bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
Condition: Growth Disorders
MeSH terms: Growth Disorders; Failure to Thrive
Intervention: rh IGF-1 (mecasermin)
Intervention description: Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 µg/kg, escalated to a targeted maximum dose of 240 µg/kg.
Intervention MeSH terms: Mecasermin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 4 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Insulin-like Growth Factor Deficiency; IGF-1; Short Stature

Summary:

      This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect
      long term safety and efficacy data on the continued use of recombinant human insulin-like
      growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency
      (IGFD). The secondary objective is to use the data collected to learn more about the
      relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parents or legally authorized representatives must give signed informed consent before
             any trial related activities are conducted

          -  Where required, assent of the subject will be appropriately documented prior to any
             study related activities

          -  Completion of assessments at Visit 9 (Month 120 of Study MS301 [NCT00125164])

        Exclusion Criteria:

          -  Incomplete participation in MS301 (NCT00125164)

          -  Known or suspected allergy to the trial product (mecasermin, recombinant human IGF-1
             injection) or its formulation

          -  Development or presence of a chronic condition except as approved by the Medical
             Monitor

          -  Pregnancy

          -  Any social or medical condition that, in the opinion of the investigator, would be
             detrimental to either the subject or the study
Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
Condition: Atrial Fibrillation; Lung Cancer
MeSH terms: Atrial Fibrillation
Intervention: Amiodarone; Control arm, standard care
Intervention description: Perioperative orally administered; Control
Intervention MeSH terms: Amiodarone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; Lung cancer; Pulmonary resection; Post-operative complications

Summary:

      Atrial fibrillation is a very common complication of pulmonary resection. Patients who
      develop atrial fibrillation require additional treatment and are more likely to stay in the
      hospital for longer period of time increasing the costs associated with the operation. We
      propose a randomized controlled trial to see if oral amiodarone given for one week before
      surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the
      incidence of atrial fibrillation in patients who received preoperative amiodarone and compare
      them to the incidence of atrial fibrillation in patients who did not received preoperative
      amiodarone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Resectable lung nodule or mass

        Exclusion Criteria:

          -  Allergy to amiodarone

          -  Currently taking amiodarone

          -  Documented atrial fibrillation within past 12 months

          -  Known pulmonary fibrosis

          -  Known hepatic dysfunction

          -  Thyroid disease

          -  2nd or 3rd degree heart block

          -  Severe SA node disease

          -  Bradycardia-induced syncope

          -  Pregnancy
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Rucaparib; Abiraterone acetate or Enzalutamide or Docetaxel
Intervention description: Rucaparib will be administered daily.; Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Intervention MeSH terms: Docetaxel; Abiraterone Acetate; Rucaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CRPC; PARP inhibitor; PARPi; BRCA; ATM; HRD; TRITON; homologous recombination; DNA repair; DNA defect; DNA anomaly; germline; somatic; mCRPC

Summary:

      The purpose of this study is to determine how participants with metastatic
      castration-resistant prostate cancer, and evidence of a homologous recombination gene
      deficiency, respond to treatment with rucaparib versus treatment with physician's choice of
      abiraterone acetate, enzalutamide, or docetaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 years old at the time the informed consent is signed

          -  Have a histologically or cytologically confirmed adenocarcinoma or poorly
             differentiated carcinoma of the prostate that is metastatic

          -  Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL
             (1.73 nM)

          -  Be eligible for treatment with physician's choice of comparator treatment (abiraterone
             acetate, enzalutamide or docetaxel)

          -  Experienced disease progression after having received 1 prior next generation androgen
             receptor-targeted therapy

          -  Have a deleterious mutation in a BRCA1/2 or ATM gene

        Exclusion Criteria:

          -  Active second malignancy, with the exception of curatively treated non melanoma skin
             cancer, carcinoma in situ, or superficial bladder cancer

          -  Prior treatment with any PARP inhibitor

          -  Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer

          -  Symptomatic and/or untreated central nervous system metastases

          -  Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
             in the opinion of the investigator, interfere with absorption of study drug
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
Condition: Hepatitis C
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: SOF/VEL/VOX; Placebo
Intervention description: 400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food; Tablet administered orally once daily with food
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Infection

Summary:

      The primary objectives of this study are to evaluate the safety and efficacy of treatment
      with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
      virus (HCV) infection who have previously received treatment with direct-acting antiviral
      therapy.

      Participants randomized to placebo may be eligible for deferred treatment with active
      SOF/VEL/VOX.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  Treatment experienced with a direct acting antiviral medication for HCV

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
Condition: Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis
Intervention: cephalosporins; Fluoroquinolones; Clindamycin; Ampicillin/Gentamicin
Intervention description: Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed; If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance; If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.; 5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin
Intervention MeSH terms: Ciprofloxacin; Clindamycin; Gentamicins; Penicillins; Ampicillin; Cephalosporins; Fluoroquinolones; Lincosamides
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Percutaneous Nephrolithotomy; Kidney Stones; Antibiotics

Summary:

      The Investigators objective is to compare the clinical efficacy of a single-day protocol with
      a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly
      unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further
      propagation of resistant microbes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients >18 years old

          -  Negative urine culture within 1 month prior to procedure

          -  Renal Calculi which would optimally require PCNL for treatment.

