bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: RT001; Placebo
Intervention description: RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001.; The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 12 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the Efficacy, Long Term Safety and Tolerability of
      RT001 in subjects with Friedreich's Ataxia
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female 12 to 50 years of age

          2. Medical history consistent with the symptoms of FRDA at ≤ 25 years of age

          3. Detection of biallelic pathogenic variants in frataxin gene (FXN)

          4. Ambulatory (with or without assistive device) and capable of performing other
             assessments/evaluations.

          5. Must be able to walk 25 feet during the timed 1-minute walk

        Key Exclusion Criteria:

          1. Received treatment with other experimental therapies within the last 30 days prior to
             the first dose

          2. Previously participated in the RT001 trial

          3. Refusal to discontinue fish oils or other oil-based supplements for the duration of
             the study (Screening till last study procedure completed)

          4. History of malignancies (other than basal cell carcinomas)

          5. Inability to complete CPET protocol

          6. Female who is breastfeeding or has a positive pregnancy test

          7. History of uncontrolled diabetes mellitus (Type 1 or 2)
Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Condition: Adjunctive Treatment of Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Pimavanserin
Intervention description: Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the safety and tolerability of long-term pimavanserin treatment in subjects with
      major depressive disorder and inadequate response to antidepressant treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059

          2. May benefit from longer term therapy with open-label pimavanserin treatment

          3. If the subject is female, she must not be pregnant or breastfeeding. She must also be
             of nonchildbearing potential OR must agree to use acceptable methods of contraception

        Exclusion Criteria:

          1. Is determined to be inappropriate for the study

          2. Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal,
             hepatic, hematologic, or other medical or mental disorder, including cancer or
             malignancies that would affect the patient's ability to participate in the program

        Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to
        ensure that all criteria for study participation are met. Patients may be excluded from the
        study based on these assessments (and specifically, if it is determined that their baseline
        health and psychiatric condition do not meet all pre-specified entry criteria).
A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: ustekinumab; placebo
Intervention description: Type = exact number, Form = solution for injection, Number = 45 and 90, Unit = mg, Route = subcutaneous (SC) administered at Weeks 0, 4 and 16. Both treatments (45 mg and 90 mg) administered every 12 weeks after Week 16 depending on clinical response.; Form = solution for injection, route = SC administered at Weeks 0 and 4. At Weeks 12 and 16, placebo will be crossed over to receive ustekinumab 45 mg or 90 mg.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 766.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ustekinumab; CNTO1275; Plaque type Psoriasis; Interleukin-23; IL-23; Psoriasis; Interleukin 12; IL-12

Summary:

      The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab
      (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with plaque-type psoriasis diagnosed at least 6 months prior and covering at
             least 10% of total body surface areas

          -  Have psoriasis area-and-severity index score of >=12

          -  Patients who are considered by treating dermatologist to be a candidate for
             phototherapy or systemic treatment of psoriasis

          -  Have no history of latent or active TB

        Exclusion Criteria:

          -  Currently have nonplaque forms of psoriasis or drug-induced psoriasis

          -  Have any therapeutic agent targeted at reducing IL-12 or IL-23

          -  Have had a BCG vaccination within the previous 12 months

          -  Have a history of chronic or recurrent infectious disease or who have or have had a
             serious infection requiring hospitalization or intravenous antibiotics within the
             previous 2 months

          -  Have or ever have had a nontuberculous mycobacterial infection or opportunistic
             infection

          -  Patients known to be infected with human immunodeficiency virus, hepatitis B, or
             hepatitis C

          -  Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
             hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral,
             or psychiatric disease

          -  Patients with a malignancy or who have a history of malignancy (with the exception of
             certain skin cancers and pre-invasive cervical cancer)
A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
Condition: Allergy
MeSH terms: Hypersensitivity
Intervention: SCH 39641; Placebo for SCH 39641
Intervention description: Rapidly dissolving tablet sublingually once daily; Rapidly dissolving tablet sublingually once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 914.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immunology

Summary:

      This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in
      participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary
      objective was to compare treatment-emergent adverse events (AEs) for participants treated
      with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis
             of 2 years duration or more, with or without asthma

          -  Must have a positive skin prick test response to Ambrosia artemisiifolia

          -  Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted
             value

          -  Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the
             Screening Visit must be within normal limits or clinically acceptable to the
             investigator/sponsor

          -  Females of child-bearing potential must agree to use medically accepted methods of
             contraception

        Exclusion Criteria:

          -  Unstable asthma or has experienced an occurrence of any clinical deterioration of
             asthma that resulted in emergency treatment, hospitalization due to asthma, or
             treatment with systemic corticosteroids in previous 3 months

          -  Received an immunosuppressive treatment within 3 months

          -  History of anaphylaxis with cardio-respiratory symptoms.

          -  History of chronic urticaria or angioedema

          -  Current severe atopic dermatitis

          -  Female subject who is breastfeeding, pregnant, or intending to become pregnant

          -  Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month
             within the last 5 years

          -  History of allergy, hypersensitivity or intolerance to the ingredients of the
             investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or
             self-injectable epinephrine

          -  Unable to or will not comply with the use of self-injectable epinephrine

          -  Participating in any other clinical trial
A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab Pegol (CDP870)
Intervention description: Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn
      from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an
      exacerbation of Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
             clinical studies in which the subject completed the Week 2 assessment in CDP870-031
             [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose
             Crohn's Disease was significantly worse as determined by the investigator and whose
             Clinical Disease Activity Index (CDAI) score at entry to this study is either
             (subjects may have received active or placebo treatment):

               1. At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6
                  CDP870 032 [NCT00152425] responders) OR

               2. Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032
                  [NCT00152425] responders) with an absolute score of at least 350 points

          -  Subjects must be able to understand the information provided to them and give written
             informed consent

        Exclusion Criteria:

          -  Any exclusion criterion that would have prevented the subject's participation in the
             qualifying pivotal study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]),
             although the upper limit of 450 in the CDAI score is not applicable. In addition the
             criterion that excludes previous participation in a clinical trial of Certolizumab
             Pegol does not apply
Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: Idebenone
Intervention description: Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients > 45 kg/99 lbs: idebenone 2250 mg/day
Intervention MeSH terms: Idebenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Friedreich's Ataxia; Idebenone; ICARS

Summary:

      This study is meant to assess the safety and tolerability of idebenone in patients with
      Friedreich's Ataxia over a 12 months period.
    

Eligibility criteria:

        Inclusion criteria:

          -  Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and
             presenting at Week 24 (Visit 5) of that study

          -  Body weight ≥ 25kg/55 lbs

          -  Negative urine pregnancy test

          -  Patients who in the opinion of the investigator are able to comply with the
             requirements of this study

        Exclusion criteria:

          -  Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of
             the investigator are attributable to idebenone and preclude further treatment with
             idebenone

          -  Clinically significant abnormalities of clinical hematology or biochemistry including,
             but not limited to, elevations greater than 2 times the upper limit of normal of AST,
             ALT or creatinine

          -  Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily
             requirement) or other sources of idebenone within the past month

          -  Parallel participation in another clinical drug trial

          -  Past or present history of abuse of drugs or alcohol

          -  Pregnancy or breast-feeding
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: CardioFocus EAS-AC
Intervention description: PVI for PAF
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Treatment of PAF using EAS-AC

Summary:

      The purpose of this study is to determine the safety and effectiveness of the endoscopic
      ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF)
      with pulmonary vein isolation (PVI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic, Paroxysmal atrial fibrillation (AF)

          -  18 to 70 years of age

          -  Failure of at least one AAD

          -  Others

        Exclusion Criteria:

          -  Generally good overall health as determined by multiple criteria

          -  Willing to participate in a study

          -  Others
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Odanacatib; Placebo for Odanacatib; Vitamin D3; Calcium carbonate
Intervention description: 50 mg tablet orally once weekly (OW); 50 mg tablet orally OW; 5600 IU orally OW; If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16071.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the event-driven base study is to determine the safety and efficacy,
      especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with
      osteoporosis. In a placebo-controlled extension of the base study, participants continued to
      receive the same blinded study medication for a total of up to 5 years of blinded study
      medication combined between the base study and the extension. After participants received 5
      years of blinded study medication, they received open-label odanacatib through the end of the
      first extension. Participants were then invited to enroll in a second extension study in
      which they received open-label odanacatib for an additional 5 years. Two imaging substudies
      (PN032-Base/Extension and PN035) were conducted for participants in the MK-0822-018 Study.
      Additional safety information was collected for participants who discontinued from the base
      study or the blinded first extension in an observational follow-up study, MK-0822-083
      (EudraCT number: 2007-002693-66) .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone
             mineral density

          -  Ambulatory (able to walk)

        Exclusion Criteria:

          -  Must not be taking osteoporosis therapy or have a metabolic bone disorder other than
             osteoporosis

          -  Has or has had a hip fracture

          -  Currently participating in another drug study
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: turoctocog alfa; turoctocog alfa
Intervention description: Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.; Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe, and North and South America. The aim of this
      clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant
      factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A

          -  Age below 12 years and weight at least 11 kg

        Exclusion Criteria:

          -  Surgery planned to occur during trial participation (exceptions are port placement,
             dental extractions, and minor, uncomplicated emergent procedures)

          -  Congenital or acquired coagulation disorders other than haemophilia A

          -  Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Bimekizumab
Intervention description: Study participants will receive bimekizumab at pre-specified time points.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; PsA; Auto-Injector; Bimekizumab

Summary:

      The purpose of the study is to evaluate for each self-injecting device presentation the
      ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject
      bimekizumab at study start and 4 weeks after training in self-injection technique using the
      bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject fulfills all inclusion criteria for the PA0012 [NCT04009499] study

          -  Subject is considered reliable and capable of adhering to the DV0004 protocol (eg,
             able to understand and complete questionnaires, able to use investigational
             self-injecting device presentations according to the instructions for use (IFU), and
             able to adhere to the visit schedule) according to the judgment of the Investigator

          -  Subject is willing to self-inject

        Exclusion Criteria:

        -Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study
        exclusion criteria are met
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: FKB327; Humira®
Intervention description: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.; Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 728.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid; Arthritis

Summary:

      The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison
      to Humira® in rheumatoid arthritis patients who have inadequate disease control on
      methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged 18 years or over

          2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months

          3. Patient has active RA

          4. Patient has taken a stable dose of methotrexate for at least 3 months

        Exclusion Criteria:

          1. Patient has been previously treated with adalimumab

          2. Patient has been previously treated or has ongoing treatment with prohibited
             medications

          3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks

          4. Patient has positive result for HIV, HBV, HCV or TB infection

        Other Inclusion/Exclusion criteria may apply.