bioihbjkbjnl/mcl2 huggingface dataset:
Interscalene Block Versus Superior Trunk Block
Condition: Joint Disease; Pain; Pain, Acute; Pain, Chronic
MeSH terms: Joint Diseases; Acute Pain; Chronic Pain
Intervention: Bupivacaine; Ultrasound
Intervention description: Anesthetic that will help treat pain and sensation after shoulder arthroscopy; Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block
      (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair,
      stabilization, rotator cuff repair).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who will be undergoing primary unilateral labral repair/stabilization of the
             shoulder

          -  Age 18 to 80 years

          -  Planned use of general anesthesia with LMA and interscalene or superior trunk block

          -  Ability to follow study protocol

          -  English speaking

          -  ASA I - III

        Exclusion Criteria:

        Pre-existing neuropathy of the operative limb

          -  Younger than 18 years old and older than 80

          -  Patients with pulmonary severe respiratory disease

          -  Allergy to one of the study medications

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months)

          -  Contraindication to general anesthesia, interscalene or superior trunk block

          -  Herniated Cervical Disk, Cervical Myelopathy

          -  BMI >35
Pilot Study of Velcade® in IgA Nephropathy
Condition: Chronic Kidney Disease; IgA Nephropathy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Glomerulonephritis, IGA
Intervention: Bortezomib (Velcade®)
Intervention description: Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Intervention MeSH terms: Bortezomib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic kidney disease; IgA nephropathy; Velcade®; Proteinuria; Bortezomib; Proteasome inhibitor

Summary:

      The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to
      induce complete or partial remission in patients with severe IgA nephropathy.

      The secondary objectives are to assess clinical outcomes relating to safety and efficacy,
      such as infection, malignancy, preservation of renal function, partial responders, relapse
      rate, and to study mechanistic assays to predict remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 18 years of age or older.

          2. Must have IgA nephropathy documented by kidney biopsy.

          3. Must have greater than 1gm of proteinuria a day.

          4. Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or
             Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.

        Exclusion Criteria:

          1. Low platelet count and neutrophil count within certain limits defined for enrollment.

          2. Underlying peripheral neuropathy.

          3. Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled
             angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
             of acute ischemia or active conduction system abnormalities.

          4. Allergic to VELCADE®, boron or mannitol.

          5. Female subjects who are pregnant or breast-feeding.

          6. Recent use of investigational drug within 14 days before enrollment.

          7. Having serious medical conditions and infections (including HIV,or hepatitis B or C)
             or psychiatric illness likely to interfere with participation in the study.

          8. Diagnosed or treated for cancer within 3 years of participation in the study, with the
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
             the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Condition: Deep Vein Thrombosis; Postthrombotic Syndrome
MeSH terms: Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
Intervention: Rivaroxaban; Diosmin; compression stockings
Intervention description: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month; 600 mg q.d. for 12 month; above knee stocking for 12 month
Intervention MeSH terms: Rivaroxaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized open-labeled clinical trial with a masked outcomes assessor
Masking: Single (Outcomes Assessor)
Masking description: Outcomes assessor does not involve in randomisation and treatment process, has no information about the patient's belonging to one of the study groups
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: deep vein thrombosis; postthrombotic syndrome; anticoagulation; treatment; prevention

Summary:

      The randomized clinical study aimed to assess the efficacy and safety of standard
      anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of
      standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis
      reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age over 18 years

          -  The first episode of femoro-popliteal deep vein thrombosis (DVT)

          -  Verification of DVT by duplex ultrasound

          -  Informed consent signed

        Exclusion Criteria:

          -  Suspicion of pulmonary embolism (PE)

          -  Verified PE

          -  Bilateral DVT

          -  Contraindications for rivaroxaban (in accordance with the official instructions)

          -  Contraindications for diosmin (in accordance with the official instructions)

          -  Active cancer

          -  Verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins C,
             S, antithrombin 3)

          -  Use of other anticoagulants for more than 7 days from the DVT verification

          -  Impossibility of using compression stocking after 3 days from DVT verification

          -  Performed surgical intervention on the superficial or deep veins of the lower
             extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior
             cava filter)

          -  Continuous use of other drugs that affect the hemostasis system (except for
             acetylsalicylic acid in a dose of not more than 100 mg).

