bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Betaferon/Betaseron; Rebif; Betaferon/Betaseron
Intervention description: 250ug administrated with Betaject; 44ug administered with Rebiject II; 250ug administrated with Betaject light
Intervention MeSH terms: Interferon beta-1b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; RRMS

Summary:

      The purpose of this study is to compare the injection site reaction and injection site pain
      after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different
      autoinjectors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females

          -  Age >= 18 years old

          -  Patients after a first demyelinating event suggestive of MS (only for Betaferon) as
             well as patients with a definite diagnosis of RRMS (Betaferon et Rebif)

          -  First justified prescription of one interferon beta by subcutaneous route (as
             described in Summary of Product Characteristics [SmPC] of Betaferon or Rebif)

          -  Females of child-bearing potential must agree to practice adequate contraceptive
             methods over the duration of the study (not applicable for men)

          -  Patient can follow and comply with all study procedures of the trial protocol

          -  Laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-GT, full blood count
             and differential white blood cell count [WBC]) must be available and the results must
             be normal.

          -  Written informed consent

        Exclusion Criteria:

          -  Any contraindication to the prescription of Betaferon or Rebif, as described in the
             SmPC of products:

               -  Pregnancy or lactation

               -  Known hypersensitivity to natural or recombinant interferon beta, to mannitol, to
                  human albumin or any other excipients used

               -  History of severe depression or suicide attempt or current suicidal ideation.

               -  Patient with decompensated liver disease

               -  Epilepsy not adequately controlled by treatment

          -  Patient previously included in this study.

          -  Patient previously treated by sub-cutaneous route with either Betaferon or Rebif.

          -  Participation in any clinical trial within the past 30 days involving the
             investigational drug intake.

          -  Medical, psychiatric or other conditions that compromise the patient's ability to
             understand the patient information, to give informed consent, to comply with the trial
             protocol or to complete the study.
Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
Condition: Renal Transplant
Intervention: Tacrolimus
Intervention description: See description in arm/group sections
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Renal Transplant; Tacrolimus; UNC; Phase IV

Summary:

      Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough
      levels and clinical outcomes. The primary endpoint of this study is to evaluate the
      proportion of patients reaching target levels (8-10 ng/mL) on Day 3 and Day 7 after kidney
      transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All new kidney transplant recipients aged 18 to 65 years who are admitted at UNC-CH
             and provided informed consent will be included in this study.

        Exclusion Criteria:

        - Patients will be excluded from participating in the study to receive genotype-guided
        tacrolimus dosing if he/she meets any of the exclusion criteria described below.

          -  Recipients who did not consent to participate in the study.

          -  Highly sensitized patients (ie, pretransplant T or B cell flow crossmatch positive)

          -  Recipients of ABO incompatible kidney transplant

          -  Recipients with preformed donor-specific antibodies (DSA)

          -  Human Leukocyte Antigen (HLA) identical kidney transplant

          -  Recipients of non-kidney transplant

          -  Recipients of repeat transplant if they are on immunosuppression at the time of
             transplant

          -  Patients using medications that have known pharmacokinetic (PK) drug interaction with
             tacrolimus

          -  Patients in whom tacrolimus therapy is contraindicated
Levofloxacin Pharmacokinetics (PK) in the Severely Obese
Condition: Obesity; Critical Illness
MeSH terms: Critical Illness
Intervention: Levofloxacin 750 mg IV
Intervention description: PK in obesity
Intervention MeSH terms: Levofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity is known to affect the concentrations of certain medications in the body.
      Levofloxacin is a commonly used antibiotic. Based on what the investigators know about
      levofloxacin and how it moves through the body, obesity may affect levofloxacin
      concentrations. This study aims to show the effect of obesity on levofloxacin concentrations.

      The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to
      severely obese, critically ill patients will yield serum concentrations that are likely to be
      therapeutic.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 55 years of age

          2. Body mass index > 35 kg/m2

          3. Has been prescribed levofloxacin, but the medication has not yet been administered
             (hospitalized cohort only)

        Exclusion Criteria:

          1. Hypersensitivity to fluoroquinolones

          2. Creatinine clearance < 50 ml/min

          3. Administration of levofloxacin within the previous 7 days

          4. Pregnant or lactating females

          5. Participation in another investigational protocol within the past 30 days
Effects of Perampanel on Neurophysiology Test Perimeters
Condition: Healthy
Intervention: Perampanel 6 MG
Intervention description: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: 12 healthy males will undergo testing, then receive the drug intervention, followed by blood draw and testing again
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to evaluate the effects of perampanel, a FDA approved drug for epilepsy, on
      commonly performed neurophysiology tests: electroencephalogram (EEG), somatosensory evoked
      potential (SEP), brainstem auditory evoked potential (BAEP), and visual evoked potential
      (VEP). Many other drugs used in the treatment of epilepsy have been shown to affect the
      results of these test but no one has yet examined if perampanel affects these tests. The
      investigators plan to recruit 12 healthy normal male subjects. All subjects will have VEP,
      SSEP, EEG, and BAER performed before and 1 hour (when Cmax is reached) after receiving 6mg of
      oral perampanel. Subjects will also receive a blood draw 1 hour after ingestion of perampanel
      for serum perampanel level. In a previous study done at another institution, healthy
      volunteers have tolerated a single dose of perampanel at 6 mg quite well. There is no placebo
      nor randomization. Subject's participation concludes after completion of post-perampanel
      ingestion neurophysiology tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects between the ages of 18 to 50 years old with a body mass index of
             19-29 kg/m2 will be recruited.

        Exclusion Criteria:

          -  Subjects would be excluded if they use recreational drugs and have any neurologic
             disease, psychiatric condition or any other condition that may affect outcome and risk
             subject safety. Furthermore, anyone that would not be able to participate in
             neurophysiology tests will also be excluded. Subject will also be excluded should they
             take any over the counter medication or consume caffeine or alcohol 12 hours prior to
             the study.
The Invia Motion at Cesarean Study
Condition: Negative Pressure Wound Therapy; Cesarean Section; Infection
Intervention: Invia Motion
Intervention description: Invia Motion NPWT system at cesarean delivery
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Medela Invia pump
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Healthy volunteers: No

Summary:

      To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at
      cesarean delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled/non-labor or unscheduled/labor cesarean delivery

          2. Gestational age greater than or equal to 23 weeks

        Exclusion Criteria:

          1. Unwilling or unable to provide consent

          2. Non-availability for postoperative follow-up

          3. Contraindication to NPWT
Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Condition: Thyroid Cancer; Postsurgical Hypothyroidism
MeSH terms: Thyroid Neoplasms; Hypothyroidism
Intervention: Levothyroxine
Intervention description: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps. Initial dose 1.5-1.8 mcg per kg, orally and daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: levothyroxine

Summary:

      In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than
      the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and
      more unpredictable TSH (thyroid stimulating hormone) levels.

      The investigators therefore hypothesize that following thyroidectomy for Stage I/II
      differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more
      predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone
      levels in the postoperative period.

      The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules
      to tablet form for TSH suppression following thyroidectomy for presumed stage I/II
      differentiated thyroid cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II

          -  Planned total or near-total thyroidectomy

          -  Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively

          -  Normal serum TSH within 12 months preceding surgery

        Exclusion Criteria:

          -  AJCC Stage III or greater

          -  Undifferentiated, Anaplastic or Medullary Thyroid Cancer

          -  Planned postoperative TSH goal other than 0.1-0.5 mU/L

          -  History of gastrointestinal malabsorption or gastric bypass surgery

          -  Pregnancy

          -  Use of medications that alter the absorption or metabolism of levothyroxine

          -  Prior use of levothyroxine
Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management
Condition: Skin Diseases, Infectious
MeSH terms: Communicable Diseases; Infections; Abscess; Skin Diseases, Infectious; Skin Diseases
Intervention: Trimethoprim-sulfamethoxazole; Placebo group
Intervention description: Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.; Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.
Intervention MeSH terms: Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole; Simethicone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 161.0
Sex: All
Minimum age: 3 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: skin abscess; CA-MRSA

