bioihbjkbjnl/mcl2 huggingface dataset:
A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo; Pioglitazone; MSDC-0160 90 mg; MSDC-0160 220 mg
Intervention description: Once daily, oral; Once daily, oral; Once daily, oral; Once daily, oral
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type
      2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 2 Diabetes naive or on metformin

          -  Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.

        Exclusion Criteria:

          -  Use of diabetes medications other than metformin.

          -  History of heart failure or previous myocardial infarction.

          -  Blood pressure great than 160/100 mmHg.
Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa
Condition: Eating Disorders
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Intervention: Olanzapine; Placebo
Intervention description: Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.; Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Anorexia Nervosa

Summary:

      This study will evaluate the effectiveness of the antipsychotic medication olanzapine in
      treating outpatients with anorexia nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria (not including amenorrhea) for AN

          -  Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2

          -  Patient (or family if the patient is a minor) refuses hospitalization

          -  Free of psychotropic medication (4 weeks medication free for fluoxetine and
             antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose
             of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry

          -  Prior treatment of AN

        Exclusion Criteria:

          -  Any medical or psychiatric problem requiring urgent attention and/or any significant
             comorbid illness not likely to benefit from proposed treatments

          -  Allergy to olanzapine

          -  Significant orthostatic high blood pressure

          -  Recent commencement of psychotherapy in the community

          -  Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting
             serum glucose greater than 140 mg/dL

          -  Known history of current or past jaundice

          -  Known history of narrow angle glaucoma

          -  Active substance abuse or dependence

          -  Schizophrenia, schizophreniform disorder, or bipolar illness

          -  Movement disorder or presence of tics

          -  History of tardive dyskinesia

          -  History of seizures

          -  Pregnant
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MP-513 Lowest Dose and Metformin; MP-513 Low Dose and Metformin; MP-513 Medium Dose and Metformin; MP-513 High Dose and Metformin; Placebo and Metformin
Intervention description: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.; MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.; MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.; MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.; Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 448.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin resistance

Summary:

      The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination
      with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate
      the safety and efficacy of MP-513 in combination with Metformin with an extension treatment
      for up to 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are aged ≧ 18 years old.

          -  Patients whose HbA1c is ≧ 7.0 % and < 10.0%.

          -  Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.

          -  Patients who took metformin monotherapy for at least 56 consecutive days at the
             screening visit.

        Exclusion Criteria:

          -  Patients with type 1 diabetes or secondary form of diabetes.

          -  Patients with heart failure symptoms.

          -  Patients with serious diabetic complications.

          -  Patients with severe hepatic disorder or severe renal disorder.

          -  Patients who are the excessive alcohol addicts.

          -  Patients who are pregnant, lactating and probably pregnant patients and patients who
             can not agree to contraception.
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Condition: Symptomatic Focal Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: 2.0mg of ALG-1001; Balanced Salt Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human
      subjects with symptomatic focal vitreomacular adhesion
    

Eligibility criteria:

        Inclusion Criteria:

          1. Symptomatic focal vitreomacular adhesion

          2. Vitreomacular traction syndrome

          3. Stage 1 and 2 macular holes, ≤ 350 µm

          4. BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study
             eye

          5. BCVA of 20/800 ETDRS or better in the fellow eye

          6. Male or female subjects, 18 years of age or older

          7. Signed Informed Consent

        Exclusion Criteria:

          1. High myopes > -8.0 D spherical equivalent

          2. History of prior vitrectomy in the study eye

          3. History of photocoagulation to the retina in the study eye

          4. Macular hole in the study eye > 350 µm

          5. Subjects with epiretinal membranes in the study eye

          6. Subjects with broad VMA, defined as VMA of >1500 µm

          7. Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular
             Degeneration (AMD), or retinal vascular occlusion in the study eye

          8. Subjects with aphakia in the study eye

          9. Subjects with uncontrolled glaucoma

         10. Subjects with lenticular or zonular instability

         11. Subjects with prior ocular surgery or intravitreal injection in the study eye within
             90 days of study enrollment

         12. Pregnant or nursing women
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Placebo; Brivaracetam
Intervention description: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Intervention MeSH terms: Brivaracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy: partial onset seizures; brivaracetam

Summary:

      This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50
      mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female from 16 to 65 years

          -  Well-characterized focal epilepsy or epileptic syndrome according to the International
             League Against Epilepsy (ILAE) classification

          -  History of partial onset seizures

          -  Subjects having at least 4 partial onset seizures during the 4-week Baseline Period
             and at least 2 partial onset seizures during the 3 months prior to Visit 1

          -  Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a
             stable dose.

        Exclusion Criteria:

          -  Seizure type IA non-motor as only seizure type

          -  Seizures occurring only in clusters

          -  Status epilepticus during the last 2 years before Visit 1

          -  History of cerebrovascular accident (CVA)

          -  Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Condition: Hypercholesterolemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: MK-0616; Placebo
Intervention description: MK-0616 administered orally; Placebo matching MK-0616 administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of MK-0616, an oral PCSK9
      inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with
      hypercholesterolemia. The primary hypothesis is that at least one of the four doses of
      MK-0616 tested in this study is superior to placebo on percent change from baseline in LDL-C
      at Week 8.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD
             risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a
             corresponding LDL-C that falls within the protocol-specified range at screening.

          -  Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days
             before screening, or has not received treatment with any lipid-lowering therapy for
             ≥30 days before screening.

          -  A female participant is not pregnant or breastfeeding, not a woman of child-bearing
             potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the
             intervention period and for at least 8 weeks after the last dose of study
             intervention.

        Exclusion Criteria:

          -  History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical
             criteria.

          -  History of nephrotic syndrome.

          -  History of unstable angina, a myocardial infarction, percutaneous transluminal
             coronary angioplasty, transient ischemic attack, or stroke within 3 months before
             Screening.

          -  Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at
             Screening.

          -  History of malignancy ≤3 years before screening, except for adequately treated basal
             cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe
             limitations relative to screening.

          -  Currently participating in or has previously participated in an interventional
             clinical study within 3 months before Screening.

          -  Has moderate or greater renal insufficiency.
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: CX516; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 175.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment; Memory Loss; Alzheimer's Disease; Brain Aging; Ampalex®; CX516

Summary:

      Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild
      cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is
      evidence CX516 enhances brain activity by specifically targeting remaining glutamate
      receptors in the affected portions of the brain. This study will test the safety and efficacy
      of CX516 in the symptomatic treatment of participants with mild cognitive impairment.
    

Eligibility criteria:

        Inclusion criteria

          -  Clinical diagnosis of mild cognitive impairment

          -  Good general health with no additional diseases that would interfere with the study.

        Exclusion criteria

          -  Any significant neurologic disease (other than suspected incipient Alzheimer's
             disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia,
             Huntington's disease, head trauma, chronic CNS infection.

          -  History of major depression or another major psychiatric disorder within the past 6
             months.

          -  History of schizophrenia, mania or recurrent psychotic episodes.

          -  History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within
             the past year.

          -  History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the
             Investigator and considering the age of the participant.

          -  Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal
             or hematological illness or unstable medical condition which could interfere with drug
             safety, or absorption, distribution, metabolism and excretion, or lead to difficulty
             complying with the protocol.
A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
Condition: Diabetic Retinopathy; Posterior Vitreous Detachment; Disease Progression
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Vitreous Detachment; Disease Progression
Intervention: ocriplasmin 0.0625mg; ocriplasmin 0.125mg; Sham injection
Intervention description: Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart; Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart; 3 sham injections approximately 1 month apart. No actual injections. No medication is used.
Intervention MeSH terms: Fibrinolysin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal
      injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe
      non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment
      (PVD) in order to reduce the risk of disease progression to proliferative diabetic
      retinopathy (PDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 years or older

          -  Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent
             of 20/50 or better) in the study eye

          -  HbA1c ≤ 12%, as assessed by the central laboratory

          -  Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field
             stereo colour fundus photograph

          -  Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on
             non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic
             macular oedema

          -  No evidence of total PVD in the study eye

          -  Written informed consent obtained from the subject prior to screening procedures

        Exclusion Criteria:

          -  History of or current ocular condition in the study eye that may interfere with the
             assessment of the progression to PDR

          -  Presence of epiretinal membrane in the study eye

          -  Presence of foveal ischemia in the study eye

          -  Presence of pre-retinal or vitreous haemorrhage in the study eye

          -  Presence of iris or angle neovascularisation in the study eye

          -  Any active ocular / intraocular infection or inflammation in either eye

          -  Aphakic study eye

          -  Uncontrolled hypertension in the opinion of the Investigator

          -  Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the
             Investigator's opinion suggesting lens / zonular instability
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Placebo; Vismodegib
Intervention description: Participants will receive matching placebo to vismodegib for 12 weeks.; Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, placebo-controlled study will assess the efficacy and safety
      of vismodegib with surgery in participants with basal cell carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma

          -  Free of any significant physical abnormalities (e.g., tattoos) at the target basal
             cell carcinoma site

          -  Willing and able to participate in the study as an outpatient and agreement to make
             frequent visits to the clinic during the treatment and follow-up periods and to comply
             with study requirements

        Exclusion Criteria:

          -  Prior treatment with vismodegib

          -  Known hypersensitivity to any of the study drug excipients

          -  Any metastatic basal cell carcinoma

          -  Any locally advanced basal cell carcinoma considered to be inoperable or to have a
             medical contraindication to surgery

          -  Evidence of clinically significant and unstable diseases or conditions (e.g.,
             cardiovascular, immunosuppressive, hematologic)

          -  Any dermatological disease at the target basal cell carcinoma site that may cause
             difficulty with examination

          -  Recent, current, or planned participation in another experimental drug study
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
Condition: Colic
MeSH terms: Colic
Intervention: Nepadutant
Intervention description: Nepadutant oral solution
Intervention MeSH terms: MEN 11420
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No
Keywords: Feeding intolerance; Infant; tachykinin antagonist; Infant colic; Nepadutant

Summary:

      The present pilot study is aimed to obtain preliminary data on the effect of three ascending
      oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.
      In addition, the assessment of drug exposure (PK assessment) will provide additional
      information on the dose-effect relationship, thus supporting the dose selection and dosing
      schedule in the future studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants with a clinical diagnosis of feeding intolerance.

          -  Age ≤ 6 months at the enrolment.

          -  Normal growth.

          -  Infants who can refrain from use of erythromycin, metoclopramide, antihistaminic drug,
             proton pump inhibitors (PPIs), antacids, antimuscarinic drugs, simethicone and
             dimethicone from 1 week prior randomization until end of study.

        Exclusion Criteria:

          -  Any clinically relevant event (excluding those relevant to the condition under study)
             which has occurred within one week prior to randomization.

          -  Any pharmacological treatment starting within one week prior to randomization.

          -  Infants for whom a change in the diet (i.e. weaning) has been performed within one
             week prior to randomization or is planned during the study period.