bioihbjkbjnl/mcl2 huggingface dataset:
Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal; Hemolysis
Intervention: Danicopan; Placebo; C5 Inhibitor
Intervention description: Oral tablet; Oral tablet; Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Paroxysmal Nocturnal Hemoglobinuria (PNH); Extravascular Hemolysis (EVH); Factor D inhibitor; Complement; Danicopan; C5 inhibitor

Summary:

      The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy
      to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with
      PNH who have clinically evident EVH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PNH

          -  Clinically Evident EVH defined by:

               -  Anemia (Hgb ≤9.5 gram/deciliter) with absolute reticulocyte count ≥120 x
                  10^9/liter

          -  Receiving an approved C5 inhibitor for at least 6 months prior to Day 1

          -  Platelet count ≥30,000/microliters (µL)

          -  Absolute neutrophil counts ≥500/μL

          -  Documentation of/or willingness to receive vaccinations for N. meningiditis and
             prophylactic antibiotics as required

        Exclusion Criteria:

          -  History of a major organ transplant or hematopoietic stem cell transplantation (HSCT)

          -  Participants with known aplastic anemia or other bone marrow failure that requires
             HSCT or other therapies including anti-thymocyte globulin and/or immunosuppressants

          -  Known or suspected complement deficiency

          -  Laboratory abnormalities at screening, including:

               -  Alanine aminotransferase >2 x ULN (>3 x ULN in case of patients with documented
                  liver iron overload defined by serum ferratin values

                    -  500 ng/ML)

               -  Direct bilirubin >2 x ULN (unless due to EVH or documented Gilbert's Syndrome)

          -  Current evidence of biliary cholestasis

          -  Estimated glomerular filtration rate of <30 milliliters/minute/1.73 meter squared
             and/or are on dialysis

          -  Evidence of human immunodeficiency virus, hepatitis B, or active hepatitis C infection
             at screening
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
Condition: Opioid Dependence; Opioid Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: SUBOXONE; RBP-6000; Placebo
Intervention description: SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.; Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.; Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo controlled, multicenter study in male and female
      participants who are seeking treatment for opioid use disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
             (DSM-5) criteria for moderate or severe opioid use disorder

          -  By medical history has met DSM-5 criteria for moderate or severe opioid use disorder
             for the 3 months immediately prior to signing the informed consent form

          -  Is seeking medication-assisted treatment for opioid use disorder

          -  Is an appropriate candidate for opioid partial-agonist medication-assisted treatment
             in the opinion of the investigator or medically responsible physician

          -  Body mass index (BMI) of ≥ 18.0 to ≤ 35.0 kg/m^2

        Exclusion Criteria:

          -  Current diagnosis other than opioid use disorder requiring chronic opioid treatment

          -  Current substance use disorder as defined by DSM-5 criteria with regard to any
             substances other than opioids, cocaine, cannabis, tobacco, or alcohol.

          -  Positive urine drug screen (UDS) result at screening for cocaine or cannabis AND meets
             DSM-5 criteria for either moderate or severe cocaine or cannabis use disorder,
             respectively

          -  Meets DSM-5 criteria for moderate or severe alcohol use disorder

          -  Received medication-assisted treatment for opioid use disorder (e.g., methadone,
             buprenorphine) in the 90 days prior to providing written informed consent
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 658.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel,
      225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy
      (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study

               5. Dissociative disorder

               6. Posttraumatic stress disorder

               7. MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Intervention: Semaglutide; Placebo
Intervention description: Subcutaneous (under the skin) injection of semaglutide once-weekly.; Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the change in participant's body weight from the start to the end of
      the study. This is to compare the effect on body weight in people taking semaglutide (a new
      medicine) and people taking "dummy" medicine. In addition to taking the medicine, the
      participant will have talks with study staff about healthy food choices, how to be more
      physically active and what a participant can do to lose weight.

      The participant will get semaglutide for the first 20 weeks. Then the participant will get
      either semaglutide or "dummy" medicine - which treatment the participant gets after the 20
      weeks is decided by chance. The participants will need to take 1 injection once a week. The
      study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper
      arm. The study will last for about 1.5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age greater than or equal to 18 years at the time of signing informed
             consent

          -  Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27
             kg/sqm with the presence of at least one of the following weight related comorbidities
             (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or
             cardiovascular disease

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Exclusion Criteria:

          -  Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central
             laboratory at screening

          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records
Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
Condition: Lambert-Eaton Myasthenic Syndrome
MeSH terms: Lambert-Eaton Myasthenic Syndrome; Syndrome
Intervention: Amifampridine Phosphate; Placebo Oral Tablet
Intervention MeSH terms: Amifampridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LEMS

Summary:

      This study evaluates the effect of withdrawing amifampridine phosphate treatment from
      patients with LEMS. One half of the patients will continue to receive amifampridine phosphate
      and the other half will receive placebo, during this double-blind study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age and currently receiving amifampridine phosphate for
             LEMS.

          2. Diagnosis of LEMS by antibody testing or electromyography (EMG).

          3. Completion of anti-cancer treatment at least 3 months (90 days) prior to Screening.

          4. If receiving peripherally acting cholinesterase inhibitors (e.g. pyridostigmine), a
             stable dose of cholinesterase inhibitors is required for at least 7 days prior to
             randomization and throughout the study.

          5. If receiving permitted oral immunosuppressants (prednisone or other corticosteroid), a
             stable dose is required for at least 30 days prior to randomization and throughout the
             study.

          6. Female patients of childbearing potential must practice an effective, reliable
             contraceptive regimen during the study.

          7. Able to perform all study procedures and assessments.

          8. Willing and able to travel to study site and attend all clinic study visits.

          9. Willing and able to provide written informed consent.

        Exclusion Criteria:

          1. Clinically significant long corrected QT (QTc) interval on ECG in previous 12 months.

          2. Seizure disorder.

          3. Active brain metastases.

          4. Unable to ambulate.

          5. Pregnant or lactating females.

          6. Any other condition which, in the opinion of the Investigator, might interfere with
             the patient's participation in the study or confound the assessment of the patient.
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Coinfection; Hepatitis
Intervention: LDV/SOF
Intervention description: 90/400 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to determine the antiviral efficacy, safety, and
      tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with
      chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection

          -  Individuals must not be taking or requiring treatment with HBV antiviral therapy at
             screening. For participants that are HBV treatment experienced, the most recent
             treatment must have been completed at least 6 months prior to Day 1.

          -  Cirrhosis determination by Fibroscan

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female or male is of childbearing
             potential

        Key Exclusion Criteria:

          -  Current or prior history of clinically-significant illness or any other major medical
             disorder that may interfere with individual's treatment, assessment or compliance with
             the protocol

          -  Pregnant or nursing female

          -  Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)

          -  Hepatocellular carcinoma (HCC) or other malignancy

          -  Current or prior history of clinical hepatic decompensation

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Mylan Insulin Aspart Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: MYL-1601D Product; FlexPen NovoLog®
Intervention description: (100 U/mL); (100 U/mL)
Intervention MeSH terms: Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy
      profile between MYL-1601D and NovoLog® in patients with T1DM.
    

Eligibility criteria:

        Inclusion criteria

          1. Written and signed informed consent.

          2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to
             screening.

          3. Subject is able and willing to comply with the requirements of the study protocol.

        Exclusion Criteria

          1. History or presence of a medical condition or disease that in the Investigator's
             opinion would place the subject at an unacceptable risk from study participation.

          2. History of hypersensitivity to any of the active or inactive ingredients of the
             insulin/insulin analogue preparations used in the study, OR history of significant
             allergic drug reactions.

          3. Any clinically significant abnormality in electrocardiogram or safety laboratory
             tests.

          4. Any elective surgery requiring hospitalization planned during the study period.

          5. History of a significant medical condition, such as unstable angina, myocardial
             infarction, stroke or transient ischemic attack in the 6 months before screening.

          6. Subjects with major depressive illness in the last 3 years.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial
NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: NT0102; Placebo
Intervention description: NT0102 (methylphenidate polistirex [MPP] extended release [XR] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride.; Matching ODT placebo was given once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to
      evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit
      Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory
      classroom study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently being treated for ADHD

        Exclusion Criteria:

          -  Other psychiatric diagnoses

          -  Significant cognitive impairment

          -  Chronic medical illnesses

          -  Structural cardiac defects

          -  Significant abnormal lab tests

          -  Taking disallowed medications

          -  Positive drug test
Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer
Condition: Differentiated Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Selumetinib; Placebo; Radioactive Iodine Therapy
Intervention description: 3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period; 3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period; A single oral radioactive iodine dose of 100 mCI(3.7 GBq) 131I (+/-10% at the time of administration)to be administered 30 days after randomization. Additionaly, Thyrogen (Recombinant human TSH) will be used to stimulate iodine uptake according to the manufacturer's recommendation(0.9 mg intramuscular injection once a day for the 2 days prior to the dose of radioactive iodine)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Selumetinib, Differentiated Thyroid Cancer , AZD6244

Summary:

      The study is designed to evaluate the clinical efficacy, safety and tolerability of
      selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph
        node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to
        receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone
        suppression

        Exclusion criteria:

        Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell
        carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved
        toxicity ≥ common terminology criteria for adverse event Grade 2
A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study
Condition: Keratosis, Actinic
MeSH terms: Keratosis, Actinic; Keratosis; Recurrence
Intervention: MAL Cream; Vehicle cream
Intervention description: No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.; No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose for this study is to assess recurrence of Actinic Keratosis in
      participants achieving complete response treated in earlier study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed earlier study RD.06.SPR.112199 (NCT04085367) and
             achieved complete response at last visit

          -  Participants fully understand and sign an informed consent form (ICF) before any study
             procedure begins

          -  Participants willing and able to perform all study protocol requirements

        Exclusion Criteria:

          -  Participants developing or experiencing any condition that may not be safe for them or
             not compliant will be excluded

          -  Pertinent not compliant with study conditions or PI instructions during the earlier
             study - Lumexia Ph 3