Summary:

      The purpose of this study is to determine if antibiotics are required in the management of
      skin abscess following incision and drainage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-toxic patients

          -  immunocompetent patients

          -  3 months to 18 years old

          -  English-speaking patients

          -  skin abscesses

          -  not on antibiotics

        Exclusion Criteria:

          -  toxic patients

          -  immunocompromising co-morbidities

          -  less than 3 months old or older than 18 years of age

          -  non-english speaking

          -  on antibiotics
Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Vildagliptin
Intervention description: Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)
Intervention MeSH terms: Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, type 2; vildagliptin

Summary:

      This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2
      diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment
    

Eligibility criteria:

        Inclusion criteria

          1. Outpatients who were 20 years of age and older with diagnosis of T2DM.

          2. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy
             at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal.
             The glucose control goal was defined as HbA1c ≤ 6.5%.

          3. Male or female with child-bearing potential agreed to use an effective method of
             contraception approved by the investigator during the study.

          4. Understood the nature of the study, and had signed informed consent form.

        Exclusion criteria

          1. Patients with contraindications mentioned in the Summary of Product Characteristics
             for vildagliptin or metformin.

          2. Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit
             1.

          3. Patients with history of hepatic impairment, including but not limited to those with
             pretreatment AST or ALT > 3 ULN at Visit 1.

          4. Female patients who needed to lactate during the study.
Radial Reload Laparoscopic LAR Case Series
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Covidien Radial Reload Stapler with Tri-Staple Technology
Intervention description: Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or
      anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary
      endpoints.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is able to understand and sign Informed Consent Form.

          2. The subject is between 18-85 years of age.

          3. The subject is anticipated to undergo a resection of the rectum with anastomosis below
             the peritoneal reflection.

          4. The subject is anticipated to undergo mobilization and stapling of the rectum
             laparoscopically.

        Exclusion Criteria:

          1. Any female patient, who is pregnant, suspected pregnant, or nursing.

          2. The participant is unable or unwilling to comply with the study requirements,
             follow-up schedule.

          3. The participant has co-morbidities which, in the opinion of the investigator, will not
             be appropriate for the study.
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: VIVITROL 380 mg; Placebo
Intervention description: Administered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension.; Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: alcoholism; addiction; alcohol detoxification

Summary:

      This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the
      associated brain activation patterns in alcohol-dependent adults who had recently completed
      alcohol detoxification and were seeking further treatment for their alcohol dependence. The
      study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal
      increases in response to alcohol-related cues.

      In the double-blind portion, subjects received a single administration of study drug
      (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to
      continue to the open-label portion and receive 2 additional months of treatment with VIVITROL
      380 mg.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Current diagnosis of alcohol dependence, meeting at least 3 criteria from the
             Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV)

          -  Recently completed alcohol detoxification and seeking treatment for alcohol dependence

          -  Women of childbearing potential must agree to use an approved method of contraception
             for study duration

        Primary Exclusion Criteria:

          -  Pregnancy or lactation

          -  Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of
             normal (ULN) and/or esophageal variceal disease

          -  Current dependence (within the past year) to benzodiazepines or cocaine, or current or
             history of opioid dependence according to DSM-IV criteria

          -  Use of any opioids and/or methadone within 14 days prior to the screening visit, or
             likely to require opioid therapy during the study period

          -  Previous enrollment in a VIVITROL clinical trial or previous VIVITROL experience

          -  Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
             polylactide-co-glycolide (PLG)

          -  Parole, probation, or pending legal proceedings having the potential for incarceration
             during the study period