bioihbjkbjnl/mcl2 huggingface dataset:
5-Alpha Reductase and Anabolic Effects of Testosterone
Condition: Male Hypogonadism; Muscle Atrophy; Sarcopenia; Benign Prostate Hypertrophy
MeSH terms: Sarcopenia; Muscular Atrophy; Prostatic Hyperplasia; Hypogonadism; Hypertrophy
Intervention: Testosterone Enanthate; Finasteride; Placebo
Intervention description: 125 mg, i.m. injection, once/week, for 52 weeks; 5 mg, oral, once/day, for 52 weeks; Placebo
Intervention MeSH terms: Methyltestosterone; Finasteride; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Male
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: anabolic effects; finasteride; male hypogonadism; sarcopenia; testosterone

Summary:

      The purpose of this study is to determine whether a higher-than-replacement dose of
      testosterone and finasteride can be combined to safely increase muscle strength in older men
      who have a low blood concentration of testosterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 60 years males

          -  Primary care at the Malcolm Randall VA Medical Center in Gainesville, Florida.

          -  Consenting subjects who have a morning (between 6:00 AM and 10:00 AM) serum total
             testosterone 300 ng/dL or bioavailable testosterone concentration 70 ng/dL and no
             exclusion criteria will be randomized to receive either testosterone or placebo.

        Exclusion Criteria:

          -  Subjects with cognitive impairment will be identified by the Mini-Cog test and
             excluded. The Mini-Cog has high sensitivity and specificity for cognitive impairment,
             and is not affected by level of education.

          -  We will also exclude subjects with receptive aphasia, or a contraindication to
             testosterone replacement (i.e., history of or active prostate or breast cancer, severe
             benign prostatic hyperplasia as assessed by elevated American Urologic Association
             Symptom Index (AUASI) score > 25), congestive heart failure (Class 3 or 4), sleep
             apnea syndrome, polycythemia (Hct > 55%), or prostate specific antigen (PSA) > 2.6
             ng/mL) will be excluded.

          -  Obese subjects (BMI > 35) will also be excluded.

          -  Subjects currently receiving testosterone supplementation or subjects who have an
             allergy to testosterone will also be excluded.

          -  Subjects previously receiving testosterone replacement therapy must be off such
             medication for at least four weeks.
Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: fostamatinib; placebo
Intervention description: fostamatinib 100 mg twice daily; placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on
      ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a
      disease-modifying anti-rheumatic drug (DMARD).

      The study will last for 57 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the
             age of 16

          -  Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints
             (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or
             C-reactive protein ≥10 mg/L.

          -  Currently taking one of the following disease-modifying anti-rheumatic drugs:
             methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.

          -  Patients without essential hypertension or with essential hypertension if their blood
             pressure is controlled (<140/90 mmHg) with anti-hypertensive medications being stable
             at least 4 weeks prior to randomisation.

        Exclusion Criteria:

          -  Females who are pregnant or breastfeeding.

          -  Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue
             diseases or chronic pain disorders

          -  History of liver problems that have required previous investigations

          -  Evidence of tuberculosis infection

          -  Conditions that preclude or render difficult the 24-hour ambulatory blood pressure
             monitoring technique.
Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001; ACC-001; ACC-001
Intervention description: IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18; IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18; IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 52 Years
Maximum age: 87 Years
Healthy volunteers: No

Summary:

      The purpose of this long term extension study is to assess safety, tolerability and
      immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD
      who were randomized in the preceding P2 double blind studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA
             (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.

          -  Screening brain MRI scan is consistent with the diagnosis of AD.

          -  MMSE score 10 and above.

        Exclusion Criteria:

          -  Significant neurological diseases other than AD.

          -  Brain MRI evidence of vasogenic edema during the preceding studies.

          -  Clinically significant illness.
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: AN2728 ointment, 2%; AN2898 ointment, 1%; AN2898 ointment vehicle; AN2728 ointment vehicle
Intervention description: AN2728 ointment, 2%, applied twice daily for 6 weeks; AN2898 ointment, 1%, applied twice daily for 6 weeks; AN2898 ointment vehicle applied twice daily for 6 weeks; AN2728 ointment vehicle applied twice daily for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: atopic dermatitis

Summary:

      The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and
      effective treatments for mild-to-moderate atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month

          -  Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding
             involvement of the face, scalp, and groin

          -  Presence of two (2) comparable target lesions

          -  Willing and able to apply study medications as directed, comply with study
             instructions, and commit to attending all visits

          -  Females of childbearing potential must use at least one highly effective method of
             birth control. Males with partners of childbearing potential should inform them of
             their participation in this clinical study and use highly effective methods of birth
             control during the study.

        Exclusion Criteria:

          -  Concurrent or recent use of certain topical or systemic medications or phototherapy
             without a sufficient washout period

          -  Active or potentially recurrent dermatologic condition other than atopic dermatitis in
             the target lesion area that may confound evaluation

          -  Significant confounding conditions as assessed by study doctor

          -  History or evidence of allergies requiring acute or chronic treatment (except seasonal
             allergic rhinitis)

          -  Participated in any other trial of an investigational drug or device within 30 days or
             participation in a research study concurrent with this study

          -  Pregnancy or lactation
Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: Axitinib; Radiation Therapy
Intervention description: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity; 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: GBM; brain tumor

Summary:

      The purpose of this study is to determine whether the addition of an investigational
      medication, axitinib, to radiation therapy will improve the outcome of treatment in patients,
      above the age of 70.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed patients with histologically proven glioblastoma multiforme

          -  Age above 70 years

          -  Karnofsky score of 50-80

          -  Adequate organ function as defined by laboratory values

          -  Life expectancy of >12 weeks

          -  No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood
             pressure readings taken at least 1 hour apart. The baseline systolic blood pressure
             readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be
             90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are
             eligible.

