bioihbjkbjnl/mcl2 huggingface dataset:
Gabapentin for Alcohol Withdrawal Syndrome
Condition: Alcohol Withdrawal Syndrome
MeSH terms: Syndrome; Substance Withdrawal Syndrome
Intervention: Gabapentin; Benzodiazepines; Divalproex Sodium
Intervention description: Gabapentin administered as a taper; Benzodiazepines administered using a symptoms triggered protocol; Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
Intervention MeSH terms: Chlordiazepoxide; Gabapentin; Lorazepam; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gabapentin; Alcohol Withdrawal Syndrome; benzodiazepine; symptom-triggered

Summary:

      The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is
      symptom-triggered administration of benzodiazepines. This method of treatment has several
      drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have
      been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS
      but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings
      is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due
      to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS,
      a study to compare gabapentin to symptom-triggered lorazepam will be completed.
    

Eligibility criteria:

        Inclusion criteria

          1. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score >4.

          2. Adults age 18 or older.

          3. Sufficient understanding of English.

          4. Hospitalized on Hospital Internal Medicine or Generose.

        Exclusion criteria

          1. Severe renal impairment (estimated CrCl < 30).

          2. Intensive Care Unit (ICU) level of care.

          3. Not responsive due to alcohol intoxication or withdrawal.

          4. Already taking gabapentin more than 300 mg three times a day.

          5. Prescribed pregabalin.

          6. Primary seizure disorder.

          7. Acute benzodiazepine withdrawal.

          8. Concurrent substance use disorders (such as opioid use disorder, stimulant use
             disorder) if the disorder is assessed to be clinically significant. Cannabis use
             disorder will be allowed.

          9. Concurrent anticonvulsant medications for psychiatric indications (e.g. bipolar
             disorder) will be allowed.

         10. Pregnancy.

         11. Involuntary legal status (e.g., on court commitment).

         12. Patients admitted greater than 12 hours prior to potential enrollment.

         13. Patients receiving therapeutic dose of gabapentin (rather than continuation of home
             dose) prior to enrollment.
The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis
Condition: Hypokalemia
MeSH terms: Phlebitis; Hypokalemia
Intervention: potassium chloride replacement; Experimental - 4% Sodium Bicarbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during
      peripheral intravenous potassium chloride replacement therapy for adult patients in a
      Medical/Surgical unit. Using a randomized controlled double blinded experimental study
      design, patients who are 21 years or older are alert, awake, and oriented at the time of
      enrollment and have been ordered peripheral intravenous potassium chloride replacement will
      be recruited from one Medical/Surgical during the first 24-48 hours of their admission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  admitted to the medical/surgical unit within the last 24 to 48 hours

          -  awake, alert, and oriented times three

          -  21 years old and greater

          -  receiving first peripheral intravenous potassium chloride replacement therapy as
             ordered by physician or ARNP as part of care and regardless of research

          -  potassium level of 3.5 mmol/L or less.

        Exclusion Criteria:

          -  patients who have been in the medical/surgical unit more than 48 hours.

          -  altered mental status defined as not being awake, alert, and oriented times three

          -  patients who already received intravenous potassium chloride replacement during the
             current admission and with the current IV access

          -  patients receiving intravenous potassium replacement therapy through a central line

          -  patients that are not ordered potassium replacement by physician or ARNP as part of
             their care while hospitalized.
Nebulized Hypertonic Saline for Inpatient Use in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: hypertonic saline; standard saline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline
      (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale
      scores after 4 treatments within 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age

          -  Admitted to Doctors Hospital with a clinical diagnosis of COPD

          -  Documented obstruction on spirometry from prior records available at the time of the
             study.

        Exclusion Criteria:

          -  Patients younger than 18 years of age

          -  Spirometry data not available

          -  History of smoking less than twenty pack-years

          -  Possibility of other primary cause of the patient's change in dyspnea or cough (e.g.
             pneumonia, congestive heart failure with pulmonary edema, myocardial infarction)

          -  Patient is found to have a different primary cause after initial enrollment

          -  Non-English speaking subjects
Smoking Cessation in Hispanic Construction Workers
Condition: Smoking Cessation
Intervention: Nicorette Gum; Nicoderm CQ; Smoking Quitline Referral; Behavioral Smoking Cessation Counseling
Intervention description: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy); GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy); Fax referral to the State smoking Quitline; One time face-to-face smoking cessation counseling and follow-up phone call
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study arms will be conducted simultaneously.
Masking: None (Open Label)
Enrollment: 134.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hispanics; Construction workers; Tobacco Quitline; Nicotine replacement therapy

Summary:

      Construction workers have the highest rate of smoking among all occupations, and are
      frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with
      smoking to increase their health risks. Minority construction workers, in particular, have
      higher smoking and lower cessation rates compared to other groups, and they generally show
      lower access and participation in cessation and health promotion services. The number of
      Hispanic workers employed in the construction industry in the US has tripled in the past
      decade to 2.6 million (23% of all construction workers). This study will develop, administer,
      and evaluate a novel smoking cessation program in a hard-to-reach and underserved population
      of Hispanic male construction workers using using pilot cluster randomized clinical trial
      (RCT) to test the developed intervention for feasibility and potential efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hispanic

          -  Construction worker

          -  Have smoked ≥ 5 cigarettes/day in the past year.

