bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Efficacy of Single-agent Carlumab (an Anti-Chemokine Ligand 2 [CCL2]) in Participants With Metastatic Castrate-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Carlumab
Intervention description: Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Infusion; Carlumab; CNTO 888

Summary:

      The purpose of this study is to determine the safety and effectiveness of the study drug
      carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the
      gland that makes fluid that aids movement of sperm).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological documentation of adenocarcinoma of the prostate

          -  Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and
             had disease progression following the last therapy

          -  Serum prostate specific antigen (PSA) greater than or equal to 5.0 nanogram/milliliter
             (ng/ml) within 4 weeks prior to the first dose of study agent

          -  Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50
             nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks
             prior to the first dose of study agent

          -  At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study
             agent

        Exclusion Criteria:

          -  Experience a hormonal treatment withdrawal response (including a lowering of PSA that
             was previously rising or symptomatic improvement)

          -  Known or symptomatic Central Nervous System metastases

          -  Residual toxicities resulting from previous therapy that are Grade 2 or more (except
             for alopecia)

          -  Known allergies, hypersensitivity, or intolerance to carlumab or its excipients or
             clinically significant reactions to chimeric or human proteins

          -  Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of
             study agent
Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: PS-341, doxorubicin
Intervention description: bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle
Intervention MeSH terms: Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary objective is to determine the effectiveness of the combination of bortezomib and
      doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase
      II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with
      doxorubicin IV on days 1 and 8 of a 21-day cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologically confirmed metastatic breast cancer

          -  Measurable or evaluable disease

          -  Age > 18, PS 0,1,2

          -  MUGA > 45%

          -  Received one or fewer chemotherapies or investigational regimens for metastatic
             disease, no limit to the number of prior hormonal therapies. May have had single agent
             Herceptin and/or Herceptin plus single-agent chemotx.

          -  Must meet designated laboratory criteria within 14 days of enrollment

        Exclusion Criteria:

          -  Doxorubicin for metatstatic disease.

          -  Pregnant or lactating.

          -  Active infections, no myocardial infarction within 2 months of enrollment.

          -  Investigational drugs within 14 days of enrollment.

          -  Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4
             weeks of enrollment.

          -  Neuropathy that is > grade 2.

          -  Active brain mets.

          -  Hypersensitivity to bortezomib, boron, or mannitol.
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: UB-311; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine
      (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and
      immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the
      secondary endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mild Alzheimer's Disease

          -  Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)

          -  Clinical dementia rating (CDR) scores of 0.5 or 1

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Clinically significant neurological disease other than Alzheimer's disease

          -  Major psychiatric disorder

          -  Severe systemic disease

          -  Serious adverse reactions to any vaccine

          -  Other exclusion criteria apply
Early Versus Delayed BCG Vaccination of HIV-exposed Infants
Condition: HIV Exposure; HIV Infection
MeSH terms: HIV Infections
Intervention: BCG
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Maximum age: 24 Hours
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine immunogenicity; Immune activation

Summary:

      In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected
      children develop AIDS and die faster in SSA than those in developed countries. Bacille
      Calmette-Guerin (BCG) vaccine is given to infants at birth in SSA to protect them from severe
      forms of TB. BCG is known to cause immune cells to be active and replicate faster. The immune
      system of neonates also responds differently to BCG that to other vaccines and infections. We
      hypothesize that the routine immunization of neonates with BCG contributes to generalized
      immune activation in HIV-exposed infants resulting in skewed immune responses to vaccines and
      infections and increased rates of disease progression in those infants that become
      HIV-infected. However, delaying BCG until HIV testing is completed would result in
      operational difficulties, and may not induce the appropriate immune response. Delayed BCG
      would also render many HIV-exposed uninfected infants at high risk for disseminated TB. We
      plan to assess immune cells in infants to determine the impact of the timing of BCG
      vaccination on immune responses to tuberculosis (TB) and other vaccines. We will also compare
      the immune activation and disease progression of those infants that become HIV-infected in
      the BCG or control arms. Our results will provide key insights into the effect of BCG
      vaccination on immune responses to HIV as well as inform the optimal timing of BCG
      vaccination for HIV-exposed infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy neonate

          -  Maternal HIV

          -  > 36 weeks gestation

          -  Birth weight > 2.4kg

          -  Remaining in area 4 months

        Exclusion Criteria:

          -  Complications during pregnancy and delivery

          -  Household TB contacts
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: TMC207; Placebo; Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
Intervention description: TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.; Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.; Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
Intervention MeSH terms: Bedaquiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Tuberculosis; MDR TB

Summary:

      The objective of this study is to demonstrate that the antibacterial activity of TMC207 is
      better than placebo when added to a standardized Background Regimen (BR) for treatment of
      multi-drug resistant TB. Also safety and tolerability will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of non-childbearing potential

          -  Patients with newly diagnosed sputum smear-positive pulmonary MDR-TB infection

          -  Patients must consent to HIV-testing

          -  Patients must be willing to discontinue all TB drugs to allow 7 days washout

          -  Patients having normal weight

          -  Patients are willing to be hospitalized per standard of care.

        Exclusion Criteria:

          -  Previously having been treated for MDR-TB

          -  Having a significant cardiac arrhythmia that requires medication

          -  For HIV infected patients, having a CD4+ count < 300 cells/µL

          -  Patients with complicated or severe extrapulmonary manifestations of TB or
             neurological manifestations of TB

          -  Patients who will require surgical procedure for management of their TB

          -  Evidence of chorioretinitis, optic neuritis, or uveitis at screening

          -  Having had a drug susceptibility test performed prior to screening and being not
             susceptible to at least 3 of the 5 classes of TB drugs used to treat MDR-TB

          -  Women who are pregnant and/or breastfeeding.
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Alogliptin; Alogliptin; Alogliptin; Alogliptin; Voglibose; Placebo
Intervention description: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks; Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks; Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.; Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Intervention MeSH terms: Alogliptin; Voglibose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 480.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy

Summary:

      The purpose of this study was to evaluate the dose-response relationships of alogliptin, once
      daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal
      clinical dose for type 2 diabetic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after
             the start of screening(Week -4).

          -  A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the
             start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from
             the HbA1c value at the start of screening.

          -  Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4
             weeks or longer before the start of screening (Week -8).

        Exclusion Criteria:

          -  Received any antidiabetic drug within the last 4 weeks before the start of screening
             (Week -8) or during screening.
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Telotristat Etiprate; Placebo
Intervention description: 500 mg telotristat etiprate (LX1606) administered orally.; Matching placebo administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and
      preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in
      participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic
      acid/mesalamine therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ulcerative colitis of at least 6 months duration

          -  Disease extends at least 15 cm proximally from the anal verge, documented within the
             past 3 years

          -  Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is
             willing to remain on a stable dose for the duration of the study

          -  Age ≥18 and <70 years of age

          -  Able and willing to provide written informed consent

        Exclusion Criteria:

          -  Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis, or clinical findings suggestive of Crohn's disease

          -  Clinical signs of fulminant colitis or toxic megacolon

          -  History of dysplasia associated lesion or mass (DALM)

          -  Subjects who have had surgery for ulcerative colitis, or in the opinion of the
             investigator, are likely to require surgery for ulcerative colitis during the study

          -  History of primary sclerosing cholangitis

          -  Any physical or laboratory abnormality deemed by the investigator as clinically
             significant

          -  Major surgery within 60 days of Screening

          -  Use of any investigational agent within 30 days of Screening or any therapeutic
             protein or antibody within 90 days of Screening
The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass
Condition: Hypercalciuria; Hypercalciuria, Familial Idiopathic; Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Hypercalciuria
Intervention: Transdermal estradiol
Intervention description: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 40 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Hypercalciuria, Familial Idiopathic; Hypercalciuria; Osteopenia; Osteoporosis; Postmenopausal women

Summary:

      The purpose of this study is to assess if estrogen replacement normalizes urinary calcium
      excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for
      differences in response to estrogen replacement in women with familial hypercalciuria
      compared to nonfamilial hypercalciuria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women

