bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sotagliflozin; Sotagliflozin; Placebo
Intervention description: High dose Sotagliflozin, once daily, before the first meal of the day; Low dose Sotagliflozin,once daily, before the first meal of the day; Placebo, once daily, before the first meal of the day
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 782.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: High level of sugar (glucose) in the blood

Summary:

      This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose
      or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when
      used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have
      inadequate glycemic control with insulin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant who gave written informed consent to participate in the study in
             accordance with local regulations.

          -  Adult participants 18 years and older with a diagnosis of T1D made at least 1 year
             prior to informed consent.

          -  Participants treated with insulin or insulin analog delivered via continuous
             subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).

          -  Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed
             the study diary as required per protocol.

          -  At the Screening Visit, A1C was between 7.0% to 11.0%.

          -  Females of childbearing potential must use an adequate method of contraception and
             have a negative pregnancy test.

        Exclusion Criteria:

          -  Use of antidiabetic agent other than insulin or insulin analog at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
             screening.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the
             Investigator.
Liraglutide In Overweight Patients With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Overweight
Intervention: liraglutide; placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the effects of liraglutide (a drug used to treat type
      2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to
      insulin.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin
        pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous
        glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily.
        3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years
        6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be <30 years. 8) evidence of
        auto-immunity to beta cells (GAD-65 and islet cell antibody screen)

        Exclusion Criteria:

        1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial
        infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in
        the previous four weeks; 3)Hepatic disease (transaminase > 3 times normal) or cirrhosis;
        4)Renal impairment (serum eGFR <30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive
        status; 6)Participation in any other concurrent clinical trial; 7)Any other
        life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic
        regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to
        give informed consent 12) history of gastroparesis 13)history of medullary thyroid
        carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of
        smoking for the duration of the study; 15) Use of any agent other than insulin for
        treatment of diabetes (metformin, pramlintide or thiazolidinediones.
A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
Condition: Rabies
MeSH terms: Rabies
Intervention: Zagreb; Essen
Intervention description: Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22; Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 644.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rabies virus, postexposure, vaccine schedule, children, older adults

Summary:

      This study was designed to evaluate the safety and immunogenicity of two simulated
      postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese
      children and older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals between 6-17 years of age and 51 years of age or older

          -  Individuals who were in good health

          -  Provided consent, complied with study procedures and duration of follow-up

        Exclusion Criteria:

          -  Contraindications to vaccination with rabies vaccine

          -  Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination

          -  Known hypersensitivity to the components of the vaccine

          -  Previously received any rabies vaccine or immune globulin

          -  Previous or planned treatment with antimalarial medications

          -  History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse
             within the past 2 years, malignancy

          -  Female subjects who were pregnant or unwilling to practice acceptable birth control
             methods

          -  Individuals enrolled or plans to enroll in another investigational trial
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 533.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effects of combination treatment of Nivolumab
      with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated
      advanced Melanoma.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Potential subjects must have advanced Melanoma (stage III or IV as confirmed by
             biopsy) with spread to other sites in the body and unable to be removed by surgery.

          -  Potential subjects must be newly diagnosed with advanced melanoma and received no
             treatment for the advanced disease.

        NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1,
        anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell
        costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was
        used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs
        must be discontinued 6 months prior to study entry and the side effects related to the
        prior therapy resolved.

          -  Potential subjects (with disease spread to brain) who previously received primary
             treatment are permitted if there was no evidence of disease as confirmed by the MRI
             (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the
             first dose of the study drug). Potential subjects must not have received intravenous
             steroid treatment (>10 mg/day) intravenously for at least 2 weeks prior to study drug
             administration.

        Exclusion Criteria:

          -  Leptomenigeal metastases

          -  Subjects with autoimmune disease. Subjects with Type I diabetes mellitus,
             hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo,
             psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected
             to recur in the absence of an external trigger are permitted to enroll.

          -  All side effects from previous primary treatments other than alopecia, fatigue, or
             peripheral neuropathy must have resolved to Grade 1 or baseline before administration
             of study drug.
Evaluation of Dapagliflozin Taken Twice-daily
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: dapagliflozin; dapagliflozin; dapagliflozin; metformin; placebo
Intervention description: 2.5 mg tablet, taken orally, twice daily; 5 mg tablet taken orally, twice daily; 10 mg tablet taken orally, once daily; >/= 1500 mg total daily dose, tablets taken orally, twice daily; placebo
Intervention MeSH terms: Metformin; Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; metformin treated; inadequate control; metformin treatment alone

Summary:

      This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5
      mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is
      beneficial in diabetes treatment, and if so, how it compares to treatment with metformin
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Diagnosis of T2DM

          -  Current antihyperglycaemic treatment with metformin immediate release formulation
             monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment.
             Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.

