bioihbjkbjnl/mcl2 huggingface dataset:
IV Glucose for Dehydration Treatment
Condition: Dehydration
MeSH terms: Dehydration
Intervention: 5% Dextrose (D5) in Normal Saline (NS); Normal Saline (NS)
Intervention description: D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS; NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 2 Months
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dehydration; Gastroenteritis; Dehydration in Gastroenteritis

Summary:

      To determine whether the addition of dextrose to IV fluids in the treatment of
      gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of
      dextrose containing fluids in the treatment of gastroenteritis will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females age 2 months to 12th birth date

          2. Gastroenteritis (as diagnosed by ED attending or fellow physician)

          3. Need for IV fluids

          4. Dextrose stick of greater than 60 and less than 170

          5. Parental/guardian English speaking and granting informed consent

        Exclusion Criteria:

          1. Underlying chronic disease affecting glucose metabolism or reason/persistence of
             symptoms: Renal failure, Diabetes Mellitus, Diabetes Insipidus, Metabolic Disorder, VP
             shunt, Migraine Headaches

          2. Shock

          3. Vomiting greater than 72 hours since onset of illness

          4. Patients that have received IV fluids at an outside institution within 12 hours
Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: gemcitabine; docetaxel; cisplatin; etoposide; radiation therapy
Intervention description: After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.; Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.; As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles); As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles); In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks
Intervention MeSH terms: Cisplatin; Gemcitabine; Docetaxel; Etoposide; Etoposide phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the 2 year survival of patients with Stage III unresectable non-small cell lung
      cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent
      chemotherapy and radiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologic or cytologic proof of single primary non-small cell lung cancer

          -  No prior chemotherapy or radiation therapy

          -  no prior malignancy

        Exclusion Criteria:

          -  pregnancy or breastfeeding

          -  serious concomitant systemic disorder

          -  unintentional weight loss greater than 10%
Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Clofarabine; Cytarabine; Decitabine
Intervention description: 20 mg/m^2 by vein as a 1- to 2-hour intravenous infusion daily for 5 days.; 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions.; 20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
Intervention MeSH terms: Cytarabine; Decitabine; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome; AML; MDS; Clofarabine; Ara-C; Cytarabine; Decitabine

Summary:

      The goal of this clinical research study is to learn if clofarabine given in combination with
      cytarabine and decitabine can help to control the disease in patients with AML or MDS who are
      60 years old or older. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previously untreated AML and high-risk MDS (>/= 10% blasts or >/= IPSS
             intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g.
             flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth
             factors is allowed.

          2. Age >/= 60 years.

          3. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.

          4. Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate
             transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x
             ULN) and renal function (creatinine </= 1.5 mg/dL).

          5. Sign written informed consent

        Exclusion Criteria:

          1. Cardiac ejection fraction < 40%.

          2. Prior therapy with clofarabine or decitabine.

          3. Active and uncontrolled disease/infection as judged by the treating physician.

          4. Pregnancy

          5. Acute promyelocytic leukemia (APL).

          6. Women of childbearing potential and men who do not practice contraception.

          7. Women of childbearing potential and men must agree to use contraception prior to study
             entry and for the duration of study participation.
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: AKB-6548; Placebo
Intervention description: oral dose administered once daily for 42 days; oral Placebo administered once daily for 42 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; safety; efficacy; tolerability; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic
      response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in
      pre-dialysis participants with anemia with repeat dosing for 42 days.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 79 years of age, inclusive

          -  Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis

          -  Hemoglobin (Hgb) ≤ 10.5 g/dL

          -  Transferring saturation ≥ 20%

          -  Ferritin ≥ 50 ng/mL

        Key Exclusion Criteria:

          -  Body mass index >42

          -  Red blood cell transfusion within 12 weeks

          -  Androgen therapy within the previous 21 days prior to study dosing

          -  Therapy with any approved or experimental erythropoiesis stimulating agent (ESA)
             within the 11 weeks prior to the Screening visit

