bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
Condition: Seizure; Epilepsy; Cerebral Malaria
MeSH terms: Malaria; Malaria, Cerebral; Seizures
Intervention: Oral Levetiracetam; Standard AED
Intervention description: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days; Active comparitor, Standard AED
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 24 Months
Maximum age: 83 Months
Healthy volunteers: No

Summary:

      Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%
      and leaving one third of survivors with long term neurologic and psychiatric sequelae.
      Seizures occur commonly with CM and are associated with an increased risk of death and
      neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral
      levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy
      studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity
      of pediatric CM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Comatose with Blantyre Comas Score ≤ 2

          -  P. falciparum parasitemia via thick blood film or rapid diagnostic test

          -  Active seizure in past 24 hours

        Exclusion Criteria:

          -  Serum creatinine > 2mg/dL

          -  Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs),
             antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing
             medications
Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients
Condition: Octreotide; Sputum
Intervention: Octreotide
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether administration of octreotide (12-25
      mcg/hour) for 72 hours in combination with the standard of care treatment is effective in
      reducing bronchorrhea (excessive airway secretions) in mechanically ventilated patients. The
      use of this drug (octreotide) to manage bronchorrhea has not been approved by the United
      States Food and Drug Administration (FDA) and is used as an experimental drug in this
      research study. We are anticipating to enroll approximately 30 subjects in this study at
      Danbury Hospital, with 15 patients randomly assigned to the "Routine Care" group, which will
      serve as the control group, and 15 patients randomly assigned to the octreotide group.
      Control group will only receive the standard of care and will not receive this drug. Total
      subject participation in this study will be for 4 days (96 hours) or until their breathing
      tube is removed (extubation), whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are being weaned from mechanical ventilation

          -  Excessive bronchial secretions (over 200 ml/24 hours) is deemed by the Primary Team to
             be a major barrier to extubation

        Exclusion Criteria:

          -  Known hypersensitivity to octreotide

          -  Persistent bradycardia (HR < 60)

          -  Mobitz type II or 3rd degree heart block in patients without a pacemaker

          -  Patients being treated with intravenous agents for hypertensive urgency or emergency

          -  Surgical patients

          -  Initiation of therapy with systemic or inhaled steroids within 72 hours prior to the
             enrollment into the study, as these may further change the rate of secretions*

          -  Initiation of therapy with systemic or inhaled anticholinergics within 48 hours prior
             to the enrollment into the study, as these may further change the rate of secretions
Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: Nidufexor; Placebo; Standard of Care (SoC)
Intervention description: 50 mg (two 25 mg) LMB763 capsules for oral administration; Placebo capsules for oral administration; Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore
      has the potential to improve the management of diabetic kidney disease when added to the
      standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin
      receptor blocker (ARB)).

      This non-confirmatory Phase 2 study was designed to determine the safety, tolerability,
      efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB
      at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes
      and nephropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female patients, 18-75 years

          -  Written informed consent

          -  Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to
             screening

          -  Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at
             screening while receiving a dose of angiotensin converting enzyme inhibitor or
             angiotensin receptor blocker that is the standard of care as judged by the study
             doctor.

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus

          -  Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at
             screening

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, unless they are using basic methods of contraception
             during dosing of study treatment

          -  Uncontrolled diabetes mellitus at screening

          -  History or current diagnosis of ECG abnormalities prior to first study dose

          -  History of kidney disease other than diabetic nephropathy at screening

          -  Uncontrolled hypertension at screening

          -  Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2
             inhibitors.
Islet Allotransplantation With Steroid Free Immunosuppression
Condition: Type 1 Diabetes; Hypoglycemia; Metabolic Diseases
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia; Metabolic Diseases
Intervention: islet transplantation; daclizumab - sirolimus - tacrolimus
Intervention description: Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.; Immunosuppressive consisted of Tacrolimus, target through level at 3-6 ng/ml, Sirolimus, target through level at 12-15 ng/ml for three months and at 7-10 ng/ml thereafter. A five-dose induction course of Daclizumab 1mg/Kg was administered biweekly beginning one hour prior to the first infusion
Intervention MeSH terms: Sirolimus; Tacrolimus; Daclizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: diabetes; hypoglycemia

