bioihbjkbjnl/mcl2 huggingface dataset:
Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.
Condition: Familial Chylomicronemia Syndrome (FCS) (HLP Type I)
MeSH terms: Hyperlipoproteinemia Type I; Syndrome
Intervention: LCQ908
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Familial Chylomicronemia Syndrome (FCS) (HLP type I); LCQ908

Summary:

      This study was to determine long-term safety and tolerability, and continued efficacy in
      lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS)
      (HLP type I).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed.

          2. Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after
             52 weeks or FCS subjects who have previously completed study CLCQ908A2212.

        Exclusion Criteria:

          1. Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug
             related adverse events.

          2. Subjects from the CLCQ908B2302 study who have developed any other contraindication to
             participation (for example, renal failure)

          3. History of malignancy of any organ system (other than localized basal cell carcinoma
             of the skin), treated or untreated, within the past 5 years, regardless of whether
             there is evidence of local recurrence or metastases.

          4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test.

          5. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%.

          6. Treatment with fish oil preparations within 4 weeks prior to randomization.

          7. Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior
             to randomization.

          8. Treatment with fibrates within 8 weeks prior to randomization. Washout may occur
             following screening if required.

          9. Glybera [alipogene tiparvovec (AAV1-LPLS447X )] gene therapy exposure within the two
             years prior to screening.

         10. eGFR <45 ml/min/1.73m2 or history of chronic renal disease.

        Other protocol defined inclusion/exclusion criteria may apply.
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic Acid; Placebo
Intervention description: Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.; 100 mL physiologic 0.9% normal saline for intravenous infusion.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2456.0
Sex: Female
Minimum age: 68 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis, Zoledronic Acid

Summary:

      This extension study is designed to assess the long term safety and efficacy of zoledronic
      acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301
      (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year
      core study ended. Baseline is the same as Year 3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

        Exclusion Criteria:

          -  Poor kidney, eye, or liver health

          -  Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the
             study medication)

          -  Abnormal calcium levels in the blood

        Other protocol-defined inclusion/exclusion criteria may apply.
Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Vildagliptin; Metformin; sulfonylurea (SU); Basal Insulin
Intervention description: 50 mg b.i.d; metformin is to be kept unchanged
Intervention MeSH terms: Metformin; Vildagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: type 2 diabetes; basal insulin; vildagliptin

Summary:

      To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus
      SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T2DM patients inadequately controlled with metformin+ SU combination therapy at max
             tolerated doses and in whom the decision to start basal insulin has been taken

          -  with stable metformin+ SU combination therapy for at least 12 weeks prior to
             randomization

          -  with a glycemic target of HbA1c <= 7%

          -  with HbA1c at inclusion >7% and <=9%

          -  Patients willing and able to start basal insulin and perform appropriate self
             monitoring of blood glucose (SMBG)

        Exclusion Criteria:

          -  contraindication for either SUs, metformin or insulin and history of hypersensitivity
             to vildagliptin

          -  acute or chronic diseases that interfere with efficacy/safety results of this trial or
             put patient at risk

        Other protocol defined inclusion/exclusion criteria may apply
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Intervention: nusinersen; Sham procedure
Intervention description: Administered by intrathecal (IT) injection as specified in the treatment arm.; Small needle prick on the lower back at the location where the IT injection is normally made
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Maximum age: 210 Days
Healthy volunteers: No
Keywords: Spinal Muscular Atrophy; SMA; SMN; SMNRx; ISIS-SMNRx; ISIS-SMN Rx; ISIS 396443; IONIS-SMNRx; IONIS-SMN Rx; Spinraza; ENDEAR

Summary:

      The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS
      396443) administered intrathecally (IT) to participants with infantile-onset with
      infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to
      examine the safety and tolerability of nusinersen administered intrathecally to participants
      with infantile-onset SMA.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Be born (gestational age) between 37 and 42 weeks

          -  Be medically diagnosed with spinal muscular atrophy (SMA)

          -  Have Survival Motor Neuron2 (SMN2) Copy number = 2

          -  Body weight equal to or greater than 3rd percentile for age using appropriate
             country-specific guidelines

          -  Be able to follow all study procedures

          -  Reside within approximately 9 hours ground-travel distance from a participating study
             center, for the duration of the study

        Key Exclusion Criteria:

          -  Hypoxemia (oxygen [O2] saturation awake less than 96% or O2 saturation asleep less
             than 96%, without ventilation support) during screening evaluation

          -  Clinically significant abnormalities in hematology or clinical chemistry parameters or
             Electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit
             that would render the participant unsuitable for participation in the study

          -  Participant's parent or legal guardian is not willing to meet standard of care
             guidelines (including vaccinations and respiratory syncytial virus prophylaxis if
             available), nor provide nutritional and respiratory support throughout the study

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Condition: Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer; Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
MeSH terms: Prostatic Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasm Metastasis; Neoplasms, Second Primary; Bone Neoplasms; Bone Marrow Diseases
Intervention: amg 162
Intervention description: 120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone metastases; Hormone-refractory prostate cancer; Multiple myeloma; Denosumab; Breast cancer; 20050103; 20050136; 20050244; Advanced cancer; Tumor; Prostate cancer; Zoledronic acid

Summary:

      The purpose of this study is to describe the safety and tolerability of denosumab
      administration as measured by adverse events, immunogenicity, and safety laboratory
      parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects currently enrolled in study 20050103, 20050136, or 20050244

