bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; placebo
Intervention description: Treatment Group 1: 10 mg BID CP-690,550 (100 subjects). Strata 1: 10 mg BID CP-690,550 on background methotrexate (50 subjects); Strata 2: 10 mg BID CP-690,550 monotherapy (50 subjects).; Placebo CP-690,550 (100 subjects). Strata 1: Placebo CP-690,550 on background methotrexate (50 subjects); Strata 2: Placebo CP-690,550 monotherapy (50 subjects). Influenza and pneumococcal vaccines will be administered to all subjects
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response
      Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid
      Arthritis receiving CP-690,550 with and Without background Methotrexate
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject must meet the American College of Rheumatology (ACR) classification
             criteria for the diagnosis of RA by satisfying at least four of the seven criteria.

          -  The subject must have active disease at both screening and baseline

        Exclusion Criteria:

          -  History of any documented influenza or pneumococcal infection within the last 3
             months.

          -  Receipt of any vaccine within 1 month prior to the initial study drug administration
             (CP-690,550 or placebo CP-690,550).

          -  If a subject has received an influenza vaccine within 6 months or a pneumococcal
             vaccine within 5 years of initial study drug administration.
Thiamine as a Metabolic Resuscitator After Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Intervention: Thiamine 500 mg IV; Placebo
Intervention description: Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.; 100mL of intravenous normal saline will be given every 12hours for 5 doses in the placebo arm
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A randomization list was prepared by an independent statistician using 1:1 randomization in blocks of four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 500mg dose is mixed in 100mL of normal saline. Placebo will be 100mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac arrest; post-arrest

Summary:

      This is a randomized, double-blind, placebo controlled study to investigate the effect of
      intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen
      consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA).
      .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient (age ≥ 18 years)

          -  Cardiac arrest occurring with sustained (> 20 minutes) return of spontaneous
             circulation (ROSC)

          -  Within 4.5 hours of cardiac arrest event

          -  Lactate >/=3

        Exclusion Criteria:

          -  Clinical indication for thiamine administration (alcoholism, known or highly suspected
             deficiency) or treatment with thiamine beyond the amount found in a standard
             multivitamin within the last 10 days

          -  Traumatic etiology of arrest

          -  Comfort measures only or anticipated withdrawal of support within 24 hours

          -  Protected populations (pregnant women, prisoners)

          -  Known allergy to thiamine
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Etokimab; Placebo
Intervention description: Humanized monoclonal antibody, administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ANB020; etokimab; eczema; moderate to severe

Summary:

      This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of
      multiple doses of etokimab in adult participants with atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participants must be 18 to 75 years of age, at the time of signing the
             informed consent.

          2. Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m^2) at screening.

          3. Clinically confirmed diagnosis of AD.

          4. Eczema Area and Severity Index (EASI) score ≥ 16, body surface area (BSA) involvement
             ≥ 10%, and an Investigator's Global Assessment (IGA) score (5-point scale) ≥ 3 at
             baseline.

          5. Participants with a history of inadequate response to topical treatment, use of
             systemic treatments to treat AD, and/or for whom topical treatments are otherwise
             medically inadvisable.

          6. Daily use of non-medicated emollient for at least 7 days prior to baseline.

        Exclusion Criteria:

          1. Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole
             within 2 weeks before dosing.

          2. Prior exposure to an anti-interleukin (IL)-33 antibody.

          3. Exposure to an investigational or licensed or other anti T-helper 2 (Th2) type
             cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is
             longer.

          4. History of prior exposure to any investigational or biologic systemic treatment within
             5 half lives of the screening or is currently enrolled in another clinical study.

          5. Have received systemic treatment for AD (including systemic corticosteroids,
             immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning
             booth) within 4 weeks before screening.

