bioihbjkbjnl/mcl2 huggingface dataset:
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
Condition: Cerebral Palsy; Muscle Spasticity; Children
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: Botulinum toxin type A
Intervention description: Intramuscular (IM) injection on day 1 of each treatment cycle.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this research study was to determine the long term safety and efficacy of
      repeated treatments with Dysport® used in the treatment of lower limb spasticity in children
      with dynamic equinus foot deformity due to cerebral palsy.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects were eligible for participation in the study if they met the following criteria:

          1. Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22
             or Week 28 follow up visit.

          2. Without any major protocol deviations and/or any ongoing adverse events (AEs), either
             of which, in the opinion of the Investigator would pose an unacceptable risk to the
             subject were he/she to continue receiving treatment in this open label extension
             study.

          3. Written informed consent obtained from the child's parent(s)/guardian(s) for this
             study, and assent from the child when and where applicable.

        Exclusion Criteria:

        Subjects were excluded from entering the study for the following reasons:

          1. Major limitation in the passive range of motion at the ankle, as defined by maximum
             ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed <80° (TS angle)
             in the most affected leg to be injected.

          2. Unwillingness or inability to comply with the protocol.

          3. Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC)
             and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.

          4. Treatment with any drug that interferes either directly or indirectly with
             neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used
             during surgery (e.g. curare) within the last 30 days prior to study medication or a
             planned treatment with such drugs.

          5. Be pregnant and/or lactating.

          6. Female subjects, not willing to use contraceptive measures throughout the course of
             the study if post pubertal and sexually active.

          7. An infection at the injection site(s).

          8. Planned treatment with any new investigational drug or device during the study period.
Arimoclomol in Amyotropic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Arimoclomol; Placebo
Intervention description: 2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily; 2 matched placebo capsules taken 3 times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arimoclomol; ALS

Summary:

      A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate
      the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets revised El Escorial criteria for clinically possible, clinically
             probable / clinically probable ALS laboratory-supported, clinically definite ALS or
             clinically definite familial ALS laboratory-supported

          -  18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria,
             dysphagia, shortness of breath)

          -  ALS Functional Rating Scale-Revised (ALSFRS-R) equal to or above 35 and erect (seated)
             Slow Vital Capacity (SVC) % predicted equal to or above 70% at Screening

        Exclusion Criteria:

          -  Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking
             hours at the time of Screening and Baseline

          -  Pregnant or breast-feeding

          -  Current or anticipated use of diaphragmatic pacing

          -  Any other relevant medically significant condition which could present risk to the
             subject or interfere with the assessment of safety or has an increased risk of causing
             death during the trial
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Condition: Secondary Hyperparathyroidism; Chronic Kidney Disease
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide; Cinacalcet; Oral Placebo; Intravenous Placebo
Intervention description: Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.; Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.; Administered orally once a day.; Administered intravenously (IV) three times per week.
Intervention MeSH terms: Cinacalcet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 683.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT

Summary:

      The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is
      not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels
      by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary
      hyperparathyroidism (SHPT) who require management with hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis
             with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to
             screening laboratory assessments

          -  Subjects must have SHPT as defined by one central laboratory screening predialysis
             serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to
             randomization

          -  Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2
             weeks of the date of randomization

          -  Subjects receiving calcium supplements must have no more than a maximum dose change of
             50% within 2 weeks before screening laboratory assessments are obtained, and the dose
             must remain unchanged through randomization

        Exclusion Criteria:

          -  Eligible subjects cannot have received cinacalcet during the 3 months preceding the
             first screening laboratory assessment

          -  Other criteria may apply
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: (vic-)trastuzumab duocarmazine; Physician's choice
Intervention description: Intravenous SYD985, Q3W; See drug label
Intervention MeSH terms: Capecitabine; Trastuzumab; Vinorelbine; Lapatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 437.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is
      superior to physician's choice in prolonging progression free survival.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Female patients with histologically-confirmed, unresectable locally advanced or
             metastatic breast cancer;

          -  Patients should have had either progression during or after at least two
             HER2-targeting treatment regimens for locally advanced or metastatic disease or
             progression during or after (ado-)trastuzumab emtansine treatment for locally advanced
             or metastatic disease;

          -  HER2-positive tumor status;

          -  Patients must have measurable or non-measurable disease that is evaluable per RECIST
             1.1;

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

          -  Estimated life expectancy > 12 weeks at randomization;

          -  Adequate organ function and blood cell counts.

        Main Exclusion Criteria:

          -  Current or previous use of a prohibited medication as listed in the protocol;

          -  History of infusion-related reactions and/or hypersensitivity to trastuzumab,
             (ado-)trastuzumab emtansine;

          -  History of keratitis;

          -  Severe, uncontrolled systemic disease at screening;

          -  Left Ventricular Ejection Fraction (LVEF) < 50%, or a history of clinically
             significant decrease in LVEF during previous treatment with trastuzumab or
             (ado-)trastuzumab emtansine;

          -  Cardiac troponin value above the Upper Limit of Normal (ULN);

          -  History of clinically significant cardiovascular disease;

          -  Untreated brain metastases, symptomatic brain metastases, brain metastases requiring
             steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to
             randomization;

          -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
             obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
             active pneumonitis on screening chest CT scan.
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1997.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series
      in Healthy Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants born at >36 weeks of gestation and 2 months of age at the time
             of consent.

