bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin glargine
Intervention description: Administered subcutaneously (s.c., under the skin) once daily.; Administered subcutaneously (s.c., under the skin) once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The aim of this trial is to
      compare the efficacy of insulin decludec with insulin glargine on glycaemic control using
      continuous glucose monitoring in patients with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes

          -  HbA1c (glycosylated haemoglobin) below or equal to 8.5%

          -  Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total
             daily dose below 120 U

          -  BMI (body mass index) below 35 kg/m^2

        Exclusion Criteria:

          -  Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose
             lowering drug other than insulin/insulin analogues

          -  Subjects with regular use of acetaminophen who are not willing to use another
             analgetic during CGM (Continuous Glucose Monitoring) periods

          -  Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary
             arterial bypass graft or angioplasty within 24 weeks prior to visit 1

          -  Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last
             12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis
             during the previous 6 months
An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)
Condition: Diabetes Mellitus, Type 2; Chronic Renal Insufficiency
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin; Placebo to Sitagliptin; glipizide; Placebo to glipizide
Intervention description: One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily.; One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily.; One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.; One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
Intervention MeSH terms: Sitagliptin Phosphate; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

Summary:

      The purpose of this study is to determine the safety and tolerability of an investigational
      drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic
      Renal Insufficiency (inadequate kidney function).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus
             (T2DM) (a specific type of diabetes).

          -  Patient has renal (kidney) insufficiency (inadequate kidney function)

        Exclusion Criteria:

          -  Patient has had heart problems (such as a heart attack or chest pain) or stroke within
             the past 6 months or any condition or therapy which, in the opinion of the
             investigator, may not be in the patient's best interest to participate.

          -  Pregnant or breast feeding
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Condition: Nocturia
MeSH terms: Nocturia
Intervention: SER120 750 ng; SER120 1500 ng; Placebo
Intervention description: SER120 750 ng; SER120 1500 ng; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 810.0
Sex: All
Minimum age: 50 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      To investigate the efficacy and safety of SER120 nasal spray formulations in patients with
      nocturia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female 50 years or older

          -  Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per
             night

        Exclusion Criteria:

          -  CHF

          -  Diabetis Insipidus

          -  Renal insufficiency

          -  Hepatic insufficiency

          -  Incontinence

          -  Illnesses requiring systemic steroids

          -  Malignancy within the past 5 years

          -  Sleep apnea

          -  Nephrotic syndrome

          -  Unexplained pelvic mass

          -  Urinary bladder neurological dysfunction

          -  Urinary bladder surgery or radiotherapy

          -  Pregnant or breast feeding
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
Condition: Chronic Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: ibrutinib; Placebo; Prednisone
Intervention description: Ibrutinib capsules administered orally daily; Placebo capsules administered orally daily; Prednisone administered daily
Intervention MeSH terms: Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 193.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: chronic graft versus host disease; PCYC1140; PCYC1140IM; 1140; Ibrutinib; GVHD; Steroid dependent; refractory; chronic; PCI32765; IMBRUVICA; Pharmacyclics; PCYC; graft versus host disease; immunology; new onset graft versus host disease; INTEGRATE; Corticosteroids; prednisone

Summary:

      To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects
      with newly diagnosed moderate to severe cGVHD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  New onset moderate or severe cGVHD as defined by the 2014 National Institutes of
             Health (NIH) Consensus Development Project Criteria

          -  Need for systemic treatment with corticosteroids for cGVHD

          -  No previous systemic treatment for cGVHD (including extracorporeal photopheresis
             [ECP])

          -  Participants may be receiving other immunosuppressants for the prophylaxis or
             treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or
             treatment of acute GVHD it must be at or below 0.5 mg/kg/d

          -  Age ≥12 years old

          -  Karnofsky or Lansky (subjects <16 years) performance status ≥60

        Key Exclusion Criteria:

          -  Received any previous systemic treatment for cGVHD with the exception of
             corticosteroids administered for cGVHD within the 72 hours prior to signing the
             informed consent form.

          -  Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD

          -  Any uncontrolled infection or active infection requiring ongoing systemic treatment

          -  Progressive underlying malignant disease or any post-transplant lymphoproliferative
             disease

          -  Known bleeding disorders

          -  Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
Opioid Prescription After Cesarean Trial
Condition: Pregnancy Related; Opioid Use; Pain
Intervention: 0 to 20 tablets of oxycodone 5mg; Fixed opioid prescription
Intervention description: Individualized opioid prescription protocol (IOPP) that includes shared decision making; 20 tablets of oxycodone 5mg
Intervention MeSH terms: Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
Masking: Single (Outcomes Assessor)
Enrollment: 5521.0
Sex: Female
Healthy volunteers: No

Summary:

      Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to
      discharge to either an individualized opioid prescription protocol (IOPP) that includes
      shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)

          -  Singleton, twin or triplet gestation

        Exclusion Criteria:

          -  An opioid prescription filled during the current pregnancy

          -  Known history of opioid use disorder, by medical record review

          -  Contraindication to opioids (oxycodone)

          -  Contraindications to both acetaminophen and ibuprofen

          -  Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain
             trajectory will be completely different

