bioihbjkbjnl/mcl2 huggingface dataset:
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: DVS SR; Paroxetine
Intervention description: Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper; 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
Intervention MeSH terms: Paroxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 807.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: major depressive disorder; MDD; depression

Summary:

      This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate
      sustained release (DVS SR) in subjects with major depressive disorder.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          1. Outpatient men and women at least 18 years of age.

          2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and
             Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent
             episode, without psychotic features.

          3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.

        Primary Exclusion Criteria:

          1. Treatment with DVS SR at any time in the past.

          2. Significant risk of suicide based on clinical judgment, including common suicidal
             thoughts and suicide having been considered as a possible solution even without
             specific plans or intent.

          3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
             hypertension), ophthalmologic, neurologic, or any other medical condition that might
             confound the study or put the subject at greater risk during study participation.
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
Condition: Type 1 Diabetes; Dawn Phenomenon
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Lantus (glargine)
Intervention description: Described in Arm Description
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glucose; cortisol; growth hormone; glucagon; insulin

Summary:

      1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding
           glycemic control during the early AM (dawn phenomenon) in individuals with type 1
           diabetes.

        2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals
           with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained prior to performing screening evaluations.

          -  Male or female, 18 yrs or older.

          -  Diagnosis of type 1 diabetes made 5 years prior to screening visit.

          -  A1C > 6.0% and 9.0% at screening visit.

          -  Body Mass Index (BMI) 35 kg/m2 at screening visit.

          -  Documented undetectable C-Peptide

          -  Ability to follow instructions for Continuous Glucose Monitoring System (CGMS).

          -  Multiple daily injection participants on at least 3 injections per day. May be treated
             with NPH or glargine.

        Exclusion Criteria:

          -  Pregnant or lactating females, or females planning to become pregnant during the study
             or not using an acceptable method of contraception. Females of childbearing potential
             must have a negative pregnancy test at Visit 3 and Visit 5. Females who become
             pregnant during the study will be discontinued.

          -  Type 2 diabetes.

          -  Two or more severe hypoglycemic episodes (requiring assistance) within six months of
             Screening.

          -  Drugs known to affect glycemia (eg. steroids, beta blockers) or conditions that are
             likely to require steroid therapy or cause metabolic instability in the next 6 months.

          -  History of allergy or intolerance to NPH or glargine.

          -  History of hypoglycemia unawareness i.e. no warning symptoms accompanying low (<50
             mg/dl) blood glucose levels.

          -  Unable and/or unlikely to comprehend and/or follow the study protocol (including self
             blood glucose monitoring, CGMS).

          -  Currently using an insulin pump.

          -  Pituitary disorder (Acromegaly, Cushing's, Hypothyroidism etc.) or tumor.

          -  Two or more severe hypoglycemic episodes (requiring assistance) within six months of
             Screening.
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
Condition: Iron Deficiency Anemia; Impaired Renal Function
MeSH terms: Renal Insufficiency; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferric Carboxymaltose (FCM); Iron Sucrose (Venofer)
Intervention description: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg; 5 doses of 200 mg for a total cumulative dose of 1000 mg
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2561.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IDA

Summary:

      The primary objective of this study is to examine the efficacy and safety (cardiovascular) of
      an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron
      sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal
      function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects > or = to 18 years of age.

          -  Chronically impaired renal function.

          -  Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.

          -  Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation
             (TSAT) is < or = to 30%.

          -  If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks
             prior to randomization.

        Exclusion Criteria:

          -  Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or
             Venofer.

          -  Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).

          -  Requires dialysis for treatment of chronic kidney disease OR is being considered for
             initiation of dialysis during the time period of this trial.

          -  No evidence of iron deficiency.

          -  Any non-viral infection.

          -  AST or ALT at screening as determined by central labs greater than 1.5 times the upper
             limit of normal.

          -  Known positive hepatitis with evidence of active disease.

          -  Received an investigational drug within 30 days of screening.

          -  Alcohol or drug abuse within the past 6 months.

          -  Hemochromatosis or other iron storage disorders.

          -  Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG
             Performance Status greater than 1.

          -  Any other laboratory abnormality, medical condition or psychiatric disorder which in
             the opinion of the investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with study requirements.

          -  Pregnant or sexually-active female subjects who are not willing to use an acceptable
             form of contraception.
Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: ecallantide; Phosphate Buffer Saline (PBS), pH 7.0
Intervention description: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.; given as three 1mL subcutaneous injections.
Intervention MeSH terms: Ecallantide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide)
      versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  10 years of age or older

          -  Executed informed consent

          -  Documented diagnosis of HAE (Type I or II)

          -  Presentation at the site within 8 hours of patient recognition of an moderate to
             severe HAE acute attack

        Exclusion Criteria:

          -  Receipt of an investigational drug or device, within 30 days prior to study treatment

          -  Receipt of non-investigational C1-INH within 7 days of treatment

          -  Receipt of DX-88 (ecallantide) within 3 days prior to study treatment

          -  Diagnosis of acquired angioedema (AAE), estrogen-dependent angioedema or drug-induced
             angioedema (including angiotensin-converting enzyme inhibitor induced angioedema)

          -  Pregnancy or breastfeeding
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: bapineuzumab; bapineuzumab; placebo
Intervention description: Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.; Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.; Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 901.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: antibody; immunotherapy

Summary:

      This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in
      patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab
      or placebo. Each patient's participation will last approximately 1.5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination
             (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the
             diagnosis of AD

          -  Concurrent use of cholinesterase inhibitor or memantine allowed, if stable

          -  Caregiver will participate and be able to attend clinic visits with patient

        Exclusion Criteria:

          -  Significant neurological disease other than AD

          -  Major psychiatric disorder

          -  Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF)
             shunt, or foreign metal objects in the body]

          -  Women of childbearing potential
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2539.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metabolism and Nutrition Disorder; Prediabetes

Summary:

      This is a study of tirzepatide in participants with overweight and obesity. The main purpose
      is to learn more about how tirzepatide affects body weight. The study has two phases: A main
      phase and an extension phase. The main phase of the study will last 72 weeks. Participants
      with prediabetes will continue in the extension for another 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and
             previous diagnosis with at least one of the following comorbidities: hypertension,
             dyslipidemia, obstructive sleep apnea, cardiovascular disease

          -  History of at least one unsuccessful dietary effort to lose body weight

        Exclusion Criteria:

          -  Diabetes mellitus

          -  Change in body weight greater than 5 kg within 3 months prior to starting study

          -  Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of
             obesity

          -  History of pancreatitis

          -  Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia syndrome type 2 (MEN-2)

          -  History of significant active or unstable major depressive disorder (MDD) or other
             severe psychiatric disorder within the last 2 years

          -  Any lifetime history of a suicide attempt
Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: carvedilol controlled release/lisinopril; lisinopril + placebo
Intervention description: carvedilol CR + lisinopril given as separate pills; lisinopril plus placebo to match carvedilol CR
Intervention MeSH terms: Carvedilol; Lisinopril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 348.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: target blood pressure; hypertension; COREG CR; carvedilol CR; Stage 1 or 2 essential hypertension; lisinopril

Summary:

      Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2
      essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline.
      Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril +
      placebo. Subjects will be uptitrated over a 6 week period until target blood pressure
      (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of
      subjects who achieve target blood pressure after 6 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 18-80 years; stage 1 or 2 hypertension currently receiving 0 or 1
             antihypertensive medication; mean sitting systolic blood pressure >/=140mmHg to
             </=170mmHg, or mean sitting diastolic blood pressure >/=90 to </=105mmHg. Subjects
             taking one hypertensive medication had their medication withdrawn and entered a
             wash-out phase prior to randomization.

        Exclusion Criteria:

          -  Subject taking two or more antihypertensive medications, known contraindication to
             angiotensin-converting enzyme (ACE) inhibitors or alpha- or beta-blocker therapy,
             subject has Type 1 or Type 2 diabetes
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Condition: Tetanus; Diphtheria; Acellular Pertussis
MeSH terms: Diphtheria
Intervention: Infanrix™/Hib; Infanrix; Hiberix
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 660.0
Sex: All
Minimum age: 90 Days
Maximum age: 120 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and
      Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and
      immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female between, and including, 90 and 120 days of age at the time of the
             first vaccination,

          -  written informed consent obtained from the parent or guardian of the subject

        Exclusion Criteria:

          -  Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus
             influenzae disease can not participate,

          -  Subjects who have received previous vaccination against diphtheria, tetanus, acellular
             pertussis and/or Haemophilus influenzae type b diseases can not participate.
Stepping Stones and Creating Futures Intervention Trial
Condition: IPV; Sexual Violence
Intervention: Stepping Stones and Creating Futures
Intervention description: Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills.
Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1351.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: informal settlements; poverty

Summary:

      This study evaluates whether the behavioural/structural interventions of Stepping Stones and
      Creating Futures can reduce the incidence of intimate partner violence in urban informal
      settlements amongst young people. Half the participants will receive the interventions, while
      the other half will be in a control wait-list, only receiving the intervention after final
      data collection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normally resident in informal settlement cluster

          -  Not formally employed

          -  Able to communicate in main study languages (English, isiZulu, iXhosa)

        Exclusion Criteria:

          -  Under 18

          -  Mental deficit (learning difficulty, mental illness or substance abuse)
Hormone and Information Processing Study
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: testosterone gel; placebo gel
Intervention description: 50-100mg applied topically daily for six months; applied topically daily for six months
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: Male
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: selective androgen receptor modulators (SARMs); hormone replacement therapy; age-associated cognitive decline; testosterone supplementation

Summary:

      The purpose of this study is to examine the effects of testosterone (T) replacement on
      changes in thinking and memory, as well as mood in older men with mild cognitive impairment
      (MCI) and low T levels. The study will also examine whether taking testosterone has effects
      on biological markers related to Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male 60-90 years of age

          -  Diagnosis of mild cognitive impairment (MCI)

          -  Low testosterone level

          -  Primary language is English

          -  Availability of an informant who knows the participant well enough to answer questions

          -  Stable medications for the previous 3 months

          -  Normal complete blood count (CBC), and no clinically significant blood chemistry

          -  American Urological Association (AUA) symptom score less than or equal to 19

          -  Body Mass Index (BMI) less than 33 and stable weight in the previous year

        Exclusion Criteria:

          -  Prior history of prostate cancer or prostate specific antigen level greater than
             4.0ng/ml

          -  Peripheral or vascular disease

          -  Significant history of alcohol abuse, current alcohol abuse (more than 2 drinks per
             day), or other substance abuse

          -  History of severe head injury (with loss of consciousness greater than 30 minutes)

          -  Significant neurological illness, such as Parkinson's disease, seizure disorder,
             multiple sclerosis, major stoke

          -  Smokes cigarettes

          -  Major psychiatric illness, such as schizophrenia or bipolar disorder

        Prohibited Medications:

          -  Anti-convulsants

          -  Anti-psychotics

          -  Sedating antihistamines

          -  Sedative/hypnotics

          -  Benzodiazepines

          -  Hormone or testosterone regimens

          -  Gonadotropin-releasing hormone (GNRH) antagonists

          -  Flutamide

          -  Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable
             dose for 3 months or more