          6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or
             murine monoclonal antibodies.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Geodon for the Treatment of Refractory Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Ziprasidone; Sertraline
Intervention description: Sertraline augmentation with ziprasidone; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Intervention MeSH terms: Ziprasidone; Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: anxiety disorder; SAD; ziprasidone; sertraline; antidepressant; antipsychotic

Summary:

      The purpose of this study is to examine the effectiveness and tolerability of augmentation
      treatment of ziprasidone to achieve remission among patients with social anxiety disorder
      (SAD) who did not remit on sertraline treatment alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults 18-65 years of age

          -  primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria

          -  minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline

          -  minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline

          -  written informed consent

          -  negative serum pregnancy test for women of childbearing potential

          -  normal EKG

        Exclusion Criteria:

          -  current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic
             disorder, mental retardation or other pervasive developmental disorder, or cognitive
             disorder due to a general medical condition

          -  any current primary anxiety disorder other than SAD

          -  current primary depression

          -  history of substance abuse or dependence within the last 3 months

          -  suicide risk or serious suicide attempt within the last year

          -  clinically significant medical condition or laboratory or EKG abnormality

          -  women of childbearing potential who are unwilling to practice an acceptable method of
             contraception

          -  patients needing concurrent use of psychotropic medications

          -  history of hypersensitivity to sertraline or ziprasidone

          -  recent (less than 2 months) initiation of psychotherapy for SAD

          -  history of failure to respond to augmentation with an adequate trial of an atypical
             antipsychotic

          -  patients who are currently taking any of the following medications: Erythromycin,
             Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and
             Levitra
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
Condition: HER2 Positive Breast Carcinoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Copper Cu 64-DOTA-Trastuzumab; Laboratory Biomarker Analysis; Pertuzumab; Positron Emission Tomography; Therapeutic Conventional Surgery; Trastuzumab
Intervention description: Given IV; Correlative studies; Given IV; Undergo PET; Undergo surgery; Given IV
Intervention MeSH terms: Copper; Antineoplastic Agents, Immunological; Trastuzumab; Pertuzumab; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission
      tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab
      before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive
      breast cancer that has spread from where it started to nearby tissue or lymph nodes.
      Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a
      patient's response to trastuzumab and pertuzumab before surgery in patients with locally
      advanced HER2 positive breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be women who have histological confirmation of HER2 positive breast
             cancer

          -  The primary tumor must be >= 2.0cm in size and/or have biopsy proven axillary nodes
             that are >= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging
             (MRI)

          -  The current cancer must over express HER2 as determined by immunohistochemistry (IHC)
             and/or fluorescence in situ hybridization (FISH)

          -  Patients may not have received prior HER2 directed therapies

          -  Participants must have normal cardiac ejection fraction (per label, as defined as
             institutional normal)

          -  Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and
             chemotherapy

          -  Ability to provide informed consent

          -  Negative Serum Pregnancy test

        Exclusion Criteria:

          -  Participants who are not considered candidates for pertuzumab + trastuzumab +
             chemotherapy

          -  Concurrent malignancy other than non-melanoma skin cancer

          -  Patients must not have known metastatic disease

          -  Patients must not have received prior treatment for the current breast cancer
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: testosterone matrix transdermal system
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hypogonadism, testosterone, transdermal system

Summary:

      Watson's testosterone transdermal system delivers male sex hormone through skin for the
      treatment of men with sex hormone insufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, 18 - 65 years of age;

          -  Documented testosterone deficiency;

          -  BMI 18 to 33.

        Exclusion Criteria:

          -  Evidence of prostate cancer and benign prostate hyperplasia;

          -  Taking medications that interfere testosterone metabolism;

          -  History of alcohol or drug substance abuse;

          -  Abnormal ECG;

          -  Allergic to transdermal products;

          -  Skin condition that interfere transdermal system application and assessment
Propranolol Dose Escalation in Lymphedema in Patients
Condition: Primary Lymphedema
MeSH terms: Lymphedema
Intervention: Propranolol
Intervention description: escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day
Intervention MeSH terms: Propranolol
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: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to investigate the safety and efficacy of propranolol in the treatment of
      patients with primary lymphedema. The primary goal is to assess patient tolerability of
      increasing doses of propranolol. The secondary goal is to assess lymphedema symptoms and
      signs in response to propranolol treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary lymphedema

          -  Measurable disease

          -  Adequate functional status: Karnofsky >50% (>age 16), Lanky >50 (<age 16),

          -  No prior therapy within 4 weeks of enrollment

          -  Adequate bone marrow, renal function, cardiac, and pulmonary function, negative
             pregnancy test (for women).