          -  Fetal or neonatal death prior to randomization

          -  Inability to randomize within 1 day before planned discharge from the hospital

          -  Inability to participate in shared decision making as assessed by research staff

          -  Language barrier (non-English or Spanish speaking)

          -  Participation in this trial in a previous pregnancy

          -  Participation in another intervention study that influences the primary outcome in
             this trial
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Condition: Osteoarthritis; Postoperative Pain
MeSH terms: Osteoarthritis; Pain, Postoperative
Intervention: pregabalin; pregabalin; Placebo
Intervention description: 150 milligram (mg)/ day (double blind); 300 mg/day (double blind); Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: opioid

Summary:

      Pregabalin added to the standard of care with dosing starting preoperatively and continuing
      for up to 6 weeks post surgery will decrease the intensity of post-operative pain following
      total knee replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia
             (neuroaxial with or without peripheral nerve block).

          -  Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity
             to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as
             part of the standard of care.

          -  The subject's preoperative health is graded as American Society of Anesthesiology
             Class 1 to Class 3

        Exclusion Criteria:

          -  Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or
             subjects with planned second knee total knee arthroplasty at time of present
             procedure.

          -  Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing
             spondylitis, psoriatic arthritis); Lyme disease.

          -  Subjects with fibromyalgia and or other chronic pain syndromes
Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Ondansetron followed by placebo; Placebo followed by Ondansetron
Intervention description: Participants will take 16mg of ondansetron daily for the first three months followed by 3 months of placebo. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.; Participants will take placebo daily for the first three months followed by 3 months of 16mg of ondansetron daily. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
Intervention MeSH terms: Ondansetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Ondansetron; P50 sensory gating; Evoked potentials; 5-HT3 receptors; Atypical antipsychotics

Summary:

      This study will examine the effects of ondansetron on auditory nerve activity in people with
      schizophrenia who are being treated with new antipsychotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for schizophrenia

          -  Stable, chronic schizophrenia

          -  Currently taking atypical medications

          -  Use of effective form of contraception throughout study

        Exclusion Criteria:

          -  History of any alcohol or drug abuse within 3 months of study start date

          -  Any other major neurological disorders

          -  History of or current head trauma

          -  Any medical conditions affecting the central nervous system

          -  Current epilepsy, asthma, migraine headache, previous myocardial infarction, stroke,
             diabetes, hypertension, narrow angle glaucoma, or neuromuscular illnesses

          -  Pregnant
A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
Condition: Invasive Candidiasis
MeSH terms: Candidiasis; Candidiasis, Invasive
Intervention: caspofungin acetate
Intervention description: Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. Duration of Treatment - 14-90 days.
Intervention MeSH terms: Caspofungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3
      times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or
      systemic yeast infections)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical and Laboratory evidence of blood stream &/or systemic candida infections

        Exclusion Criteria:

          -  Possible candida contamination

          -  Candida colonization (non invasive infection), urine, cardiac, bone or brain and
             prosthetic device infections

          -  Acute or moderately severe liver disease

          -  Abnormal liver function tests

          -  Abnormal blood clotting for patients on blood thinners
VEC-162 Study in Adult Patients With Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: VEC-162 20 mg; Placebo; VEC-162 50 mg
Intervention description: 20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks; Placebo capsules, PO daily for five weeks; 50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind
      treatment period of VEC-162 as compared to placebo in male and female patients with primary
      insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with a diagnosis of primary insomnia as defined in DSM-IV.

          -  Habitual bedtime between 9:00 pm and 1:00 am.

          -  No history or evidence of restless leg syndrome or periodic limb movement disorder or
             sleep apnea.

          -  Patients must sign a written consent form.

        Exclusion Criteria:

          -  History of drug or alcohol abuse as defined in DSM-IV.

          -  History of psychiatric disorders, including Major Depressive Disorder, Generalized
             Anxiety Disorder and delirium.

          -  History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea,
             narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other
             than chronic insomnia.

          -  Recent history of shift work or jet lag.
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: MenACWY-CRM; MenACWY-CRM; Routine Vaccines
Intervention description: This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.; This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.; Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 751.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Infants; Persistence

Summary:

      The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant
      vaccination schedule including kinetics of immune response in the early phases of the series.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants of both genders who are in generally good health will be eligible for this
             study. For infants to be enrolled, the parents/legal representatives need to provide
             written informed consent and to be available for all study visits.

        Exclusion Criteria:

          -  Serious, acute, or chronic illnesses are reasons for exclusion.
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Alimta or Taxotere; erlotinib [Tarceva]
Intervention description: 500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere); 150mg po daily
Intervention MeSH terms: Erlotinib Hydrochloride; Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that
      of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC
      experiencing disease progression after failure of platinum-based chemotherapy.Eligible
      patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either
      Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on
      study treatment is until disease progression ,and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  histologically documented, locally advanced or recurrent or metastatic NSCLC;

          -  measurable disease;

          -  disease progression during 1-4 cycles of platinum-based chemotherapy.

        Exclusion Criteria:

          -  any other malignancies within the last 5 years;

          -  unstable systemic disease.