bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide
Intervention description: Injected subcutaneously s.c. (under the skin) once daily.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 635.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety
      of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Japanese subjects at least 20 years of age at the time of informed
             consent

          -  Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to
             screening

          -  HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)

          -  Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is
             defined as unchanged medication and unchanged dose) for for at least 60 days before
             screening according to approved Japanese labelling

        Exclusion Criteria:

          -  Treatment with insulin within 12 weeks prior to screening

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 60 days before screening

          -  Screening calcitonin equal or above 50 ng/l

          -  History of pancreatitis (acute or chronic)

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia type 2 (MEN 2)

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV

          -  Within the past 180 days any of the following: myocardial infarction, stroke or
             hospitalisation for unstable angina and/or transient ischemic attack

          -  Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous
             cell skin cancer, polyps and in-situ carcinomas)

          -  Any condition which, in the opinion of the investigator might jeopardise subject's
             safety or compliance with the protocol
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: asenapine; olanzapine
Intervention description: 5-10 mg sublingually twice daily for 26 weeks; 5-20 mg by mouth once daily for 26 weeks
Intervention MeSH terms: Olanzapine; Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an extension study of A7501013 (P05771/NCT00145496) to further test

      the efficacy and safety of Asenapine compared with a

      marketed agent (olanzapine) in the treatment of patients with

      persistent negative symptoms of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Continue to meet all demographic and procedural

        inclusion criteria of the A7501013 trial to enter into

        this extension trial.

          -  Have demonstrated an acceptable degree of compliance

        and completed the A7501013 trial, and would benefit

        from continued treatment according to the investigator.

        Exclusion Criteria:

          -  Have an uncontrolled, unstable clinically significant

        medical condition.

          -  Have been judged to be medically noncompliant in the

        management of their disease.
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: IDP-124 Lotion; IDP-124 Vehicle Lotion
Intervention description: IDP-124 Lotion, twice-daily application; IDP-124 Vehicle Lotion, twice-daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 338.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic
      Dermatitis in Pediatric and Adult Subjects
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female at least 2 years of age and older

          -  Written and verbal informed consent must be obtained; subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit)

          -  Nonimmunocompromized male or female who failed to respond adequately to other topical
             prescription treatment for AD or for whom those treatments are not advisable

          -  Subjects must be willing to comply with study instructions and return to the clinic
             for required visits; subjects under the age of consent must be accompanied by the
             parent or legal guardian at the time of assent/consent signing

        Key Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or who wish to become pregnant during the
             study period

          -  Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg,
             clinically infected AD)

          -  Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline,
             which would interfere with evaluations

          -  History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or
             ichthyosis (other than ichthyosis vulgaris)
Effect of Cervical Occlusion During Intrauterine Insemination (IUI)
Condition: Infertility
MeSH terms: Infertility
Intervention: Intrauterine Insemination; IUI with the standard inseminator
Intervention description: The intervention arm will undergo temporary (15 minutes) cervical occlusion with the eliptosphere intracervical catheter. This catheter is typically used to perform saline infusion ultrasounds to image the uterine cavity in our practice.; The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: Female
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination
      (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for
      sonohysterograms as compared to those performed with a standard inseminator.

      The investigators will compare pregnancy rates in patients undergoing routine IUI either with
      balloon occlusion or with standard insemination. The patients will receive the standard
      clinical care per the investigators' office guidelines, except they will be randomized to
      insemination with either of two catheters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing IUI for unexplained infertility in our office: Center for
             Reproduction and Infertility (Providence, RI)

        Exclusion Criteria:

          -  "Abnormal" Semenalysis TMC < 5 million

          -  Blocked Fallopian tubes
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD; Smoking
Intervention: Osmotic-Release Methylphenidate; Placebo
Intervention description: OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.; OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS
      MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e.,
      nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence
      for smokers with Attention Deficit Hyperactivity Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ADHD2

          -  Smoked cigarettes for at least 3 months

          -  Currently smoking > 10 cigarettes/day

          -  Have an interest in quitting

          -  Negative urine screen for cocaine, methamphetamine, opiates, benzodiazepines, and
             marijuana

        Exclusion Criteria:

          -  Have a clinical diagnosis for current abuse or dependence for any psychoactive
             substance other than nicotine, depression, or anxiety; or a life-time clinical
             diagnosis of psychosis or bipolar disorder

          -  Allergic to OROS-MPH

          -  Pregnant or breastfeeding

          -  Abnormal electrocardiogram (ECG)

          -  Taking a Monoamine Oxidase (MAO) Inhibitor

          -  Taking any medication used for treating either ADHD or smoking

          -  Use of tobacco products other than cigarettes in the past week

          -  Blood pressure readings greater than 135/85 and/or a heart rate more than 90 beats per
             minute on three consecutive clinic visits
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
Condition: Infertility
MeSH terms: Infertility
Intervention: Follitropin Delta (FE 999049); Follitropin Alfa (GONAL-F)
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 513.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This trial investigates the immunogenicity of FE 999049 in repeated cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent Documents signed prior to screening evaluations related to this
             protocol

          -  Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)

          -  Anti-FSH antibody results from baseline and at least one post-dosing assessment in the
             previous cycle(s) available.