        Exclusion Criteria:

          -  Secondary lymphedema

          -  Patients already receiving other investigational drugs

          -  Patients with known contraindications to receiving propranolol

          -  Other medical comorbidities including but not limited to: pheochromocytoma,
             bradycardia, bronchospasm/reactive airway disease, decompensated heart failure, heart
             block, ongoing active infections.
A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
Condition: Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin
Intervention: brentuximab vedotin
Intervention description: 1.8 mg/kg every 3 weeks by IV infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases; Lymphoma

Summary:

      This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and
      safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or
      refractory ALCL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with relapsed or refractory systemic ALCL who have previously received front
             line chemotherapy.

          -  Documented anaplastic lymphoma kinase (ALK) status.

          -  Histologically-confirmed CD30-positive disease; tissue from the most recent post
             diagnostic biopsy of relapsed/refractory disease must be available for confirmation of
             CD30 expression via slides or tumor block.

          -  Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by
             both positron emission tomography and spiral computed tomography.

          -  Received any previous autologous stem cell transplant at least 12 weeks (3 months)
             prior.

          -  At US sites, patients greater than or equal to 12 years of age may be enrolled. At
             non-US sites, patients must be greater than or equal to 18 years of age.

        Exclusion Criteria:

          -  Previous treatment with brentuximab vedotin.

          -  Previously received an allogeneic transplant.

          -  Patients with current diagnosis of primary cutaneous ALCL (patients who have
             transformed to systemic ALCL are eligible).

          -  Known cerebral/meningeal disease.
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Alogliptin; Alogliptin; Alogliptin; Alogliptin; Voglibose
Intervention description: Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.; Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.; Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.; Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.; Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Intervention MeSH terms: Alogliptin; Voglibose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 438.0
Sex: All
Minimum age: 29 Years
Maximum age: 87 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy

Summary:

      The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once
      daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40
      consecutive weeks in participants who completed a phase 2 dose-ranging study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had completed the phase 2 dose-ranging study (i.e., the subject had completed the
             study visit at Week 12).

        Exclusion Criteria:

          -  Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase
             or alanine aminotransferase value 2.5 times or more of the upper reference limit at
             Week 8 of treatment in the phase 2 dose-ranging study).

          -  Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL
             or more at Week 8 of treatment in the phase 2 dose-ranging study).
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Condition: Infertility
MeSH terms: Infertility
Intervention: Kisspeptin 1.6nmol/kg; Kisspeptin 3.2nmol/kg; Kisspeptin 6.4nmol/kg; Kisspeptin 9.6nmol/kg; Kisspeptin 12.8nmol/kg; Kisspeptin 9.6 nmol/kg double; Kisspeptin 9.6 nmol/kg + saline
Intervention description: single kisspeptin dose 1.6 nmol/kg subcutaneously; single kisspeptin dose 3.2 nmol/kg subcutaneously; single kisspeptin dose 6.4 nmol/kg subcutaneously; single kisspeptin dose 9.6 nmol/kg subcutaneously; single kisspeptin dose 12.8 nmol/kg subcutaneously; kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously; kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Different dose for each volunteer
Masking: Double (Participant, Care Provider)
Masking description: participants and IVF physicians were blinded.
Enrollment: 175.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: No
Keywords: kisspeptin; infertility; in vitro fertilisation

Summary:

      We want to find out if kisspeptin is successful in stimulating oocyte maturation when it is
      used as a 'trigger' injection during IVF therapy for infertility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 - 34 years

          -  Body mass index between 18 and 29 kg/m2

          -  Stable body weight for at least 3 months

          -  Normal early menstrual cycle follicular phase serum FSH concentration

          -  Serum anti-Mullerian hormone (AMH) > 40pmol/L

          -  No more than one previous IVF treatment cycle

          -  Both ovaries intact

        Exclusion Criteria:

        History of any medical, psychological or other condition, or use of any medications,
        including over-the-counter products, which, in the opinion of the investigators, would
        either interfere with the study or potentially cause harm to the volunteer

          -  Without access at home to a telephone, or other factor likely to interfere with
             ability to participate reliably in the study

          -  Treatment with an investigational drug within the preceding 2 months

          -  Donated blood during the preceding 3 months or intention to do so before the end of
             the study

          -  Previous poor response to IVF treatment