          -  Participants meeting the criteria of ESA resistance within the previous 4 months

          -  Individual doses of intravenous iron of greater than 250 mg within the past 21 days

          -  Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal
             (ULN)

          -  Alkaline phosphatase >2x ULN

          -  Total bilirubin >1.5x ULN

          -  Uncontrolled hypertension

          -  New York Heart Association Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to
             dosing
Development of a Collapsible Folding Manual Wheelchair
Condition: Wheelchair Users
Intervention: Endeavor
Intervention description: Collapsible, forward folding manual wheelchair
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: manual wheelchair; assistive technology; travel wheelchair

Summary:

      The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding,
      ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in
      confined areas. This enables access to narrow environments such as those encountered in
      offices, restrooms, and transportation settings. When using the small access wheels, the
      wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead
      compartment. It is anticipated that the Endeavor will maximize mobility; increase access to
      confined areas; and ease the demands of travel for people with disabilities.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Use a manual wheelchair as a primary means of mobility.

          2. Male and females over the age of 18.

          3. The ability to adequately fit in a wheelchair with a 16" seat width.

          4. A minimum of 6 months experience using a manual wheelchair as primary means of
             mobility.

          5. Able to transfer independently.

          6. Drive own vehicle from vehicle seat.

        Exclusion Criteria:

          1. Active pressure sores as reported by subject.

          2. History of traumatic upper extremity injury that would prevent you from folding,
             lifting and storing a manual wheelchair.
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
Condition: Ovarian Carcinoma; Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: AZD2281
Intervention description: PARP inhibitor Olaparib tablets, oral
Intervention MeSH terms: Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 parallel arms for the 2 tumour types and the BRCA mutation groups:
Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally
High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
Known BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally.
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Breast cancer; Ovarian cancer; BRCA; Triple negative; Poly(ADP ribose) polymerases; Known BRCA or Recurrent High Grade Serious/ Undifferentiated Tubo- Ovarian Carcinoma; Known BRCA or Triple Negative Breast Cancer

Summary:

      This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with
      recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers
      to identify objective response rate and to assess for early markers of activity and to assess
      correlative markers that may provide helpful information for subsequent clinical trials.
      Approximately 110 patients from 7 centers in Canada will be enrolled into this study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary,
             fallopian tube or peritoneum

          -  Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast

          -  Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or
             undifferentiated tubo-ovarian carcinoma.

          -  Performance status of no more than 2.

        Exclusion Criteria:

          -  Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within
             4 weeks prior to entry

          -  Major surgery with 4 weeks of entering the study and must have recovered from effects
             of any major surgery .
Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
Condition: Neurogenic Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension
Intervention: Atomoxetine; Placebo
Intervention description: norepinephrine transporter inhibitor; placebo
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: norepinephrine transporter inhibitors

Summary:

      Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic
      hypotension are scarce and not effective. If left untreated, these patients have the highest
      risk of syncope, falls and fall-related injuries. The proposed study will determine the
      clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated
      with neurogenic orthostatic hypotension in patients with autonomic failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  40 years old or older

          -  Neurogenic Orthostatic Hypotension (defined by a reduction of ≥20 mmHg drop in SBP
             within 3 minutes of standing, associated with impaired autonomic reflexes as assessed
             by autonomic function tests.

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  Hypersensitivity to atomoxetine (severe allergic reaction, rash, urticaria,
             anaphylaxis)

          -  Use of other norepinephrine transporter inhibitors such as Wellbutrin (Bupropion),
             Cymbalta (Duloxetine), Effexor (venlafaxine), Pristiq (desvenlafaxine), Savella
             (milnacipran)

          -  Previous history (within 14 days prior to enrollment) and current use of monoamine
             oxidase inhibitors

          -  Concomitant use of strong CYP2D6 inhibitors such as delavirdine, paroxetine,
             fluoxetine, quinidine

          -  Pre-existing sustained severe hypertension (BP ≥ 140/80 mmhg in the sitting position)