          -  Diagnosis of hypercalciuria

          -  Diagnosis of low bone mass

          -  Vitamin D replete (serum 25-hydroxyvitamin D level >35 ng/mL)

        Exclusion Criteria:

          -  Secondary causes of hypercalciuria (primary hyperparathyroidism, sarcoidosis, vitamin
             D excess, malignant neoplasm, and renal tubular acidosis)

          -  Other metabolic bone disease (primary hyperparathyroidism, hyperthyroidism,
             hypercortisolemia, severe gastrointestinal disorders, liver cirrhosis, renal failure
             (Cr >1.5), active malignancy including multiple myeloma, rheumatological diseases, and
             Paget's disease of bone)

          -  Use of medications affecting bone and calcium metabolism (corticosteroids in the
             previous 3 months, suppressive dose of thyroid hormone, calcium channel blockers,
             anti-convulsants, aromatase inhibitors, thiazolidinediones, and cyclosporine A)

          -  History of coronary artery disease

          -  Breast cancer or suspected estrogen-dependent neoplasia

          -  Previous venous thromboembolic event

          -  Stroke

          -  Active liver disease

          -  Tobacco use within the past 6 months

          -  Negative colonoscopy within the previous 10 years or sigmoidoscopy within the previous
             5 years

          -  Negative mammogram within the previous 2 years

          -  Negative Pap smear within the previous 3 years in women < or = 65 years old with an
             intact cervix

          -  No vaginal bleeding within the prior 5 months.

          -  Age > or = 70

          -  > or = 20 years since last menstrual period or use of hormone replacement therapy
Sb-705498 Rectal Pain Study
Condition: Irritable Colon
MeSH terms: Irritable Bowel Syndrome
Intervention: SB-705498
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: TRPV1 antagonist; Fecal Urgency; rectal pain; IBS

Summary:

      SB-705498 has demonstrated efficacy in several preclinical and human experimental pain
      models. This study will investigate the efficacy of SB-705498 in patients with rectal pain.
      This will be a double-blind, placebo-controlled, two-way crossover study. 21 patients with
      faecal urgency (Group 1), and 21 patients with IBS (Group 2) will complete this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female/male aged 18-65.

          -  Women of child bearing potential must use an effective method of contraception

          -  Faecal urgency as defined by Chan

          -  ECG, which has no abnormalities

          -  Normal Clinical labs

          -  Informed consent and understand protocol requirements

          -  IBS subjects: Has irritable bowel syndrome (IBS) as defined by Rome II criteria

          -  Rectal hyperalgesia

        Exclusion Criteria:

          -  Any clinical or biological abnormality found at screen (other than those related to
             the disease under investigation)

          -  History of alcohol, substance or drug abuse

          -  Uncontrolled hypertension

          -  A history or presence of cardiovascular risk factors

          -  Participation in a trial within 3 months before the start of the study

          -  History of allergy

          -  Unable to withdraw from analgesic medications for their rectal hyperalgesia
             (opioid-dependent patients can be included if they are willing to withdraw from their
             opiate medication
Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: dalotuzumab; irinotecan hydrochloride; cetuximab; placebo
Intervention description: IV infusion; IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Irinotecan; Cetuximab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 558.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with
      cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic
      colorectal cancer (CRC) compared to cetuximab and irinotecan alone.

      The primary study hypothesis is that administration of dalotuzumab in combination with
      cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype
      improves Overall Survival OR Progression-free Survival compared to participants treated with
      cetuximab and irinotecan alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have confirmed wtKRAS CRC.

          -  Participant must have previously failed both irinotecan and oxaliplatin containing
             regimens, and should have progressed on or within 3 months of completing their last
             line of therapy with objective evidence of progression as verified by previous
             radiologic scans.

        Exclusion Criteria:

          -  Participant has had cancer treatment within 2 weeks before the first dose of study
             drug(s) or if the side effects from the drugs have not gone down to a certain level 2
             weeks before the first dose of study drugs.

          -  Participant has had a bad side effect to irinotecan therapy.

          -  Participant has human immunodeficiency virus (HIV).

          -  Participant has Hepatitis B or C.

          -  Participant is pregnant or breast feeding or planning to have a child while on this
             study.