bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Empagliflozin; Placebo; Placebo
Intervention description: For blinding purposes
Intervention MeSH terms: Empagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group,
      efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with
      Type 2 Diabetes Mellitus with insufficient glycaemic control
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus

          -  Patients on diet and exercise regimen who are pre-treated with any insulin therapy
             alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to
             screening

          -  Fasting C-peptide must be > 0.5 ng/mL

          -  HbA1c at screening in Patients who are treated with insulin alone must be >=7.5% and
             <=10.0%

          -  HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD)
             must be >=7.0% and <=9.5% at screening, and >=7.5% and <=10.0% at placebo run-in
             period

          -  Age at informed consent must be >=20 and <75 years

          -  BMI at screening must be >22 and <=40 kg/m2

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Patients who experience uncontrolled hyperglycaemia before randomization

          -  Patients who are treated with sulfonylurea whose dose is more than a half of daily
             maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and
             sodium-glucose co-transporter 2 (SGLT-2) inhibitor

          -  Patients with recent cardiovascular and/or stroke events

          -  Patients with hepatic and/or renal dysfunction

          -  Patients who received anti-obesity drugs or other treatment leading to unstable body
             weight

          -  Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin

          -  Pre-menopausal women who are nursing or pregnant

          -  Further exclusion criteria apply
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
Condition: Infertility
MeSH terms: Infertility
Intervention: menotropin; recombinant FSH
Intervention MeSH terms: Menotropins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 620.0
Sex: Female
Minimum age: 21 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant
      Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in
      women undergoing controlled ovarian stimulation (COS) following GnRH treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days,
             with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.

          -  Subjects must be high responders, defined as subjects who have a serum anti-Müllerian
             hormone (AMH) ≥5 ng/mL at screening.

          -  Documented history of infertility (e.g., unable to conceive for at least 12 months or
             for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level
             between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6
             months prior to randomization.

        Exclusion Criteria:

          -  Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).

          -  History of recurrent miscarriage not followed by a live birth (recurrent is defined as
             two (2) or more consecutive miscarriages).

          -  Previous in vitro fertilization (IVF) or assisted reproductive technology (ART)
             failure due to a poor response to gonadotropins. Poor response is defined as
             development of ≤2 mature follicles or history of 2 previous failed cycle cancellations
             prior to oocytes retrieval due to poor response.
Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Paroxetine
Intervention description: Paroxetine 20-40mg po QD for 12 weeks
Intervention MeSH terms: Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine if treatment of post-traumatic stress disorder in
      combat veterans with paroxetine changes brain responses as measured by functional magnetic
      resonance imaging and if brain responses can predict who will get better with treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans with clinical diagnosis of post-traumatic stress disorder from combat related
             to deployment to Afghanistan/Iraq (Operation Enduring Freedom/Operation Iraqi Freedom)

        Exclusion Criteria:

          -  Intolerance or sensitivity to paroxetine

          -  Major medical or neurologic illness

          -  Current psychotropic medication or active psychotherapy treatment

          -  Other major psychiatric illness
Early Postpartum Intrauterine Device (IUD) Placement
Condition: Contraception
Intervention: Levonorgestrel IUS
Intervention description: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postpartum; Contraception; Intrauterine device; Intrauterine system; Mirena; Paragard; Uterine involution

Summary:

      Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead
      to negative consequences during the subsequent pregnancy. Providers have traditionally
      delayed starting birth control, especially placement of intrauterine devices (IUDs),
      post-delivery for a number of reasons. The first postpartum visit after a woman has given
      birth is typically scheduled for 6 weeks after her delivery, during which she is typically
      provided with her chosen method of birth control. This study will evaluate two different IUD
      placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to
      determine if placement time affects a woman's follow-through obtaining the IUD and keeping it
      inserted in place. The researchers will also look at bleeding patterns and patient/provider
      satisfaction with the IUD placement
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18 years or older

          -  Voluntarily requesting either copper T380A or levonorgestrel IUD placement for
             postpartum contraception

          -  Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the
             time of enrollment

          -  English or Spanish speaking

          -  Able to give consent and agree to terms of the study

          -  No contraindications to use of either intrauterine device

        Exclusion Criteria:

