bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; exenatide; placebo
Intervention description: subcutaneous injection, 5mcg, twice a day; subcutaneous injection, 10mcg, twice a day; subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 181.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; LY2148568; Byetta; Lilly; Amylin

Summary:

      This long term, placebo-controlled trial is intended to assess the efficacy and safety of
      exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with
      oral antidiabetic(s) but not well controlled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes.

          -  Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and
             thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU
             alone, the dose must be within the dose range from maximum maintenance dose to maximum
             approved dose. The patients with concomitant use of alpha glucosidase inhibitors
             (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or
             nateglinide) can be included in this study, but these drugs must be discontinued at
             study start.

          -  Have HbA1c 7.0% to 10% at study start.

          -  Have a body weight >=50 kg.

        Exclusion Criteria:

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Have participated in this study previously or any other study using exenatide or
             glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.

          -  Have been treated with any exogenous insulin within 90 days before study start.

          -  Have been continuously treated with any drug that directly affects gastrointestinal
             motility for more than a total of 21 days in the 90 days prior to study start.

          -  The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not
             allowed.
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Intervention: Abatacept; Placebo; Abatacept
Intervention description: IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).; IV infusions, IV, N/A, every 4 weeks, 6 months.; Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Juvenile Idiopathic Arthritis

Summary:

      The primary purpose of the clinical research study is to assess the safety of treating
      children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will
      assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid
      Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence
      of disease flare.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis;

          -  Current active arthritis;

          -  Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD);

          -  Subjects must discontinue use of any DMARD other than methotrexate prior to the first
             dose of study medication

        Exclusion Criteria:

          -  Presence of infection or history of frequent acute or chronic infections;

          -  Joint replacement surgery required during the study or history of surgery on more than
             5 joints;

          -  Live vaccines within 3 months of the first dose of study medication;

          -  Unresolved serious bacterial infection or chronic bacterial infection;

          -  Subjects who currently have intermittent fever due to JRA/JIA, rheumatoid rash,
             hepato-splenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: SYM-1219
Intervention description: Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Intervention MeSH terms: Secnidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 325.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of
      SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent
      girls with bacterial vaginosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are adult females or postmenarchal adolescent girls ≥ 12 years of age.

          -  Are in good general health as confirmed by a medical history and physical examination,
             with no known medical or mental health conditions that, in the Investigator's opinion,
             may interfere with study participation.

          -  Have a negative urine pregnancy test result prior to study treatment initiation. In
             addition, female patients of childbearing potential must be using an acceptable form
             of birth control as determined by the Investigator

          -  Agree to abstain from alcohol for 3 days following study treatment.

          -  Have a clinical diagnosis of bacterial vaginosis

          -  Agree not to use vaginal douches or similar products for the duration of the study.

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study.

          -  Are menstruating or have vaginal bleeding at the Baseline visit (Day 1).

          -  Are menopausal as determined by the Investigator

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis,
             Neisseria gonorrhoeae or Herpes simplex

          -  Have active genital lesions, including active Herpes simplex lesions, or other vaginal
             or vulvar conditions which could confound the interpretation of the clinical response,
             as determined by the Investigator

          -  Have consumed any alcohol within 12 hours prior to treatment with study medication.

          -  Have a history of an abnormal Pap smear which required cervical biopsy or cervical
             cauterization within 3 months of the Baseline visit (Day 1).

          -  Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
Safety and Efficacy Trial of Testosterone Undecanoate
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate
Intervention description: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: testosterone; male hypogonadism; low testosterone

Summary:

      The purpose of the study is to determine if oral testosterone undecanoate is effective and
      safe in the treatment of low testosterone in men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples
             collected 1 hour apart in the morning between 6:00 and 10:00 AM)

        Exclusion Criteria:

          -  Significant intercurrent disease of any type, in particular liver, kidney,
             uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or
             psychiatric illness including depression.

          -  Recent history of stroke, including transient ischemic attack (TIA) or acute coronary
             event

          -  Untreated, severe obstructive sleep apnea

          -  Hematocrit <35% or >48%

          -  Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and
             serum creatinine >2.0 mg/dL

          -  BMI > or equal to 38

          -  Stable doses of lipid-lowering medication for less than three months

          -  Stable doses of oral medication for diabetes for less than two months

          -  Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum
             PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate
             cancer.

          -  History of breast cancer

          -  Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary
             supplements that may increase serum T, such as androstenedione or DHEA with the
             previous 4 weeks

          -  Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors

          -  Known history of abuse of alcohol or any drug substance with the previous 2 years

          -  Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or
             long-acting opioid analgesics

          -  Receipt of any drug as part of a research study within 30 days of initial dose
             administration in this study

          -  Blood donation within the 12 week period before initial dose administration in this
             study
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix 80 mg / Degarelix 80 mg; Degarelix 160 mg / Degarelix 160 mg; Leuprolide 7.5 mg / Degarelix 80 mg; Leuprolide 7.5 mg / Degarelix 160 mg
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 386.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Degarelix; prostate cancer

Summary:

      Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486
      CS21A study. The study continued until all non-discontinued participants had received
      treatment for at least 5 years.
    