          -  Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino
             transaminase [ALT] >2 x upper limit of normal range)

          -  Impaired renal function (serum creatinine equal or more than 1.6 mg/dl)

          -  Myocardial infarction within 6 months prior to enrollment

          -  Congestive heart failure (LV hypertrophy acceptable)

          -  History of serious neurologic disease such as cerebral hemorrhage, or stroke

          -  Inability to comply with the protocol, e.g., uncooperative attitude, inability to
             return for follow-up visits, unlikelihood of completing the study, and mental
             conditions rendering the subject unable to understand the nature, scope, and possible
             consequences of the study

          -  Narrow-angle glaucoma
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Condition: Neutropenia
MeSH terms: Neutropenia
Intervention: SPI-2012; Pegfilgrastim; Docetaxel; Cyclophosphamide
Intervention description: SPI-2012 SC injection.; Pegfilgrastim SC injection, per manufacturer's Prescribing Information.; Docetaxel given based on standard dose for chemotherapy.; Cyclophosphamide given based on standard dose for chemotherapy.
Intervention MeSH terms: Cyclophosphamide; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration
      of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are
      candidates for adjuvant or neoadjuvant chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant
             chemotherapy

          -  Candidate for docetaxel and cyclophosphamide chemotherapy

          -  Female or male at least 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) ≤ 2

          -  Absolute neutrophil count (ANC) ≥ 1.5×109/L

          -  Platelet count ≥ 100 x 10^9/L

          -  Creatinine ≤ 1.5 x upper limit of normal (ULN)

          -  Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).

          -  Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT)
             and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤
             2.5 x ULN

          -  Hemoglobin > 9 g/dL

          -  Alkaline phosphatase ≤ 1.5 x ULN

        Exclusion Criteria:

          -  Known sensitivity to E. coli-derived products or known sensitivity to any of the
             products to be administered

          -  Known Human Immunodeficiency Virus (HIV) infection

          -  Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral
             load or immunological evidence of chronic active disease

          -  Active infection or any serious underlying medical condition that would impair ability
             to receive protocol treatment

          -  Prior bone marrow or stem cell transplant

          -  Prolonged exposure to glucocorticosteroids and immunosuppressive agents
Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Intervention: Resveratrol; Placebo
Intervention description: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.; Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Intervention MeSH terms: Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: metabolic syndrome; central obesity; resveratrol; insulin secretion; insulin sensitivity

Summary:

      The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult
      population suffers the disease.

      Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's
      also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has
      beneficial effects on glucose and lipids metabolism, blood pressure and body weight.

      The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome,
      insulin sensitivity and insulin secretion.

      The investigators hypothesis was that the administration of resveratrol modifies the
      metabolic syndrome, insulin sensitivity and insulin secretion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients both sexes

          -  Age between 30 and 50 years

          -  Metabolic Syndrome according to the IDF criteria

          -  Waist circumference

          -  Man ≥90 cm

          -  Woman ≥80 cm

          -  And two of the following criteria:

          -  High density lipoprotein

          -  Man ≤40 mg/dL

          -  Woman ≤50 mg/dL

          -  Fasting glucose ≥100 mg/dL

          -  Triglycerides ≥150 mg/dL

          -  Blood pressure ≥130/85 mmHg

          -  Informed consent signed

        Exclusion Criteria:

          -  Women with confirmed or suspected pregnancy

          -  Women under lactation and/or puerperium

          -  Hypersensibility to resveratrol

          -  Physical impossibility for taking pills

          -  Known uncontrolled renal, hepatic, heart or thyroid diseased

          -  Previous treatment for the metabolic syndrome components

          -  Body Mass Index ≥39.9 kg/m2

          -  Fasting glucose ≥126 mg/dL

          -  Triglycerides ≥500 mg/dL

          -  Total cholesterol ≥240 mg/dL

          -  Low density lipoprotein (c-LDL) ≥190 mg/dL

          -  Blood Pressure ≥140/90 mmHg