          -  Preterm delivery prior to 32 weeks gestation

          -  Recent pregnancy with multiple gestation

          -  Current incarceration

          -  Known congenital or acquired uterine anomaly, including fibroids that distort the
             uterine cavity

          -  Current or recent pelvic infection (chorioamnionitis treated for fever in labor only
             is not an exclusion)

          -  Suspected hypersensitivity or contraindication to the chosen IUD

          -  No insurance coverage for postpartum care, including Citizen Alien Waived Emergent
             Medical (CAWEM)
Subcutaneous vs. Intramuscular Testosterone
Condition: Testosterone Deficiency; Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: Testosterone
Intervention description: Testosterone cypionate injection
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy
      for the treatment of T deficiency will receive both subcutaneous testosterone therapy and
      intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM
      injection and one group will receive an IM injection followed by a SQ injection. The primary
      objective of this study is to measure testosterone concentration in men after these two
      treatment routes and determine if there are any significant differences due to modes of
      administration. Endpoints will include total serum testosterone and calculated free
      testosterone. A questionnaire will also be administered to assess overall patient experience
      with each route of administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to read, write, and understand English

          -  Age greater than or equal to 18

          -  Diagnosed with testosterone deficiency

          -  Pre-enrollment testosterone concentration of less than 350 ng/dL

          -  Planning to initiate testosterone treatment at MHB

          -  Willing to be followed at MHB for at least one month

          -  Willing to provide informed consent for this study

        Exclusion Criteria:

          -  Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen
             Receptor Modulators, unless off therapy for at least 12 weeks

          -  American Urological Association Prostate Symptom score of 15 or greater or significant
             prostatic symptoms

          -  History of carcinoma, tumors or induration of the prostate or the male mammary gland,
             including suspicion thereof

          -  Pre-enrollment serum PSA more than 4 ng/ml

          -  Serious psychiatric disease or uncontrolled medical illness, as suspected from the
             history or clinical examination

          -  Used any sex hormones or steroidal anabolic drug supplements within 28 days before
             pre-enrollment testosterone collection or at any time throughout the study

          -  Incapable of giving informed consent or complying with the protocol
A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI
Condition: Mucopolysaccharidosis VI; Maroteaux-Lamy Syndrome
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis VI; Syndrome
Intervention: Naglazyme
Intervention description: Weekly infusion for minimum of 52 weeks. Naglazyme is diluted in sterile 0.9% sodium chloride solution
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Maximum age: 1 Year
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and efficacy of two dose levels of
      Naglazyme in infants under the age of one year who have MPS VI by monitoring physical
      appearance, x-ray of the skeletal system and growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent by a parent or legal guardian

          -  Parent or legal guardian willing and able to comply with all study procedures

          -  Equal to or greater than 36 weeks estimated gestational age by physical exam at birth

          -  Has a diagnosis of MPS VI based on a documented prenatal diagnosis or fibroblast or
             leukocyte N-acetylgalactosamine 4-sulfatase (ASB) enzyme activity level of less than
             10% of the lower limit of the normal range of the measuring laboratory

          -  Is less than one year of age

          -  Has no evidence of skeletal dysplasia based on physical exam

        Exclusion Criteria:

          -  Parent of legal guardian perceived to be unreliable or unavailable for study
             participation

          -  Use of any investigational drug within 30 days prior to screening, or requirement for
             any investigational agent prior to completion of all scheduled study assessments

          -  Has concurrent disease or condition that would interfere with study participation or
             safety (i.e., has previously undergone hematopoietic stem cell transplantation such as
             bone marrow or cord blood transplantation, or major organ transplantation)

          -  Any condition that, in the view of the principle investigator, renders the subject at
             high risk from treatment compliance and/or completing the study

          -  Has known hypersensitivity to Naglazyme

          -  Has previously received Naglazyme
Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Condition: Multiple Sclerosis, Relapsing, Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Interferon beta-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple sclerosis, relapsing, remitting; Interferon-beta

Summary:

      This study is planned to evaluate emotional disorders during treatment by interferon (IFN)
      beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label
      exploratory study with no change of therapeutic behavior but with standardized
      neuropsychologic follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged ≥ 18 years