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Major known congenital malformation or serious chronic disorder

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results

          -  Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B
             vaccine dose administered at >30 days old, or previous receipt of any licensed or
             investigational pneumococcal vaccine, or planned receipt through study participation
Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: ER niacin/laropiprant; Comparator : placebo (unspecified)
Intervention description: One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.; ER niacin/laropiprant Placebo
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 796.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant
      versus placebo in Type 2 Diabetes Mellitus patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable
             dose of antidiabetic medication for at least 3 months

        Exclusion Criteria:

          -  Patients taking Cholestin, niacin (>50 mg/day), fibrate therapy, hormonal
             contraceptives, intermittent Hormone Replacement Therapy, or certain corticosteroids

          -  Patients with any of the following conditions: active liver disease or kidney disease,
             poorly controlled high blood pressure, active peptic ulcer, or other heart or blood
             diseases

          -  Patients with abnormal laboratory results from a blood test that will be given before
             starting the study
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Intervention: Placebo; Relamorelin
Intervention description: Placebo injected subcutaneously twice daily.; Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of relamorelin compared to placebo in
      participants with diabetic gastroparesis. Participants will report daily severity scores of
      their diabetic gastroparesis symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 or Type 2 diabetes mellitus

          -  Meet the per protocol criteria of diabetic gastroparesis

          -  Compliance with diary

          -  Compliance with the per protocol study treatment dosing instructions

        Exclusion Criteria:

          -  Currently receiving nutrition intravenously, by nasogastric tube, or other feeding
             tube

          -  Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating
             disorder at the time of Screening (Visit 1)

          -  Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

          -  History of gastrointestinal disorders that may be similar to gastroparesis

          -  Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
Condition: Cystic Fibrosis; Advanced Lung Disease
MeSH terms: Cystic Fibrosis; Lung Diseases; Fibrosis
Intervention: Lumacaftor; Ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination
      therapy in subjects 12 years and older with CF and advanced lung disease and who are
      homozygous for the F508del CFTR mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del-CFTR mutation; historical genotype must be documented in
             the participant's source documents.

          -  Percent predicted FEV1 <40 of adjusted for age, sex, and height at Screening

        Exclusion Criteria:

          -  Participant currently receiving invasive mechanical ventilation.

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant

          -  Any clinically significant laboratory abnormalities at screening that would interfere
             with the study assessments or pose an undue risk for the subject

          -  A 12-lead electrocardiograms (ECG) demonstrating QTcF >450 msec at Screening

          -  History of solid organ or hematological transplantation

          -  History of alcohol or drug abuse in the past year

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating lumacaftor and/or ivacaftor) within 30 days of screening.

          -  Use of strong inhibitors, moderate inducers, or strong inducers of CYP3A

          -  Pregnant and nursing females: Females of childbearing potential must have a negative
             pregnancy test at Screening and Day 1.

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements

          -  Use of beta blockers or the equivalent at Screening.
Azithromycin for COVID-19 Treatment in Outpatients Nationwide
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: Azithromycin; Placebos
Intervention description: Participants will be shipped a single 1.2 g dose of oral azithromycin; Participants will be shipped a dose of matching placebo
Intervention MeSH terms: Azithromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This individually randomized telemedicine-based trial aims to evaluate the efficacy of a
      single dose of azithromycin for prevention of progression of COVID-19 in patients with a
      recent positive SARS-CoV-2 test who are not currently hospitalized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a positive SARS-CoV-2 test and test results received within the previous
             seven days

          -  Not currently hospitalized

          -  Willing and able to receive study drug by mail

          -  Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via
             email or over the phone

          -  No known allergy or other contraindication to macrolides

          -  Age 18 years or older at the time of enrollment

          -  No known history of prolongation of the QT interval (eg. History of torsades de
             pointes, congenital long QT syndrome, bradyarrhthmia)

          -  No recent use of hydroxychloroquine within the past 7 days for participants >55 years
             of age

          -  Not currently taking nelfinavir or warfarin (Coumadin)

          -  Provision of informed consent

          -  Not currently pregnant
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab
Intervention description: -Specified dose on specified days; -Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of different administration regimens of nivolumab plus
      Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females, ages 15 years ≥ of age (Except where local regulations and/or
             institutional policies do not allow for subjects < 18 years of age to participate)

          -  Subjects must have been diagnosed with stage III or/and stage IV histologically
             confirmed melanoma that is unresectable or metastatic

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Subjects have not been treated by systemic anticancer therapy for unresectable or
             metastatic melanoma

        Exclusion Criteria:

          -  Subjects with active brain metastases or leptomeningeal metastases

          -  Subjects with ocular melanoma

          -  Subjects with active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply