bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Irinotecan associated to fluorouracil and leucovorin
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 70 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Chemotherapy; gastric cancer; geriatric evaluation; efficacy; safety

Summary:

      The number of patients over 70 years old with cancer is increasing in France. This population
      is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a
      lot between subjects of the same age. Physicians hesitate to treat them with optimal doses
      because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty
      eight percent of gastric cancers are diagnosed in patients over the age of 70 in France.
      FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising
      treatment for digestive cancer. It increases the level of response and survival without major
      toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their
      conditions.

      The principal objectives are to demonstrate the efficacy of treatment, safety, survival and
      to find out if geriatric assessment data can help to better predict chemotherapy toxicity.
      The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic
      gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day
      1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of
      cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up
      and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and
      Lachs-Balducci screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  70 years of age or older

          -  Gastric cancer, locally advanced or metastatic

          -  No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6
             months

          -  One measurable lesion

          -  ECOG < 3

          -  Biology and biochemistry within normal limits

          -  Life expectancy > 12 weeks

        Exclusion Criteria:

          -  Other palliative chemotherapy for this cancer

          -  Other cancer in the last 5 years

          -  Previous treatment with irinotecan

          -  Atropine treatment not possible

          -  Concomitant cancer therapy except bone radiotherapy

          -  Metastases to brain or meninges with symptoms

          -  Other severe pathology uncontrolled

          -  Problem of compliance
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Enoxaparin; BIBR 1048; BIBR 1048; BIBR 1048; BIBR 1048
Intervention description: Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period; 50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period; 150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period; 225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period; 300 mg q.d BIBR 1048 capsule for 5-10 treatment period
Intervention MeSH terms: Enoxaparin; Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1973.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to establish the dose-response relationship with
      regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg
      b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients
      undergoing primary elective total hip and knee replacement.
    

Eligibility criteria:

        Inclusion criteria

          1. Patients scheduled to undergo a primary elective total hip or knee replacement.

          2. Male of female being 18 years or older.

          3. Patients weighing at least 40 kg.

          4. Written informed consent for study participation.

        Exclusion criteria

          1. Bleeding diathesis, constitutional or acquired coagulation disorders.

          2. Major surgery or trauma(e.g., hip fracture) within the last 3 months.

          3. Cardiovascular disease

          4. Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral
             ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological
             findings.

          5. Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal
             ulcer within the last year.

          6. History of or acute intracranial disease

          7. Liver disease

          8. Renal disease

          9. Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee
             replacement operation.

         10. Pre-menopausal women who are not surgically steriles, are nursing and are of
             child-bearing potential and are not practising acceptable methods of birth control

         11. Known allergy to contrast media

         12. Thrombocytopenia

         13. Allergy against heparin.

         14. Active malignant disease or current cytostatic treatment.

         15. Treatment with an investigational drug in the past month.

         16. Leg amputee

         17. Known alcohol or drug abuse
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Diuretics
Intervention description: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Intervention MeSH terms: Diuretics
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure; Cardiac filling pressure

Summary:

      This chronic, prospective, non-randomized feasibility study is designed to evaluate the
      Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic
      Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter
      Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers
      Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) Extension
      Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling
      pressures from the Chronicle device to provide timely medication adjustments (diuretics) to
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients implanted with a Chronicle IHM device (Model 9520, Model 9520B) or Chronicle
             ICD device (Model 7286)

          -  Patients who have been prescribed daily diuretic therapy for the management of heart
             failure

          -  Patients currently participating in the COMPASS-HF Extension Phase Study (IDE
             #G020304)

          -  Patients willing and able to give informed consent

        Exclusion Criteria:

          -  Patients with non-physiologic Right Ventricular (RV) pressure values

          -  Patients who have diuretic resistance

          -  Patients who have an estimated Glomerular Filtration Rate(eGFR) <30 ml/min (recorded
             within the last six months)

          -  Patients who have a Chronicle IHM device (Model 9520) that was implanted as part of
             the Pulmonary Arterial Hypertension (PAH) Pilot Study (IDE #G020303)

          -  Patients who do not have the ability to actively participate in the management of
             their own heart failure care (determine by physician discretion)(e.g. patient does not
             have ability to operate study equipment, patient does not have a history of compliance
             to sending CareLink transmissions)

          -  Patients who have a reasonable probability of needing a device replacement during the
             study (approximately two months)

          -  Patients enrolled or planning to participate in a concurrent drug and/or device study
             during the course of this clinical trial

          -  Patient who are pregnant (all females of child-bearing potential must have a negative
             pregnancy test within 1 week of enrollment)
A Study of Fabrazyme in Pediatric Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: Fabrazyme (agalsidase beta)
Intervention description: 1 mg/kg every 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: a-Galactosidase A; aGal; r-haGAL; Fabry; GL-3; Fabrazyme

Summary:

      People with Fabry disease have an alteration in their genetic material (DNA) which causes a
      deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove
      certain types of fatty substances called "glycolipids". These glycolipids are normally
      present within the body in most cells. In people with Fabry disease, glycolipids build up in
      various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A
      is not present, or is present in small quantities. The build up of glycolipid levels (also
      referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the
      clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood
      with pain in the hands and feet. This study explored the safety, efficacy and
      pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patient or legal guardian must provide written informed consent

          -  Patients must have a clinical diagnosis of Fabry disease and active Fabry disease
             (clinical signs and symptoms)

          -  Patients must be at least 7 years of age but no older than 15 years of age at time of
             enrollment

          -  Patients must be Tanner Stage ≤ III

          -  Female patients must have a negative pregnancy test prior to each infusion and use a
             medically accepted form of contraception throughout the study

        Exclusion Criteria:

          -  Patient has a clinically significant organic disease (with the exception of symptoms
             relating to Fabry disease) that in the opinion of the investigator would preclude
             participation in the trial

          -  Patient has participated in a study employing investigational drug within 30 days of
             the start of this study

          -  Patient has received prior treatment with enzyme replacement therapy

          -  Patient is unable to comply with the clinical protocol
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ASN002
Intervention description: Daily dose of ASN002 for up to 110 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: eczema

Summary:

      This is a randomized open label study to evaluate the long term safety of ASN002 in subjects
      with moderate to severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject with a history of moderate to severe atopic dermatitis who participated in the
             preceding ASN002AD-201 and ASN002AD-101 study

          -  Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment
             according to the investigator's judgment.

