bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Lidocaine and Ketorolac for Pain Management
Condition: Pain
Intervention: Lidocaine; Ketorolac Tromethamine; Normal Saline Drip; Normal Saline Push
Intervention description: 1.5 mg/kg IV lidocaine drip (given over 10 minutes); IV ketorolac 30mg push; Normal Saline Drip Placebo given over 10 minutes; Normal Saline Push Placebo
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Pain; Lidocaine; Ketorolac

Summary:

      The literature regarding analgesic modalities, their combinations and routes of
      administrations for patients with pain related to renal colic is expanding. NSAID's (IV
      ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic either
      alone or in combinations. Despite their synergism and analgesic superiority when administered
      together, both classes of these medications possess a set of unfavorable side effects that
      limit their use. Emerging data of the use of IV lidocaine for patients with renal colic
      demonstrated good analgesic efficacy and safety profile. However, none of the trials directly
      compared lidocaine to ketorolac or the combination of both as viable options in patients
      unable to tolerate or to have serious contraindications to opioids. We designed a
      double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and
      feasibility of non-opioid analgesics and their combinations in patients with renal colic. The
      hypothesis and proposed study will try to determine if a combination of IV lidocaine and
      reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid
      analgesic modality is effective for controlling pain of renal colic origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Emergency Medicine Patient

          -  clinical diagnosis of acute renal colic

          -  pain score of >=5 out of 10 on the numeric rating scale

          -  - age 18 - 64 years of age

        Exclusion Criteria:

          -  documented or suspected pregnancy, breastfeeding

          -  contraindication to nonsteroidal anti-inflammatory drugs or lidocaine

          -  known renal dysfunction

          -  received analgesics within 4 hours before presentation

          -  history of bleeding diathesis

          -  history of peptic ulcer disease

          -  current use of warfarin

          -  HR<50 or >150

          -  history of cardiac arrhythmias

          -  peritonitis or presence of any peritoneal sign

          -  altered mental status

          -  weight > 100kg
Studying the Effects of Sibutramine on Eating Behavior
Condition: Obesity
MeSH terms: Obesity
Intervention: Sibutramine; Placebo
Intervention description: 1 week of active sibutramine (15mg); 2 weeks of placebo
Intervention MeSH terms: Sibutramine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Obesity; sibutramine; eating behavior

Summary:

      Obesity is a major public health concern, and the search for useful pharmacologic
      interventions is ongoing. This study aims to develop a comprehensive series of assessments to
      directly assess eating behavior, cognitive functioning, and psychological functioning under
      sibutramine and placebo conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderately obese

          -  stable weight for a minimum of 3 months

          -  systolic blood pressure less than or equal to 140 mm Hg

          -  diastolic blood pressure less than or equal to 90 mm Hg

          -  pulse less than or equal to 95 beats per minute

          -  English language proficiency

        Exclusion Criteria:

          -  on medications known to affect appetite, weight, or metabolism

          -  current or past history of: binge eating disorder, anorexia nervosa or bulimia
             nervosa, major depression

          -  current or past evidence of psychosis, bipolar illness

          -  current or past history of alcohol or drug abuse or dependence

          -  known history of learning disorder or developmental disability

          -  current or past attention deficit hyperactivity disorders

          -  low platelet count

          -  current diabetes mellitus

          -  uncontrolled asthma, or controlled only with oral steroids

          -  hypothyroidism not adequately treated

          -  pregnancy, planning to become pregnant, or lactation within the previous 6 months

          -  history of neurological disorder or injury

          -  history of moderate or severe head injury

          -  waist circumference greater than 188 cm

          -  indwelling metallic object, non-removable metal jewelery, medicinal patch or recent
             metallic ink tattoo

          -  pacemaker

          -  metallic implants

          -  medication patches

          -  significant claustrophobia

          -  color blindness
LARC Forward Contraceptive Counseling at MHCC
Condition: Contraception
Intervention: Long Acting Reversible Contraception (LARC); Referral for Long Acting Reversible Contraception (LARC); Prescription for Short-Acting Hormonal Contraception
Intervention description: Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon; Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.); Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 17 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LARC; IUD; Contraceptive Implant; Contraception; Community college

