bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients
Condition: Febrile Neutropenia
MeSH terms: Neutropenia; Febrile Neutropenia; Hyperthermia; Fever
Intervention: Doripenem; doripenem
Intervention description: 500 mg every 8 hours; 1000 mg every 8 hours
Intervention MeSH terms: Doripenem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neutropenia; doripenem

Summary:

      Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic
      patients.

      Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported
      as Probability of Target Attainment (40% Time (fT)> minimum inhibitory concentration (MIC))
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult neutropenic (< 500 cells) patients who are febrile

        Exclusion Criteria:

          -  Patients with Creatinine Clearance < 30 ml/min or allergy to carbapenems will be
             excluded.
A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms
Condition: Parkinsonian Syndromes
MeSH terms: Parkinsonian Disorders; Syndrome
Intervention: DaTSCAN SPECT imaging
Intervention description: A single intravenous injection of DaTSCAN with a total activity of 111-185 MBq (volume of 2.5 or 5.0 mL). SPECT scanning to be performed 3 to 6 hours after DaTSCAN injection.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorder; Clinically uncertain Parkinsonian Syndromes

Summary:

      Patients come to their doctor showing possible symptoms of a movement disorder. It is
      possible that these symptoms may get worse over time. There is more than one disease that can
      cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and
      Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because
      the symptoms caused by these illnesses are almost the same. On the other hand the correct
      treatment for Parkinson´s Disease is different from the correct treatment for Essential
      Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can
      affect the way the doctor treats these patients and whether it can affect their quality of
      life directly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical
             or incomplete presentation of tremor, rigidity, bradykinesia or postural instability.

          -  Onset of clinical manifestations within the last 5 years

        Exclusion Criteria:

          -  Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy
             or between Parkinson´s Disease and Multiple System Atrophy

          -  Subjects with an established/certain movement disorder clinical diagnosis

          -  Presence of known causes of tremor
A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir
Intervention description: Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.
Intervention MeSH terms: Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of
      Levemir® (insulin detemir) administered once daily according to two titration algorithms
      after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin
      treatment with or without other anti-diabetic drugs (OADs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Diagnosed with type 2 diabetes mellitus at least 3 months prior to Visit 1 (week -2)

          -  - Treatment with at least 1000 mg metformin per day with/without other OADs at a
             stable dose (at either the maximal tolerated dose or at least half of the maximum
             recommended dose according to the package insert) for at least 3 months prior to Visit
             1

          -  - Insulin-naïve subjects

          -  - HbA1c above or equal to 7.5% by central laboratory analysis

          -  - Body mass index (BMI) below or equal to 35.0 kg/m^2

        Exclusion Criteria:

          -  - Female who is breast-feeding

          -  - The receipt of any investigational product within 4 weeks prior to Visit 1

          -  - Any contraindication to insulin detemir according to the domestic labelling

          -  - Anticipated change of dose of any systemic treatment with products, which in the
             investigator's opinion could interfere with glucose metabolism (such as systemic
             corticosteroids, beta-blockers, monoamine oxidase [MAO] inhibitors)

          -  - Clinically significant diseases which, in the investigator's opinion, may confound
             the results of the trial or pose additional risk in administering trial product

          -  - Any conditions that the investigator judges would interfere with trial participation
             or evaluation of the results
Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight Changes
Intervention: Insulin detemir; Dietary regimen
Intervention description: Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.; Subjects receive dietary consultation by a dietician at six occasions during the trial.
Intervention MeSH terms: Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 611.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe, and North and South America. The aim of this trial is to
      investigate if a dietary intervention has an effect on weight when initiating insulin
      treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs
      (OADs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start

          -  Insulin naive subjects

          -  HbA1c: 7.0-9.0 % (both inclusive)

          -  Body Mass Index (BMI): 25.0-45.0 kg/m^2 (both inclusive)

        Exclusion Criteria:

          -  Use of Thiazolidinedione (TZDs) or Glucagon-like peptide-1 analogue (GLP- 1) receptor
             agonists within the last 3 months prior to trial enrollment

          -  Cardiovascular disease within the last 6 months

          -  Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for
             diabetic ketoacidosis during the previous 6 months

          -  Uncontrolled treated/untreated severe hypertension, impaired liver function, impaired
             renal function, known proliferative retinopathy or maculopathy requiring treatment

          -  Cancer and medical history of cancer in the past 5 years (except basal cell skin
             cancer or squamous cell skin cancer)

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Condition: Lumbar Spinal Stenosis; Thoracic Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Intervention: Tranexamic Acid; Placebo
Intervention description: A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.; A single topical application of matching placebo, which is 100 mL of normal saline.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: lumbar spine surgery; thoracic spine surgery

Summary:

      Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine
      surgery will decrease the overall blood loss post-operatively. This reduction in blood loss
      will reduce the need for transfusion. In addition it will also significantly reduce the cost
      of the surgical procedure.

