bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY900014 in Participants With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug LY900014
      compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in
      adults with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T1D for at least 1 year prior to screening and continuously using insulin for at
             least 1 year.

          -  HbA1c of ≥7.0 and ≤9.5%.

          -  Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.

          -  Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn
             (NPH) insulin as basal insulin.

        Exclusion Criteria:

          -  Have used other antihyperglycemic medications or therapies (inhaled, oral or
             injectable) within 90-days of screening.

          -  Have had more than 1 severe hypoglycemic episode within 6 months of screening.

          -  Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis
             within 6 months of screening.

          -  Have clinically significant gastrointestinal disease.
17OHP-C Dosing Among Obese Pregnant Women
Condition: Premature Birth; Absorption; Chemicals
MeSH terms: Premature Birth
Intervention: 17-Hydroxyprogesterone Capronate
Intervention description: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is
      associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher
      doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to
      compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Pregnant women, with a singleton gestation

          -  Ages 18 - 55

          -  Able to read and write in English and / or Spanish

          -  History of spontaneous PTB

          -  Obesity (≥ 30 kg / m2 ) vs non-obese groups (18 - 29.9 kg / m2 ) defined by first
             documented body mass index at an office visit

          -  Gestational age between 12 weeks, 0 days and 24 weeks, 6 days of gestation

          -  An ultrasound before 24 + 6 weeks gestation to confirm dating and to rule out major
             fetal anomalies

          -  Willing to have weekly injections at the physician's office

          -  The newborn will be enrolled on the mothers consent for chart review only

        https://register.clinicaltrials.gov/prs/html/definitions.html?popup=true#Eligibility

        Exclusion Criteria:

          -  - Multifetal gestation

          -  Known fetal anomaly

          -  Current progesterone treatment

          -  Known or suspected breast cancer, other hormone-sensitive cancer, or history of these
             conditions

          -  Current or history of thrombosis or thromboembolic disorder

          -  Current anticoagulation

          -  Undiagnosed abnormal vaginal bleeding unrelated to pregnancy

          -  Cholestatic jaundice of pregnancy

          -  Liver tumors, benign or malignant, or active liver disease

          -  uncontrolled hypertension (controlled hypertension is eligible)

          -  A seizure disorder

          -  Current or planned cervical cerclage

          -  Plan to deliver elsewhere
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Belimumab 200 mg SC; Standard therapy
Intervention description: Placebo; Belimumab 200 mg SC; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 839.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subcutaneous; Lupus; Systemic Lupus Erythematosus; SLE; Belimumab; Autoimmune Disease; Antibodies

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab
      administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age.

          2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.

          3. Active SLE disease.

          4. Autoantibody-positive.

          5. On stable SLE treatment regimen which may include corticosteroids (for example,
             prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants
             (for example, azathioprine, methotrexate, mycophenolate, etc.)

        Exclusion Criteria:

          1. Pregnant or nursing.

          2. Have received treatment with any B cell targeted therapy (for example, rituximab or
             belimumab).

          3. Have received treatment an investigational biological agent in the past year.

          4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.

          5. Have severe active lupus kidney disease.

          6. Have severe active central nervous system (CNS) lupus.

          7. Have required management of acute or chronic infections within the past 60 days.

          8. Have current drug or alcohol abuse or dependence.

          9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis
             C.

         10. Have a history of hypersensitivity reactions to contrast agents or biological
             medicines.
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; TEZ/IVA; IVA; Placebo; Placebo
Intervention description: Participants received VX-659/TEZ/IVA orally once daily in the morning.; Participants received TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening.; Participants received placebo matched TEZ/IVA orally once daily in the morning.; Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the
      F508del mutation (F/F).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation (F/F)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon
Condition: Malaria
MeSH terms: Malaria
Intervention: 1. Artemether-Lumefantrine (AL); 2. Amodiaquine-Artesunate (AQ-AS)
Intervention description: Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).; Amodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Amodiaquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 816.0
Sex: All
Minimum age: 6 Months
Maximum age: 120 Months
Healthy volunteers: No
Keywords: Efficacy; Safety; Children; Cameroon

Summary:

      This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria
      combination drugs (ACTs) for the treatment of children aged 6-120 months in different
      locations in Cameroon. Randomized clinical trials will provide local data on the safety of
      the test drugs, and on putative marker mutations of the development of resistance to ACT. The
      study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral
      Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of
      Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be
      determined using a WHO standardized 28-day protocol. Safety will be monitored through
      clinical examination and biochemical and hematological indices. Molecular markers of
      artemisinin resistance will be investigated by molecular sequencing and comparison of
      parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections
      will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on
      generation of gametocytes will be determined from gametocyte carriage rates measured by
      microscopy.
    

Eligibility criteria:

        Inclusion criteria:

          -  children aged 6-120 months;

          -  axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;

          -  P. falciparum asexual parasitemia between 1000 and 100000/µl;

          -  ability to attend follow-up visits.

