bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Anifrolumab
Intervention description: Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is an Open Label Extension study.
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus

Summary:

      The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in
      adults with moderate to severe active systemic lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be willing to use 2 methods of effective contraception

          -  Must have venous access

          -  Must be willing to forego participation in other clinical trials for SLE.

        Exclusion Criteria:

          -  Any concurrent condition that in the opinion of the investigator would interfere with
             the evaluation of the investigational product

          -  Major surgery within 8 weeks before signing informed consent form (ICF)

          -  Elective major surgery planned during the study period

          -  Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day,
             Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or
             intramuscular methotrexate > 25 mg/week

          -  A live or attenuated vaccine within 4 weeks of signing the ICF

          -  Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: dabigatran
Intervention description: Experimental dose chosen based on age and weight
Intervention MeSH terms: Dabigatran
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      The aim of the study is to investigate the safety and tolerability of dabigatran etexilate
      solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to
      older children and adults and to confirm dabigatran etexilate dosing algorithm for children
      aged less than 1 year.
    

Eligibility criteria:

        Inclusion criteria:

          -  Neonates and infants with aged < 12 months at Visit 1

          -  Objective diagnosis of VTE

          -  End of planned treatment course with anticoagulant therapy as per standard of care at
             the investigator site.

          -  Written informed consent provided by the patient's parent(s) (or legal guardian)
             according to local regulations at Visit 1.

        Exclusion criteria:

          -  Weight less than 3 kg at Visit 1

          -  Conditions associated with an increased risk of bleeding

          -  renal dysfunction

          -  hepatic disease

          -  Anemia or thrombocytopenia at screening
Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
Condition: Leukemia; Acute Disease; Acute Myeloid Leukemia; Nonlymphocytic Leukemia; Myelodysplastic Syndromes
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Acute Disease
Intervention: vosaroxin
Intervention description: Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Leukemia; Myeloid; Elderly; Hematologic; Blood; Cancer; Malignancy; SNS-595; Sunesis; Hematologic Diseases; Myelodysplastic Syndromes; Older; voreloxin; reveal-1

Summary:

      This study will evaluate the overall remission rate of treatment with vosaroxin (formerly
      voreloxin) Injection in patients at least 60 years of age with previously untreated AML
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. At least 60 years of age and diagnosis of previously untreated AML (either de novo or
             from an antecedent hematologic disorder or therapy related AML)

          2. At least 20% blasts by BM biopsy or aspirate

          3. ECOG performance status of 0,1,or 2

          4. Adequate cardiac, renal and liver function

        Key Exclusion Criteria:

          1. Uncontrolled DIC

          2. Active central nervous system involvement by AML

          3. Requiring hemodialysis or peritoneal dialysis

          4. Some prior history of heart attack or stroke (depending on how long ago the event
             occurred)
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
Condition: Gastro-oesophageal Junction Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: AZD4547; paclitaxel
Intervention description: Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule.; Infusion administered once a week, 3 weeks on and 1 week off
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 960.0
Sex: All
Minimum age: 25 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: gastro-oesophageal junction cancer; gastric cancer; lower third oesophageal cancer; polysomy; amplification; FGFR

Summary:

      The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547
      compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose
      tumours are found to have FGFR2 polysomy or gene amplification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male aged 25 or over

          -  Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma
             (including adenocarcinoma of the lower third of the oesophagus or the gastro
             oesophageal junction )

          -  Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy
             for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.

          -  At least one lesion, not previously irradiated, that has baseline at least 10mm in the
             longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT)
             or Magnetic Resonance Imaging (MRI)

          -  Provision of either an archival tumour sample or a fresh tumour sample for
             confirmation of FGFR2 polysomy/gene amplification

        Exclusion Criteria:

          -  Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in
             structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in
             cremophor EL (polyoxyethylated castor oil)

          -  Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant
             therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or
             any cancer treatment within 4 weeks before the first dose of the study treatment

          -  With the exception of alopecia, any unresolved toxicities from prior therapy with a
             Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study
             treatment.