          -  Have access to telephone

          -  Have no plans to move in the next six months

          -  Are interested in making a serious quit attempt in the next 30 days

          -  Have no contraindication to NRT (e.g., history of hypersensitivity to nicotine, recent
             (past month) myocardial infarction, any history of serious arrhythmias or unstable
             angina pectoris, chronic dermatological disorder (e.g., psoriasis)).

        Exclusion Criteria:

          -  Inability to understand consent procedures

          -  Not Hispanic

          -  Not a construction worker

          -  Haven't smoked ≥ 5 cigarettes/day in the past year.

          -  No access to telephone

          -  Has plans to move in the next six months

          -  Not interested in making a serious quit attempt in the next 30 days

          -  Has a contraindication to NRT

          -  Has a generalized chronic dermatological disorder (e.g., psoriasis)
Computerized Cognitive Training for Diabetic Elderly Veterans
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: computerized cognitive training; control games
Intervention description: A variety of computer games tailored to address their personal cognitive deficits.; A variety of computer games that are engaging but not designed to enhance cognitive skills
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: All
Minimum age: 55 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: computerize cognitive training; dementia; cognitive decline; Diabetes Mellitus, Type 2

Summary:

      Computerized cognitive training (CCT) is an intervention has improved cognitive functioning
      in the elderly with and without cognitive impairment. The investigators will study the effect
      of a CCT program over an active control, "classic" computerized games. The outcomes will be
      memory and executive functions/attention, diabetes elf-management and adherence to
      medications, and glycemic and blood pressure control. Non-demented elderly Veterans with
      diabetes mellitus, who are at high risk for cognitive impairment, will be from the James J.
      Peters, Bronx, NY and Ann Arbor, MI VAMCs. This novel potential service fits the portfolio of
      the Quality Enhancement Research Initiative for Diabetes Mellitus (QUERI-DM) for which the
      Ann Arbor VAMC is a primary center. If successful, the VA National Center for Prevention and
      MyHeatheVet will collaborate in disseminating results to encourage implementation throughout
      the VA
    

Eligibility criteria:

        Inclusion Criteria:

          -  55 years old or above

          -  A diagnosis of type 2 diabetes

          -  Access to computer and internet

          -  Has an informant

          -  Self-management score 18 or below

        Exclusion Criteria:

          -  Dementia or prescribed AD medications

          -  Major medical, psychiatric, or neurological conditions that affect cognitive
             performance

          -  Severe impairment of vision, hearing or fine motor control necessary for computer
             operation
Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Cystoscopic Fluid containing Neosporin G. U. Irrigant; Cystoscopy; Cystoscopic Fluid/Placebo
Intervention description: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL; Diagnostic cystoscopy performed during pelvic floor surgery; Normal saline cystoscopic fluid
Intervention MeSH terms: Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 242.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective
      gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative
      antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic
      medical therapies have been utilized to attempt to decrease this rate with little
      improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease
      postoperative UTIs. The investigators have designed a prospective randomized controlled study
      to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative
      urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult women at least 18 years of age

          -  Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally
             Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ
             prolapse repair that require cystoscopy.

        Exclusion Criteria:

          -  Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair

          -  Pregnancy

          -  History of nephrolithiasis

          -  Allergy to study medications

          -  Congenital urogenital anomaly

          -  Neurogenic bladder
Treatment of Giardia Lamblia Infections in Children
Condition: GIARDIASIS
MeSH terms: Giardiasis
Intervention: Metronidazole; Tinidazole
Intervention description: P/r suppositories; P/o tablets
Intervention MeSH terms: Metronidazole; Tinidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 6 Months
Maximum age: 10 Years
Healthy volunteers: No

Summary:

      This study investigates the efficacy and safety of rectally administered metronidazole for
      pediatric Giardia lamblia infection, as well as the acceptance of this treatment regimen by
      patients/caregivers. The investigators hypothesize that rectal metronidazole is non-inferior
      to single-dose of oral tinidazole and will cure at least 72% of patients, a well as will be
      tolerated as good as tinidazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical symptoms could be explained by giardiasis AND

