bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Setipiprant; Placebo; Finasteride
Intervention description: Setipiprant tablets, orally, BID for 24 weeks.; Placebo tablets, orally, BID for 24 weeks.; Finasteride tablet, orally, once daily for 24 weeks.
Intervention MeSH terms: Finasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: Male
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability and efficacy of the oral administration of
      setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males
      with androgenetic alopecia (AGA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has androgenetic alopecia (AGA)

          -  Participant agrees to maintain current hair care regimen, refraining from hair
             weaving, hair colorants or dyes and non-study hair growth products during the study.

        Exclusion Criteria:

          -  History of hair loss for reasons other than AGA

          -  Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft

          -  Use of products within 6 months of study start used continuously for at least 1 month
             that could impact hair growth

          -  Hair-weaving within 6 months

          -  Use of hair colorants or dyes within 6 months.
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
Condition: Nasal Polyps
MeSH terms: Nasal Polyps
Intervention: Furosemide; Placebo
Intervention description: furosemide; placebo
Intervention MeSH terms: Furosemide
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
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal
      polyposis following sinus surgery. This project aims to further investigate that claim
      through a blinded randomized controlled clinical trial following patients who undergo
      functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly
      assigning participants to receive topical furosemide versus placebo nasal spray for 2 months
      post operatively. Outcomes would be compared at 6 months through endoscopic grading scores
      using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to
      measure the rate and degree of recurrence and impact on symptoms in the treatment group
      versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for
             functional endoscopic sinus surgery

        Exclusion Criteria:

          -  Hypersensitivity to furosemide or sulfonamides

          -  pregnancy

          -  history of tinnitus

          -  history of sensorineural hearing loss

          -  poorly controlled diabetes

          -  current diuretic therapy

          -  known electrolyte disorder

          -  currently taking aminoglycosides

          -  BUN and creatinine levels out of the normal range

          -  history of renal disease

          -  allergy to sulfonamides
Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661; Ivacaftor; Placebo matched to VX-661; Placebo matched to Ivacaftor
Intervention description: Tablet, oral use; Film coated tablet, oral use; Tablet, oral use; Film coated tablet, oral use
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CF

Summary:

      The objective of this study was to evaluate the safety and efficacy of VX-661in combination
      with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del
      cystic fibrosis transmembrane conductance regulator (CFTR) mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del CFTR mutation

          -  FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height

          -  Stable CF disease as judged by the investigator

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant

          -  Pregnant and nursing females: Females of childbearing potential must have a negative
             pregnancy test at screening and Day 1 of the PC Phase and Day -7 or Day 1 of the OLE
             Phase (whichever was applicable)

          -  Sexually active participants of reproductive potential who are not willing to follow
             the contraception requirements

          -  The participant or a close relative of the participant is the investigator or sub
             investigator, research assistant, pharmacist, study coordinator, or other staff
             directly involved with the conduct of the study.
Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Intervention: 2 mg IV hydromorphone
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 298.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain; Acute; Emergency Department; Severe; Hydromorphone; Dilaudid; Adult

Summary:

      The purpose of this study is to determine the safety and speed of onset of 2mg intravenous
      hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency
      department with acute severe pain
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than 21 years

          2. Age less than 65 years of age

          3. Pain with onset within 7 days

          4. ED attending physician's judgment that patient's pain warrants use of morphine

          5. Normal mental status

        Exclusion Criteria:

          1. Prior use of methadone

          2. Use of other opioids or tramadol within past seven days

          3. Prior adverse reaction to hydromorphone.

          4. Chronic pain syndrome

          5. Alcohol intoxication

          6. SBP <90 mm Hg

          7. Use of MAO inhibitors in past 30 days

          8. C02 measurement greater than 46
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children
Condition: Anesthesia, General; Neuromuscular Blockade
Intervention: Sugammadex Injection 2mg/kg; Sugammadex Injection 4mg/kg; Sugammadex Injection 8mg/kg; Neuromuscular reversal agent injection
Intervention description: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
Intervention MeSH terms: Atropine; Neostigmine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: sugammadex; pharmacokinetics; pharmacodynamics; pediatric anesthesia

Summary:

      This study administers sugammadex sodium to pediatric patients under general anesthesia with
      rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma
      concentration of sugammadex sodium and monitoring of neuromuscular blockade.
    

Eligibility criteria:

        Inclusion Criteria: All of below

          -  Pediatric patients undergoing surgery under general anesthesia with requirement of
             early reversal of neuromuscular blockade

          -  Aged between 2 and 17

          -  American Society of Anesthesiologists Physical Status Classification 1 and 2

        Exclusion Criteria: Any of below

          -  One or more legal guardian declines to enroll in the study

          -  History of hypersensitivity to any anesthetic agents including rocuronium

          -  Presence of underlying cardiovascular or genitourinary disease

          -  Under usage of neuromuscular blocking agents before surgery

          -  Under usage of drugs influencing the effect of neuromuscular blocking agents

          -  History of malignant hyperthermia

          -  Anticipation of massive hemorrhage during surgery
AGN-242428 in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: AGN-242428; Placebo
Intervention description: AGN-242428 administered as an oral capsule(s) once daily.; Placebo administered as an oral capsule(s) once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics
      and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe
      plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6
             months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening
             and baseline

          -  Severity of disease must be at least moderate, defined as Psoriasis Area and Severity
             Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10

          -  Participant is a candidate for phototherapy or systemic therapy for psoriasis

          -  Body weight of at least 55 kilograms (kg) (121 (pound) lbs)

        Exclusion Criteria:

          -  Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced
             psoriasis

          -  Psoriasis which has not been stable for the 4 weeks prior to screening and which is
             unstable at Study Day 1

          -  History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of
             bilirubin metabolism

          -  History of active mycobacterium tuberculosis (TB) infection or untreated or
             inadequately treated latent TB

          -  Positive QuantiFERON test for TB infection at screening

          -  Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to
             baseline

          -  Positive drug and/or alcohol test at screening (with the exception of marijuana).
             Retesting in the case of a positive alcohol test is allowed at the discretion of the
             sponsor

          -  Current treatment or history of treatment with any anti-Tumor Necrosis Factor alpha
             (TNFα) biologic therapy within 3 months or 5 half-lives of study, and/or all other
             biologics within 6 months of study (Day 1)

          -  Efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the
             failures occurred within 1 year of the initiation of the therapy of the first biologic
             agent

          -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin
             (TBL) exceeding 1.5 times the upper limit of normal (ULN) at screening.
Study of Eteplirsen in Young Participants With Duchenne Muscular Dystrophy (DMD) Amenable to Exon 51 Skipping
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eteplirsen
Intervention description: Infusion for intravenous use.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 6 Months
Maximum age: 48 Months
Healthy volunteers: No
Keywords: DMD; Duchenne; Eteplirsen; dystrophy; dystrophin; exon 51

Summary:

      This is a multicenter, open-label, dose-escalation study to evaluate the safety,
      tolerability, and PK of once-weekly IV infusions of eteplirsen in approximately 12 male
      participants, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD
      with a deletion mutation amenable to exon 51 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male between 6 months to 48 months of age (inclusive)

          -  Diagnosis of DMD with a deletion mutation amenable to exon 51 skipping

          -  Parent(s) or legal guardian(s) who is willing to provide written informed consent

        Exclusion Criteria:

          -  Received treatment that might have an effect on muscle strength or function within 12
             weeks prior to dosing

          -  Received previous or current treatment with any experimental treatment

          -  Clinically significant illness other than DMD

          -  Clinically significant laboratory abnormality

          -  Any other condition that could interfere with the participation in the study.
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Intervention: AMG 714; Placebo; Placebo Gluten Challenge; Gluten Challenge
Intervention description: AMG 714 administered by subcutaneous injection; Matching placebo to AMG 714 administered by subcutaneous injection; Gluten-free cookies (Finnish rusks); Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: celiac; gluten; Interleukin 15 (IL-15); AMG 714; gluten challenge

Summary:

      This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of
      the effects of gluten exposure in adult patients with celiac disease during a gluten
      challenge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening

          -  On a gluten-free diet for at least 12 months

          -  Negative celiac serology

          -  Avoidance of pregnancy

        Exclusion Criteria:

          -  Severe complications of celiac disease, such as refractory celiac disease

          -  Celiac symptoms

          -  Other concomitant autoimmune disease

          -  Chronic, active gastrointestinal disease

          -  Infections, concomitant diseases

          -  Prohibited medications
Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)
Condition: Metastatic Medulloblastoma; High Risk Supratentorial PNET; Metastatic PNET
MeSH terms: Medulloblastoma; Neuroectodermal Tumors, Primitive
Intervention: Carboplatin; Vincristine; 24 Gy
Intervention description: Administered concurrently with craniospinal radiation.; Administered concurrently with craniospinal radiation.; Craniospinal radiation.
Intervention MeSH terms: Carboplatin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 3 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the efficacy of the combination of reduced dose
      craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with
      concurrent carboplatin and vincristine administration for metastatic classical histology
      medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 3 years and less than 25 years

          -  Patients with classic histology or desmoplastic histology metastatic medulloblastoma
             by histological diagnosis and by head and spine MRI.

          -  Patients with high-risk supratentorial, non-metastatic, PNET

          -  Patients with metastatic PNET

          -  Newly diagnosed patients who have not received prior therapy, with the exception of
             one short course of emergent chemotherapy in newly presenting patients with
             neurological compromise per provider decision

          -  Only patients who are expected to survive at least 6 weeks will be eligible for this
             study.

        Exclusion Criteria:

          -  Patients who are pregnant may not be treated on this study

          -  Patients with anaplastic histology
Medical Treatment of "High-Risk" Neurofibromas
Condition: Neurofibromatosis 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Intervention: Peg-Interferon alpha-2b; Celecoxib (Celebrex); Temozolomide (temodar); Vincristine Sulfate (Oncovin)
Intervention description: age and weight dependant; age and weight dependant; age and weight dependant; age and weight dependant
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Celecoxib; Vincristine; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Neurofibromas; Neurofibromatosis 1; Celecoxib; Celebrex; Peg-Interferon alpha-2b; PEG-Intron; Temozolomide; Temodar; Vincristine Sulfate; Oncovin

Summary:

      Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called
      plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in
      severe pain, physical disability, organ dysfunction and/or become life-threatening.
      Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform
      neurofibromas, and surgery does not provide lasting help. This study will evaluate the
      effectiveness of two treatment combinations in patients with "high-risk" plexiform
      neurofibromas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  "High-Risk" Plexiform Neurofibromas associated with a diagnosis of NF1

          -  2-30 years old (minimum bodyweight of 10 kilograms)

          -  Adequate renal function

        Exclusion Criteria:

          -  Previously untreated active optic glioma

          -  History of any previous allergy to study medications

          -  History of ischemic vascular disease

          -  Pregnancy / Breast feeding
Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Intervention: Fidaxomicin 200 mg; fecal microbiota transplantation (FMT)
Intervention description: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.; Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles
Intervention MeSH terms: Fidaxomicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fecal microbiota transplantation; Fidaxomicin

Summary:

      Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from
      mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in
      treating severe and fulminant CDI. Current evidence suggests that FMT in combination with
      vancomycin is required, and that multiple treatments are necessary. The investigators think
      fidaxomicin may be a better option in the context and may potentially reduce the number of
      FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In
      this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to
      determine efficacy and safety in treating patients with severe or fulminant CDI. The
      investigators want to see if this approach may reduce the number of FMT treatment required,
      and/or the length of hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years with severe1 or fulminant2 CDI, without an adequate response to
             metronidazole IV 500 mg q8H and vancomycin 500 mg PO q6h for at least 2 days or after
             Fecal Microbiota Transplant (FMT). An adequate response is defined as a decrease in
             stool frequency or inflammatory markers (WBC or C reactive protein) by 10% over 48
             hours

          -  Those with ability to provide informed consent or an alternative decision maker
             providing assent

        Exclusion Criteria:

          -  Those with bowel perforation

          -  Those taking chemotherapy or radiation treatment with absolute neutrophil count of <
             1000 cells/mm3

          -  Those with known colonic strictures

          -  Those with subtotal colectomy or planning to have a colectomy

          -  Those with significant ileus