bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Intervention: thyroid hormone and folinic acid
Intervention description: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
Intervention MeSH terms: Leucovorin; Folic Acid; Hormones; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Months
Healthy volunteers: No
Keywords: Down syndrome; Young children; Psychomotor development; Thyroid hormone; Folinic acid; Psychometric tests; GMDS; Griffiths; Genetic factors; Biochemical factors

Summary:

      Evaluation of the following in very young children with Down syndrome:

        -  the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically
           and by ultrasensitive thyreostimulating hormone (TSH) assay),

        -  the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,

        -  any interaction between these two treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation
             trisomy 21

          -  patient having undergone a cardiac ultrasound not demonstrating any severe heart
             disease

          -  patient aged 6 to 18 months at inclusion

        Exclusion Criteria:

          -  congenital hypothyroidism

          -  hypothyroidism demonstrated by laboratory tests (TSH > 7mUI/l)

          -  presenting or having presented hyperthyroidism

          -  presenting or having presented leukaemia

          -  presenting or having presented West syndrome or any other form of epilepsy or unstable
             neurological disease

          -  presenting or having presented signs of central nervous system distress: stroke,
             postoperative hypoxia, meningitis)

          -  presenting severe heart disease on cardiac ultrasound, with haemodynamic effects

          -  presenting non-controlled cardiac arrhythmia

          -  Apgar < 7 to 5 min at birth

          -  Gestational age < 231 days (33 gestation weeks)
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart; insulin detemir; insulin aspart; Faster-acting insulin aspart
Intervention description: Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.; Injected subcutaneously (s.c., under the skin), dose individually adjusted.; Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1290.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of the
      trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared
      to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes.
      This trial consists of two periods: a 26 week treatment period followed by a 26 week
      additional treatment period.
    

Eligibility criteria:

        Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the
        time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at
        least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin
        analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior
        to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by
        central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion
        Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior
        to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic
        event during the last 12 months) or hypoglycaemic unawareness as judged by the
        Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months
        prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to
        screening (Visit 1), defined as stroke, decompensated heart failure New York Heart
        Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris,
        coronary arterial bypass graft or angioplasty
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Dalcetrapib (RO4607381); Evidence-based medical care for Acute Coronary Syndrome; Placebo
Intervention description: 600mg po daily; As prescribed; po daily
Intervention MeSH terms: Dalcetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15871.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and
      mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS)
      and evaluate the long term safety profile of the drug. Eligible patients in stable condition
      will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a
      background of standard medication for ACS (including aspirin, antihypertensives and statins).
      The anticipated time on study treatment is 2+ years, and the target sample size is 15,600
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=45 years of age;

          -  recently hospitalized for ACS;

          -  clinically stable;

          -  receiving evidence-based medical and dietary management of dyslipidemia.

        Exclusion Criteria:

          -  uncontrolled diabetes;

          -  clinically unstable;

          -  severe anemia;

          -  uncontrolled hypertension;

          -  concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP-690,550; CP-690,550; Placebo/CP-690,550; Placebo/CP-690,550
Intervention description: 10 mg oral BID, Continuous treatment for 52 Weeks; 5 mg oral BID, Continuous treatment for 52 Weeks; 0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo); 0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 901.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Xeljanz; tofacitinib; chronic; Pruritus; Itch; DLQI; severe; moderate; treatment; safety; efficacy; CP-690,550; Plaque Psoriasis; Psoriasis Vulgaris; Jax-inhibitor; Oral Treatment

Summary:

      The main objective of this study is to compare the effects of CP-690,550 with the effects of
      placebo in patients being treated for moderate to severe chronic plaque psoriasis. This
      one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are 18 years or older with diagnosis for at least 12 months of moderate to severe
             plaque psoriasis covering as least 10%of body surface area

          -  a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be
             candidates for systemic or light therapy

          -  No evidence of active or latent tuberculosis

        Exclusion Criteria:

          -  Non-plaque or drug induced forms of psoriasis

          -  cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot
             discontinue phototherapy (PUVA or UVB)

          -  any uncontrolled significant medical condition
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; insulin detemir; metformin
Intervention description: Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.; Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm; Metformin tablets, at least 1500 mg/day
Intervention MeSH terms: Metformin; Liraglutide; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 987.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and North America. The aim of this clinical trial is to
      assess and compare the effect of insulin detemir in combination with liraglutide and
      metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will
      continue their own pre-trial metformin treatment during the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as
             monotherapy for at least 3 months prior to screening, at a stable dose of at least
             1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal
             to half of the maximum approved dose), both at a stable dose for at least 3 months
             prior to screening. Previous short-term insulin treatment in connection with
             intercurrent illness is allowed at the discretion of the Investigator

          -  HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy

          -  HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a
             sulphonylurea

        Exclusion Criteria:

          -  Previous treatment with insulin (except for short-term treatment in connection with
             intercurrent illness at the discretion of the Investigator)

          -  Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
             in a period of 3 months prior to screening

          -  Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the
             Investigator

          -  Impaired kidney function

          -  Impaired liver function

          -  Uncontrolled treated/untreated hypertension

          -  Cancer or any clinically significant disease or disorder as judged by the Investigator

          -  Previous participation in the run-in phase of this trial. Re-screening is allowed once

          -  History of chronic pancreatitis or idiopathic pancreatitis
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: DVS SR
Intervention description: Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

Summary:

      This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate
      sustained release (DVS SR) in the treatment of child and adolescent outpatients with major
      depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study B2061014 and who in the investigator's opinion would benefit from long
             term treatment with DVS SR

          -  Willingness and ability to comply with scheduled visits, treatment plan and procedures

        Exclusion Criteria:

          -  Subject requires precaution against suicide

          -  Subject not in a generally healthy condition
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
Condition: Choroidal Neovascularization (CNV)
MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab; Sham control
Intervention description: Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.; The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 183.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vision Impairment; Abnormal growth of blood vessels

Summary:

      This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult
      and adolescent patients with visual impairment due to choridal neovascularization (CNV).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting
             the fovea;

          -  BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;

          -  Visual loss in the study eye should mainly be due to the presence of any eligible
             types of CNV;

        Key Exclusion Criteria:

          -  Women of child-bearing potential;

          -  Active malignancies;

          -  History of stroke less than 6 months prior to screening;

          -  Uncontrolled systemic inflammation or infection;

          -  Active diabetic retinopathy, active ocular/periocular infectious disease or active
             severe intra-ocular inflammation;

          -  CNV- conditions with a high likelihood of spontaneous resolution;

          -  History of intravitreal treatment with steroids;

          -  History of laser photocoagulation;

          -  History of intraocular treatment with any anti-angiogenic drugs.
Tiotropium / Respimat One-Year Study
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium Inhalation Solution; Placebo
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 983.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the
      Respimat inhaler in patients with COPD.
    

Eligibility criteria:
An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
Condition: Pain
Intervention: Celecoxib
Intervention description: Day 1
The first dose: Celecoxib 400mg
The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed
Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8)
- Celecoxib 200mg twice daily
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: posttraumatic pain

Summary:

      To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic
      pain for the duration of 8 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with posttraumatic pain which is able to be controlled with an oral NSAID

          -  Patients with "pain" that meets both of the following criteria within 48 hours after
             injury:

        "Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS):
        45.0 mm or more

          -  Patients with "inflammation" that meets the following criteria within 48 hours after
             injury.

        "Inflammation" Categorical: "Mild", "Moderate" or "Severe"

        Exclusion Criteria:

          -  Patients who have received analgesics and anaesthetics for injury

          -  Patients with a history/complication of aspirin-induced asthma

          -  Patients taking excluded medications

          -  Patients with a history/complication of ischaemic heart disease, serious cardiac
             arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a
             history/plan of revascularization
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease
MeSH terms: Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases
Intervention: LY2127399; Placebo every 2 weeks; Placebo every 4 weeks
Intervention description: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug; Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.; Administered via subcutaneous injection for 52 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE; Systemic Lupus Erythematosis; Lupus; autoimmune disease; LY2127399; Immune System Disease

Summary:

      The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two
      different doses of LY2127399 administered in addition to standard of care therapy in
      participants with active SLE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR)
             criteria

          -  Have positive antinuclear antibodies (ANA)

          -  Agree not to become pregnant throughout the course of the trial

          -  Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting
             all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

        Exclusion Criteria:

          -  Have active severe Lupus kidney disease

          -  Have active Central Nervous System or peripheral neurologic disease

          -  Have received intravenous immunoglobulin (IVIg) within 180 days of randomization

          -  Have active or recent infection within 30 days of screening

          -  Have had a serious infection within 90 days of randomization

          -  Have evidence or test positive for Hepatitis B

          -  Have Hepatitis C

          -  Are human immunodeficiency virus (HIV) positive

          -  Have evidence of active or latent tuberculosis (TB)

          -  Presence of significant laboratory abnormalities at screening

          -  Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or
             basal cell or squamous epithelial skin cell that were completely resected with no
             reoccurrence in the 3 yrs prior to randomization

          -  Have received greater than 40 mgs of prednisone or equivalent in the past 30 days

          -  Have changed your dose of antimalarial drug in the past 30 days

          -  Have changed your dose of immunosuppressive drug in the past 90 days

          -  Have previously received rituximab
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis; Hepatitis, Chronic
Intervention: entecavir
Intervention description: Tablets, Oral, 1 mg, once daily, up to 72 weeks
Intervention MeSH terms: Entecavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis B Virus, Liver Transplant

Summary:

      The purpose of this clinical research study is to learn if the study drug entecavir will
      prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic
      liver transplant (OLT) due to HBV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease
             because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000
             copies/mL) prior to liver transplant

          -  Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least
             24 weeks prior to screening

        Exclusion Criteria:

          -  Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple
             tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and
             total tumor diameter is ≥ 8 cm

          -  Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV),
             Epstein-Barr virus (EBV) or hepatitis C virus (HCV)