          -  HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and
             Enrolment Visit 1.

        Exclusion Criteria:

          -  Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of
             the Young (MODY) or secondary causes of diabetes mellitus

          -  History of diabetic ketoacidosis

          -  Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria,
             polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment

          -  FPG >270 mg/dL (>15.0 mmol/L)

          -  BMI >45 kg/m2
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Capecitabine; Sunitinib malate
Intervention description: 1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles; 37.5 mg daily, continuous dosing
Intervention MeSH terms: Capecitabine; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced breast cancer; metastatic breast cancer; treatment resistant; treatment failure

Summary:

      To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast
      cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a
      taxane and for whom further anthracycline therapy is not indicated
    

Eligibility criteria:

        Inclusion Criteria:

          -  breast adenocarcinoma

          -  prior treatment with an anthracycline and a taxane either concurrently or sequentially
             in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than
             1 chemotherapy regimen in the advanced setting

        Exclusion Criteria:

          -  Prior treatment with regimens of chemotherapy in the advanced/metastatic disease
             setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/
             taxanes treatments.

          -  Any prior regimen with capecitabine
Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MP-513; MP-513; Placebo of MP-513
Intervention description: MP-513 10 mg, once a day, for 4 weeks; MP-513 20 mg, once a day, for 4 weeks; MP-513 placebo, once a day, for 4 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: 99.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in
      patients with type 2 Diabetes for 4 weeks administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are 20 - 75 years old

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 8 weeks before administration of investigational drug

          -  Patients whose HbA1c is ≥6.5% and <10.0%

          -  Patients who were not administered diabetes therapeutic drugs prohibited for
             concomitant use within 8 weeks before administration of investigational drug.

        Exclusion Criteria:

          -  Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or
             secondary diabetes (Cushing disease, acromegaly, etc)

          -  Patients who are accepting treatments of arrhythmias

          -  Patients with serious diabetic complications

          -  Patients who are the excessive alcohol addicts

          -  Patients with severe hepatic disorder or severe renal disorder.

          -  Patients who are pregnant, lactating, and probably pregnant patients, and patients who
             can not agree to contraception
Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years
Condition: Infections, Papillomavirus
Intervention: Placebo; Cervarix TM
Intervention description: Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.; Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: Female
Minimum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Papillomavirus

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
      uterus or womb). This infection may go away by itself, but if it does not go away (this is
      called persistent infection), it can lead in women over a long period of time to cancer of
      the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and
      immunogenicity of the vaccine in women aged 26 years and above. This study will therefore
      assess additional immunogenicity parameters of the vaccine in women from selected
      investigative sites.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A female enrolled in study 104820 and who received three doses of study
             vaccine/control.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  Written informed consent obtained from the subject prior to enrolment in this
             ancillary study.

        Exclusion Criteria:

          -  Pregnancy.

          -  Administration of any HPV vaccine other than that foreseen by the study protocol.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine since study start.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             study start.

          -  Administration of immunoglobulins and/or any blood products within 90 days preceding a
             blood sampling.
ViVEXX Carotid Revascularization Trial (VIVA)
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Intervention: Carotid Artery Stenting
Intervention description: placement of a bare metal stent at sites of stenosis in the carotid artery
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Carotid; Artery; Stenosis

Summary:

      To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire
      Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery
      stenosis in patients at high risk for carotid endarterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one
             of the following criteria:

               -  Symptomatic: > than or = to 50% carotid stenosis by angiography and a history of
                  non-disabling stroke, transient ischemic attack (TIA) in the hemisphere supplied
                  by the target vessel within 180 days of the procedure.

               -  Asymptomatic: > than or = to 80% carotid stenosis by angiography without
                  neurological symptoms.

          -  High risk for carotid endarterectomy: anatomical and co-morbid.

        Exclusion Criteria:

          -  History of symptoms of stroke or TIA within 24 hours of the procedure

          -  Extensive or diffuse atherosclerotic disease

          -  Severe vascular tortuosity or anatomy that would preclude the safe introduction of the
             device
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide or Matching Placebo
Intervention description: Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 805.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IBS

Summary:

      The purpose of this study is to determine the safety and efficacy of linaclotide administered
      to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has completed a colonoscopy according to the AGA criteria, with no clinically
             significant findings

          -  Patient has successfully completed protocol procedures (with no clinically significant
             findings): physical exam, 12-lead ECG, or clinical laboratory tests

          -  Patient meets protocol criteria for diagnosis of IBS-C

          -  Patient demonstrates continued IBS-C through Pretreatment Period

          -  Patient is compliant with IVRS

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments