bioihbjkbjnl/mcl2 huggingface dataset:
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Tramadol Hydrochloride/Dexketoprofen Trometamol; Tramadol Hydrochloride/Paracetamol; Placebo
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 654.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute pain; Acute moderate to severe pain; Postoperative pain; Dexketoprofen Tramadol; Dexketoprofen trometamol; Tramadol hydrochloride; Multimodal analgesia; Third molar extraction; Fixed drug combination; Paracetamol; Analgesics

Summary:

      The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral
      fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment
      of moderate to severe acute pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged more than 18 years. Females participating in the study
             must be either non-childbearing potential or routinely using an effective method of
             birth control resulting in a low failure rate.

          -  Scheduled for outpatient surgical extraction -under local anaesthesia of lower third
             molar teeth, with at least one partially impacted in the mandible requiring bone
             manipulation.

          -  Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS
             score ≥ 4).

        Exclusion Criteria:

          -  History of allergy or hypersensitivity to the study treatments, RM or to any other
             NSAIDs, opioids and acetyl salicylic acid.

          -  History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal
             bleeding or other active bleedings.

          -  History of any illness or condition that, in the opinion of the Investigator might
             pose a risk to the patient or confound the efficacy and safety results of the study.

          -  Patients using and not suitable for withdrawing the prohibited medications specified
             in the protocol.
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
Condition: HIV-1-infection
MeSH terms: Substance-Related Disorders
Intervention: Bictegravir/emtricitabine/tenofovir alafenamide
Intervention description: B/F/TAF single tablet formulation
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Substance use

Summary:

      This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir
      alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances. The
      study will also evaluate retention in care and adherence to B/F/TAF by self-report and
      pharmacokinetic analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection

          -  Treatment naive or experienced

          -  Self-reported illicit substance use or confirmed urine drug screen within past 6
             months of any of the following: cocaine, heroin, methamphetamine, MDMA, phencyclidine,
             ketamine, gamma hydroxybutyrate, cathiniones, or inappropriate prescription opiate,
             benzodiazepine or stimulant use (excluding nicotine, alcohol, marijuana for criteria)

          -  HIV RNA >1000 copies/mL

          -  Creatinine clearance > 30 mL/min (Cockroft-Gault)

          -  ALT and AST < 5 times the upper limit of normal

          -  Willing and able to provide written informed consent

        Exclusion Criteria:

          -  History of integrase or tenofovir related HIV resistance mutations

          -  Pregnancy

          -  Serious illness requiring systemic treatment and/or hospitalization within 30 days
             prior to study entry
N-of-1 Trials In Children With Hypertension
Condition: Pediatric Hypertension
MeSH terms: Hypertension
Intervention: NICHE method; Usual care; Amlodipine; Lisinopril; Hydrochlorothiazide; Losartan
Intervention description: Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.; Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.; Calcium-channel blocker; antihypertensive; Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive; Thiazide diuretic; antihypertensive; Angiotensin II receptor blocker (ARB); antihypertensive
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide; Lisinopril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 10 Years
Maximum age: 22 Years
Healthy volunteers: No

Summary:

      The single patient (n-of-1) randomized trial is an underused approach to resolving
      therapeutic uncertainty by using a patient's own data to inform an individualized treatment
      plan. The proposed research is designed to assess whether the n-of-1 trial approach improves
      blood pressure control compared to usual care. This trial aims to advance learning about not
      only the treatment of pediatric hypertension but also the use of a neglected type of
      randomized trial to optimize the care of each patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  treating physician determines that pharmacologic therapy is indicated for treatment of
             hypertension

          -  ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment

        Exclusion Criteria:

          -  age < 10 years

          -  resistant hypertension (requiring ≥ 3 drug therapy)

          -  absolute contraindication or allergy to any of the tested drugs.
A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Condition: Femoro Acetabular Impingement
MeSH terms: Femoracetabular Impingement
Intervention: liposomal bupivicaine; Fascia iliaca blockade
Intervention description: local field infiltration; fascia iliaca compartment blockade
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hip arthroscopy

Summary:

      The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local
      field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and
      falls in the postoperative period following hip arthroscopy
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients (>18 years old)

          -  diagnosed FAI that are indicated for hip arthroscopic labral repair and
             femoroplasty/acetabuloplasty.