Summary:

      This prospective randomized controlled study will evaluate if Long Acting Reversible
      Contraceptive (LARC) forward counseling in combination with same-day LARC placement increases
      overall LARC uptake within a community college population compared to LARC forward counseling
      and referral to a secondary clinic for LARC placement. The study will be conducted at Mount
      Hood Community College (MHCC) in Oregon. Participants will be enrolled into three groups. All
      groups will receive the same standardized contraceptive counseling ("LARC forward
      counseling") and participants will be able to choose between a LARC method and short-acting
      method of birth control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish-speaking women.

          -  17-30 years of age.

          -  Currently enrolled in a 2-year certificate program at Mount Hood Community College.

          -  At risk for pregnancy (sexually active with men or anticipate becoming sexually active
             in the next 6 months).

          -  Do not desire pregnancy within the next 12 months.

          -  No contraindications to LARC according to the Center for Disease Control and
             Prevention medical eligibility criteria (CDC MEC)

        Exclusion Criteria:

          -  Women who are not currently sexually active with men and who do not anticipate
             becoming sexually active with a male partner in the next 6 months.

          -  Women who have had a tubal ligation or other sterilization procedure.

          -  Women who desire pregnancy within the next 12 months.

          -  Women currently already using a LARC method for contraception.
Vildagliptin Versus Dapagliflozin on Glucagon
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Vildagliptin; Dapagliflozin
Intervention description: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks; Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks
Intervention MeSH terms: Dapagliflozin; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects
      on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2
      diabetes and whether this is associated with effects on glucose homeostasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written consent has been given.

          2. Patients with type 2 diabetes treated with a stable dose of metformin during the last
             three months

          3. Age 20-70 years.

          4. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.

          5. Ability to complete the study

        Exclusion Criteria:

          1. Use of other glucose-lowering therapy than metformin within three months prior to
             visit 1.

          2. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.

          3. Type 1 diabetes, positive GAD antibodies

          4. Estimated glomerular filtration rate <60 ml/min

          5. Acute infections which may affect blood glucose control within 4 weeks prior to visit
             1

          6. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.

          7. Any history of acute pancreatitis

          8. Any history of anaphylaxis, angioedema, and exfoliative skin conditions including
             Stevens-Johnson syndrome.

          9. Liver disease such as cirrhosis or chronic active hepatitis

         10. History of coronary heart disease or heart failure class III or IV

         11. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at
             least one unit of blood within the past 2 weeks or a blood transfusion within the past
             8 weeks.

         12. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment
             (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.

         13. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable
             for the study

         14. Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
Hernia Repair in Multiply Morbid Patients
Condition: Ventral Hernia
MeSH terms: Hernia; Hernia, Ventral
Intervention: Strattice Reconstructive Tissue Matrix (Hernia Repair); Proceed Surgical Mesh (Hernia repair)
Intervention description: Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.; Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hernia repair, surgical mesh, co-morbidities

Summary:

      Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in
      a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia
      repair is at increased risk of wound related complications, which may be exacerbated by the
      choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia
      recurrence. It is hypothesized that patients receiving a mesh of biologic origin may
      experience fewer wound related complications and hence at least an equal rate of hernia
      recurrence, compared to those receiving a synthetic mesh.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults of either gender

          -  must have 2 or more co-morbidities

        Exclusion Criteria:

          -  local or systemic infection

          -  expected survival of <24 months

          -  non-ambulatory
A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dulaglutide Pen; Semaglutide Pen
Intervention description: Injected on a practice pad.; Injected on a practice pad.
Intervention MeSH terms: Dulaglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this study participants will try out two different types of drug injection pens
      (dulaglutide and semaglutide) on a practice pad and decide which device they prefer. No study
      drug will be administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  Self-injection naïve to all injectable treatment (for example, diabetes therapies and
             other medical conditions)

          -  Injection naïve to performing all injectable treatment (for example, diabetes
             therapies and other medical conditions) to others

        Exclusion Criteria:

          -  Currently diagnosed with gestational diabetes and/or type 1 diabetes

          -  Cognitive or physical difficulties that could interfere with ability to understand the
             training, perform the injection tasks, or complete the study questionnaires as judged
             by the investigator

          -  Is a health care practitioner who is trained in giving injections
Prevention of Tuberculosis in Prisons
Condition: Tuberculosis, Pulmonary; Antibiotic Prophylaxis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Intervention: Isoniazid 900 milligrams; Placebo
Intervention description: Oral tablet, with the isoniazid 900mg, given two weekly. The administration will be supervised.; Oral tablet, without the active ingredient, similar in size, weight, color, taste and odor.
Intervention MeSH terms: Anti-Bacterial Agents; Isoniazid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 467.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis; Primary prevention; Prisoners; Controlled Clinical Trial; Isoniazid

Summary:

      The purpose of this study is to determine if the isoniazid is effective in the prevention of
      tuberculosis in a prison population, exposed to the high endemicity of the disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age above 18 and under 45 at the time of inclusion;

          -  Sign the informed consent form.

        Exclusion criteria:

          -  Be indigenous;

          -  Active TB or previous use of isoniazid;

          -  Score Alcohol Use Disorders Identification Test ≥15.

          -  Reactive serology for HIV, hepatitis B and C;

          -  Reactive result for quantiferon, considering as positive the result of Tube 1 and / or
             Tube22 above 0.2 IU / mL;

          -  Liver enzymes (Aspartate aminotransferase and Alanate aminotransferase) three times
             the upper limit;

          -  History or treatment for epilepsy;
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: trospium chloride; placebo
Intervention description: Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks; Placebo once daily on an empty stomach for 14 weeks.
Intervention MeSH terms: Trospium chloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 322.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily
      in reducing urgency, urinary frequency and urinary urge incontinence in female patients with
      incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification

          -  Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary
             incontinence

          -  Taking five or more concomitant medications (may be prescription, non-prescription, or
             supplement/vitamin) daily for indications other than Overactive Bladder (OAB).

        Exclusion Criteria:

          -  Predominant stress or insensate incontinence

          -  History of neurogenic bladder

          -  Two urinary tract infections in the last six months

          -  Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)

          -  Donated >500mL blood in the 30 days prior to the screening visit
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
Condition: PCOS; Depression; Vitamin D Deficiency; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Vitamin D Deficiency; Depression; Depressive Disorder
Intervention: Metformin; Vitamin D
Intervention description: Oral medication daily; Oral medication daily
Intervention MeSH terms: Vitamin D; Cholecalciferol; Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PCOS; Depression; Vitamin D; Insulin Resistance; Anxiety; Quality of life; Mood disorders

Summary:

      Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in
      improving symptoms of depressed mood in polycystic ovary syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)

          -  Vitamin D insufficiency (serum Vitamin D <30 ng/mL)

          -  Insulin resistance

          -  Mild or greater severity of depression by Beck Depression Inventory-II

        Exclusion Criteria:

          -  Current metformin use

          -  Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D
             insufficiency

          -  Insulin-dependent diabetes mellitus

          -  Pregnancy or breastfeeding

          -  Untreated hypothyroidism

          -  Current active substance abuse

          -  Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data
Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Lifestyle Intervention; Metformin
Intervention description: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.; At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patient Recruitment:
The investigators are targeting the highest risk pre-diabetic patients for this study. Patient recruitment will occur through the involved health clinics.
Control Participants Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited from the ECHORN Cohort Study (ECS).
ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups. These participants will be offered a delayed intervention at the end of 2.5years, given the evidence supporting behavioral modification for diabetes prevention.
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 40 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk
      pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.

      Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle
      intervention, with escalation to Metformin therapy will lower the incidence of diabetes among
      the highest risk pre-diabetic individuals of Caribbean-descent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI>25 or WC>88/102cm

          -  No history of type I or type II diabetes or gestational diabetes

          -  Not on blood sugar altering medication

          -  Ability to attend weekly sessions

          -  HbA1c 6-6.4%

        Exclusion Criteria:

          -  Pregnant

          -  eGFR<45 mL/min/1.73 m2

          -  Prescribed Metformin and randomized to the control arm