        Exclusion Criteria:

          -  Prior treatment with chemotherapy or radiation for glioblastoma multiforme

          -  Patients with extensive tumor hemorrhage

          -  Any of the following within the 12 months prior to study drug administration:
             myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,
             symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
             attack and 6 months for deep vein thrombosis or pulmonary embolism
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Linagliptin; Linagliptin; Linagliptin; Placebo; Glimepiride
Intervention description: Linagliptin medium dose tablet once daily; Linagliptin high dose tablet once daily; Linagliptin low dose tablet once daily; Placebo tablets once daily; Glimepiride tablets once daily
Intervention MeSH terms: Glimepiride; Linagliptin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 333.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objective of the study is to test the efficacy, safety and tolerability of several doses
      of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks
      together with metformin in patients with type 2 diabetes mellitus who are not at goal with
      their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as
      add-on therapy to metformin for comparison. The influence of several factors (gender, age,
      weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in
      this study.
    

Eligibility criteria:

        Inclusion criteria:

        Inclusion_Criteria:

          -  Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly
             treated with metformin alone or with metformin and one other oral antidiabetic d rug

          -  HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral
             antidiabetic drug

          -  HbA1c 7.5 10.0% at screening for patients treated with metformin alone

          -  HbA1c 7.5 10.0% at beginning of the placebo run-in phase

          -  Age > 21 and < 75 years

          -  MI > 25 and < 40 kg/m2 (Body Mass Index)

        Exclusion criteria:

        Exclusion_Criteria:

          -  Clinically relevant cardiovascular disease

          -  Impaired hepatic function

          -  Renal insufficiency or impaired renal function

          -  Treatment with rosiglitazone or pioglitazone within 6 months prior to screening

          -  Treatment with insulin within 3 months prior to screening
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: rMenB; rMenB+OMV NZ
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 40 Months
Maximum age: 62 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Pre-school; Meningococcal disease; Prevention; Vaccination

Summary:

      The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension
      study will be to explore antibody persistence in children at approximately 40 months of age
      and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ
      administered to subjects at approximately 40 months of age. Antibody persistence will be
      subsequently measured at 18-20 months after these booster doses when the subjects are 60
      months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be
      recruited in the study to serve as a baseline comparator for assessing antibody persistence
      at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.
      Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if
      they have not already received these vaccines prior to enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 40 to 44-months-old children, who participated and completed the study V72P9
             (follow-on subjects)

          -  Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)

        Exclusion Criteria:

          -  Previous ascertained or suspected disease caused by N meningitidis

          -  History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component

          -  Any serious chronic or progressive disease

          -  Known or suspected impairment/ alteration of the immune system

          -  Receipt of, or intent to immunize with another vaccine, within 30 days prior and after
             vaccination with the investigational vaccines (within 14 days for licensed flu
             vaccines)
Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Carboplatin
Intervention description: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles; 75 mg/m2, intravenous (IV), every 21 days x 6 cycles; Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first
      line combination therapy with either cisplatin or carboplatin in the palliative setting of
      stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be
      included in about 15 centers in Germany and randomized to one of the above treatment regimens
      in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a
      standard length of 21 days. Primary objective will be the Progression Free Survival Time of
      patients as assessed in both treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV

          -  No previous systemic chemotherapy for this cancer

          -  At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria
             In Solid Tumors (RECIST) criteria

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate
             organ function

          -  Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

        Exclusion Criteria:

          -  Serious concomitant systemic disorder or active infection

          -  Mild to moderate renal insufficiency, but unable to interrupt salicylates or other
             nonsteroidal anti-inflammatory drugs

          -  Symptomatic central nervous system (CNS) metastases requiring concurrent
             corticosteroid therapy

          -  Presence of clinically significant third-space fluid collections
Citalopram for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Citalopram; Citalopram; Placebo
Intervention description: 20 mg once per day for 9 weeks; 40 mg per day for 9 weeks; 0 mg per day for 9 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Cocaine; citalopram; treatment; serotonin

Summary:

      This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine
      dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent
      patients will be assigned equally to one of three medication conditions: placebo or the
      Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or
      40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase
      periods of sustained abstinence substantially more than placebo. Performance on a set of
      behavioral tasks of impulsivity will be analyzed as potential predictors of treatment
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between 18 and 60 years of age

          -  meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine
             dependence

          -  be in acceptable health on the basis of interview, medical history and physical exam

          -  able to provide the names of at least 2 persons who can generally locate their
             whereabouts.

        Exclusion Criteria:

          -  diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or
             nicotine

          -  have a psychiatric disorder or neurological disease or disorder requiring ongoing
             treatment and/or making study participation unsafe

          -  medical conditions contraindicating citalopram pharmacotherapy

          -  taking medications known to have significant drug interactions with the study
             medication

          -  pregnant or nursing for female patients

          -  having plans to leave the immediate geographical area within 3 months
A Study of LY3437943 in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3437943; Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in
      participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on
      diet and exercise alone or on a stable dose of metformin. This study will last about 43
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Type 2 Diabetes (T2D)

          -  Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and
             exercise alone or with a stable dose of metformin (either immediate release or
             extended release, 1000 milligram (mg)/day and not more than the locally approved dose)
             for at least 3 months prior to screening.

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus (T1DM)

          -  Have ketoacidosis

          -  Have retinopathy, maculopathy

          -  Have history of pancreatitis

          -  Have obesity induced by other endocrine disorders

          -  Have uncontrolled hypertension

          -  Have acute or chronic hepatitis

          -  Have chronic kidney disease

          -  Have an autoimmune abnormality for example, lupus or rheumatoid arthritis

          -  Have an active or untreated malignancy