        Exclusion Criteria:

          -  patients undergoing revision procedures, bilateral procedures,

          -  advanced osteoarthritis (<2mm joint space on plain radiographs)

          -  frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis
             angle >15 degrees)

          -  diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic
             arthritis, or post traumatic deformity).

          -  allergy to liposomal bupivicaine
Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Condition: Post-operative Pain Management
MeSH terms: Pain, Postoperative
Intervention: Exparel; Bupivacaine
Intervention description: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine; 60cc Bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric
      bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine
      injection solution) injections intra-operatively at time of incision site closure. The
      control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of
      incision site closure. The medication for the control group is our current standard of care.
      The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog
      Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will
      be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours
      a member of the research team will administer a 2-part questionnaire containing the VAS and
      the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is
      validated for assessment of the patient's experience of pain and it hindrance to daily
      activity in the post operative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  bariatric surgery patients

          -  laparoscopic roux-en-y gastric bypass

          -  use of EEA stapler anastomosis

        Exclusion Criteria:

          -  age <18 years

          -  previous history of roux-en-y gastric bypass

          -  patients undergoing other bariatric procedures

          -  pre-operative opioid analgesics
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Pregnancy in Diabetics; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Neutral Protamine Hagedorn (NPH); Detemir insulin
Intervention description: NPH will peak between 4-12 hours after injection with a duration of action around 14 hours; Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
Intervention MeSH terms: Protamines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregnancy

Summary:

      To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases
      rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2
      Diabetes Mellitus (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Preexisting type 2 diabetes mellitus requiring medical treatment or

          -  overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c
             (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two
             step method ( 50g glucose challenge test (GCT) >135 mg/dl followed by 100 GCT with at
             least 2 values above thresholds: Fasting Blood Glucose (FBG) >90, 1 hr >180, 2 hr >
             155, 3 hr > 140 mg/dl).

          -  Gestational age ≤20 weeks

          -  Willing to start insulin therapy or to continue insulin treatment during pregnancy

          -  Singleton or twin pregnancy

        Exclusion Criteria:

          -  Known allergy/prior adverse reaction to NPH/detemir

          -  Patients <18y

          -  Known major fetal anomalies

          -  Diabetic nephropathy (Creatinine (Cr)≥1.5)

          -  Diabetic proliferative retinopathy

          -  Patients with Type 1 diabetes or gestational diabetes
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Condition: Kidney Calculi; Urologic Diseases; Benign Prostatic Hypertrophy
MeSH terms: Urologic Diseases; Prostatic Hyperplasia; Kidney Calculi; Nephrolithiasis; Hypertrophy; Calculi
Intervention: Tranexamic acid
Intervention description: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Male
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This study is designed to assess if there is a significant difference in same day discharge
      rates after Holmium Laser Enucleation of the Prostate (HoLEP). The investigators attempt to
      perform HoLEP as a same-day discharge (SDD) procedure, but at Northwestern Memorial, the SDD
      rate is currently approximately 60%. The limiting factor in SDD is hematuria. Tranexamic acid
      (TXA) is a clot promoting drug that is commonly used by orthopedic, cardiac and obstetric
      surgeons to prevent bleeding. The primary outcome will be to assess if there is a difference
      in SDD rates in those who receive TXA vs. those who do not.

      Secondary outcomes will assess bleeding complications (defined as unplanned ED visit/clinic
      visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for
      perioperative transfusion) between participants who receive TXA vs. those do not. The study
      will also assess differences in perioperative complications associated with TXA including but
      not limited to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between
      the groups. The study will also assess for the duration of postoperative hematuria between
      groups as well as differences in operative times between the groups.

      The investigators anticipate that there may be up to a 25% increase in SDD rates in those who
      receive TXA vs. those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males 18-89 undergoing HoLEP

          -  Willing to sign the Informed Consent Form

          -  Able to read, understand, and complete patient questionnaires, pain texts, and
             medication diary

        Exclusion Criteria:

          -  Allergy or hypersensitivity to TXA, history of acute venous or arterial thrombosis,
             intrinsic risk for thrombosis or thromboembolism, history of thromboembolic disease,
             hereditary thrombophilia, use of hormonal agents

          -  Patients having any additional simultaneous procedure other than a HoLEP
             (cystolitholapaxy allowed).

