bioihbjkbjnl/mcl2 huggingface dataset:
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101 powder provided in capsules; Placebo powder provided in capsules
Intervention description: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 4 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: Characterized Peanut Allergen; Peanut; OIT; Oral Desensitization; Peanut Allergen; Allergy; Peanut Allergy; Peanut-Allergic Children; Children; Peanut-Allergic Adults

Summary:

      This is a multi-center, randomized, double-blind placebo controlled study of efficacy and
      safety of characterized peanut oral immunotherapy in peanut allergic individuals.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ages 4 through 26 years, inclusive

          -  Clinical history of allergy to peanuts or peanut-containing foods

          -  Serum IgE to peanut >0.35 kU/L (determined by UniCAP within the past 12 months) and/or
             a SPT to peanut >3 mm compared to control

          -  Experience dose-limiting symptoms at or before the 100mg dose of peanut protein
             (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via
             PRACTALL guidelines

          -  Use of birth control by females of child-bearing potential

        Key Exclusion Criteria:

          -  History of Cardiovascular disease

          -  History of frequent or repeated, severe or life-threatening episodes of anaphylactic
             shock

          -  History of other chronic disease

          -  History of eosinophilic gastrointestinal disease

          -  Severe asthma

          -  Mild or moderate asthma if uncontrolled

          -  Use of omalizumab within the past 6 months or current use of other non-traditional
             forms of allergen immunotherapy

          -  Use of beta-blockers(oral), angiotensin-converting enzyme (ACE)

          -  Pregnancy, lactation

          -  Having the same place of residence as another study subject

          -  Participation in an interventional clinical trial 30 days prior to randomization
(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Placebo; HBB 20 mg
Intervention description: 1-5 tablets per episode; Active drug, one to five tablets per episode
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB)
      20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment
      of intensity of abdominal pain associated with cramping (APC) in the treatment of two
      episodes.
    

Eligibility criteria:

        Inclusion Criteria:

        History of recurrent abdominal pain with cramping (APC) for at least three months.

        Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on
        a 0-10 point scale) lasting one hour in the eDiary during the run-in period.

        Exclusion Criteria:

        Experiencing daily episode of APC during Run-in period Active gastrointestinal disease
        during the past 12 months including malignancy, inflammatory bowel disease, celiac disease
        or complete or partial bowel obstruction and who have undergone major gastrointestinal
        surgery with the past 12 months (patients with history of appendectomy, cholecystectomy,
        bilateral tubal ligation and c-section within past 12 months are allowed in the study).
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Metformin; Placebo
Intervention description: Monitoring of tolerability and symptoms.; Monitoring of tolerability and symptoms.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: kidney disease; polycystic kidney disease; autosomal dominant kidney disease; kidney cysts; PKD

Summary:

      This study will test to see if metformin is safe and if it is tolerated compared to placebo
      in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages
      of chronic kidney disease. We will also measure its effect on progression of kidney disease
      as reflected in the kidney size and the kidney function, along with its effect on kidney pain
      and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English

        Exclusion Criteria:

        Subject is not on active military duty; Subject is not currently participating in another
        clinical trial; Subject's current GFR is not <50 cc/min/1.73m2; Subject does not have
        diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject
        does not have a solitary kidney; Subject does not have an allergy or intolerance to
        metformin; Subject is not pregnant or lactating or intending to become pregnant within the
        next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject
        does not have active coronary artery disease; Subject does not have an MRI incompatible
        device/implant; Subject does not have severe claustrophobia; Subject has not had any solid
        organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not
        currently take any medications that interact with metformin, such as nifedipine,
        furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide,
        quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within
        2 weeks) the drug tolvaptan (Jynarque or Samsca)
Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: KHK4083; Placebo
Intervention description: Anti-OX40 Monoclonal Antibody KHK4083; Matching placebo
Intervention MeSH terms: KHK4083
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: subcutaneous administration
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AD; eczema; skin diseases; biologics

Summary:

      A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study
      for subjects with moderate to severe AD whose disease cannot be adequately controlled with
      topical medications or for whom topical treatment is medically inadvisable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily signed informed consent to participate in the study;

          -  Chronic AD, according to American Academy of Dermatology Consensus Criteria or the
             local diagnostic criteria, that has been present for at least 1 year before screening;

          -  EASI score ≥16 at screening and baseline;

          -  IGA score ≥3 (moderate) at both screening and baseline;

          -  BSA ≥10% at both screening and baseline;

          -  Documented recent history (within 1 year prior to screening visit) of inadequate
             response to treatment with topical medications or for whom topical treatments are
             otherwise medically inadvisable (e.g., because of important side effects or safety
             risks).