          -  Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling
             outside of the reference ranges in the protocol inclusion/exclusion section.

          -  Taking other regular medication that are predicted to interact with AZD4547 due to
             their route of metabolism.
Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: placebo; BI1356 low dose; BI1356 high dose
Intervention description: comparison of different dosages of drug (low vs high) vs placebo; comparison of different dosages of drug (low vs high) vs placebo; comparison of different dosages of drug (low vs high) vs placebo
Intervention MeSH terms: Linagliptin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 40.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to identify the dose of linagliptin in paediatric
      patients.

      Other efficacy objectives include the comparison of the lowering effect of linagliptin low
      dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of
      treatment.

      Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD)
      and the PK/PD relationship of linagliptin in the paediatric population.
    

Eligibility criteria:

        Inclusion criteria:

          1. Paediatric patients (children and adolescents), aged 10 to 17 years with documented
             diagnosis of type 2 diabetes mellitus

          2. Insufficient glycaemic control (i.e. an HbA1c > 6.5% and <= 10.5%) despite treatment
             with diet and exercise and/or metformin (>= 1000 mg per day (or the maximum tolerated
             dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or
             concomitant stable basal insulin (total daily dose must be <= 0.5U/kg with less than
             10% of weekly dose change for 12 weeks prior to randomisation)

          3. Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase
             (GAD) auto-antibodies

          4. C-peptide levels (serum) >= 1.5 ng/ml (at 90 min following a Boost challenge)

        Exclusion criteria:

          1. History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3
             months

          2. Current short-acting insulin or having received short-acting insulin for more than 3
             days within 1 month prior to randomisation

          3. Treatment with weight reduction medications (including anti-obesity treatments)
A Study of LY2623091 in Participants With High Blood Pressure
Condition: Primary Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: LY2623091; Tadalafil; Spironolactone; Placebo
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Spironolactone; Tadalafil; Mineralocorticoid Receptor Antagonists; Mineralocorticoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as LY2623091 in participants with high blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a history of hypertension.

          -  If participants are naïve to treatment of hypertension, or have not been treated with
             any antihypertensive medications within the 30 days immediately prior to screening:

               -  Have seated systolic (SBP) of ≥140 and <170 millimeters of mercury (mmHg) at
                  screening and at the end of the lead-in period.

          -  If participants are currently being treated for hypertension:

               -  Are taking a stable dose of 1 or 2 antihypertensive medications for at least the
                  previous 30 days. A combination antihypertensive medication from 2 classes is
                  considered as 2 antihypertensive medications.

               -  Are willing to discontinue the antihypertensive medications during the study.

               -  Have seated SBP of ≥140 and <170 mmHg at the end of the lead-in period.

          -  Have a body mass index (BMI) ≥18.5 and <40 kilograms/m^2.

        Exclusion Criteria:

          -  Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP)
             ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or
             hospitalization due to hypertension.

          -  Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or
             randomization.

          -  Have a history of hospitalization due to hyperkalemia, or history of drug
             discontinuation due to elevated serum potassium levels.

          -  Have a serum potassium ≤3.5 or >5.0 millimoles per liter (mmol/L).

          -  Have an estimated glomerular filtration rate (eGFR) <50 milliliters/minute/1.73 m^2.
Fexofenadine Use in Gastroesophageal Reflux Symptoms
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Fexofenadine; Placebo - Cap
Intervention description: Fexofenadine 180 mg in the morning; Placebo cap in the morning
Intervention MeSH terms: Fexofenadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The investigators wish to study the effectiveness of Fexofenadine (an over the counter
      allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still
      have symptoms despite being on a proton pump inhibitor. The investigators will do this by
      giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill)
      for 2 weeks. The participants will not know which drug they are getting at a particular time.
      This will help the investigators better assess the true effectiveness of Fexofenadine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A minimum 6-month history of heartburn and regurgitation, as their main symptom

          -  Experience at least 3-4 days with episodes of heartburn or regurgitation per week

          -  Female patients who are postmenopausal or using acceptable methods of birth control.