          -  Anticipated need for perineal urethrostomy at the time of HoLEP

          -  Patient not undergoing catheter removal and voiding trial at Northwestern Memorial
             Hospital
Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome
Condition: Shoulder Hand Syndrome; Complex Regional Pain Syndromes
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome
Intervention: Suprascapular and median nerve blocks
Intervention description: Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: Open label preliminary study testing the tolerability of the procedure.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Suprascapular nerve block; Median nerve block; CRPS; Shoulder hand syndrome

Summary:

      Shoulder-hand syndrome (SHS) in stroke patients is painful and lowers quality of life.
      Unfortunately, the cause of SHS is not known, diagnosing SHS can be difficult, and treating
      it can be hard. Recent research has shown that certain nerve blocks are good for treating
      shoulder pain for stroke patients, but no one has looked specifically as SHS. Investigators
      think that specific nerve blocks involving a shoulder nerve (the suprascapular, or SSc nerve)
      and a hand nerve (the median nerve) will be helpful in reducing SHS pain. Investigators will
      use ultrasound guidance to accurately inject these nerves. These injections have never been
      described for SHS patients however, so investigators want to make sure people with SHS can go
      through with the injections without too much pain or discomfort. That is, the investigators
      want to test the tolerance of these injections for people with SHS. Investigators are also
      hoping to better understand how consistent a set of diagnostic criteria, called the Budapest
      criteria, are at diagnosing SHS in order to be able to accurately diagnose this condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are required to be 18 years of age or older and have a presumptive diagnosis
             of SHS post-stroke with a minimum visual analog scale of 40mm (greater than 40mm is
             considered moderate pain).

        Exclusion Criteria:

          -  Subjects will be excluded from the study if they have significant cognitive impairment
             (mini-mental state examination <23) and language deficits (difficulty cooperating due
             to aphasia) as this may affect their response to the outcome measures. Subjects with
             uncontrolled hypertension (>180/110), septicemia, and brachial plexus injuries will be
             excluded. Patients who are blind and deaf will also be excluded, as they will be
             unable to adequately complete the post-procedure survey and VAS. Patients on
             anticoagulation medications will also be excluded on a case-by-case basis and
             medications will be held prior to injection if required for safety. Patients with INR
             >1.5 will be excluded.
Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
Condition: Obese; Cigarette-smoking; Schizophrenia
MeSH terms: Schizophrenia
Intervention: Naltrexone; Placebo Naltrexone; Bupropion; Placebo Bupropion
Intervention description: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.; Placebo Naltrexone created and masked by the pharmacy to be used as a control.; 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.; Placebo Bupropion created and masked by the pharmacy to be used as a control.
Intervention MeSH terms: Naltrexone; Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to observe the efficacy of Naltrexone and Bupropion
      combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of schizophrenia by the International Classification of Diseases 10th
             Revision (ICD-10);

          -  age between 18 and 65 years old;

          -  on stable antipsychotic medication treatment for at least one month;

          -  BMI > 28 kg/m2 according to BMI criterion for obesity in the Chinese population ， or
             BMI>27 kg/m2 in the presence of dyslipidemia, or male with waist circumference over
             90cm;

          -  smoking at least 10 cigarettes daily for one year or longer;

          -  desire to lose weight and quit smoking.

        Exclusion Criteria:

          -  Binge eating or other eating disorders;

          -  Current use of weight loss or antidiabetic medications;

          -  Current substance use (except nicotine or caffeine);

          -  Elevated hepatic transaminase levels (>2.5x normal range);

          -  Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4）
             abnormalities;

          -  History of seizure disorder;

          -  History of unstable cardiac problems or other unstable medication conditions;

          -  Being pregnant or nursing (for women).
Subconjunctival Versus Direct Mitomycin C in Trabeculectomy
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: Mitomycin-C injection; Mitomycin-C sponge
Intervention description: MMC delivered by preoperative subconjunctival injection; MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: trabeculectomy, mitomycin-C, glaucoma

Summary:

      Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of
      trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing,
      specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites,
      concentrations and times. This study aims to compare the two application routes that are
      commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral
      application in terms of IOP lowering effect, bleb appearance and complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  medically uncontrolled glaucoma

          -  healthy and freely mobile conjunctiva in superior bulbar region

        Exclusion Criteria:

          -  previous incisional glaucoma surgery

          -  no light perception vision

          -  pregnant or nursing women

          -  iris neovascularization or proliferative retinopathy

          -  iridocorneal endothelial syndrome

          -  chronic or recurrent uveitis

          -  steroid-induced glaucoma

          -  pathologic myopia or refractive error less than -6.00 diopters

          -  unwillingness or inability to give consent

          -  inability to return for scheduled protocol visits