Eligibility criteria:

        Inclusion/Exclusion Criteria:

          -  Patients with histologically proven prostate cancer of all stages in whom endocrine
             treatment is indicated.

          -  Signed informed consent

          -  The patients must have completed the FE 200486 CS21 Study.
Actinic Keratoses Treatment With Metvix® in Combination With Light
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Metvix®; Photodynamic Therapy Blue light; Photodynamic Therapy Daylight
Intervention description: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug; Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug
Intervention MeSH terms: Methyl 5-aminolevulinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to compare efficacy and safety of Metvix® natural
      daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in
      subjects with mild actinic keratoses (intra-individual comparison)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female above 18 years;

          -  Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the
             scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

        Exclusion Criteria:

          -  Subject with clinical diagnosis of at least one severe AK on TAs

          -  Subject with clinical diagnosis of other skin disease (including non-melanoma skin
             cancer) on the TAs;

          -  Subject with pigmented AK on the TAs
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: TachoSil®; Surgicel® Original
Intervention description: Intraoperative application as secondary hemostatic treatment; Intraoperative application as secondary hemostatic treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 253.0
Sex: All
Healthy volunteers: No
Keywords: Liver resection; Liver transplantation; Liver surgery; Secondary hemostasis

Summary:

      The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection
      surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
      Hemostatic efficacy will be evaluated intraoperatively after application of randomized
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Resection of at least the equivalent tissue volume of 1 anatomical segment of the
             liver

          -  Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after
             conventional resection procedure and primary control of arterial pulsating bleeding or
             major venous hemorrhage by sutures, ligations, clips, vascular stapler, point
             electrocautery or focal radiofrequency ablation

          -  Need for additional supportive hemostatic treatment

          -  Expected ability to lightly press the trial treatment to the liver resection wound for
             3 minutes

        Exclusion Criteria:

          -  Indication for emergency surgery

          -  Known coagulopathy (as judged relevant by the investigator)

          -  Known or suspected hypersensitivity to any ingredient of the investigational medicinal
             products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)

          -  Patient unwilling to receive blood products

          -  Known current alcohol or drug abuse

          -  Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of
             childbearing potential

          -  Dry surgical field of the targeted application area

          -  Occurrence of any serious surgical complication

          -  Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding

          -  Application of topical hemostatic material on the liver resection wound

          -  Radiofrequency precoagulation of the liver resection wound except focal radiofrequency
             ablation of vessels as primary hemostatic treatment
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 7-valent pneumococcal conjugate vaccine
Intervention description: 13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.; 7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 603.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of
      13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric
      vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and
      Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with
      13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune
      responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and
      immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month old infants (42 to 98 days)

          -  Available for the duration of the study and reachable by telephone

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal, Hib conjugate,
             diphtheria, tetanus, pertussis, polio, or meningococcal vaccine

          -  Previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Bleeding disorder, immune deficiency or suppression, or significant chronic or
             congenital disease

          -  Receipt of blood products or gamma globulin
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
Condition: Bilateral Nasolabial Fold Wrinkles
Intervention: Autologous Human Fibroblast (azficel-T); Placebo
Intervention description: Collection of 3 mm post auricular skin punch biopsies.
Three injection treatments administered 5 ± 1 weeks apart on each side of the face.; Collection of 3 mm post auricular skin punch biopsies.
Three injection visits administered 5 ± 1 weeks apart on each side of the face.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of moderate to severe bilateral nasolabial fold wrinkles

Summary:

      The purpose of this study is to evaluate the safety profile and the treatment effect of
      Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold
      wrinkles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is at least 18 years of age

          -  Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as
             per protocol

          -  Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol

          -  Ability to comply with the study requirements

          -  Negative pregnancy test (Females)

          -  Healthy post-auricular skin for biopsy

        Exclusion Criteria:

          -  Excessive dermatochalasis of the treatment area

          -  Inability to lessen the nasolabial fold wrinkles by physically spreading the area
             apart

          -  Total area to be treated exceeds 20 cm in length

          -  Physical attributes which may prevent assessment or treatment as judged by the
             evaluator

          -  Use of an investigational product/procedure within 30 days prior to enrollment or
             plans for use during the study

          -  Previous treatment with the sponsor's product

          -  History of active autoimmune disease or organ transplantation

          -  Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma
             is excluded)

          -  Active or chronic skin disease

          -  Known genetic disorders affecting fibroblasts or collagen

          -  Active systemic infection

          -  Requires chronic antibiotic or steroidal therapy

          -  Use of certain commercial products/procedures to the treatment area prior to study
             enrollment or plans for use during the study

          -  Use of systemic agents that increase bleeding or clotting, or disorders equated with
             these effects

          -  Known allergic reactions to agents used in preparation of treatment

          -  Excessive exposure to sun without adequate sun protection