        Exclusion Criteria (selected)

          -  Esophageal stricture

          -  Primary esophageal motility disorder

          -  Systemic sclerosis

          -  Active inflammatory bowel disease

          -  Zollinger-Ellison syndrome

          -  Active gastric or duodenal ulcer

          -  Active infectious or inflammatory conditions of the small or large intestine

          -  Malabsorption syndromes of the intestine

          -  History of gastrointestinal cancer

          -  Current active cancer

          -  Prior gastric or intestinal surgery

          -  Pregnant or breast feeding

          -  Other serious psychiatric or medical disease
Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Cabergoline; Norethindrone acetate
Intervention MeSH terms: Cabergoline; Norethindrone; Norethindrone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Female
Minimum age: 15 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent,
      cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of
      endometriosis-associated pain in young women with endometriosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Surgically confirmed endometriosis

          -  Age between 15-40 y, and premenopausal

          -  Pelvic pain score ≥3 on a Visual Analog Scaleover the last month

        Exclusion Criteria:

          -  Use of other concurrent hormone medications (such as birth control pills)

          -  Impaired liver function (ALT > 2x normal) or liver disease (cirrhosis, hepatitis)

          -  Pregnancy

          -  Breast cancer

          -  Active thromboembolic disease

          -  Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic
             disorders
Vision Response to Dopamine Replacement
Condition: Albinism; Oculocutaneous Albinism
MeSH terms: Albinism; Albinism, Oculocutaneous
Intervention: Levodopa/carbidopa
Intervention description: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
Intervention MeSH terms: Levodopa; Carbidopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No
Keywords: levodopa; Albinism; dopamine; oculocutaneous albinism; vision; retina function

Summary:

      The purpose of the study is to evaluate and document physiologic and functional changes in
      visual performance and retinal function of patients diagnosed with albinism (a dopamine
      deficiency state) following a trial of oral Levodopa/carbidopa treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of oculocutaneous albinism

          -  age over 3 and weight over 25 lbs.

        Exclusion Criteria:

          -  ocular only albinism

          -  ocular pathology other than albinism

          -  neurologic disease, history of myocardial infarction, history of clinical depression,
             pregnancy
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
Condition: Premalignant Vulvar Lesion; Benign Vulvar Lesion
MeSH terms: Precancerous Conditions
Intervention: Cefazolin
Intervention description: -If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
Intervention MeSH terms: Cefazolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The principal investigator along with all members of the study team involved in data analysis as well as the patients will be blinded to the randomization group. The research assistant will disclose the randomization group to the anesthesiologist who will screen the patient for allergies and then obtain the appropriate antibiotics from the pharmacy and administer the antibiotics as appropriate. These will be administered prior to the procedure and so the surgeon will remain blinded to the administration
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A randomized control trial will provide the most reliable data to determine the role of
      prophylactic antibiotics to decrease the wound complication rate. The investigators plan to
      perform a pilot study to evaluate actual rates of wound complications and how long it takes
      to recruit 50 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All women, >=18 undergoing vulvar surgery

          -  Biopsy proven benign or premalignant lesion requiring surgical management.

          -  Women of childbearing age will be required to have a negative human chorionic
             gonadotropin (HCG) test within seven days of surgery.

          -  Scheduled to undergo surgical management for their vulvar disease supervised by a
             faculty member within the Division of OBGYN at Washington University School of
             Medicine

          -  Ability to understand and willingness to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable).

        Exclusion Criteria:

          -  Women who are pregnant

          -  Women scheduled to undergo a radical vulvectomy

          -  Women scheduled to undergo a concomitant graft, flap or plastic surgery

          -  Women <18 years of age

          -  History of prior vulvar radiation

          -  Inability to sign an informed consent form prior to registration on study

          -  Inability to understand spoken or written English

          -  Prisoner