        Exclusion criteria:

          -  co-infections;

          -  underlying chronic disease;

          -  severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml),
             respiratory distress, inability to drink, persistent vomiting in past 24 hours;

          -  recent history of multiple convulsions;

          -  jaundice;

          -  the inability to stand or sit;

          -  history of allergy to study drugs.
An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol; Placebo
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/mL
Route of Administration: Subcutaneous use; Active Substance: Placebo
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 0.9 % saline
Route of Administration: Subcutaneous use
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia; Psoriasis

Summary:

      The purpose of this study is to investigate the efficacy and safety of two dose levels of
      certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when
      administered every 2 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided informed consent

          -  Adult men or women >= 18 years

          -  Chronic plaque psoriasis for at least 6 months

          -  Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and
             Physician's Global Assessments score >= 3

          -  Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Erythrodermic, guttate, generalized pustular form of psoriasis

          -  History of current, chronic, or recurrent infections of viral, bacterial, or fungal
             origin as described in the protocol

          -  Congestive heart failure

          -  History of a lymphoproliferative disorder including lymphoma or current signs and
             symptoms suggestive of lymphoproliferative disease

          -  Concurrent malignancy or a history of malignancy as described in the protocol

          -  History of, or suspected, demyelinating disease of the central nervous system (e.g.,
             multiple sclerosis or optic neuritis)

          -  Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
             study or within 5 months following last dose of study drug (in Czech Republic and
             Germany) and within 3 months for all other countries. Male subjects who are planning a
             partner pregnancy during the study or within 10 weeks following the last dose of study
             drug

          -  Any other condition which, in the Investigator's judgment, would make the subject
             unsuitable for participation in the study

          -  Other protocol-defined exclusion criteria may apply
Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
Condition: Urinary Retention Postoperative
MeSH terms: Urinary Retention; Prolapse
Intervention: Phenazopyridine
Intervention description: Phenazopyridine 200 mg on morning of postoperative day 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine if phenazopyridine reduces the rate of postoperative urinary retention after
      pelvic organ prolapse surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing overnight admission after prolapse surgery

        Exclusion Criteria:

          -  Unable to provide consent

          -  Under 18 years of age

          -  Pregnant women

          -  Prisoners

          -  Using intermittent self-catheterization preoperatively

          -  Neurological disease or spinal cord injury resulting in voiding dysfunction

          -  Undergoing spinal or epidural anesthesia for the procedure

          -  Allergy to phenazopyridine

          -  Renal insufficiency

          -  Liver disease

          -  Intra-operative bladder injury necessitating use of prolonged indwelling Foley
             catheter
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine; Aripiprazole; Placebo
Intervention description: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention MeSH terms: Aripiprazole; Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 617.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Aripiprazole; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents

Summary:

      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
             disorganized type, catatonic type or undifferentiated type), as confirmed by the
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (SCID)

          -  Patients with normal physical examination, laboratory, vital signs,and/ or
             electrocardiogram (ECG)

          -  Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1

          -  Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS)
             total score ≥ 80 and ≤ 120

          -  CGI-S score ≥ 4

        Exclusion Criteria:

          -  Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

          -  Bipolar I and II disorder

          -  Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and
             other cognitive disorders

          -  DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in
             this study

          -  Women who are pregnant or breast feeding
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 465.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared
      to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive
      disorder (MDD) who have a partial response to ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study

               5. Dissociative disorder

               6. Posttraumatic stess disorder

               7. MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: Evolocumab
Intervention description: Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; PCSK9 mutations; Severe Familial Hypercholesterolemia; evolocumab; Repatha; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia; Pediatric; Paediatric

Summary:

      The main purpose of this study is to describe the safety and tolerability of 80 weeks of
      subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age
      with familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

        Heterozygous Familial Hypercholesterolemia (HeFH):

        -Completed Study 20120123 (NCT02392559) while still on assigned investigational product and
        did not experience a treatment-related serious adverse event

        Homozygous Familial Hypercholesterolemia (HoFH):

          -  Male or female, ≥ 10 to ≤ 17 years of age at time of enrollment

          -  Diagnosis of HoFH

          -  On a low-fat diet and receiving background lipid-lowering therapy

          -  Lipid-lowering therapy unchanged for ≥ 4 weeks prior to LDL-C screening; fibrates must
             be stable for at least 6 weeks prior to screening.

          -  Fasting LDL-C at screening ≥ 130 mg/dL (3.4 mmol/L)

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

        -Currently receiving treatment in another investigational device or drug study, or less
        than 30 days since ending treatment on another investigational device or drug study(s);
        except Study 20120123

        HoFH:

          -  Moderate to severe renal dysfunction

          -  Active liver disease or hepatic dysfunction,

          -  Creatine kinase > 3 times the upper limit of normal (ULN) at screening