        Exclusion Criteria:

          -  Current or past history of clinically significant illness(es) deemed by the
             Investigator to be likely to affect the study conduct and assessments. Examples
             include, but are not limited to, clinically significant cardiovascular (e.g., New York
             Heart Association [NYHA] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver
             (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous
             system, psychiatric, or autoimmune diseases/disorders;

          -  Any of the following laboratory abnormalities at screening:

               -  Serum creatinine: >1.5 mg/dL

               -  AST or ALT: ≥2.5 times the upper limit of normal (ULN)

               -  Neutrophil count: <1.5×10³/μL

               -  Other laboratory abnormalities that may affect the completion or evaluation of
                  the study, as judged by the Investigator;

          -  Active malignancies, or onset or a history of treatment of malignancies within 5 years
             prior to informed consent (except curatively treated in situ cervical carcinoma,
             cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Alanyl-glutamine
Intervention description: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; glutamine; diarrhea; alanyl-glutamine

Summary:

      The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the
      treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with
      standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality
      and recurrent disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult of either gender, 18 years or older, with C. difficile infection (CDI)

          -  Diarrhea associated with C. difficile positive stool assay

          -  Within 48 hours of receiving either metronidazole for mild-moderate disease or
             vancomycin for severe uncomplicated disease

          -  Admitted in the hospital at the time of enrollment

          -  Ability to provide informed consent

          -  Have an understanding of study procedures

          -  Ability to comply with study procedures for the entire length of the study

        Exclusion Criteria:

          -  Hypotension or shock

          -  Megacolon or moderate to severe ileus

          -  Acute abdomen

          -  Severe leukocytosis (WBC > 20,000 cells /µL)

          -  Admission to intensive care unit on enrollment

          -  Inability to tolerate oral medication

          -  Other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal
             disease)

          -  Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)

          -  Enrollment in another investigational drug trial

          -  Currently receiving other alternative treatment for CDI (e.g. antibiotics other than
             metronidazole or vancomycin; probiotics; immunoglobulin therapy; fecal transplant)

          -  Pregnancy

          -  Unavailable for follow-up visits

          -  Life expectancy of < 6 months

          -  Chronic liver disease or in subjects without known liver disease, ALT > 3x normal

          -  Chronic kidney disease or in subjects without known kidney disease, estimated
             Creatinine clearance of < 30 ml/min, even after rehydration
Valchlor in the Treatment of Lichen Planopilaris
Condition: Lichen Planopilaris
MeSH terms: Lichen Planus
Intervention: Mechlorethamine 0.016% Top Gel
Intervention description: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Intervention MeSH terms: Mechlorethamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Adults patient with active Lichen Planopilaris or Frontal Fibrosing Alopecia
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Valchor

Summary:

      The primary objective of this study is to assess the potential effectiveness of once daily
      application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
      The primary measurement of efficacy will be with the Lichen Planopilaris Activity Index
      (LPPAI) before and after 6 months of treatment. Secondary measures of efficacy will be the
      mean follicular density, Physician Global assessment (PGA) score, and the Dermatology Quality
      of Life Index (DQLI) score before and after six months of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 18 years or older.

          -  Biopsy proven diagnosis of Lichen Planopilaris

          -  Biopsy proven diagnosis of Fontal Fibrosing Alopecia (a clinical variant of LPP
             restricted to frontal scalp)

          -  Good general health as confirmed by medical history

          -  Patients who are willing and capable of cooperating to the extent and degree required
             by the protocol; and

          -  Patients who read and sign an approved informed consent for this study

        Exclusion Criteria:

