bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Condition: Encephalitis; Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Blood sample; JE-CV administered in Study JEC02
Intervention description: Blood sample for immunogenicity assessment; Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 596.0
Sex: All
Minimum age: 2 Years
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Encephalitis; Japanese Encephalitis; Japanese Encephalitis Chimeric Virus Vaccine; Toddlers

Summary:

      This is a long-term follow-up of the persistence of immune response in participants who
      previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02
      (NCT00735644) . No vaccination was administered during the present long-term follow-up study.

      Primary Objective:

        -  To describe the yearly persistence of humoral immune response to Japanese encephalitis
           after a single dose of JE-CV
    

Eligibility criteria:

        Inclusion Criteria :

          -  Provision of Informed Consent Form signed by at least one parent or other legally
             acceptable representative, and by at least one independent witness if required by
             local regulations.

          -  Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination
             blood sample at baseline in JEC02 trial.

          -  Participant and parent/legally acceptable representative able to attend all scheduled
             visits and comply with all trial procedures.

        Exclusion Criteria :

          -  Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up
             to inclusion in JEC05 trial.

          -  Planned participation in another clinical trial up to the first year of the follow-up
             in the present trial.
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Condition: Cataract Extraction; Pain; Inflammation
MeSH terms: Cataract; Inflammation
Intervention: ketorolac
Intervention description: Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.
Placebo
Intervention MeSH terms: Ketorolac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 248.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the
      treatment of inflammation and pain associated with cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing cataract surgery

        Exclusion Criteria:

          -  Uncontrolled ocular disease in cataract surgery eye
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Intervention: Placebo; Relamorelin
Intervention description: Placebo injected subcutaneously twice daily.; Relamorelin 10 μg injected twice daily for 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
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
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
Condition: Genetic Disorder; Noonan Syndrome
MeSH terms: Dwarfism; Noonan Syndrome; Genetic Diseases, Inborn; Syndrome
Intervention: somatropin
Intervention description: Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 3 Years
Maximum age: 10 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to investigate the long-term
      efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese children with Noonan syndrome clinically diagnosed in one of the following
             ways: 1. Clinically diagnosed by at least two medical experts using van der Burgt
             score list, 2. Clinically diagnosed by one medical expert using van der Burgt score
             list and diagnosed by result of genetic testing for Noonan syndrome, 3. Clinically
             diagnosed by one medical expert using van der Burgt score list and diagnosed by the
             same medical expert based on the results of centralised evaluation of facial change
             using van der Burgt score list

          -  Height SDS (standard deviation score): -2 SDS or below (according to the Japanese
             reference data)

          -  Age: boys 3 to below 11 years, girls 3 to below 10 years

          -  Height records must be available within the period between 40 and 64 weeks prior to
             Visit 1 (screening)

          -  Prepubertal children (definition for girls breast and pubes of Tanner stage is I, and
             none of menses, and for boys testicular volume below 4 mL, and pubes and penis of
             Tanner stage is I)

        Exclusion Criteria:

          -  Children with known or suspected hypersensitivity against human growth hormone (hGH)
             or related products (including any components of the trial products)

          -  Children with diabetic type diagnosed with the Japanese Diabetes Society
             Classification

          -  Children with history or presence of active malignancy

          -  Children who have received GH (growth hormone) treatment

          -  Children who have received systemic administration of the following medications within
             two years prior to Visit 1 (screening): Thyroid hormone (except replacement therapy),
             antithyroid hormone, androgen, oestrogen, progesterone, anabolic steroid,
             adrenocortical steroid treatment period for at least 13 weeks), derivative of
             gonadotropin releasing hormone and somatomedin C (IGF-I)
Exacerbation Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 µg; Tiotropium
Intervention description: Indacaterol 150 µg o.d. delivered via SDDPI; Tiotropium 18 µg o.d. delivered via handihaler®
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3439.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Indacaterol; Tiotropium; COPD

Summary:

      This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults aged ≥40 years, who have signed an Informed Consent form prior
             to initiation of any study-related procedure

          -  Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe
             COPD and including:

               1. Smoking history of at least 10 pack years, both current and ex-smokers are
                  eligible

               2. A documented history of at least 1 moderate or severe exacerbation in the
                  previous 12 months

        Exclusion Criteria:

          -  Patients who have received systemic corticosteroids and/or antibiotics for a COPD
             exacerbation in the 6 weeks prior to screening or during the run-in period

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular comorbid conditions

        Other protocol-defined inclusion/exclusion criteria may apply
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Uncontrolled Asthma
MeSH terms: Asthma
Intervention: Tralokinumab; Placebo
Intervention description: Subcutaneous injection; Subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1207.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Reactive Airways; Respiratory Tract Disease; Obstructive Lung Disease; Lung Diseases

Summary:

      A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12 -75

          2. Documented physician-diagnosed asthma.

          3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg
             fluticasone propionate dry powder formulation equivalents) and a LABA

          4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of
             age) of their PNV.