      Specific Aim 1: The goal of this study is to quantitatively assess whether topical
      application of tranexamic acid placed into the surgical wound during lumbar spine surgery
      will decrease post-operative blood loss, thus lowering the need for blood transfusions. By
      reducing the number of transfusions participants can avoid the well-known complications
      associated with them. The investigators do not plan on measuring serum tranexamic acid
      levels.

      Several meta-analyses and level I studies have shown that intravenous (IV) administration of
      tranexamic acid is effective in reducing postoperative blood loss and the need for
      transfusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-85 years, both male and female

          -  Undergoing elective multi-level spinal surgery with a posterior approach to the
             thoracolumbar spine.

          -  Negative pregnancy test

        Exclusion Criteria:

          -  Allergy to tranexamic acid

          -  Preoperative anemia (Hemoglobin <11 grams per deciliter [g/dL] )

          -  Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio
             >1.4, or Partial Thromboplastin Time > 1.5 times normal)

          -  History of deep vein thrombosis, stroke, or pulmonary embolism

          -  Pregnant or breast feeding

          -  Liver function tests 2 times the upper limit of normal, and those with creatine
             greater than 1.6 milligrams per deciliter (mg/dL)

          -  Infection

          -  Revision procedure in which the only procedure is removing instrumentation

          -  Renal impairment

          -  Dural tear
Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation
Condition: Atrial Fibrillation; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Atrial Fibrillation
Intervention: apixaban; warfarin
Intervention description: oral anticoagulant; oral anticoagulant
Intervention MeSH terms: Warfarin; Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal dialysis

Summary:

      This is a prospective, randomized, open-label, blinded end-point evaluation trial. The
      patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and
      end-stage renal disease (ESRD) .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, age at least 18 years, or the local age of consent, whichever is
             greater.

          -  Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from
             separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor,
             event monitor or implantable loop recorder).

          -  CHA2DS2-VASc score of ≥ 2.

          -  End-stage renal disease treated with hemodialysis for ≥ 3 months.

          -  Considered by the treating physician(s) to be candidate for oral anticoagulation.

          -  If of childbearing potential, be willing to avoid pregnancy during the study.

        Exclusion Criteria:

          -  Not considered by the treating physician(s) to be candidates for oral anticoagulation
             (for example, hemoglobin < 8.5g/dL, history of intracranial hemorrhage, active
             bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic
             impairment, or anaphylactic reaction to apixaban)

          -  Moderate or severe mitral stenosis

          -  Conditions other than AF that require anticoagulation such as mechanical prosthetic
             valve, deep venous thrombosis, or pulmonary embolism

          -  Need for aspirin at a dose > 81 mg a day or need for P2Y12 antagonist therapy (for
             example clopidogrel, prasugrel, or ticagrelor)

          -  Life expectancy < 3 months

          -  Anticipated kidney transplant within the next 3 months

          -  Prisoners or others who are involuntarily incarcerated or detained

          -  Pregnant, breastfeeding, or considering pregnancy.

          -  Participation in a clinical trial of an experimental treatment within the past 30 days
Intraoperative Floppy Iris Syndrome
Condition: Cataract; Floppy Iris Syndrome
MeSH terms: Cataract; Syndrome
Intervention: DisCoVisc; Healon5
Intervention description: Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.; Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Discovisc; Ophthalmic Visco Surgical Device

Summary:

      An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract
      surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy
      Iris Syndrome exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with floppy iris syndrome

          -  operable bilateral cataracts

        Exclusion Criteria:

          -  Intraocular Pressure (IOP) > 21mmHg

          -  ocular inflammatory disease

          -  systemic or ocular diseases affecting Endothelial Cell Count
Immunogenicity of the Booster Dose of Two MenC Vaccines
Condition: Meningococcal Infection
MeSH terms: Meningococcal Infections
Intervention: conjugated polysaccharide menC vaccine
Intervention description: Booster vaccine dose at 14 to 18 months.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 389.0
Sex: All
Minimum age: 14 Months
Maximum age: 19 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal vaccine; Immunization, secondary; vaccines conjugated; Meningococcal disease

Summary:

      The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in
      the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to
      assess the interchangeability of the two different vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy toddlers of both sexes

          -  Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the
             day before he is 19 months of age)

          -  Children previously vaccinated with two doses of polysaccharide meningococcal C
             vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C
             conjugated to CRM197 before 7 month of age.