Summary:

      The restoration of endogenous insulin secretion carries significant hopes for shifting the
      paradigm of life long exogenous insulin therapy in selected groups of patients with type 1
      diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in
      2000 new standards for islet transplantation in patients with brittle T1D by achieving
      insulin independence in 80 percent of patients. These seminal results have however proved
      much more difficult to duplicate than initially expected.

      This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for
      confirming the consistent short term efficacy and safety of sequential islet
      allotransplantation with steroid free immunosuppression in patients with severe T1D.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 1 diabetes documented for more than 5 years

          -  arginine stimulated C-peptide lower than 0.2 ng/mL

          -  one of the following:hypoglycemia unawareness OR metabolic lability documented by one
             or more severe hypoglycemias or two or more hospital admissions for ketoacidosis
             within the previous year.

        Exclusion Criteria:

          -  body mass index greater than 28 kg/m2

          -  non stable arteriopathy or heart disease

          -  active infection

          -  previous transplantation

          -  hyperimmunization

          -  insulin daily needs above 1.2 U/Kg

          -  creatinine clearance below 60 ml/mn or urinary albumin excretion above 300 mg/d

          -  malignancy

          -  smoking

          -  desire for pregnancy

          -  psychiatric disorders

          -  lack of compliance
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Loteprednol etabonate base (QD); Loteprednol etabonate base (BID); Loteprednol etabonate base (QID); Loteprednol etabonate suspension; Vehicle of loteprednol etabonate
Intervention description: Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks; Loteprednol etabonate ophthalmic base BID dosing for 2 weeks; Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week; Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.; Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic
      base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention
      of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen
      Challenge model and in an environmental model during pollen season. Comparisons will be made
      following 2 weeks of dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive history of ocular allergies and positive skin test reaction to cat hair, cat
             dander, grasses, ragweed, and/or trees within the past 24 months.

          -  Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as
             measured using the ETDRS chart.

          -  Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of
             instillation of the last titration of allergen at visit 1.

          -  Positive bilateral CAC reaction in 1 out of 3 time points for the initial and
             re-challenge at visit 2.

        Exclusion Criteria:

          -  Known contraindications or sensitivities to the study medication or its components.

          -  Any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety or trial parameters.

          -  Use of disallowed medications during the period indicated prior to study enrollment or
             during the study.
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo matching with BMS-945429; Placebo matching with BMS-945429; Placebo matching with BMS-945429; Placebo matching with BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429
Intervention description: Injection, Intravenous (IV), 0 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks; Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day; Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks; Injection, Intravenous (IV), 600 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day; Injection, Intravenous (IV), 300 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day; Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks; Injection, Intravenous (IV), 150 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks; Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks; Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to characterize the safety, efficacy and dose response of
      BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an
      insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor
      (anti-TNF) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior
             12 months. Diagnosed for at least 3 months

          -  Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450

          -  Failed conventional therapy or steroid dependent

        Exclusion Criteria:

          -  Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non
             colonic/ileal disease

          -  Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis

          -  History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds
Condition: Invasive Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Intervention: fosmanogepix
Intervention description: IV and oral fosmanogepix
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: APX001; APX001A; fosmanogepix; manogepix; aspergillus; aspergillosis; covid; covid19; mold; mould; pulmonary aspergillosis; pulmonary aspergillus; galactomannan; Karius; SARS-CoV-2; fusarium; mucorales; mucor; rhizopus; scedosporium; fungal disease; invasive fungal disease; EORTC

Summary:

      This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal
      infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp.,
      and Mucorales fungi).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, 18 years or older.