          5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1

          6. ACQ-6 score ≥1.5

        Exclusion Criteria:

          1. Pulmonary disease other than asthma

          2. History of anaphylaxis following any biologic therapy

          3. Hepatitis B, C or HIV

          4. Pregnant or breastfeeding

          5. History of cancer

          6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years

          7. Previous receipt of tralokinumab
Comparison of Two Treatments for Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Sertraline; Cognitive behavioral therapy (CBT)
Intervention description: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.; CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Antidepressants; Cognitive behavior therapy

Summary:

      This study will compare the short- and long-term effectiveness of two different treatments
      for people with post-traumatic stress disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of PTSD

          -  Experienced traumatic event at least 12 weeks prior to study entry

          -  Willingness to discontinue current CBT or antidepressant treatment

        Exclusion Criteria:

          -  Current diagnosis of schizophrenia or delusional disorder

          -  Medically unstable bipolar disorder, depression with psychotic features, or depression
             requiring psychiatric treatment

          -  Current diagnosis of alcohol or substance dependence within 3 months prior to study
             entry

          -  Ongoing intimate relationship with the perpetrator of the traumatic event

          -  History of nonresponse to either CBT or sertraline

          -  Medical contraindication for sertraline
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
Condition: Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Warfarin; Dabigatran etexilate
Intervention description: PRN (to maintain a target INR of 2.0-3.0); 150mg bid
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 2589.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The general aim of this study is to determine the comparative safety and efficacy of
      dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN)
      to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute
      symptomatic VTE.

      The primary objective is to investigate the efficacy of dabigatran compared to warfarin
      during the 6 month treatment period. The investigation of other selected efficacy aspects and
      safety are regarded as secondary objective of this trial.
    

Eligibility criteria:

        Inclusion criteria:

          -  Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving
             proximal veins, and/or Pulmonary Embolism (PE)

          -  Male or female, being 18 years of age or older

          -  Written informed consent for study participation

        Exclusion criteria:

          -  Persistent symptoms of VTE

          -  PE requiring urgent intervention

          -  Use of vena cava filter

          -  Contraindications to anticoagulant therapy

          -  Allergy to study medications

          -  Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper
             Limit of Normal (ULN) or known liver disease expected to have an impact on survival

          -  Severe renal impairment

          -  Patients considered unsuitable for inclusion
Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients
Condition: Arrhythmia
MeSH terms: Atrial Fibrillation
Intervention: Colchicine
Intervention description: colchicine given as per trial protocol
Intervention MeSH terms: Colchicine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 360.0
Sex: All
Healthy volunteers: No
Keywords: Atrial fibrillation; Colchicine; Cardiac surgery

Summary:

      This study evaluates the role of colchicine in the prevention of atrial fibrillation in
      patients undergoing open heart surgery. Half of participants will receive colchicine and the
      other half will not
    

Eligibility criteria:

        Inclusion Criteria:

          -  All consecutive adult patients undergoing elective cardiac surgery

        Exclusion Criteria:

          -  Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on
             hospital admission

          -  Known severe liver disease or current transaminases >1.5 times the upper normal limit

          -  Current serum creatinine >2.5 mg/dl

          -  Known myopathy or elevated baseline preoperative creatine kinase

          -  Known blood dyscrasias

          -  Significant gastrointestinal disease

          -  Pregnant and lactating women

          -  Known hypersensitivity to colchicine

          -  Current treatment with colchicine for any indications

          -  Emergency surgery
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Cisplatin; Vinorelbine; Gemcitabine; Docetaxel; Pemetrexed; Carboplatin; Paclitaxel; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; This arm is closed and no longer enrolling patients.
Intervention MeSH terms: Paclitaxel; Vinorelbine; Docetaxel; Carboplatin; Gemcitabine; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 505.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and
      chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus
      ipilimumab's safety and effectiveness in treating resectable NSCLC.

      This study has multiple primary endpoints.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue

          -  Lung function capacity capable of tolerating the proposed lung surgery

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

          -  Available tissue of primary lung tumor

        Exclusion Criteria:

          -  Presence of locally advanced, inoperable or metastatic disease

          -  Participants with active, known or suspected autoimmune disease

          -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as
             checkpoint inhibitors)

        Other protocol defined inclusion/exclusion criteria apply
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Condition: Hydrocephalus; Normal Pressure Hydrocephalus
MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure
Intervention: Codman VPV System
Intervention description: Valve Positioning Verification (VPV) System
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Healthy volunteers: No
Keywords: Hydrocephalus; Codman Hakim Programmable Valve; Programmable Valve; Shunt System

Summary:

      The purpose of this study is to determine the agreement rate between the CODMAN Valve
      Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in
      order to support an alternative to X-ray confirmation with respect to the valve adjustment
      process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A CODMAN Hakim Programmable Valve (CHPV) has been implanted for the management of the
             Subject's Hydrocephalus.

          -  The Subject has given written informed consent prior to enrolling in the study.

          -  The Subject requires adjustment of the CODMAN Hakim Programmable Valve (CHPV) for the
             management of Hydrocephalus·

          -  The Subject's implanted CHPV will be adjusted using the Implanted Valve Mode.

        Exclusion Criteria:

          -  The Subject's valve is located in the deep lumbar position.

          -  The Subject has an open and/or recent wound site in the region of the implanted valve.

          -  The Subject has a history of Ultrasound gel allergies.

          -  The Subject is a prisoner.

          -  The subject has been previously enrolled in this protocol.
Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intervention description: Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of subcutaneous
      methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in
      pre-dialysis participants with chronic renal anemia. Participants currently receiving
      maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous
      injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived
      from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic renal anemia

          -  Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL

          -  Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and
             Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)

          -  Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval
             during previous 2 months

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months

          -  Poorly controlled hypertension requiring hospitalization or interruption of
             darbepoetin alfa treatment in previous 6 months

          -  Acute or chronic bleeding

          -  Active malignant disease (except non-melanoma skin cancer)