          -  Informed consent signed by one or both parents who are adequately informed about the
             study.

        Exclusion Criteria:

          -  Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time

          -  Toddlers with severe chronic diseases

          -  Toddlers who have received any other vaccine within the last month or with a
             programmed vaccination within the 28 subsequent days after the administration of the
             vaccine of study.

          -  Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.

          -  Toddlers with hypersensitivity to any of the components of the vaccines to study or
             antibiotics used during the manufacturing process that could be present as non-
             detectable traces (streptomycin, neomycin, polymyxin B).

          -  Toddlers with personal history of convulsions.

          -  Toddlers with known bleeding disorder no controlled

          -  Toddlers with known congenital or acquired immunodeficiency

          -  Toddlers who are receiving or have been received any treatment that could change the
             immune response (administration of intravenous immunoglobulin, systemic
             corticosteroids or haemoderivates) within the 3 previous months.

          -  A toddler that under investigator opinion is probable to be lost during the follow-up

          -  A toddler that is currently included or is planned to be included in any other
             clinical trial.

          -  A toddler that under investigator opinion must not be included in the study due to
             other medical or social reasons.
Long Term Safety Study of PRALUENT
Condition: Heterozygous Familial Hypercholesterolemia; Non-familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Praluent
Intervention description: Subcutaneous (SC) administration
Intervention MeSH terms: Alirocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1389.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to evaluate the long term safety of PRALUENT in
      participants with heterozygous familial hypercholesterolemia (heFH) or non-familial
      hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed
      the neurocognitive function study R727-CL-1532 (NCT02957682).

      The secondary objectives of the study were:

        -  To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)

        -  To evaluate the effect of PRALUENT on other lipid parameters

        -  To evaluate the effect of PRALUENT on gonadal steroid hormones
    

Eligibility criteria:

        Key Inclusion Criteria:

        Participants randomized into the neurocognitive function study (R727-CL-1532) who completed
        treatment and the end of study (EOS) visit with no premature or permanent discontinuation
        of study drug.

        Key Exclusion Criteria:

          1. Significant protocol deviation in the parent study (neurocognitive function study
             R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as
             noncompliance

          2. Any participant who experienced an AE leading to permanent discontinuation from the
             neurocognitive function study R727-CL-1532 (NCT02957682).

          3. Any new condition or worsening of an existing condition which, in the opinion of the
             investigator or per the PRALUENT local label, would make the participant unsuitable
             for enrollment or could interfere with the participant participating in or completing
             the open-label extension (OLE) study

          4. Known hypersensitivity to monoclonal antibody or any component of the drug product

          5. Pregnant or breastfeeding women

        Note: Other inclusion/ exclusion criteria apply
Treatments for Psychogenic Nonepileptic Seizures (NES)
Condition: Convulsion, Non-Epileptic; Conversion Disorder; Depression; Stress Disorders, Post-Traumatic
MeSH terms: Seizures; Psychogenic Nonepileptic Seizures; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Conversion Disorder; Hysteria; Dissociative Disorders
Intervention: sertraline; placebo
Intervention description: flexible dose sertraline; flexible dose placebo
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: nonepileptic seizure; pseudoseizure; conversion disorder; psychogenic; Depression; Anxiety; Abuse; post-traumatic stress disorder; sertraline; serotonin; randomized controlled trial

Summary:

      The investigators propose that treatment of the comorbid disorders (depression, anxiety, and
      impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES),
      will result in a decreased number of NES. The purpose of this study is to provide pilot
      testing and data to inform the future randomized controlled trial based on the hypothesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Video electroencephalogram (vEEG) confirmed diagnosis of NES

          -  Have at least one nonepileptic seizure per month

          -  Comorbid diagnosis of either depression, anxiety, or post traumatic stress disorder
             (PTSD)

          -  Able to complete self report symptom scales

          -  Not receiving optimized antidepressant medication

        Exclusion Criteria:

          -  Equivocal electroencephalogram (EEG) findings

          -  Current suicidality, litigation, or self-mutilation

          -  Using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan

          -  Allergy/sensitivity to sertraline

          -  Current alcohol/drug dependence

          -  Serious medical illness requiring current hospitalization