          -  Having undergone the oocyte retrieval procedure, or having had cycle cancellation
             prior to oocyte retrieval due to poor ovarian response or excessive ovarian response,
             in the previous cycle(s).

          -  Failure to achieve ongoing pregnancy in the previous cycle(s).

        Exclusion Criteria:

          -  Non-compliance to protocol compliance in the previous cycle(s).

          -  Having undergone any stimulation with gonadotropins since the end-of-trial /
             end-of-cycle visit in the previous cycle

          -  One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of
             dosing on stimulation day 1

          -  Severe OHSS in a previous cycle.

          -  Any clinically relevant change to any of the eligibility criteria in the previous
             cycle(s).

          -  Clinically relevant medical history since the previous cycle which precludes
             gonadotropin stimulation or is associated with a reduced chance of pregnancy.
Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression
Condition: Human Immunodeficiency Virus (HIV) Infections
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Atazanavir + Ritonavir
Intervention description: Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-Infected Patients Evidencing Virologic Suppression

Summary:

      The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced
      protease inhibitor therapy can maintain virologic suppression without a marked increase in
      virologic failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the
             previous 6 months (24 weeks).

          -  Absence of evidence or suspected virologic failure on antiretroviral therapy

          -  Absence of known primary mutations in the protease gene

          -  Only 1 highly active antiretroviral therapy (HAART) prior to current one

          -  HIV RNA < 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed)

          -  On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI +
             tenofovir [TDF]) for at least 8 weeks before study entry, without treatment-limiting
             adverse effects

        Exclusion Criteria:

          -  Presence of a newly diagnosed HIV-related opportunistic infection or any medical
             condition requiring acute therapy at the time of enrollment.

          -  Active disease condition (e.g. moderate to severe hepatic impairment/active renal
             disease/history of clinically significant heart conduction disease)

          -  Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil
             Fumarate (TDF) or emtricitabine (FTC).

          -  CD4 < 100 cells/mm3

          -  Grade IV laboratory values: Hemoglobin < 6.5 g/dL or white blood cells (WBC) <800/mmm3
             or absolute neutrophil count < 500/mm3, or platelets < 20,000/mm3 or diffuse
             petechiae.
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL/VOX; SOF/VEL
Intervention description: 400/100/100 mg FDC tablet administered orally once daily with food; 400/100 mg FDC tablet administered orally once daily without regard to food
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 333.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic

Summary:

      The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of
      treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose
      combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12
      weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus
      (HCV) infection with or without cirrhosis who have not received prior treatment with a
      regimen containing an inhibitor of the HCV NS5A protein.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  Treatment experienced with a direct acting antiviral medication not including a NS5A
             Inhibitor for HCV

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL255
Intervention MeSH terms: Topiramate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epilepsy; partial onset seizure; adjunctive therapy

Summary:

      The purpose of this study is to examine the safety of USL255 as adjunctive therapy in
      patients with refractory partial onset-seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the maintenance period of the P09-004 study.

          -  Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant
             AEDs.
Sensoril(Ashwaganhda)for Bipolar Disorder
Condition: Bipolar I Disorder; Bipolar II Disorder; Bipolar Disorder NOS
MeSH terms: Bipolar Disorder
Intervention: Sensoril; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sensoril; Bipolar Illness; Cognitive enhancement

Summary:

      The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance
      cognitive abilities (specifically measures of attention, executive function, working memory,
      and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators
      hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and
      metabolic indices, if impaired (fasting blood glucose and lipids).

      The investigators aim to test these hypotheses by conducting a randomized, placebo
      controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer treatment)
      recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks. Measures of
      cognition, psychopathology and laboratory indices will be utilized for evaluating primary and
      secondary outcomes, along with safety assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSMIV-TR diagnosis of Bipolar Disorder

          -  Ages 18 to 65

          -  Men or Women

          -  8th grade education or greater

          -  Able to provide competent written informed consent

          -  Current main mood stabilizer and mood status (YMRS and MADRS scores less than or equal
             to 10) are stable for greater than or equal to 4 weeks by history.

        Exclusion Criteria:

          -  Medically unstable conditions

          -  Known allergy to Sensoril® (or Ashwagandha)

          -  Current cognitive decline is attributable to a diagnosis of dementia or other
             neurological disorder

          -  Pregnant or lactating women

          -  Mini-mental score (MMSE) less than or equal to 23

          -  Currently receiving donepezil, rivastigamine, or galatamine, or memantine or any
             marketed agent for slowing memory loss in dementia

          -  Abnormal clinical thyroid status

          -  Currently (or within past 2 weeks) receiving St. John's Wort, Gingko or Omega-3