bioihbjkbjnl/mcl2 huggingface dataset:
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).
Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
Condition: Muscle Wasting (Atrophy) After Hip Fracture Surgery
MeSH terms: Muscular Atrophy; Wasting Syndrome; Atrophy; Cachexia; Fractures, Bone; Hip Fractures
Intervention: bimagrumab; placebo
Intervention description: Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.; Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, interventional, multicenter, placebo-controlled, phase IIa/IIb trial in patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 251.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: bimagrumab; BYM338; hip fracture; elderly; controlled clinical trial; randomized; muscle wasting; atrophy

Summary:

      The purpose of this study was to assess if bimagrumab is safe and effective in patients with
      muscle wasting (atrophy) after hip fracture surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Must have X-ray confirmed successful hip fracture repair; Must have completed surgical
        wound healing; Ability to walk a specified distance with or without a walking aid; Must
        weigh at least 35 kg.

        Exclusion Criteria:

        Must not have history of any other lower limb fractures in the past 6 months; Must not have
        certain cardiovascular conditions; Must not have a chronic active infection (e.g. HIV,
        hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at
        least 3 months in the past year;
Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Condition: Neuromuscular Blockade
Intervention: Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline; Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;
Intervention description: The participants will be randomized to start with "Muscle relaxant #1" in the first study treatment, and will switch to "Muscle relaxant #2" in the second study treatment period.; The participants will be randomized to start with "Muscle relaxant #2" in the first study treatment, and will switch to "Muscle relaxant #1" in the second study treatment period.
Intervention MeSH terms: Rocuronium; Succinylcholine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The participants will be randomized to one of the two drug groups to start with, and will switch to the other group for the next treatment period. For the study, each participant will take two treatments in a random order: (1) rocuronium to be reversed by sugammadex, and (2) succinylcholine plus normal saline placebo.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The randomization of treatment groups will be blinded to the patients themselves, the psychiatrists and outcome assessors, except the anesthesiologists who will administer the drugs.
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Electroconvulsive Therapy, Neuromuscular Blockade

Summary:

      The investigators propose to compare the recovery of neuromuscular blockade from rocuronium
      reversal by sugammadex to succinylcholine in ECT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible and scheduled for ECT

          -  Has the capacity to consent for the study

        Exclusion Criteria:

          -  Any acute major organ failure in the last 30 days

          -  Any known or suspected neuromuscular disorders

          -  Any history of allergic reaction or intolerance to sugammadex, rocuronium, or
             succinylcholine

          -  Any conditions with severe renal impairment, including those requiring dialysis

          -  Anyone currently taking lithium

          -  Anyone currently taking hormonal contraceptives

          -  Anyone taking anti-coagulants, including vitamin K antagonists, unfractionated
             heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran
A Study of the Effect of SYN-010 on Subjects With IBS-C
Condition: Irritable Bowel Syndrome With Constipation (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Constipation
Intervention: SYN-010 21 mg; SYN-010 42 mg; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the
      Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production
      in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have IBS-C and have a positive breath CH4 test result (> 10 ppm) at
             Screening.

          -  Subject must meet the modified Rome III criteria for IBS-C.

          -  Subject must have an average abdominal pain intensity score of ≥ 3 (scale 0-10)
             reported at Screening and Baseline.

          -  Subject must have an average of fewer than 3 complete spontaneous bowel movement
             (CSBMs) per week.

          -  Subject must agree to refrain from making any lifestyle changes that may affect IBS-C
             symptoms from the time of Screening to the end of the study.

        Exclusion Criteria:

          -  Subject has taken IBS treatments (prescription or over-the-counter), proton pump
             inhibitors, laxatives, antibiotics.

          -  Subject currently has any structural abnormality of the gastrointestinal (GI) tract or
             a disease or condition that can affect GI motility, or any unexplained and clinically
             significant symptoms such as lower GI bleeding, rectal bleeding, heme-positive stool,
             iron-deficiency anemia, weight loss, or systemic signs of infection.

          -  Subject has been diagnosed with or has a family history of familial adenomatous
             polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial
             colorectal cancer.

