bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SQ; Administered SQ
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in
      participants with plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis for at least 6 months prior to enrollment

          -  At least 10% BSA of psoriasis at screening and at enrollment

          -  sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment

          -  Candidates for phototherapy and/or systemic therapy

          -  Participant must agree to use reliable method of birth control during the study; women
             must continue using birth control for at least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis

          -  History of drug-induced psoriasis

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to enrollment and during the study

          -  Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4
             weeks; or had topical psoriasis treatment within the previous 2 weeks prior to
             enrollment

          -  Concurrent or recent use of any biologic agent

          -  Have participated in any study with ixekizumab

          -  Received a live vaccination within 12 weeks prior to enrollment

          -  Serious disorder or illness other than psoriasis

          -  Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis

          -  Major surgery within 8 weeks of baseline, or will require surgery during the study

          -  Breastfeeding or nursing (lactating) women
A Study of OV101 in Individuals With Angelman Syndrome (AS)
Condition: Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
MeSH terms: Angelman Syndrome; Syndrome
Intervention: Gaboxadol; Placebo
Intervention description: OV101 versus placebo once daily at bedtime for 12 weeks; Matching placebo capsules to OV101 capsules.
Intervention MeSH terms: Gaboxadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double (Participant/Care Giver and Investigator/Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in
      pediatric subjects with Angelman syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female and 2 to 12 years old (inclusive) at the time of informed consent

          -  Confirmed molecular diagnosis of AS

          -  Has a CGI-S-AS score of 3 or more at baseline.

          -  Meets the following age-appropriate body weight criterion:

               1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.

               2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).

          -  Stable concomitant mediations for at least 4 weeks before study start

        Exclusion Criteria:

          -  Any condition that would limit study participation

          -  Clinically significant lab or vital sign abnormalities at the time of screening

          -  Poorly controlled seizures (weekly seizures of any frequency with a duration more than
             3 minutes, weekly seizures occurring more than 3 times per week, each with a duration
             of less than 3 minutes, or as defined by investigator assessment)

          -  Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks
             prior to Day 1 or during the study. Benzodiazepines chronically administered for
             seizure control are permitted.

          -  Cannot comply with protocol study assessments during screening or caregiver unable to
             comply with study requirements.

          -  Enrolled in any clinical trial or used any investigational agent within the 30 days
             before screening or concurrently with this study.
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 0.3% OPA-15406 ointment; 1% OPA-15406 ointment
Intervention description: Twice daily; Twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 366.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and
      1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: At least 2 years (at time of obtaining informed consent)

          -  Diagnosis of AD based on the Japanese Dermatological Association's criteria

          -  Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the
             screening and baseline examinations

        Exclusion Criteria:

        - Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification
        of AD, within 28 days prior to the baseline examination
Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
Condition: Acquired Thrombotic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: Caplacizumab; Placebo
Intervention description: First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.
Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.
Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.; First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.
Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.
Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the
      efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of
      prevention of further microvascular thrombosis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult male or female ≥ 18 years of age at the time of signing the informed consent
             form (ICF).

          2. Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or
             recurrent), which included thrombocytopenia and microscopic evidence of red blood cell
             fragmentation (e.g., schistocytes).

          3. Required initiation of daily PE treatment and had received 1 PE treatment prior to
             randomization

          4. Others as defined in the protocol

        Exclusion Criteria:

          1. Platelet count ≥100×10E9/L.

          2. Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L

          3. Known other causes of thrombocytopenia

          4. Congenital TTP (known at the time of study entry).

          5. Pregnancy or breast-feeding.

          6. Subjects who were previously enrolled in a clinical study with caplacizumab and
             received caplacizumab or for whom the assigned treatment arm is unknown

          7. Others as defined in the protocol
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Condition: Leiomyoma; Uterine Hemorrhage
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Intervention: Ulipristal acetate (UPA); Placebo
Intervention description: UPA tablet; Matching placebo tablet.
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the superiority of ulipristal acetate versus placebo for the
      treatment of abnormal uterine bleeding associated with uterine fibroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal women, 18-50 years, inclusive.

          -  Cyclic abnormal uterine bleeding (heavy or prolonged).

          -  Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in
             the first 8 days of menses.

          -  Minimum of one discrete leiomyoma observable by transvaginal ultrasound.

          -  Endometrial biopsy without evidence of malignancy or atypical or non-atypical
             hyperplasia

        Exclusion Criteria:

          -  History of uterine surgery that would interfere with the study endpoints.

          -  Known coagulation disorder including bleeding disorder or clotting disorder.

          -  History of, or current uterine, cervix, ovarian, or breast cancer.

          -  Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP),
             or total bilirubin two times or greater than the upper limit of normal rang
A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Insulin Lispro (U100)
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro; Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1428.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist; T2DM

Summary:

      The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide
      to insulin lispro (U100) three times a day in participants with type 2 diabetes that are
      already on insulin glargine (U100), with or without metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM)

          -  Have HbA1c between ≥7.5% and ≤11%

          -  Have been treated for at least 90 days prior to day of screening with once or twice
             daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to
             maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl
             peptidase 4 inhibitors

          -  Be of stable weight (± 5%) for at least 90 days

          -  Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening

        Exclusion Criteria

          -  Have type 1 diabetes mellitus

          -  Have had chronic or acute pancreatitis any time prior to study entry

          -  Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative
             diabetic retinopathy requiring immediate or urgent treatment

          -  Have disorders associated with slowed emptying of the stomach, have had any stomach
             surgeries for the purpose of weight loss, or are chronically taking drugs that
             directly affect gastrointestinal motility

          -  Have had a heart attack, stroke, or hospitalization for congestive heart failure in
             the past 2 months

          -  Have a personal or family history of medullary thyroid carcinoma or personal history
             of multiple endocrine neoplasia syndrome type 2

          -  Have been taking weight loss drugs, including over-the-counter medications during the
             last 3 months

          -  Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants
             on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than
             the country-specific threshold for using the protocol-required dose of metformin per
             local label)]
A Study for Patients Who Completed VITALITY-ALS (CY 4031)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: tirasemtiv
Intervention description: Oral
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amyotrophic Lateral Sclerosis; ALS; tirasemtiv

Summary:

      The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in
      patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv
      in ALS (CY 4031).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal
             consent is given, a Legal Designee of the patient must sign the ICF form

          -  Completed participation on study drug and the Follow-Up Visit in the CY 4031 study

          -  Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree
             for the duration of their participation in the study to either:

               -  Use a condom during sexual intercourse with female partners who are of
                  childbearing potential AND to have female partners use a highly effective means
                  of contraception OR

               -  Abstain from sexual intercourse during participation in the study

          -  Female patients who are not post-menopausal (≥ 1 year) or sterilized, must:

               -  Not be breastfeeding

               -  Have a negative pregnancy test

               -  Have no intention to become pregnant during participation in the study AND

               -  Practice sexual abstinence, defined as refraining from intercourse during the
                  duration of the study OR if male partners are not vasectomized with a confirmed
                  zero sperm count, require use of a condom AND use of a highly effective
                  contraceptive measure

        Exclusion Criteria:

          -  Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during
             the course of the study

          -  Has taken an investigational study drug (other than tirasemtiv) prior to dosing,
             within 30 days or five half-lives of the prior agent, whichever is greater

          -  Use of tizanidine and theophylline-containing medications during study participation

          -  Participation or planning to participate in any form of stem cell therapy for the
             treatment of ALS or another investigational drug
Pre-exposure Prophylaxis for SARS-Coronavirus-2
Condition: COVID-19; Corona Virus Infection; ARDS; Acute Respiratory Distress Syndrome
MeSH terms: Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Intervention: Hydroxychloroquine; Placebo
Intervention description: Hydroxychloroquine; 200mg tablet; oral; Placebo; tablet; oral
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1483.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for
      the prevention of COVID-19 disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - A healthcare worker at high risk for COVID-19 exposure (defined below):

          -  Persons primarily working in emergency departments (physicians, nurses, ancillary
             staff, triage personnel)

          -  Persons primarily working in intensive care units (physicians, nurses, ancillary
             staff, respiratory therapists)

          -  Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse
             anesthetists (CRNAs)

          -  First responders (i.e. EMTs, paramedics)

        Exclusion Criteria:

          -  Active COVID-19 disease

          -  Prior COVID-19 disease

          -  Current fever, cough, shortness of breath

          -  Allergy to chloroquine or hydroxychloroquine

          -  Prior retinal eye disease

          -  Known Chronic Kidney disease, Stage 4 or 5 or dialysis

          -  Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency

          -  Weight <40 kg

          -  Prolonged QT syndrome

          -  Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide,
             amiodarone, digoxin, procainamide, or propafenone

          -  Current use of medications with known significant drug-drug interactions: artemether,
             lumefantrine, mefloquine, tamoxifen, or methotrexate.
CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD5789 (trifarotene)
Intervention MeSH terms: Trifarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 453.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Acne vulgaris; Safety; Face; Trunk

Summary:

      Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of
      treatment on the face and trunk for acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening
             and Baseline visits.

          -  The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions
             at Screening and Baseline visits on the face.

          -  Exclusion Criteria:

          -  The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary
             acne form (chloracne, drug-induced acne, etc.).

          -  The Subject has more than 1 nodule on the face at Screening and at Baseline visits.

          -  The Subject has any acne cyst on the face at Screening and at Baseline visits.
Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear; Postoperative Pain
MeSH terms: Pain, Postoperative; Rotator Cuff Injuries
Intervention: Ketorolac
Intervention description: Oral Ketorolac
Intervention MeSH terms: Ketorolac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Rotator Cuff Tear; Postoperative Pain

Summary:

      1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent
           to the standard of care pain protocol for postoperative pain control following
           arthroscopic rotator cuff repair.

        2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the
           standard of care pain protocol will reduce postoperative opioid consumption following
           arthroscopic rotator cuff repair.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients between the ages of 18 and 89 years old, male or female

          2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

        Exclusion Criteria

          1. Patients below the age of 18 or above the age of 89

          2. Illiterate or non-English speaking patients

          3. Patients with contraindications to Ketorolac

          4. History of alcohol of drug abuse

          5. Chronic use of analgesic or psychotropic drugs

          6. Known peptic ulcer disease or bleeding diathesis

          7. Renal dysfunction