bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Condition: Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: Tigecycline; Imipenem/cilastatin
Intervention description: every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.; every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.
Intervention MeSH terms: Imipenem; Tigecycline; Cilastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 470.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin
      in hospitalized patients with a complicated intra-abdominal infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized male or female subjects, at least 18 year of age.

          -  Complicated intra-abdominal infection is present at most under two weeks duration.

          -  Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly
             suspected intra-abdominal infection.

        Exclusion Criteria:

          -  Anticipated length of antibiotic therapy less than 5 days or the likelihood that the
             subject will not complete the course of treatment.

          -  Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not
             susceptible to both of the study drugs.

          -  Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment
             except for subjects declared prior failures.
Sugammadex ED90 Dose in the Obese Patients
Condition: Incomplete Reversal of Neuromuscular Block
Intervention: sugammadex ED90
Intervention description: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Dose-Response Relationship; Drug; Obesity; Cyclodextrins

Summary:

      The purpose of this study is to determine the minimum effective dose of sugammadex, an
      antagonist of neuromuscular blockade used during anesthesia practice, in obese patients,
      considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg
      but no studies were found with obese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a body mass index ≥ 40 kg/m2

          -  bariatric surgery

          -  informed consent signed

        Exclusion Criteria:

          -  history of neuromuscular diseases,

          -  use of drugs that could interfere with neuromuscular transmission,

          -  allergy to neuromuscular agents of the aminosteroids class,

          -  anticipated difficulty in airway management,

          -  renal failure
Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy
Condition: Hot Flashes
MeSH terms: Prostatic Neoplasms; Hot Flashes
Intervention: Isoflavone; Placebos
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 39.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prostate cancer; soy; androgen deprivation; quality of life; isoflavones

Summary:

      This study will look at the effects of a soy supplement called Revival on memory, quality of
      life, and hot flashes in men with prostate cancer who are being treated with testosterone
      suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will
      result in at least a 50% reduction in hot flashes compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men > or =21 with prostate CA and hypogonadism for at least 3 months

        Exclusion Criteria:

          -  on growth promoting agents

          -  on appetite stimulating agents

          -  on Prednisone and others
A Comparison of Telemedical and Conventional Antihypertensive Treatment
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Telemedical blood pressure monitoring
Intervention description: Measurement of home blood pressure, three times per week for three months and once a week for three months.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 236.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Telemedicine; Blood pressure; Quality of life; Cost-effectiveness

Summary:

      The aim of the study is to compare telemedical antihypertensive treatment based on home blood
      pressure monitoring and conventional antihypertensive treatment based on monitoring of blood
      pressure in the doctor's office.

      We want to test the hypotheses that telemedical treatment is more effective in lowering blood
      pressure, provide better quality of life and is more cost-effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 20 - 80 years

          -  office blood pressure > 150/95 mmHg or systolic blood pressure >150 mmHg and diastolic
             blood pressure < 90 mmHg

        Exclusion Criteria:

          -  not able to perform home blood pressure measurements

          -  low compliance

          -  abuse of alcohol/ medicine

          -  unwillingness to participate
Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica
Condition: Healthy
Intervention: Gabapentin; Pregabalin; Placebo
Intervention MeSH terms: Pregabalin; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Enrollment: 32.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Volunteer; Pharmacodynamics; Pharmacokinetics

Summary:

      Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study
      comparing simulated driving performance, daytime sedation and cognition in healthy volunteers
      administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica®
      (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 40 and 80 years of age, inclusive.

          -  Body weight > 50 kg and BMI between 18 and 32 kg/m2, inclusive.

          -  Able to give informed consent.

          -  Licensed, experienced driver who had driven at least 3 times a week for the past 3
             years and had visual acuity adequate for driving, as assessed by the investigator or
             designee.

          -  Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving
             skills, as determined by the investigator or designee.

          -  Karolinska Sleep Scale (KSS) score of <=5.

          -  Other criteria apply.

        Exclusion Criteria:

          -  Known history of allergic reaction, hypersensitivity or clinically significant
             intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the
             ingredients in the protocol-specified meals.

          -  Pregnant or lactating or considered at risk of pregnancy.

          -  Any medical condition or any laboratory abnormality or ECG abnormality that would, in
             the opinion of the investigator, contraindicate study participation.

          -  Impaired liver function (e.g., alanine aminotransferase [ALT] ≥2 times the upper limit
             of normal [ULN] or bilirubin ≥2 times ULN), known active hepatic disease (e.g.,
             hepatitis), or evidence of clinically significant liver disease or other condition
             affecting the liver that may suggest the potential for an increased susceptibility to
             hepatic toxicity with oral gabapentin or pregabalin exposure.

          -  Any history of renal disease that, in the opinion of the investigator, would
             contraindicate study participation; or subject had significantly impaired renal
             function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.

          -  History or evidence of a sleep disorder, including sleep apnea (obstructive, central
             or mixed), narcolepsy or primary insomnia.

          -  Other criteria apply.
Remission Through Early Monitored Insulin Therapy - Duration Month
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Glargine; Lispro; Dexcom G6
Intervention description: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.; Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.; Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.
Intervention MeSH terms: Insulin Glargine; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: 10 participants will be recruited soon after diagnosis of type 2 diabetes and started on short term insulin therapy to achieve euglycemia with insulin doses guided by continuous glucose monitor algorithm
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin therapy; Continuous glucose monitor

Summary:

      REMIT-DM is a feasibility pilot study where participants will be recruited soon after their
      diagnosis of type 2 diabetes to be placed immediately on insulin therapy for maximum of four
      weeks with titrations of insulin guided by glucose levels and trends provided by a continuous
      glucose monitor (CGM), with the purpose of achieving diabetes remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18

          2. A1C criteria - >7.0

          3. Newly diagnosed with T2D within 4 years

          4. Lifestyle controlled

          5. Subject may be on up to 2 medications for diabetes.

          6. Smart phone or home computer compatible with DEXCOM CLARITY software

          7. English speaking

          8. Assessed by endocrinologist and diabetes educator to be able to perform skills
             necessary for CGM use and insulin delivery

        Exclusion Criteria:

          1. Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies

          2. Pregnant

          3. Chronic Kidney Disease (CKD) Stage IV or greater

          4. Mental and/or cognitive disorder (based on documented disorder and/or assessment of
             physician or educator)

          5. No access to computer for downloading CGM

          6. BMI <18.0
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Lyrica (pregabalin); placebo
Intervention description: 150 mg twice a day, oral administration; Twice a day, oral administration
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: epilepsy partial seizure treatment with pregabalin or placebo; vision testing

Summary:

      Patients with partial seizures currently taking 1-3 antiepileptic medications will have a
      50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to
      their current medications for 3 months. Neither the study doctor nor the patient will know
      the medication assignment. Vision testing will be performed prior to receiving the study
      treatment and at the end of the study to see if there are any changes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Epilepsy partial seizure subjects.

          -  Currently taking 1 to 3 antiepileptic drugs.

        Exclusion Criteria:

          -  Pre-existing eye diseases (glaucoma).

          -  Insufficient response to pregabalin in the treatment of partial seizure, or patients
             currently receiving pregabalin treatment.
Study of Memantine to Treat Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: Memantine
Intervention description: 10 mg BID x 3 months
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in
      patients with Huntington's disease (HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 or older.

          -  Diagnosis of HD with current complaints of memory or concentration difficulties.

          -  Dementia Rating Scale score of <129, to ensure that patients have sufficient cognitive
             impairment.

          -  Adequate visual and auditory acuity to allow neuropsychological testing.

          -  Good general health with no additional diseases expected to interfere with the study.

          -  Patient is not institutionalized.

          -  Sufficient English skills to complete all testing without assistance of an English
             language interpreter.

          -  Availability of a responsible caregiver who agrees to supervise administration of
             study drug, monitor the patient's compliance and adverse events, and accompany the
             patient to all clinic visits.

        Exclusion Criteria:

          -  1. Any significant neurologic disease other than HD.

          -  Severe psychotic features or other severe psychiatric problems within the last three
             months which could lead to difficulty complying with the protocol.

          -  History of alcohol or substance abuse within the past two years (DSM IV criteria).

          -  Any significant systemic illness or unstable medical condition which could lead to
             difficulty complying with the protocol.

          -  History of MI in the past year or head trauma with loss of consciousness greater than
             20 minutes.

          -  Insulin-requiring diabetes.

          -  Use of any FDA approved cognitive enhancing prescription medications or
             investigational drugs within 30 days.

          -  Use of ginkgo biloba or DHEA within four weeks prior to baseline.

          -  Use of narcotic analgesics within 4 weeks prior to baseline.

          -  Patients who, in the investigator's opinion, would not comply with study procedures.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: ribavirin [Copegus]; ribavirin [Copegus]; peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]; peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
Intervention description: 600mg po bid for 48 weeks; 800mg po bid for 48 weeks; 180 micrograms sc weekly for 48 weeks; 270 micrograms sc weekly for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The effects of treatment with different doses of PEGASYS in combination with different doses
      of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer,
      body weight greater than 85kg (187lbs) and no prior treatment with interferon. The
      anticipated time on study treatment is 3-12 months and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  body weight >85kg (187lbs);

          -  CHC (genotype 1);

          -  liver biopsy (in <24 calendar months of first dose), with results consistent with CHC
             infection;

          -  use of 2 forms of contraception during study and 6 months after the study in both men
             and women.

        Exclusion Criteria:

          -  women who are pregnant or breastfeeding;

          -  male partners of women who are pregnant;

          -  conditions associated with decompensated liver disease;

          -  other forms of liver disease, including liver cancer;

          -  human immunodeficiency virus infection;

          -  previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor
Condition: Labor; Forced or Induced, Affecting Fetus or Newborn
Intervention: Oxytocin; Transcervical Foley catheter
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 323.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: induction; Foley catheter; oxytocin

Summary:

      The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for
      induction of labor will increase the rate of delivery within 24 hours stratified by parity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years

          -  Pregnant, singleton gestation, vertex presentation

          -  Admitted for induction of labor between gestational ages 24 - 42 weeks

          -  Bishop score <6

        Exclusion Criteria:

          -  Multiple gestation

          -  Non-vertex presentation

          -  Latex allergy or latex-free Foley catheter to be placed

          -  Fetal death

          -  Anomalous fetus

          -  Placenta/vasa previa

          -  Placental abruption (known or suspected)

          -  Intrapartum bleeding

          -  Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal
             variability AND decelerations of any kind, OR late decelerations occurring >50% of
             contractions

          -  2 or more previous cesarean section, myomectomy, or classical cesarean

          -  Need to use ripening agents prior to Foley placement

          -  Spontaneous labor

          -  Active genital herpes

          -  Inability to consent

          -  Any contraindication to a vaginal delivery
Thoracoabdominal Arortic CTA Study
Condition: Thoracic Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
Intervention: Isovue
Intervention description: iodine contrast
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Suspected or confirmed; TAA; Computed tomography angiography; CTA; Contrast agent; Radiation dose; Thoracoabdominal aortic aneurysm

Summary:

      The purpose of this study is to compare the contrast agents and imaging techniques used for
      thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and
      adjusted based on the contrast agent, since contrast agents have varying iodine
      concentrations. If the contrast iodine concentration is higher, it may be possible to adjust
      the imaging parameters and lower the overall radiation dose to the patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing thoracoabdominal aortic (TAA) CTA

          -  Able to provide informed consent

          -  Body Mass Index (BMI) equal to or less than 30

        Exclusion Criteria:

          -  Creatinine greater than 2.0

          -  Allergy to contrast media

          -  Pregnant women