          -  Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score
             of 6 or 7).
A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid
Condition: Pemphigoid, Bullous
MeSH terms: Pemphigoid, Bullous
Intervention: Mometasone furoate; AKST4290; Placebo
Intervention description: Topical mometasone furoate; Oral AKST4290; Oral placebo
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 60 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Autoimmune disease; Skin disease; Vesiculobullous

Summary:

      This study will evaluate the therapeutic effect and safety of adjunctive AKST4290 in subjects
      with bullous pemphigoid (BP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of mild to moderate BP at screening.

          -  Treatment naïve or initiation of whole-body high potency topical steroid treatment ≤ 7
             days of screening (lesion-only treatment for any amount of time with any topical
             steroids prior to screening is allowed without restriction).

          -  Provide a signed and dated informed consent form in accordance with local regulations
             and/or IRB/IEC guidelines.

        Exclusion Criteria:

          -  Severe BP.

          -  Initiation of gliptins and other treatments (e.g., etanercept, sulfasalazine,
             furosemide, penicillin) that can trigger BP if this treatment was started within 4
             weeks prior to screening and is considered possibly related to the onset of BP.

          -  Any concomitant medications in the last 3 months prior to screening and assessed by
             the investigator as possibly related to the development of BP.

          -  Planned use of intravenous immunoglobulin or other concomitant treatments for BP
             (i.e., doxycycline, dapsone) during the study period.

          -  Use of systemic immunosuppressants (i.e., mycophenolate, azathioprine, methotrexate)
             within 4 weeks prior to screening.

          -  Treatment with rituximab within 1 year prior to screening.

          -  Subjects taking warfarin.

          -  Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first
             dose of study agent or known diseases (other than BP) that could require the use of
             systemic steroids within the study period.

          -  Clinically relevant abnormal laboratory value at screening, including hematology,
             blood chemistry, or urinalysis (laboratory testing may be repeated once during the
             screening phase).

          -  Participation in studies of investigational drugs must have been discontinued within
             30 days or 5 half lives of the drug (whichever was longer) prior to screening.
Clopidogrel Pharmacogenomics Project
Condition: Disease Susceptibility
MeSH terms: Disease Susceptibility
Intervention: clopidogrel 75 mg; Clopidogrel 150 mg
Intervention description: 75 mg once daily; clopidogrel 150 mg
Intervention MeSH terms: Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clopidogrel pharmacogenomics study; Performing genetic study looking at clopidogrel resistance

Summary:

      Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely
      determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed
      research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene,
      increasing the maintenance clopidogrel dose from 75 to 150 mg will result in significant
      reduction in the rate of measured clopidogrel resistance defined by multiple measures of
      platelet function
    

Eligibility criteria:

        Inclusion Criteria:• Currently taking clopidogrel 75 mg/day and aspirin (minimum 81 mg/day)
        with an indication for chronic dual antiplatelet therapy (>90 days)

          -  No evidence of acute coronary syndrome within 30 days of enrollment, defined by
             elevation of Troponin I above the upper limit of normal

          -  Coronary atherosclerosis documented on previous coronary angiogram

          -  No known contraindications to combination therapy with aspirin and clopidogrel

          -  Prognosis for survival greater than one year based on physician's assessment

          -  Able to attend all scheduled visits.

          -  Access to phone

          -  Subject is a female with a negative urine or serum pregnancy test or post-menopausal
             for at least 1 year prior to randomization. Females of childbearing potential must be
             practicing adequate birth control to be eligible. It is the Investigator's
             responsibility for determining whether the Subject has adequate birth control for
             study participation

        Exclusion Criteria:• Recent acute coronary syndrome (<30 days)

          -  Recent hospitalization or physician visit for bleeding disorder(<90 days) or history
             of chronic blood loss

          -  Recent blood transfusion (<90 days)

          -  Any contraindication to aspirin or clopidogrel therapy

          -  Acute Febrile illness at the time of enrollment

          -  Subject is pregnant or lactating or planning to become pregnant
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
Condition: Clostridium Difficile; Clostridium Infections
MeSH terms: Infections; Clostridium Infections
Intervention: SYN-004; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 413.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004
      Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in
      Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract
      Infection (LRTI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Expected minimum hospital stay of 5 days

          -  Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a
             macrolide

          -  Clinical diagnosis of moderate to severe lower respiratory tract infection consisting
             of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity
             Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive
             infiltrate on chest x-ray is recommended.