        Exclusion Criteria:

          -  Patients <18 years old.

          -  Patients who are not able to give consent for study

          -  Patients currently on antibiotics immediately prior to the procedure

          -  Previous history of sepsis or SIRS from stone manipulations

          -  Foley catheter in place for greater than 1 week duration

          -  Patients under going planned, multi-staged procedures

          -  Immunosuppressed patients
A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablets for oral administration.; Tablets for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of elexacaftor
      (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or
      older.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed study drug treatment in parent study (VX19-445-117 [NCT04599465] or
             VX20-445-126 [NCT04969224]), or had study drug interruption(s) in parent study but
             completed study visits up to the last scheduled visit of the treatment period in the
             parent study

        Key Exclusion Criteria:

          -  History of drug intolerance in a parent study

        Other protocol defined Inclusion/Exclusion criteria may apply.
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
Condition: Epilepsy; Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Intervention: GWP42003-P; Placebo Control
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Cannabidiol; CBD; GWP42003-P; Epidiolex

Summary:

      To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children
      and young adults with Dravet syndrome.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant must have been male or female, aged between 2 and 18 years (inclusive).

          -  Participant must have had a documented history of Dravet syndrome that was not
             completely controlled by current antiepileptic drugs.

          -  Participant must have been taking 1 or more antiepileptic drugs at a dose that had
             been stable for at least 4 weeks.

          -  All medications or interventions for epilepsy (including ketogenic diet and vagus
             nerve stimulation) must have been stable for 4 weeks prior to screening and
             participant was willing to maintain a stable regimen throughout the study.

        Key Exclusion Criteria:

          -  Participant had clinically significant unstable medical conditions other than
             epilepsy.

          -  Participant had clinically relevant symptoms or a clinically significant illness in
             the 4 weeks prior to screening or randomization, other than epilepsy.

          -  Participant was currently using or had in the past used recreational cannabis,
             medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®)
             within the 3 months prior to study entry and was unwilling to abstain for the duration
             for the study.

          -  Participant had any known or suspected hypersensitivity to cannabinoids or any of the
             excipients of the investigational medicinal products.

          -  There were plans for the participant to travel outside their country of residence
             during the study.

          -  Any history of suicidal behavior or any suicidal ideation of type four or five on the
             Columbia-Suicide Severity Rating Scale (Children's) at screening.
KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children
Condition: Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: KPI-121 1%; Prednisolone acetate
Intervention description: eye drops; eye drops
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Maximum age: 3 Years
Healthy volunteers: No

Summary:

      This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing
      inflammation after cataract surgery in young children. Approximately half the participants
      will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a candidate for routine, uncomplicated cataract surgery

        Exclusion Criteria:

          -  Have a post-traumatic cataract.

          -  Have suspected permanent low vision or blindness in the fellow non-study eye.

          -  Have active uveitis in either eye.

          -  Have an ocular neoplasm in either eye.

          -  Have the presence of viral, bacterial, or fungal disease in either eye.

          -  Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or
             elevated IOP
Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab; Benralizumab Placebo; Seasonal influenza virus vaccine
Intervention description: Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).; Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).; Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Male and female adolescent patients; severe asthma

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      investigate the potential effect of a fixed dose of benralizumab administered subcutaneously
      (SC) on antibody responses following seasonal influenza virus vaccination
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1

          -  Weight of ≥40 kg

          -  Documented history of current treatment with Inhaled corticosteroids (ICS) and
             long-acting β2 agonists (LABA)

          -  Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50%
             predicted at Visit 1 or Visit 2.

          -  Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using
             the Maximum Post-bronchodilator Procedure OR

          -  Airway reversibility documented in the previous 12 months prior to Visit 1

          -  An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR

          -  Any condition assessed by patient recall over the previous 2-4 weeks

        Exclusion Criteria:

          -  Clinically important pulmonary disease other than asthma

          -  Known history of allergy or reaction to the Investigational Product formulation or
             influenza vaccine

          -  Receipt of an influenza vaccine within 90 days prior to randomization

          -  Poorly controlled asthma during the screening period that requires treatment with oral
             corticosteroids or a hospitalization/emergency room visit for the treatment of asthma

          -  Acute illness or evidence of significant active infection or known influenza infection
             during the current flu season
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: IDP-121 Lotion; IDP-121 Vehicle Lotion
Intervention description: IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.; IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 820.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the efficacy, safety, and tolerability of a once
      daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle
      Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an
      Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female at least 9 years of age and older.

          -  Written and verbal informed consent must be obtained. Participants less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if participant reaches age of consent during the study they
             should be re-consented at the next study visit).

          -  Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at
             the screening and baseline visit

        Key Exclusion Criteria:

          -  Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study.

          -  Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis.

          -  Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive.

          -  Participants with a facial beard or mustache that could interfere with the study
             assessments.