          -  Subjects with RRMS

          -  Subjects with at least 2 relapses in the past two years (with last relapse finished or
             finishing)

          -  Subjects with indication of IFN beta treatment determined by the investigator

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Subjects with secondary progressive multiple sclerosis (MS) without relapse

          -  Subjects with ongoing acute relapse

          -  Subjects already being treated with interferon

          -  Subjects with corticoid therapy for less than 15 days

          -  Subjects presenting acute major depression or treated with anti-depressant therapy

          -  Subjects involved in another therapeutic study

          -  Subjects with any condition which could interfere with a good compliance of this study

          -  Other protocol-defined exclusion criteria may apply
The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
Condition: Glaucoma; Application Site Pigmentation Changes
MeSH terms: Glaucoma
Intervention: latanoprost; bimatoprost; travoprost
Intervention description: Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year; Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year; Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
Intervention MeSH terms: Bimatoprost; Travoprost; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: periocular skin pigmentation; Lumigan; Travatan; Xalatan; latanoprost; bimatoprost; travoprost

Summary:

      The purpose of this study is to study changes in skin color that may be caused by using one
      of the three eye medicines: Xalatan, Travatan or Lumigan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients recently diagnosed with primary open angle glaucoma or ocular hypertension

          -  Caucasian and African American ethnicities

          -  Male and Female

          -  Age 30 and above

        Exclusion Criteria:

          -  A history of ocular medication use within the last 12 months

          -  Inflammatory/ allergic skin diseases or dermatitis

          -  presence of periocular hyperpigmented skin lesions

          -  Systemic pigmentation disorders

          -  Use of systemic drugs that can affect skin pigmentation

          -  Visitation of tanning salons, or use of self tanning products

          -  Pregnancy or patients planning to become pregnant in the near future
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
Condition: Aspergillosis; Candidemia
MeSH terms: Aspergillosis; Candidemia
Intervention: anidulafungin and voriconazole
Intervention description: Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.
Intervention MeSH terms: Voriconazole; Anidulafungin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK; fungal infection

Summary:

      The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to
      determine the drug concentration in the lung.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult subjects willing to comply with the study requirement.

        Exclusion Criteria:

          -  Clinical significant disease.

          -  Sensitive to study medication.

          -  Not willing to comply with the study requirement.
Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
Condition: Obesity
Intervention: Elonva
Intervention description: 20 obese women will be the study group and 20 normal weighing women will be the control group. Both groups will receive 150 mcg of Elonva for controlled ovarian hyperstimulation (COH). Gonadotropin-releasing hormone (GnRH) antagonist will be used to prevent premature luteinizing hormone (LH) surge. Additional daily doses of 200 IU of recombinant follicle stimulating hormone (rFSH) will be used if necessary. Human chorionic gonadotropin (hCG) will be used for oocyte maturation. 2 mature follicles will be aspirated separately in each patient. Cumulus cell (CC) samples will be collected and stored on -80 oC for subsequent analysis. Clinical and molecular parameters of IVF success will be assessed and compared between the groups.
The exclusion criteria will be: polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No

Summary:

      The aim of the present study is to determine, whether clinical efficacy of 150 mcg of
      Corifollitropin alfa is the same in normal weighing and obese women. Furthermore,
      investigators want to determine whether oocytes retrieved from normal weighing and obese
      women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular
      level.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI > 30 kg/m2

          -  BMI 18.5-24.9 kg/m2

        Exclusion Criteria:

          -  polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years
Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Behavioral: Buprenorphine/naloxone maintenance (Mtn); Behavioral: Buprenorphine/naloxone detoxification (Dtx)
Intervention description: Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.; Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Buprenorphine; Buprenorphine/naloxone; Counseling; Primary care

Summary:

      The aim of the study is to determine whether buprenorphine/naloxone maintenance versus
      detoxification using buprenorphine/naloxone, in prescription opioid dependent patients
      receiving primary care management and drug counseling in an office-based setting, leads to
      decreased illicit opioid use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  opioid dependence

        Exclusion Criteria:

          -  current dependence on alcohol, cocaine, benzodiazepines or sedatives

          -  current suicide or homicide risk

          -  current psychotic disorder or untreated major depression

          -  inability to read or understand English

          -  life-threatening or unstable medical problems