          -  Low compliance
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Condition: Scabies; Households
MeSH terms: Scabies
Intervention: Benzyl Benzoate 25% Topical Application Lotion
Intervention description: Applied to skin for the treatment of scabies
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Healthy volunteers: No

Summary:

      It is unclear whether individual treatment of scabies is similarly effective compared to
      household treatment. This study therefore compares these two treatment strategies with
      topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon.

      Subjects presenting with uncomplicated scabies are randomized into either the Individual
      Treatment group, where only the affected subjects receive treatment, or the Household
      Treatment group, where all family members are treated in parallel to the affected subjects
      regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the
      secondary endpoint is the proportion of affected household members per household after 28
      days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with active, uncomplicated scabies

          -  no known hypersensitivity or allergy against benzyl benzoate

        Exclusion Criteria:

          -  hypersensitivity or allergy against benzyl benzoate

          -  severe superinfection of scabies lesions
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: CP-690,500 5 mg; CP-690,550 10 mg
Intervention description: CP-690,550 5 mg tablet BID; CP-690,550 10 mg tablet BID
Intervention MeSH terms: Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ulcerative colitis; inflammatory bowel disease

Summary:

      This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission
      designed to evaluate flexible dosing of CP-690,550.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2
             years consecutively.

          -  In stable remission on CP-690,550 10 mg BID

          -  Agree to use highly effective contraception

          -  Negative pregnancy test

          -  Comply with visits, treatments, lab tests, diary and other study procedures

          -  Signed and dated informed consent document.

        Exclusion Criteria:

          -  Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study
             A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis or findings suggestive of Crohn's disease

          -  Likely to require surgery for ulcerative colitis during study

          -  Expected to receive any prohibited medication

          -  Expected to receive live or attenuated virus vaccination during study

          -  Women who are pregnant or breastfeeding or planning to become pregnant during the
             study

          -  Evidence of colonic malignancy or any dysplasia

          -  Acute or chronic medical or psychiatric condition that may increase risk of
             participation

          -  Investigator site staff member

          -  Subjects likely to be uncooperative or unable to comply with study procedures

          -  Participation in other studies involving investigational drugs during study

          -  Subjects with any of the following risk factors for pulmonary embolism at baseline as
             defined by EMA's PRAC:

               -  has heart failure;

               -  has inherited coagulation disorders;

               -  has had venous thromboembolism, either deep venous thrombosis or pulmonary
                  embolism;

               -  is taking combined hormonal contraceptives or hormone replacement therapy;

               -  has malignancy (association is strongest with cancers other than non-melanoma
                  skin cancers);

               -  is undergoing major surgery
Preoperative Steroids in Autoimmune Thyroid Disease
Condition: Thyroid Diseases
MeSH terms: Thyroid Diseases
Intervention: Prednisone
Intervention description: used to reduce inflammation
Intervention MeSH terms: Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled pilot study
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Autoimmune disease; Graves' Disease; Hashimoto's Thyroiditis

Summary:

      This pilot project will randomize a small sample of patients about to undergo surgery for
      their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone
      alters the inflammation of the gland and makes surgery less difficult. It will enroll 30
      participants who will each be on study for up to 7 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Graves' disease or Hashimoto's disease with positive thyroid autoantibodies
             (Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating
             Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]).

          -  Participants will be invited to join the study after the decision has been made to
             proceed with thyroidectomy as the clinical treatment of their autoimmune thyroid
             disease.

        Exclusion Criteria:

          -  Pediatric patients < 18

          -  Prior treatment with radioactive iodine (RAI)

          -  Known diagnosis of thyroid cancer

          -  Diabetic patients.

          -  Patients on any immunosuppressive regiment (such as organ transplant patients or
             patients treated for other autoimmune condition)

          -  Pregnant patients.

          -  Patients being treated for active infection.