          -  Subjects must sign the informed consent before any study specific procedures are
             performed

        Exclusion Criteria:

          -  Developed sensitivity to mammalian cell derived drug products during the 20050103,
             20050136, or 20050244 study

          -  Currently receiving any unapproved investigational product other than denosumab

          -  Subject is pregnant or breast feeding, or planning to become pregnant within 7 months
             after the end of treatment

          -  Subject (male or female) is not willing to use 2 highly effective contraception during
             treatment and for 7 months (women) or 10 months (men) after the end of treatment

          -  Male subject with a pregnant partner who is not willing to use a condom during
             treatment and for additional 10 months after the end of treatment

          -  Any disorder that, in the opinion of the investigator, may compromise the ability of
             the subject to give written informed consent and/or comply with study procedures
A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Brivaracetam; Brivaracetam
Intervention description: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study); 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epilepsy; Monotherapy; Partial Onset Seizures; Adults and Adolescents

Summary:

      Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited
      number of AEDs are approved for use as monotherapy. The objective of this study is to
      evaluate the efficacy of BRV in the conversion of partial onset seizure patients from
      combination treatment to monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects from 16 to 75 years, both inclusive

          -  Well-characterized focal epilepsy or epileptic syndrome

          -  Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not
             secondarily generalized per 4 weeks during the 8-week Baseline Period

          -  Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic
             Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose

        Exclusion Criteria:

          -  Seizure type IA non-motor as only seizure type

          -  History or presence of seizures occurring too frequently or indistinctly separated to
             be reliably counted during the 6 months preceding Visit 1 or during Baseline

          -  Other serious uncontrolled disease
Pharmacologic Treatment of PTSD in Sexually Abused Children
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Trauma-Focused Cognitive Behavioral Therapy; Sertraline Pill; Placebo Oral Tablet
Intervention description: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent; 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT; 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: PTSD; Depression; Anxiety

Summary:

      This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused
      Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic
      Stress Disorder (PTSD).
    

Eligibility criteria:

        Inclusion:

          1. Ages 10-17 years, inclusive

          2. Confirmed sexual abuse

          3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom
             clusters (reexperiencing, avoidance, arousal)

          4. Parent/primary caregiver available to participate in treatment

          5. Assent with parental consent to participate

        Exclusion:

          1. Non-English speaking

          2. schizophrenia or other severe psychotic disorder

          3. MR (IQ<60) or PDD preventing CBT treatment

          4. taking current psychotropic medication

          5. documented substance dependence (substance abuse allowed)
Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Orantinib (TSU-68); Placebo
Intervention description: 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.; 1 tablet was administered orally twice per day after meals, morning and evening.
Intervention MeSH terms: Orantinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 888.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the overall survival (OS) for Orantinib in
      combination with transcatheter arterial chemoembolization (TACE) versus placebo in
      combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be diagnosed as HCC.

          -  Patients has no indications for treatment with curative hepatic resection or curative
             percutaneous local therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

          -  Patients are able to receive oral medication.
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
Condition: HIV Infections
MeSH terms: Candidiasis
Intervention: miconazole Lauriad; Clotrimazole
Intervention description: 50 mg buccal tablet once a day for 14 days; 10mg troches administered Five Times a Day for 14 days
Intervention MeSH terms: Clotrimazole; Miconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 578.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Miconazole Lauriad; Oropharyngeal candidiasis; HIV patients; Mycology; Clinical picture of Oropharyngeal candidiasis; Candida culture positive; Treatment Experienced

Summary:

      The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg
      (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days
      of treatment (at the test of cure visit, at Day 17-19).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with clinical picture of oropharyngeal candidiasis

          -  Confirmation of oropharyngeal candidiasis by candida culture positive

          -  HIV-positive patients

          -  Patients 18 years of age

        Exclusion Criteria:

          -  Patients with signs or symptoms of systemic candidiasis

          -  Patients with signs or symptoms of esophagitis

          -  Pregnant or breast-feeding women

          -  Patients who have taken systemic antifungals within the past 30 days

          -  Patients who have taken local antifungals within the past 7 days
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
Condition: Precocious Puberty, Central
MeSH terms: Puberty, Precocious
Intervention: Leuprolide Acetate 45 mg
Intervention description: Subcutaneous injection
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 2 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension
      for treatment of children with Central Precocious Puberty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)

          -  Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not
             received prior GnRH agonist treatment for CPP

          -  Pubertal-type LH response following an abbreviated GnRHa stimulation test before
             treatment initiation

          -  Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in
             females or testicular volume ≥ 4 mL in males

          -  Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year

        Exclusion Criteria:

          -  Gonadotropin-independent (peripheral) precocious puberty

          -  Prior or current GnRH treatment for CPP

          -  Prior or current therapy with medroxyprogesterone acetate, growth hormone or
             insulin-like growth factor-1 (IGF-1)

          -  Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height
             for age)

          -  Known history of seizures, epilepsy, and/or central nervous system disorders that may
             be associated with seizures or convulsions

          -  Any other medical condition or serious intercurrent illness that, in the opinion of
             the Investigator, may make it undesirable for the subject to participate in the study
Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-118 Lotion; IDP-118 Vehicle Lotion
Intervention description: Lotion; Lotion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis
    

Eligibility criteria:

        Key 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 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).

        Key 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.