bioihbjkbjnl/mcl2 huggingface dataset:
Human Fibrinogen - Pharmacokinetics
Condition: Fibrinogen Deficiency
MeSH terms: Afibrinogenemia
Intervention: Human Fibrinogen Concentrate
Intervention description: Single intravenous infusion of 70 mg/kg body weight
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Congenital fibrinogen deficiency; Fibrinogen concentrate; Pharmacokinetics; Thrombelastography

Summary:

      This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and
      clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen
      deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen
      when a fixed dose of human fibrinogen concentrate was administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 6 years

          -  Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as
             afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable
             (i.e. < 20 mg/dL)

          -  Informed consent signed by subject or legal guardian

        Exclusion Criteria:

          -  Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human
             plasma proteins,

          -  Presence or history of deep vein thrombosis, pulmonary embolism, or arterial
             thrombosis

          -  Acute bleeding

          -  History of esophageal varicose bleeding

          -  End stage liver disease (i.e. Child-Pugh score B or C)

          -  Planned major surgery with a need for blood transfusion during the PK blood sampling
             period

          -  Polytrauma within 1 year prior to enrollment
Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: LCZ696; Placebo
Intervention description: LCZ696; matching placebo to LCZ696
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 389.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension; blood pressure; LCZ696; dual-acting; neprilysin; nep inhibitor; vasopeptidase; angiotensin receptor; ARNi; Essential hypertension

Summary:

      This study is a phase 2 study in patients with essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must give written informed consent before any assessment is performed.

          2. Patients with mild to moderate essential hypertension, untreated or currently taking
             antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110
             mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).

          3. Patients must be willing and able to undergo ambulatory blood pressure monitoring for
             a 24-hr period at the beginning and the end of the 8-week treatment.

          4. Patient must be able to communicate and comply with all study requirements and
             demonstrate good medication compliance.

        Exclusion Criteria:

          1. Patients with severe hypertension.

          2. Patients with history of angioedema, drug-related or otherwise

          3. Pregnant or nursing women

          4. Women of child-bearing potential , who do not use adequate birth control methods

          5. History or evidence of a secondary form of hypertension.

          6. History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic
             heart disease, surgical or percutaneous arterial intervention of any kind, stroke,
             TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.

          7. Diabetes mellitus.

          8. Previous or current diagnosis of heart failure (NYHA Class II-IV).

          9. Clinically significant valvular heart disease at the time of screening.

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: HTS-519 Insert
Intervention description: Maximum feasible dose of HTS-519 Insert per diseased nail
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519
      Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females 18 - 74 years of age inclusive

          -  Fungal toenail infection of one or both of the large (great) toenails

          -  The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and
             non-dermatophyte] are not allowed)

          -  Willingness not to have professional pedicures or application of any nail polish
             product or nail cosmetics to the toenails after the screening visit

        Exclusion Criteria:

          -  History of any significant chronic fungal disease other than onychomycosis or
             immunocompromised condition

          -  Any abnormalities of the nail or previous surgery of the toenail that could prevent a
             normal appearing nail if clearing of infection is achieved

          -  Significant confounding conditions as assessed by the study doctor

          -  Participation in any other trial of an investigational drug or device within 30 days
             or participation in a research study concurrent with this study

          -  No administration of systemic antifungal medications within 6 months prior to
             screening visit

          -  No application of prescription topical antifungal medications for toenail fungus
             within 3 months or other commercially available topical medications for toenail fungus
             applied directly to the toenails within 1 month prior to screening visit

          -  Tinea pedis (athlete's foot) that would require systemic treatment

        Other protocol-defined inclusion/exclusion criteria may apply
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: Azelaic acid; Vehicle foam
Intervention description: 15% foam to be applied topically twice daily; Active-ingredient-free vehicle to be applied topically twice daily
Intervention MeSH terms: Azelaic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rosacea; papulopustular; azelaic acid; foam

Summary:

      This exploratory study is being performed to determine whether a new form formulation of
      azelaic acid 15% is effective in the treatment of papulopustular rosecea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and female patient at least 18 years of age

          -  signed informed consent

          -  Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or
             pustules, persistent erythema, and telangiectasia

          -  Ability and willingness to accept and comply with treatment and required medical
             examinations

        Exclusion Criteria:

          -  Known non-responders to azelaic acid

          -  Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea

          -  Presence of dermatoses that could interfere with the rosacea diagnosis

          -  Treatment with isotretinoin in the six months prior to randomization

          -  Treatment of the face with topical retinoids during the two weeks prior to
             randomization

          -  Treatment with oral antibiotics during the four weeks prior to randomization

          -  Treatment with topical antibiotics

          -  Treatment with systemic corticosteroids during 4 weeks prior to randomization

          -  Treatment of the face with topical corticosteroids during 2 weeks prior to
             randomization

          -  Treatment of the face with topical imidazole antimycotics during 2 weeks prior to
             randomization

          -  Treatment of the face with topical azelaic acid formulations during 2 weeks prior to
             randomization

          -  Use of a sauna during 2 weeks prior to randomization and during the study

          -  Facial laser surgery for telangiectasia during 6 weeks prior to randomization

          -  Planned concurrent use of any treatment other than study medication that affects
             rosacea

          -  History of hypersensitivity to propylene glycol or any other ingredient of the study
             drugs

          -  Participation in another clinical trial during the last 4 weeks
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; cisplatin; carboplatin
Intervention description: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles; 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles; area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility
      study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as
      adjuvant combination-chemotherapy in participants with completely resected, stage Ib or
      IIa/IIb non-small cell lung cancer (NSCLC).

      A two-stage design will be employed independently for both treatment arms, with the
      possibility of stopping each treatment early for lack of feasibility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven non-small cell lung cancer stage Ib, IIa or IIb

          -  Must have complete tumor resection by pneumonectomy or lobectomy

          -  Must have been surgically proven to be N2 negative

        Exclusion Criteria:

          -  Serious concomitant systemic disorder

          -  Post-operative complications or other surgery related conditions

          -  A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated
             at least 5 years ago
Microvascular Coronary Disease In Women: Impact Of Ranolazine
Condition: Myocardial Ischemia
MeSH terms: Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
Intervention: Ranolazine; Placebo
Intervention description: 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval.; Placebo, 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval.
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Female
Healthy volunteers: No
Keywords: Ranolazine; Myocardial ischemia; Double blinded; Placebo controlled

Summary:

      1. To evaluate the impact of ranolazine extended-release tablets in women with
           subendocardial ischemia due to microvascular endothelial dysfunction on myocardial
           ischemia (Cardiac Magnetic Resonance (CMR) extent, severity.

        2. To evaluate the impact of ranolazine extended-release tablets in women with
           subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of
           angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status
           Inventory(DASI) and SF-36).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women with signs and symptoms of myocardial ischemia (chest pain, abnormal stress
             testing, abnormal noninvasive testing) in the absence of obstructive coronary artery
             disease (epicardial coronary stenosis <50% luminal diameter stenosis).

          2. Women with ≥10% myocardial ischemia by CMR perfusion.

        Exclusion Criteria:

          1. Contraindications to withholding nitrates, beta-blockers, calcium channel agents,
             ACE/ARB agents for 48 hours prior to testing.

          2. Contraindications in CMR including AICD, pacemaker, untreatable claustrophobia or
             known angio-edema.

          3. Contraindications to ranolazine including hepatic insufficiency, prolonged QT, renal
             failure.

          4. Women taking drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole,
             macrolides or HIV protease inhibitors.

          5. Women less than 18 years of age.

          6. Women on drugs that prolong the QT interval such as Class Ia or III antiarrhythmic
             agents, erythromycin, certain antipsychotics.

          7. Pregnancy or breast feeding.

          8. Life expectancy less than 6 months.
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Bepotastine Besilate Nasal Spray 2% Twice a day; Bepotastine Besilate Nasal Spray 3% Twice a day; Bepotastine Besilate Nasal Spray 4% Twice a day; Placebo Nasal Spray
Intervention description: nasal spray; nasal spray; nasal spray; nasal spray
Intervention MeSH terms: Bepotastine besilate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 601.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 12 years of age with a history of mountain cedar allergy

        Exclusion Criteria:

          -  No active nasal infection or nasal abnormality that would affect subject safety or
             symptom assessments
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]; placebo; gemcitabine; cisplatin; carboplatin
Intervention description: 150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily; orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application; 1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles; 75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin; 5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
Intervention MeSH terms: Carboplatin; Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of sequential administration of Tarceva and
      gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer.
      Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4
      week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The
      anticipated time on study treatment is until disease progression or unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  histologically documented advanced or recurrent stage IIIB or IV non-small cell lung
             cancer;

          -  measurable disease;

          -  no previous chemotherapy for non-small cell lung cancer.

        Exclusion Criteria:

          -  unstable systemic disease;

          -  any other malignancies in the last 5 years.
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: GRASPA
Intervention description: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 30.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic leukemia; Elderly patient; Asparaginase

Summary:

      The main purpose of this study is to determine the maximum tolerated and efficient dose of
      GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years
      and over, Philadelphia chromosome-negative (ALL Ph-).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient aged ≥55 years old

          -  With newly diagnosed ALL without prior treatment

          -  Capable to receive polychemotherapy (World Health Organization (WHO) performance
             status ≤2)

          -  With or without meningeal disease

          -  Having signed an Informed Consent Form

          -  Subscribed to social security insurance

        Exclusion Criteria:

          -  ALL translocation(9;22) and/or BCR-ABL (Breakpoint Cluster Region-Abelson) positive

          -  Performance status incompatible with chemotherapy treatment (WHO score >2)

          -  Patient presenting with a general or visceral contraindication to intensive treatment
             including :

               -  Cardiac insufficiency defined as Left Ventricular Ejection Fraction <50% of the
                  theoretical value

               -  Plasma creatinine concentration 2 times greater than the upper limit of
                  laboratory ranges, except if related to ALL

               -  Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) levels 5
                  times greater than the upper limit of laboratory ranges, except if related to ALL

               -  Patient with another evolutive cancer other than ALL

               -  Severe evolutive infection, or Human Immunodeficiency Virus (HIV) seropositive
                  or, active hepatitis related to B or C viral infection

          -  Prior treatment with L-asparaginase (irrespective of the form)

          -  History of grade 3 transfusional incident (life threatening)

          -  Patient presenting rare and/or dangerous anti-erythrocyte antibodies thus leading to
             the unavailability of phenotype compatible Red Blood Cells Concentrate

          -  Patient included in another clinical trial during the last 4 weeks
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Condition: Arthroplasty, Replacement, Hip; Thrombosis
MeSH terms: Thrombosis
Intervention: DU-176b
Intervention MeSH terms: Edoxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 606.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Deep Vein Thrombosis,; Anticoagulant,; Venous thromboembolic

Summary:

      Patients who undergo total hip replacement surgery are at greater risk of getting deep vein
      thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of
      the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients
      having total hip replacement surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral hip replacement

        Exclusion Criteria:

          -  Patients scheduled for bilateral hip replacement in same procedure

          -  Patients with increased risk of bleeding

          -  Uncontrolled hypertension (BP greater than 180/100 mmHg)

          -  Patients less than 111 lbs or more than 243 lbs

          -  Patients on long-term anticoagulants

          -  Patients with contraindications to venography

          -  Patients with medical history of venous thromboembolism

          -  Patients with impaired hepatic function

          -  Known to be pregnant

          -  Lactating women