bioihbjkbjnl/mcl2 huggingface dataset:
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.
BOTOX® Treatment in Pediatric Lower Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: botulinum toxin Type A; Normal Saline (Placebo)
Intervention description: Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.; Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 384.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
      pediatric patients with lower limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 kg/22 lb

          -  Cerebral palsy with dynamic muscle contracture /spasticity of the ankle

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 6 months

          -  History of surgical intervention of the lower study leg or planned surgery of any limb
             during the study

          -  Previous casting of the study limb for spasticity within 6 months or with a dynamic
             splint within 3 months, or planned casting or dynamic splinting for spasticity of the
             study limb or affected upper limb during the study
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
Condition: Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Icatibant; Placebo
Intervention description: 30 mg (3mL) subcutaneous icatibant injection in the abdominal region; Solution for injection, matched to study drug Single dose: 3 mL
Intervention MeSH terms: Icatibant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hereditary Angioedema; C1 inhibitor deficiency; HAE; Icatibant; Bradykinin antagonist; acute attack; subcutaneous

Summary:

      The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin
      antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with
      hereditary angioedema (HAE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age above 18 years;

          -  Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor
             [C1-INH] deficiency);

          -  Current edema be in the cutaneous, abdominal and/or laryngeal areas;

          -  Current edema be moderate to severe according to the investigator's Symptom Score.

        Exclusion Criteria:

          -  Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);

          -  Participation in a clinical trial of another investigational medicinal product (IMP)
             within the past month;

          -  Treatment with any pain medication since onset of the current edema attack;

          -  Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH
             preparations), less than 3 days from onset of the current edema attack;

          -  Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril);

          -  Evidence of severe, symptomatic coronary artery disease based on medical history or
             screening examination;

          -  Serious concomitant illnesses that the physician considers to be a contraindication
             for participation in the trial;

          -  Pregnancy and/or breast-feeding.
An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease
Condition: Gaucher Disease, Type 1
MeSH terms: Gaucher Disease
Intervention: VPRIV®
Intervention description: Intravenous infusion, every other week (EOW)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: VPRIV; Enzyme Replacement Therapy; Gaucher disease; glucocerebrosidase; beta-glucocerebrosidase; Acid beta-glucocerebrosidase; glucosylceramidase; D-glucosyl-N-acylsphingosine glucohydrolase; gene activation; human

Summary:

      The purpose of this study is to evaluate the long-term safety of every other week dosing of
      Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in
      patients with type 1 Gaucher disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient has completed study TKT032 or TKT034, or study HGT-GCB-039.

          2. Female patients of child-bearing potential must agree to use a medically acceptable
             method of contraception at all times during the study and must have negative results
             to a pregnancy test performed at the time of enrollment and as required throughout
             their participation in the study.

          3. Male patients must agree to use a medically acceptable method of contraception at all
             times during the study and report a partner's pregnancy to the investigator.

          4. The patient, the patient's parent(s) or legal guardian(s) has provided written
             informed consent that has been approved by the Institutional Review Board/Independent
             Ethics Committee (IRB/IEC).

          5. The patient must be sufficiently cooperative to participate in this clinical study as
             judged by the Investigator

        Exclusion Criteria:

          1. The patient has received treatment with any non-Gaucher disease-related
             investigational drug or device within the 30 days prior to study entry; such use
             during the study is not permitted.

          2. The patient is pregnant or lactating.

          3. The patient, patient's parent(s), or patient's legal guardian(s) is/are unable to
             understand the nature, scope, and possible consequences of the study.

          4. The patient has a significant comorbidity(ies) that might affect study data or
             confound the study results (e.g., malignancies, primary biliary cirrhosis, autoimmune
             liver disease, etc.).

          5. The patient is unable to comply with the protocol, e.g., has a clinically relevant
             medical condition making implementation of the protocol difficult, has an
             uncooperative attitude, is unable to return for safety evaluations, or is otherwise
             unlikely to complete the study, as determined by the Investigator
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: TRI102; Placebo
Intervention description: formulation containing active moiety (amphetamine); formulation without active moiety
Intervention MeSH terms: Amphetamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether TRI102 is effective in the treatment of
      Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this
             condition

        Exclusion Criteria:

          -  Other serious illnesses or conditions that would put the patient at particular risk
             for safety events or would interfere with treatment/assessment of ADHD
A Study of Actonel for the Prevention of Bone Loss
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Intervention: Actonel (Risedronate); Calcium; Vitamin D
Intervention description: 35 mg (pill) by mouth weekly; 500 mg by mouth twice a day for a total of 24 months.; 400 IU by mouth twice a day for a total of 24 months.
Intervention MeSH terms: Vitamin D; Risedronic Acid; Etidronic Acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Lymphoma; Acute Lymphocytic Leukemia; Lymphoblastic Lymphoma; Actonel; Risedronate; Bone Loss; Osteoporosis

Summary:

      The goal of this clinical research study is to learn if Actonel (risedronate) can help to
      prevent the development of osteoporosis (brittle and weak bones) caused by the steroid
      medication used to treat leukemia. The safety of this treatment in patients with ALL or LL
      will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than or equal to 18 years

          2. Newly diagnosed ALL or LL receiving chemotherapy with augmented BFM, Hyper-CVAD or any
             variant of hyper-CVAD.

          3. Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for
             12 consecutive months), must be willing to use contraception.