          -  Vulnerable study population

          -  Pregnant or nursing women

          -  Women planning a pregnancy within the study period

          -  Active smokers

          -  Known history of adverse reaction to mechlorethamine

          -  Use of systemic immunosuppressive

          -  Presence of ulcerated scalp lesions
Buspirone in Parkinson's Disease
Condition: Parkinson Disease; Anxiety
MeSH terms: Parkinson Disease
Intervention: Buspirone; Placebo
Intervention MeSH terms: Buspirone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet
      it frequently remains untreated and there have been no clinical trials dedicated to
      evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is
      effective for the treatment of generalized anxiety disorder in the general and elderly
      population. It is not known if it is effective for the treatment of anxiety in Parkinson's
      disease. This is a single-center, placebo-controlled, double-blind design with participants
      randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg
      twice daily) or placebo for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical
             Diagnostic Criteria

          -  Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥
             14)

          -  Able to provide written informed consent

          -  At least 18 years of age

        Exclusion Criteria:

          -  Diagnosis of atypical or secondary parkinsonism

          -  Concomitant treatment with an MAO inhibitor within the 14 days prior to screening
             visit

          -  Significant renal or hepatic impairment

          -  Significant cognitive impairment defined as MOCA score < 23

          -  On-going depression with suicidal or homicidal ideation and concern for patient safety
             based on clinical determination by the investigator

          -  Allergy or intolerance to study drug, matching placebo, or their formulations

          -  History of prior exposure to study drug

          -  Lactating or pregnant woman

          -  Concomitant treatment with a disallowed medication (detailed in section 6.2)

          -  Active drug or alcohol use or dependence that, in the opinion of the investigator,
             would interfere with adherence to study requirements

          -  Concomitant treatment with an anxiolytic or antidepressant will be allowed however
             potential participants who had dosage changes in the 30 days prior to the screening
             visit will be excluded

          -  Use of an investigational drug within 30 days prior to screening visit

          -  Any medical or psychiatric comorbidity that, in the opinion of the investigator, would
             compromise study participation

          -  Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing
Efficacy and Safety of Atacicept in IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: Placebo; Atacicept 25 mg; Atacicept 75 mg
Intervention description: Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.; Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.; Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atacicept; IgA Nephropathy; Berger´s disease; Glomerulonephritis; Proteinuria

Summary:

      This main purpose of this study was to evaluate the safety, tolerability, dose response and
      efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The
      study hypothesis was that treatment with Atacicept would reduce proteinuria compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than or equal to (>=)18 years of age

          -  Biopsy-proven Immunoglobulin (IgA) nephropathy

          -  Urine Protein to Creatinine Ratio (UPCR) >= 0.75 and <= 6 milligram per milligram
             (mg/mg) during screening

          -  Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or
             angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening

        Exclusion Criteria:

          -  Concomitant significant renal disease other than IgA nephropathy

          -  IgA nephropathy with significant glomerulosclerosis or cortical scarring

          -  Diagnosis of Henoch-Schonlein purpura

          -  Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement
             criteria

          -  Serum IgG below 6 grams per liter (g/L)

          -  Use of cyclophosphamide ever or use of other immunosuppressants or systemic
             corticosteroids within 4 months

          -  Active infection requiring hospitalization or treatment with parenteral
             anti-infectives within 4 weeks

          -  History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB
             infection

          -  History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening

          -  History of malignancy

          -  Nursing or pregnancy

          -  Any condition, including any uncontrolled disease state other than IgA nephropathy
Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients
Condition: Venous Thromboembolism; Deep Venous Thrombosis; Surgery
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Fixed Dose Enoxaparin; Variable Dose Enoxaparin
Intervention description: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.; Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants enrolled in months 1-6 of the study will all receive a fixed dose of enoxaparin. Patients enrolled in months 7-12 of the study will all receive a variable dose of enoxaparin.
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this research is to better understand how patient-level factors can be used to
      predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk
      reduction and minimize bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  receiving Video-Assisted Thoracoscopic Surgery

          -  able to have Enoxaparin initiated within 8 hours after procedure

        Exclusion Criteria:

          -  Contraindication to use of enoxaparin

          -  Intracranial bleeding/stroke

          -  Hematoma or bleeding disorder

          -  Heparin-induced thrombocytopenia positive

          -  Creatinine clearance less than or equal to 30 mL/min

          -  Serum creatinine greater than 1.6 mg/dL

          -  Epidural catheter