bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin detemir; insulin NPH; insulin aspart
Intervention description: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection; Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection; Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The purpose of this trial is to investigate if there is
      any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in
      patients with type 1 diabetes, whilst taking two different, commercially available insulins
      for the treatment of their diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes for more than 12 months

          -  Current treatment: Basal-bolus insulin regimen for more than three months (i.e. at
             least one daily injection of long-acting insulin (including insulin glargine) and
             fast-acting insulin with each main meal)

          -  HbA1c (glycosylated haemoglobin A1c) between 7.0 and 11.0%

          -  Able and willing to maintain consistent physical activity level throughout the entire
             study period

          -  Able and willing to maintain consistent eating habits throughout the entire study
             period

        Exclusion Criteria:

          -  Proliferative retinopathy that has required acute treatment within the last six months

          -  Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the
             Investigator

          -  Liver, kidney or heart problems as judged by the Investigator

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures

          -  Known or suspected allergy to trial products or related products

          -  Receipt of any investigational drug within one month prior to this trial
Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: empagliflozin 10mg; empagliflozin 25 mg; Placebo
Intervention description: For blinding purposes
Intervention MeSH terms: Empagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 65.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study
      of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus
      with insufficient glycaemic control
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus

          -  Male and female patients on diet and exercise regimen who are pre-treated with
             Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be
             >=7.0% and <=10.0% at screening

          -  Male and female patients on diet and exercise regimen who are pre-treated with
             Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10
             weeks prior to Visit 1 must be >=7.0% and <=9.0% at screening and >=7.0% and <=10.0%
             at placebo run-in

          -  Male and female patients on diet and exercise regimen who are pre-treated with OAD
             alone for at least 10 weeks prior to Visit 1 must be >=7.0% and <=10.0% at both
             screening and placebo run-in

          -  Age at informed consent must be >=20 years

          -  BMI at screening must be <=40 kg/m2

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Uncontrolled hyperglycaemia with a glucose values >270 mg/dL (>15.0 mmol/L) after an
             overnight fast during switch/washout/placebo run-in period and confirmed by a second
             measurement

          -  Patients who are drug-naïve at screening visit or treat with any of insulin,
             thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks
             prior to informed consent.

          -  Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to
             informed consent

          -  Indication of liver disease, defined by serum levels of either alanine
             aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper
             limit of normal as determined during screening and/or switch/washout/placebo run-in
             period

          -  Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45
             mL/min/1.73m2 (Japanese equation) as determined during screening and/or
             switch/washout/placebo run-in period

          -  Further exclusion criteria apply
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: dapagliflozin, 10mg tablet; Placebo for dapagliflozin
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in
      endogenous glucose production (EGP) following the induction of glucosuria (when glucose is
      excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25-35 kg/m^2

          -  Normal Glucose Tolerance subjects (24)

          -  Type 2 Diabetic Subjects (24)

          -  Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or
             combination therapy with metformin and/or a sulfonylurea

          -  Diabetic subjects must have HbA1c <8.0%

          -  Other than diabetes, subjects must be in good general health as determined by physical
             exam, medical history, blood chemistries, CBC (complete blood count), TSH
             (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and
             urinanalysis.

          -  Only subjects whose body weight has been stable (± 3 lbs) over the preceding three
             months and who do not participate in an excessively heavy exercise program will be
             included.

        Exclusion Criteria:

          -  Subjects taking drugs known to affect glucose metabolism (other than metformin and
             sulfonylurea) will be excluded.

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be
             excluded.
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Condition: Biliary Tract Surgical Procedures; Pancreaticoduodenectomy; Esophagectomy; Colectomy; Gastrectomy
MeSH terms: Hemorrhage
Intervention: Tranexamic acid + Standard of Care; Standard of Care
Intervention description: Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss); Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tranexamic acid; major abdominal surgery; blood loss

Summary:

      Tranexamic acid has been shown to reduce postoperative blood losses and transfusion
      requirements in various types of major surgery (orthopedic surgery, spine surgery,
      cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is
      being conducted to compare the efficacy of tranexamic acid plus standard of care versus
      standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient undergoing major abdominal surgery (Biliary strictures,
             Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy,
             Gastrectomy, Other major abdominal surgeries with similar expected blood loss)

        Exclusion Criteria:

          -  Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.

          -  Patients with known coagulopathy.

          -  Patients with anemia (hemoglobin levels less than 8 mg/dl)

          -  Patients with documented DVT or PE at screening or in past three months.

          -  Patients with any associated major illness (e.g., severe cardiac or respiratory
             disease).

          -  Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein
             thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or
             completed within last week
Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors
Condition: Fatigue; Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies; Fatigue
Intervention: Ferrous sulphate; Placebo
Intervention description: Volunteers will receive 80 mg/day oral ferrous sulphate (Tardyferon®) for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.; Volunteers will receive 1 pill/day oral placebo for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.
Intervention MeSH terms: Iron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fatigue; Blood donation; Iron deficiency; Ferrous sulphate; Donation; Donors; Iron; Ferritin; Hemoglobin; Anemia; Anaemia; Haemoglobin; Don; Women blood donors

Summary:

      The purpose of this study is to determine the subjective response of iron substitution
      (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin < 30ng/ml and to
      assess variation of ferritin and hemoglobin after a blood donation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women

          -  aged 18 - 50

          -  eligible for a blood donation

        Exclusion Criteria:

          -  men

          -  age below 18 or above 50

          -  not eligible for a blood donation (according to the blood donation eligibility
             guidelines of the Swiss Red Cross)

          -  hemochromatosis, psychiatric / thyroid / hepatic / rheumatismal / kidney or
             cardiopulmonary diseases that can cause fatigue

          -  intestinal disease or medical treatment that can perturb iron absorption and/or
             excretion

          -  donors with mental disorder or psychiatric disease that are unable to give consent

          -  acute or chronic inflammation

          -  diabetes and pregnancy
A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: ADVAIR DISKUS™ 250/50mcg; Placebo
Intervention description: ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.; COPD subjects-Placebo DISKUS
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; arterial stiffness; Computed Tomography; pulse wave velocity; Pulse wave analysis

Summary:

      The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary
      Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure
      associated with risk of heart disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated written informed consent obtained from the subject and/or subject's
             legally acceptable representative prior to study participation.

          -  Males or females greater then or equal to 50 years of age.

          -  A post-albuterol FEV1/FVC ratio of < or equal to 0.70

          -  A post-albuterol FEV1 < 80% of predicted normal.

          -  Patients can be current or fomer smoker and must have a cigarette smoking history of >
             greater then or equal to 10 pack-years .

        Exclusion Criteria:

          -  A current diagnosis of asthma

          -  A body mass index (BMI) of > or equal to 35kg/m2

          -  A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis,
             sarcoidosis, tuberculosis, lung fibrosis).
Everolimus in de Novo Heart Transplant Recipients
Condition: Cardiac Transplantation
Intervention: Everolimus; Mycophenolate mofetil + Everolimus
Intervention MeSH terms: Mycophenolic Acid; Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study, in de novo heart transplant patients, is to evaluate whether
      delayed introduction of everolimus reduces the occurrence of wound healing problems,
      pericardial and/or pleural effusion and early acute renal insufficiency, as compared with
      immediate introduction of everolimus, in the firs six months after heart transplantation.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female cardiac transplant candidates 18-65 years of age undergoing primary
             heart transplantation.

          -  Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization

        Exclusion criteria:

          -  Patients who are recipients of multiple solid organ transplants

          -  Patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen
             positive;

          -  Presence of Donor/Recipients serological mismatch for Hepatitis B or C;

          -  Recipients of organ from donors positive for Hepatitis B-surface antigen;

          -  Panel Reactive Antibodies (cytotoxicity method) > 30%.

          -  Other protocol-defined inclusion/exclusion criteria may apply
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Thromboembolism; Atrial Flutter
Intervention: dabigatran etexilate mesylate
Intervention description: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.
Intervention MeSH terms: Dabigatran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic
      event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of
      dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency
      ablation, or cryoablation procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female sex, age 18-85 years.

          -  Negative pregnancy test for women of childbearing potential

          -  Planned pulmonary vein isolation by antral radiofrequency or cryoablation for
             paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (NVAF),
             or left atrial flutter following prior left atrial ablation procedures

          -  CHADS2 score of 0-6 or CHADS2-VASc score 0-9

          -  Vascular hemostasis within 4-6 hours of sheath pull

          -  Able to give informed consent

        Exclusion Criteria:

          -  Unable to give informed consent

          -  Currently participating in another clinical treatment trial

          -  History of hereditary hemophilias

          -  Presence of active bleeding

          -  End stage renal disease, CrCl<15 mL/min

          -  Prior treatment failure of dabigatran (stroke or systemic thromboembolism while on
             therapeutic dabigatran)

          -  Known allergic reaction to dabigatran etexilate

          -  Intolerance to dabigatran, if medication naïve, or other contra-indications as per the
             USPI.

          -  Pregnancy

          -  History of non-compliance

          -  Inability to follow-up
Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Benzoyl peroxide with clindamycin; Benzoyl peroxide with clindamycin and doxycycline
Intervention description: Benzoyl peroxide wash - Clindamycin foam; Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules
Intervention MeSH terms: Doxycycline; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Acne

Summary:

      To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin
      vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of
      moderate acne
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with acne vulgaris . Able to understand the requirements of
             the study and sign informed consent/HIPAA authorization forms.

        Exclusion Criteria:

          -  Known hypersensitivity to any of the components of the study drugs or used of
             prohibited medications or any medical condition that contraindicate the subject's
             participation in the clinical study
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: Ferric Citrate
Intervention description: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Healthy volunteers: No

Summary:

      Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4
      "Real World" Experience Study from Kaiser Permanente Southern California
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or
             calcium carbonate

          -  Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment

          -  No allergy to iron

          -  Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment

          -  Mean PTH < 1000 pg/ml for 6 months prior to enrollment

          -  Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment

        Exclusion Criteria:

          -  History of gastrointestinal bleeding within past 6 months

          -  History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery
             within past 6 months

          -  Acute kidney injury equal to or less than 3 months before the initial screening date

          -  Active malignancy

          -  Functioning renal transplant

          -  Patients with iron overload syndrome (e.g., Hemochromatosis)

          -  History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease

          -  Active or past history of calciphylaxis