          4. Negative pregnancy test in female patients.

          5. Patients must be enrolled within 6 weeks of starting induction chemotherapy.

        Exclusion Criteria:

          1. Hypocalcemia of less than 8.4 (corrected to account for the albumin level, [see
             Appendix E for formula])

          2. Hypersensitivity to risedronate or other bisphosphonates

          3. Inability to sit or stand upright for at least 30 minutes

          4. Bone density T-score of -2.5 S.D or less.

          5. Renal insufficiency (calculated creatinine clearance <30cc/min,[see Appendix F for
             formula])

          6. Patients with a 25-hydroxyvitamin D concentration of less than 20 ng/ml and evidence
             of osteomalacia (low ionized calcium and high intact PTH).

          7. Concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride.

          8. Corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e.
             hyperparathyroidism, multiple myeloma).
A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intervention description: Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of once-monthly
      administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the
      maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia.
      Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will
      receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on
      the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses
      will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per
      deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample
      size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic renal anemia;

          -  Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment
             during previous month;

          -  Regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months;

          -  Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;

          -  Active malignant disease (except non-melanoma skin cancer).
Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Condition: Melanoma
MeSH terms: Melanoma; Pigmentation Disorders
Intervention: MelaFind(R)
Intervention description: Biopsy ratio comparison
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1383.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pigmented Skin Lesions; Dermatology; Skin Cancer; Melanoma; MelaFind

Summary:

      The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that
      uses machine vision for non-invasive early detection of cutaneous pigmented malignant
      melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with
      illumination in different spectral bands, from visible to near infrared, and automatically
      analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will
      be evaluated. The reference standard will be final interpretation of lesions by central
      dermatohistopathology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The lesion is pigmented (i.e., melanin, keratin, blood)

          -  Clinical management of the lesion by the examining dermatologist is either biopsy of
             the lesion in toto, or 3-month follow-up of the lesion

          -  The diameter of the pigmented area is between 2 and 22 millimeters

          -  The lesion is accessible to the MelaFind hand-held imaging device

          -  The patient, or a legally authorized representative, has consented to participate in
             the study and has signed the Informed Consent Form

        Exclusion Criteria:

          -  The patient has a known allergy to isopropyl alcohol

          -  The lesion has been previously biopsied, excised, or traumatized

          -  The skin is not intact (e.g., open sores, ulcers, bleeding)

          -  The lesion is within 1 cm of the eye

          -  The lesion is on mucosal surfaces (e.g., lips, genitals)

          -  The lesion is on palmar hands

          -  The lesion is on plantar feet

          -  The lesion is on or under nails

          -  The lesion is located on or in an area of visible scarring

          -  The lesion contains foreign matter (e.g., tattoo, splinter, marker)
Expanded Access Study With Peginterferon Alfa-2a (Pegasys) in Participants With Chronic Myelogenous Leukemia (CML)
Condition: Myelogenous Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Peginterferon alfa-2a
Intervention description: Peginterferon alfa-2a in doses between 90 and 450 mcg will be administered subcutaneously once weekly until medically indicated as judged by the treating investigator.
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of long-term use of
      peginterferon alfa-2a in participants with CML who have previously participated in
      peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not
      available) or ML17228 (NCT number not available) and treating physician has decided to
      continue treatment with peginterferon alfa-2a within the frame of another clinical study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with CML

          -  Previous participation in studies: ML16544, NO16006 or ML17228; for which the treating
             physician recommends a continuation of the study drug according to defined minimal
             criteria

        Exclusion Criteria:

          -  Major protocol violator in the participated study prior to participation in this study
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Condition: Kidney Neoplasms
MeSH terms: Kidney Neoplasms
Intervention: Sunitinib malate; Placebo
Intervention description: sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.; Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent
Intervention MeSH terms: Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 674.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the disease free survival time and safety of sunitinib with placebo in adjuvant
      treatment patients at high risk of recurrent kidney cancer after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High risk renal cancer per modified UISS criteria

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

          -  predominant clear cell histology

          -  No prior anti-cancer treatment

          -  Kidney tumor has been removed

          -  No evidence of macroscopic disease following surgery

        Exclusion Criteria:

          -  Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
             sarcoma or subjects with metastatic renal sites.

          -  Diagnosis of any second malignancy within the last 5 years, except basal cell
             carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that
             has been adequately treated with no evidence of recurrent disease for 12 months

          -  known HIV or Hepatitis

          -  any severe acute or chronic medical or psychiatric condition or laboratory abnormality
             that may increase the risk associated with study participation or study drug
             administration
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Lixisenatide (AVE0010); Self-injector pen device (OptiClik®); Metformin
Intervention description: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous; To be kept at stable dose (≥1.5 g/day) throughout the study.
Intervention MeSH terms: Metformin; Lixisenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      - To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c)
      from baseline to endpoint (Week 24)

      Secondary Objective:

        -  To assess the effect of the 2 lixisenatide regimens on:

             -  The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at
                Week 24

             -  Fasting Plasma Glucose (FPG)

             -  7-point Self-Monitored Plasma Glucose (SMPG) profiles

             -  Body weight

        -  To assess the safety and tolerability of the 2 lixisenatide regimens
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before
             screening visit

          -  Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior
             to screening visit.

        Exclusion criteria:

          -  Screening HbA1c < 7.0% and > 10.0%

          -  Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)

          -  Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months
             prior to screening, previous use of insulin

          -  Participants who usually did not eat breakfast

          -  Type 1 diabetes mellitus

          -  Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2

          -  Pregnancy or lactation, women of childbearing potential with no effective
             contraceptive method

          -  Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN)
             at screening

          -  Alanine aminotransferase (ALT) > 3 ULN at screening

          -  Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening

          -  History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.

          -  Personal or immediate family history of medullary thyroid cancer (MTC) or genetic
             conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)

          -  Any contra-indication related to metformin

          -  Any previous treatment with lixisenatide

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.