          -  Patients with proven or probable IMI caused by Aspergillus spp. Patients who present
             with IMI due to other filamentous fungi (eg, Scedosporium spp., Fusarium spp., and
             Mucorales fungi such as Mucor spp. or Rhizopus spp.) may also be enrolled.

          -  Have limited or no treatment options due to documented or anticipated resistance,
             contraindication, intolerance, or lack of clinical response to SOC antifungal therapy,
             as advocated by the relevant regional/country treatment guidelines.

          -  Patients where the Investigator considers that there is a potential advantage of using
             APX001 over current SOC (eg, broad spectrum of activity, emergence of IMI during
             antifungal prophylaxis, activity against resistant mold pathogens, IV and PO
             formulations, favorable DDI profile, favorable hepatic and renal safety profile, wide
             tissue distribution including brain), and/or where the SOC antifungal therapy carries
             significant risk of toxicity or treatment failure (eg, DDI risk, safety/toxicity risk,
             site of infection not accessible by SOC).

        Exclusion Criteria:

          -  Refractory hematologic malignancy.

          -  Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.

          -  Treatment with systemic (PO, IV, or inhaled) mold active antifungal therapy for 120
             hours immediately before initial dosing. Note: patients with invasive fungal infection
             caused by a mold with documented resistance to or lack of coverage by the prior SOC in
             question, may have received >120 hours prior treatment and remain eligible for the
             study.

          -  Evidence of significant hepatic dysfunction.
Myocardial Hemodynamic Effects of Levosimendan
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: levosimendan
Intervention description: 10-minute infusion
Intervention MeSH terms: Simendan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will test the hypothesis that mechanical efficiency as measured by pressure-volume
      loop assessment should improve during short-term treatment with intravenous levosimendan.

      Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which
      has been shown to have beneficial hemodynamic effects in patients with decompensated
      congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to
      troponin C. This agent is approved in Europe for treatment of heart failure patients. In the
      United States, this agent is currently under phase III investigation for intravenous
      treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal
      activity. Levosimendan has been studied in these patients with acute HF and is considered
      experimental in the United States for this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients will have either a sinus or paced atrial rhythm with atrioventricular
             synchrony on electrocardiography

          -  All patients will have a history of heart failure diagnosed clinically with history of
             prior symptoms or signs of heart failure with at least one of the following symptoms
             within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea,
             pedal edema

          -  In asymptomatic patients, patients may be enrolled if they have at least one of the
             following clinical signs of heart failure: left ventricular third and/or fourth heart
             sound, jugular venous pressure >7 mmHg, sustained left ventricular impulse, or
             pulmonary congestion on auscultation

          -  all patients will have echocardiographic evidence of left ventricular dysfunction

        Exclusion Criteria:

          -  Under age 18
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
Condition: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis
Intervention: Interferon alpha oral lozenge
Intervention description: dose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year
Intervention MeSH terms: Interferons; Interferon-alpha
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Idiopathic Pulmonary Fibrosis; Interferon alpha

Summary:

      The purpose of this study is to determine the possible efficacy of low dose, orally
      administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The only subjects to be included in this study are those diagnosed with Idiopathic
             Pulmonary Fibrosis with diagnosis based on the criteria published by the American
             Thoracic Society in the International Consensus Statement.

               1. Exclusion of other known causes of interstitial lung disease.

               2. Abnormal pulmonary function studies.

               3. Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT
                  scan.

               4. Biopsy or lavage showing no features supporting alternative diagnosis.

               5. Patient older than 50 years of age.

               6. Insidious onset of otherwise unexplained dyspnea on exertion.

               7. Duration greater than 3 months.

               8. Bibasilar, inspiratory crackles.

        Exclusion Criteria:

          -  under the age of 50

          -  history of hypersensitivity to interferons

          -  history of hypersensitivity to biological products such as vaccines

          -  pregnant or lactating women

          -  women of child bearing age not pregnancy protected during the study

          -  unresolved serious cardiovascular disease