mg tablet BID for 12 weeks; At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks
Intervention MeSH terms: Warfarin; Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 222.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on
      the composite endpoint of major and clinically relevant non-major bleeding during the
      treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 20 years outpatient (regardless of sex)

          -  Patients diagnosed as non-valvular atrial fibrillation (NVAF)

          -  One or more following risks of stroke.

        Exclusion Criteria:

          -  Recent cerebral infarction (includes TIA) within 4 weeks of week 0.

          -  Subjects who have or are suspected to have a serious/hereditary bleeding tendency,
             such as disseminated intravascular coagulation syndrome (DIC), congenital platelet
             dysfunction and von Willebrand disease (those suspected from the family history are
             included).

          -  Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency
             (those suspected from the family history are included) or those who require
             continuation of the Warfarin therapy.
Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
Condition: Pemphigus
MeSH terms: Pemphigus
Intervention: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
Intervention description: Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
Intervention MeSH terms: Dexamethasone; Rituximab; Azathioprine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pemphigus; rituximab; immunoadsorption; dexamethasone; treatment; management

Summary:

      Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies
      against certain proteins important for maintaining skin integrity. Protein A immunoadsorption
      is a dialysis-like technique selectively removing the antibodies from patient's blood.
      Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for
      production of antibodies in the patients blood that, in turn, lead to clinical signs of
      pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that
      may be used to suppress autoantibody production in pemphigus. While each of these three
      therapies had been used to treat pemphigus, none was shown effective in all cases. The
      hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and
      dexamethasone is more effective that either of these treatments alone in achieving a rapid
      and durable improvement or cure in patients with pemphigus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.

          -  Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.

        Exclusion Criteria:

          -  General condition too poor to tolerate immunoadsorption treatment.

          -  Severe dementia or psychiatric disease.