        Exclusion Criteria:

          -  Presence of a diarrheal illness within 72 hours prior to randomization

          -  Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of
             diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA
             and/or tcdB) of C. difficile in the stool

          -  Number of previous CDAD episodes >1 within 12 weeks of randomization and no C.
             difficile infection (CDI) within 4 weeks of randomization

          -  Use of antibiotics within 1 month of start of study drug except for the current
             illness.
Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: Cantharidin
Intervention description: Application of topical cantharidin
Intervention MeSH terms: Cantharidin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment
      option. Treatment is often available in private practice offices, where a prescribing
      physician may offer a non-FDA approved treatment on an individualized basis. The situation is
      different in many hospital and academic settings, such as our own for example, where the
      formulary is defined through a FDA-approved indication. The absence of an indication
      precludes its addition to many hospital formularies, thus limiting the options available to a
      prescribing physician and denying patient access to a treatment offered in the private
      practice setting. An indication and formulary status require controlled clinical trials on
      the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this
      commercially-viable cantharidin formulation has a comparable safety and efficacy profile as
      formulations previously studied under conditions which most closely match the what has been
      historically done in the clinic.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of MC by the Principal Investigator.

        Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left
        or right leg, hands, feet, buttocks, and groin.

        Execution of Informed Consent and or assent forms

        Exclusion Criteria:

        Patients with immunosuppression, including organ transplantation, HIV infection.

        Patients utilizing immunosuppressive agents (including oral corticosteroids) will be
        excluded except for patients using inhaled corticosteroids, such as those utilized for
        asthma or allergic rhinitis.

        Females who have reached menarche and are sexually active as well as pregnant patients will
        be excluded as the effects of this drug have not been evaluated in pregnancy.

        Patients who have greater than 50 MC lesions will also be excluded from the study.
Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)
Condition: Mild Cognitive Impairment (MCI)
MeSH terms: Cognitive Dysfunction
Intervention: Levetiracetam 62.5mg; Levetiracetam 125mg; Levetiracetam 250mg; Placebo
Intervention description: 62.5mg twice daily (2 weeks); 125mg twice daily (2 weeks); 250mg twice daily (2 weeks); placebo capsule twice daily (2 weeks)
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mild Cognitive Impairment; Amnestic Mild Cognitive Impairment; Functional Magnetic Resonance Imaging; Levetiracetam; Keppra; Medial Temporal Lobe; Memory Impairment; Alzheimer's Disease; AD

Summary:

      This research is being done to find out if daily use of the drug levetiracetam can improve
      memory function in individuals with memory problems like those associated with Mild Cognitive
      Impairment (MCI) and Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All: English as a first language; right handed; able to complete written informed
             consent.

          -  MCI subjects: In addition to above, must meet criteria for amnestic Mild Cognitive
             Impairment (MCI). This includes a memory complaint corroborated by an informant;
             impaired memory function for age and educational level; preserved general cognitive
             function; intact abilities of daily living; no clinical dementia.

          -  Age matched Controls: Must have memory and cognitive status that is normal for their
             age.

        Exclusion Criteria:

          -  Familial Alzheimer's Disease (AD) due to known genetic mutations

          -  AD with Parkinsonian features; major psychiatric or behavioral disorders (e.g.
             depression, agitation, psychosis, manic-depressive disorder)

          -  Primary or metastatic intracranial neoplasm

          -  History of severe head trauma

          -  Intra-cerebral hemorrhage

          -  Seizure disorder

          -  Hemispheric stroke

          -  Presence of a progressive central nervous system disease

          -  Presence of lacunar infarcts

          -  Medical contraindications to MRI including cardiac pacemaker, presence of intraocular
             or intracranial metallic objects

          -  Any known allergy to levetiracetam or behavioral problems that are a contraindication
             to taking Levetiracetam (e.g. agitation)

          -  Prescribed use of anti-seizure medications.