bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543 matching placebo; CTP-543; CTP-543
Intervention description: Administered as tablets.; Administered as tablets.; Administered as tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 706.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alopecia; Hair loss; Hair disease; CTP-543

Summary:

      This study evaluates the safety and effectiveness of an investigational study drug (called
      CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical presentation compatible with alopecia areata with a current episode lasting
             at least 6 months and not exceeding 10 years at the time of Screening. Total disease
             duration greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

          -  Willing to comply with the study visits and requirements of the study protocol.

        Exclusion Criteria:

          -  Treatment with other medications or agents within 1 month of Baseline or during the
             study that may affect hair regrowth or immune response.

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or other scalp condition that
             may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the
             body at Screening and/or Baseline.

          -  Treatment with systemic immunosuppressive medications within 3 months of Screening or
             during the study, or biologics within 6 months of Screening or during the study.

          -  Females who are nursing, pregnant, or planning to become pregnant while in the study,
             and for 30 days after last dose of study drug.

          -  Clinically significant medical condition, psychiatric disease, or social condition, as
             determined by the Investigator, that may unfavorably alter the risk-benefit of study
             participation, adversely affect study compliance, or confound interpretation of study
             results.
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
Condition: Hereditary Angioedema; HAE
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: BCX7353 capsules; Placebo oral capsule
Intervention description: BCX7353 oral capsules administered once daily; Matching oral capsules administered once daily
Intervention MeSH terms: Berotralstat
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Only Part 1 and Part 2 were blinded. As part 3 was open-label, no blinding was used
Enrollment: 121.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: BCX7353; Berotralstat

Summary:

      This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to
      evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in
      patients with Type I and Type II HAE.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A clinical diagnosis of hereditary angioedema Type 1 or Type 2, defined as having a
             C1-INH functional level and a C4 level below the lower limit of the normal (LLN)
             reference range, as assessed during the Screening period.

          -  Subject weight of ≥ 40 kg

          -  Access to and ability to use one or more acute medications approved by the relevant
             competent authority for the treatment of acute attacks of HAE

          -  Subjects must be medically appropriate for on-demand treatment as the sole medicinal
             management for their HAE during the study.

          -  Subjects must have a specified number of investigator-confirmed attacks during the
             run-in period of a maximum of 56 days from the Screening visit.

          -  Acceptable effective contraception

          -  Written informed consent

        Key Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Any clinically significant medical condition or medical history that, in the opinion
             of the Investigator or Sponsor, would interfere with the subject's safety or ability
             to participate in the study

          -  Any laboratory parameter abnormality that, in the opinion of the Investigator, is
             clinically significant and relevant for this study

          -  Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/
             anaphylaxis with unclear etiology

          -  Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days
             prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these
             drugs during the study

          -  Current participation in any other investigational drug study or received another
             investigational drug within 30 days of the Screening visit

          -  Prior enrollment in a BCX7353 study
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: Tocilizumab (TCZ); Placebo
Intervention description: Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.; Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of
      tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC)
      in hospitalized patients with severe COVID-19 pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive
             PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and
             evidenced by chest X-ray or CT scan

          -  SPO2 </=93% or PaO2/FiO2 <300 mmHg

        Exclusion Criteria:

          -  Known severe allergic reactions to TCZ or other monoclonal antibodies

          -  Active tuberculosis (TB) infection

          -  Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)

          -  In the opinion of the investigator, progression to death is imminent and inevitable
             within the next 24 hours, irrespective of the provision of treatments

          -  Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the
             past 3 months

          -  Participating in other drug clinical trials (participation in COVID-19 anti-viral
             trials may be permitted if approved by Medical Monitor)

          -  Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination

          -  Treatment with an investigational drug within 5 half-lives or 30 days (whichever is
             longer) of randomization (investigational COVID-19 antivirals may be permitted if
             approved by Medial Monitor)

          -  Any serious medical condition or abnormality of clinical laboratory tests that, in the
             investigator's judgment, precludes the patient's safe participation in and completion
             of the study

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit
             of normal (ULN) detected within 24 hours at screening (per local lab)

          -  Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab)

          -  Platelet count < 50,000/mL at screening (per local lab)
ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
Condition: Delirium
MeSH terms: Delirium
Intervention: haloperidol; Saline placebo
Intervention description: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.; control arem
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Phase: Phase 3
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: Delirium; Mechanical ventilation; Intensive care; Haloperidol

Summary:

      The purpose of this study is to determine if treating delirious intensive care unit patients
      with haloperidol improves mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult (>=18 years of age) mechanically ventilated patients admitted to the
             medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are
             expected by the ICU clinical team to require >24 hours of mechanical ventilation

        Exclusion Criteria:

          -  Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy;
             history of schizophrenia or neurologic disease that would confound the delirium
             assessment; deafness or inability to understand English or Spanish; extubation prior
             to enrollment; previously enrolled in this study; patient, family, or attending
             physician refusal; death before enrollment; treatment with haloperidol within 2 days
             prior to ICU admission; and prisoners.
Propofol in Obese Children
Condition: Pharmacodynamics; Obesity
MeSH terms: Obesity
Intervention: Propofol; Propofol
Intervention description: Each Obese child/subject in this group will receive a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design); This arm of patients(non-obese)will act as the control group for the obese children. Each non-obese child/subject will receive a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Intervention MeSH terms: Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 80.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Propofol; Childhood obesity; Pharmacodynamics

Summary:

      Obesity in children,as in adults,has rapidly become a public health concern. Studies in
      adults have shown that obesity, now considered to be a disease state, is a modifier of the
      effect of drugs on the body as well as how the body handles the drug.The anesthetic
      management of obese children poses a variety of significant challenges which include
      determination of the appropriate dose of anesthetic intravenous agents. Dosing of most drugs
      is calculated based on the effective dose in 50% of patients but the more practical and
      required information is the effective dose in 95%(ED95%)of patients. The aim of this study is
      to determine the effective dose in 95% of patients(children). The hypothesis is the ED95 of
      propofol in obese children will be higher than that of non-obese children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children between the ages of 3 and 17 years who fall into the categories of
             non-obese(BMI percentile between 25-84th percentile) or obese(>95th percentile)

          2. American Society of Anesthesiology(ASA) classification 1 or 2-

        Exclusion Criteria:

          1. Patients classified as ASA (American Society of Anesthesiology) Class 3 or greater.

          2. Patients with documented kidney or liver disease or those presenting for open surgery
             on the liver or kidney.

          3. Patients who will NOT be receiving propofol for induction as part of their anesthetic
             regimen.

          4. Patients who are currently on anti-convulsant medication or receiving drugs with
             sedative effects.

          5. Patients currently being treated for attention deficit disorder.

          6. Patients who are diagnosed with failure to thrive or those with a BMI less than 25th
             percentile.

          7. Patients who are hemodynamically unstable.

          8. Patients with egg allergy.

          9. Patients with low levels of albumin -
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: MEDI4736; Tremelimumab; MEDI4736+Tremelimumab; Cetuximab; 5-fluorouracil (5FU); Cisplatin; Carboplatin
Intervention description: Anti-PD-L1 antibody; Anti-CTLA-4 Antibody; Monoclonal Antibody; Chemotherapy Agent; Chemotherapy agent; Chemotherapy Agent
Intervention MeSH terms: Carboplatin; Fluorouracil; Cetuximab; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 823.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN

Summary:

      This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine
      the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus
      SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior
      systemic chemotherapy for recurrent or metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18 years at the time of screening

          2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx,
             hypopharynx, or larynx).

          3. A fresh tumor biopsy for the purpose of screening or an available archival tumor
             sample. Tumor lesions used for fresh biopsies should not be the same lesions used as
             RECIST target lesions, unless there are no other lesions suitable for biopsy.

          4. No prior systemic chemotherapy for recurrent or metastatic disease

          5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance
             status of 0 or 1 at enrollment

          6. No prior exposure to immune-mediated therapy,

        Exclusion Criteria:

          1. Histologically or cytologically confirmed head and neck cancer of any other primary
             anatomic location in the head and neck not specified in the inclusion criteria
             including patients with SCCHN of unknown primary or non-squamous histologies (eg,
             nasopharynx or salivary gland)

          2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in
             the primary treatment setting

          3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days
             prior to first dose of study treatment

          4. Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-122 Lotion; IDP-122 Vehicle Lotion
Intervention description: Medicated topical lotion; Vehicle topical lotion with no active ingredient
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety and efficacy of a topical lotion when applied once daily
      to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's
      Global Assessment [IGA] score of 3 or 4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a body
             surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms,
             soles, axillae, and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or
             4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded
             in this assessment).

        Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the Investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             Investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the Investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently
             participating in another clinical study with an investigational drug or device.
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine
Intervention description: Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 662.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: adolescent; children

Summary:

      Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent
      participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition
      (DSM-5™) diagnosis of MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12
             and ≤18 years in the lead-in study (12709A and 12710A).

          -  The participant must have completed Study 12709A or 12710A (Visit 12, Completion
             Visit) immediately prior to enrolment into this extension study.

          -  The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A,
             diagnosed according to DSM-5™.

          -  The participant is indicated for long-term treatment with vortioxetine according to
             the clinical opinion of the Investigator.

          -  For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able
             to understand the Informed Assent Form, and parent(s)/legal representative(s) are able
             to read and understand the Informed Consent Form.

          -  For participants who turned 18 years during the lead-in study 12710A; the participant
             has signed the Informed Consent Form.

        Exclusion Criteria:

          -  The participant has been diagnosed with another psychiatric disorder (for example
             mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A
             or 12710A.

          -  The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a
             pharmacological treatment other than a stimulant medication.

        Other protocol-defined inclusion and exclusion criteria may apply