          -  fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory
             (HUSLAB)

        Exclusion Criteria:

          -  age <6 mo or >10 years

          -  weight <9.5 kg

          -  the absence of symptoms

          -  co-infection with another pathogen, which may cause giardiasis-like symptoms
Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
Condition: Intubation Complication
Intervention: Etomidate; Ketamine
Intervention description: Etomidate will be administered as the sedative for RSI on even days; Ketamine will be administered as the sedative for RSI on odd days
Intervention MeSH terms: Ketamine; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 428.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rapid Sequence Intubation; Hemodynamics; Etomidate; Ketamine

Summary:

      The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate
      during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persons greater than 18yrs requiring rapid sequence intubation for any reason.

        Exclusion Criteria:

          -  Pregnant patients

          -  Children under the age of 18

          -  Patients with a known hypersensitivity to etomidate or ketamine
A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval
Condition: Pain
Intervention: Acetaminophen; placebo
Intervention description: Acetaminophen total dose of 1000mg; subjects randomized to this group will be given placebo tablets
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: Female
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Analgesic; Pain Control; IVF; Tylenol; Acetaminophen; Egg Retrieval; iv vitro Fertilization

Summary:

      Current standard of care is no pretreatment medications before the egg retrieval, and the
      investigators would like to evaluate if preoperative Tylenol improves procedure and post
      procedure pain control over the current practice (no pre-treatment). Specifically, this study
      will compare Tylenol with a placebo when given before retrieval procedures. The investigators
      believe that if Tylenol can offer better analgesic relief than no pretreatment medications,
      then it may reduce the amount of narcotics needed by patients during and after the procedure
      and contribute to better patient satisfaction. . This study will enroll 100 participants all
      from University of Alabama at Birmingham (UAB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  English Speaking

          -  Undergoing Transvaginal Oocyte Retrieval Procedure

        Exclusion Criteria:

          -  Acetaminophen allergy

          -  Opioid dependency
Glargine U300 Hospital Trial
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Glargine U300; Glargine U100; Glulisine Insulin
Intervention description: Glargine U300 is a new generation long-acting insulin.; Glargine U100 is a long-acting insulin.; Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Intervention MeSH terms: Insulin Glargine; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blood glucose

Summary:

      The purpose of this study is to find out if treatment with Glargine U300 when compared to
      Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),
      who are admitted to the hospital and then transition at home, after discharge from the
      hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females between > 18 years admitted to a general medicine or surgical
             service.

          -  Known histories of T2D treated with either diet alone, oral monotherapy, any
             combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide)
             or insulin therapy with the exception of degludec and glargine U300.

          -  Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without
             laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or
             positive serum or urinary ketones).

        Exclusion Criteria:

          -  Subjects with increased BG concentration, but without a known history of diabetes.

          -  Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA
             (weekly exenatide, dulaglutide or albiglutide).

          -  Patients with acute critical or surgical illness admitted to the ICU or expected to
             require admission to the ICU.

          -  Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and
             portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30
             ml/min).

          -  Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study.

          -  Female subjects who are pregnant or breast feeding at time of enrollment into the
             study.
Corticosteroids With Vedolizumab in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Prednisone; Placebo; Vedolizumab
Intervention description: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
Intervention MeSH terms: Prednisone; Vedolizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Vedolizumab; Corticosteroids; Prednisone; Crohn's disease

Summary:

      Use of co-induction with corticosteroid therapies may accelerate the remission rate when used
      with vedolizumab. Further, this may lead to higher rates of response and remission at week 10
      than would be seen with vedolizumab monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at entry 18 to 70

          -  CDAI score > 220

          -  Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been
             stable for > 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued
             (>2 weeks from last dose) prior to initiation of vedolizumab.

          -  Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10
             or more aphthous ulcers

          -  Able to provide written informed consent.

          -  Patient is planned for or eligible to initiate vedolizumab

        Exclusion Criteria:

          -  Concurrent use of anti-TNFα antibodies.

          -  No corticosteroids within prior 3 months (other than budesonide controlled ileal
             release)

          -  No stoma at the time of enrollment

          -  No absolute contraindication to systemic corticosteroid use such as hypersensitivity
             to any part of the formulation, systemic fungal infection, or recent administration of
             live or live attenuated vaccine within prior two weeks.

          -  Pregnant women or plans for pregnancy within 3 months of study inclusion

          -  Presence of stoma, more than three small-bowel resections, or documented history of
             short bowel syndrome

          -  Intestinal stricture requiring surgery

          -  Abdominal abscess

          -  Inability or unwillingness to provide informed consent

          -  Any other condition, which, in the opinion of the investigators would impede
             competence or compliance or possibly hinder completion of the study