          -  Subject has been using an emollient daily for at least 1 week prior to Day 1 and
             agrees to continue using that same emollient daily throughout the study.

          -  Men and women participating in the study must use medically acceptable birth control
             or total abstinence from sexual intercourse

          -  Subject is willing to participate and is capable of giving informed consent. Note:
             Consent must be obtained prior to any study-related procedures.

          -  Subjects must be willing to comply with all study procedures and must be available for
             the duration of the study.

          -  Subject has a body mass index (BMI) ≤ 38 kg/m2.

        Exclusion Criteria

          -  Subject is a female who is breastfeeding, pregnant, or who is planning to become
             pregnant during the study.

          -  Subject has clinically infected atopic dermatitis.

          -  A serious uncontrolled condition including hypertension, history of tuberculosis,
             hepatitis B or C infection, immune deficiency, heart disease, heart conduction
             disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor
             therapy, malabsorption syndrome, or cancer

          -  Subject has a history of skin disease or presence of skin condition that, in the
             opinion of the investigator, would interfere with the study assessments.

          -  Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or
             more episodes of eczema herpeticum in the past.

          -  Willing to comply with discontinuation of certain treatments for AD, as directed by
             the Investigator.
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CINRYZE
Intervention description: C1 esterase inhibitor (human)
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: HAE; C1 inhibitor (C1INH); Subcutaneous

Summary:

      The objectives of the study are to:

        1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection
           in subjects with hereditary angioedema

        2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by
           subcutaneous injection

        3. Assess the immunogenicity of CINRYZE following subcutaneous administration
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for this protocol, a subject must:

          1. Have a confirmed diagnosis of HAE.

          2. During the 3 consecutive months prior to screening, have a history of less than 1 HAE
             attack per month (average) treated with C1INH therapy or any other blood products,
             ecallantide (Kalbitor), icatibant (Firazyr), antifibrinolytics (e.g., tranexamic
             acid), IV fluids, or narcotic analgesics.

          3. Agree to strictly adhere to the protocol-defined schedule of assessments and
             procedures.

        Exclusion Criteria:

        To be eligible for this protocol, a subject must not:

          1. Have received C1INH therapy or any blood products for treatment or prevention of an
             HAE attack within 14 days prior to the first dose.

          2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics
             (e.g., tranexamic acid) within 14 days prior to the first dose.

          3. Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol,
             oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose.

          4. If female, have started taking or changed the dose of any hormonal contraceptive
             regimen or hormone replacement therapy (i.e., estrogen/progestin containing products)
             within 3 months prior to the first dose.

          5. Have a history of abnormal blood clotting or other coagulopathy.

          6. Have a history of allergic reaction to CINRYZE or other blood products.

          7. Be pregnant or breastfeeding.

          8. Have received an immunization within 30 days prior to the first dose.

          9. Have participated in any other investigational drug study within 30 days prior to the
             first dose.
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Condition: Acute Ischemic Stroke; Transient Ischemic Attack (TIA)
MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia
Intervention: BMS-986177; Placebo; Clopidogrel; Aspirin
Intervention description: Oral administration; Oral Administration; Oral administration; Oral administration
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2366.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to determine whether the addition of an oral Factor XIa
      Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary
      stroke prevention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female ≥40 years of age

          -  Acute Ischemic Stroke or Transient Ischemic Attack

          -  Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain
             area

        Exclusion Criteria:

          -  Predicted inability to swallow study medication

          -  Any condition that, in the opinion of the Investigator, contraindicates anticoagulant
             therapy or would have an unacceptable risk of bleeding

          -  Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke

        Other protocol defined inclusion/exclusion criteria could apply
Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly
Condition: Aging
Intervention: Rapamycin; Placebo; Rapamycin
Intervention description: treatment; control; No placebo control in this substudy group
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 70 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Geriatrics

Summary:

      The ability to mount an effective immune response declines with age, leaving the elderly
      increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug
      to prevent transplant rejection, increases the lifespan and healthspan of mice and
      ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in
      laboratory animals. Investigators are conducting a translational trial to test whether
      rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95).
    

Eligibility criteria:

        Inclusion Criteria: age 70-95

          -  participants will be in good health with all chronic diseases (hypertension, coronary
             artery disease, etc.) clinically stable.

          -  participants must have adequate cognitive function to be able to give informed
             consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

        Exclusion Criteria:

          -  unstable ischemic heart disease

          -  clinically significant pulmonary disease

          -  history of immunodeficiency or receiving immunosuppressive therapy

          -  history of a coagulopathy or receiving a medical condition requiring anticoagulation

          -  an estimated glomerular filtration rate of <30ml/min

          -  uncontrolled hypercholesteremia >350mg/dl;

          -  uncontrolled hypertriglyceridemia >500mg/dl

          -  diabetes

          -  history of skin ulcers or poor wound healing

          -  smoking

          -  liver disease

          -  treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)