          -  Any patient for whom the surgeon feels steroids would provide a clear benefit (ie.
             Extremely high auto-antibody levels with a very large, inflamed thyroid gland) will be
             treated according to the clinical judgement of the surgeon. If a surgeon feels
             steroids are indicated and prescribes them, the patient will not be eligible for the
             trial.
Intravenous Exenatide in Patients With Acute Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Intervention: Exenatide
Intervention description: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
Intervention MeSH terms: Exenatide
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
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the feasibility of exenatide infusion for the
      treatment of high blood sugars following acute brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥18 years

          -  Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for
             an anticipated length of stay >48 hours

          -  Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL

          -  Informed consent obtained via proxy

        Exclusion Criteria:

          -  Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of
             infusion) or lactating females

          -  Type 1 diabetes mellitus

          -  History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse,
             gall stones)

          -  Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min

          -  Known history of gastroparesis

          -  History of surgery on stomach, esophagus or duodenum

          -  Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome

          -  Concurrent steroid use or planned post-operative steroid use

          -  History of organ transplantation

          -  Brain death or suspected imminent brain death within the next 72 hours

          -  Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg
             for greater than 15 minutes and refractory to medical intervention

          -  Currently enrolled in another investigational drug or device protocol

          -  Insulin infusion within 3 hours of study drug administration or confirmed long acting
             insulin or sulfonylurea use prior to admission within 24 hours of study drug
             administration

          -  Known allergy to exenatide
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Condition: GERD Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: Omeprazole; LINX Reflux Management System
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Esophageal Reflux; Gastric Acid Reflux Disease; Heartburn

Summary:

      This study compares mechanical sphincter augmentation (LINX Reflux Management System) to
      double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to
      gastroesophageal reflux disease (GERD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Patient seeks consultation for lack of satisfactory symptom response to once daily
             PPIs.

          2. Age≥ 21 years old.

          3. Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score.
             Testing to be completed off GERD medications for at least 7 days, with the exception
             of antacids, which may be taken up until the morning of assessment.

          4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and
             laparoscopic surgery).

          5. Patient has provided written informed consent for participation in the randomized
             study.

        Key Exclusion Criteria:

          1. Currently taking double-dose PPIs (twice daily dosing).

          2. Hiatal hernia >3cm as determined by endoscopy.

          3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
             peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.

          4. Esophagitis Grade C or D (Los Angeles classification).

          5. Body mass index >35.

          6. Diagnosed with an esophageal motility disorder LES.

          7. Esophageal stricture or gross esophageal anatomic abnormalities

          8. History of/or known Barrett's esophagus.

          9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous
             materials.
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
Condition: Agitation,Psychomotor; Haloperidol Causing Adverse Effects in Therapeutic Use; Lorazepam Causing Adverse Effects in Therapeutic Use; Loxapine Causing Adverse Effects in Therapeutic Use
MeSH terms: Psychomotor Agitation
Intervention: Haloperidol + lorazepam; Loxapine
Intervention description: Haloperidol + lorazepam + placebo; loxapine + placebo
Intervention MeSH terms: Lorazepam; Haloperidol; Haloperidol decanoate; Loxapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to determine the noninferiority of inhaled loxapine
      compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Requires treatment for agitation in the judgment of a physician

          2. Patient either pre-consented, has surrogate consent, or able to consent (in cases of
             mild agitation).

          3. The patient is at least 18 years of age and less than 65 years of age.

          4. Patients with known or presumed schizophrenia or bipolar 1 disorder.

        Exclusion Criteria:

          1. Patients with acute respiratory signs/symptoms (eg, wheezing).

          2. Known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma or taking
             meds for asthma or COPD.

          3. Female patients who are obviously pregnant or breast-feeding.

          4. Medically unstable patients.

          5. Patients or surrogates who object to being in the study (even if previously
             pre-consented).

          6. Physician objection to patient enrollment in the study.

          7. Prisoners or incarcerated.
Intra-articular Local Anesthetic Injection and Hematoma Aspiration
Condition: Tibial Fractures
MeSH terms: Hematoma; Tibial Fractures
Intervention: Aspiration; Bupivacaine
Intervention description: A needle is placed into the knee joint and all of the blood that is in the joint is removed.; An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive aspiration of the joint alone, receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or receive no injection or aspiration therapy
Masking: Single (Participant)
Masking description: This study uses a single blind masking scheme
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aspiration; Bupivacaine; Epinephrine; Marcaine; Pain; Shin Bone

Summary:

      The primary objective of this study is to determine whether a patient with a tibial plateau
      fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic
      analgesia requirements following an intra-articular injection of local anesthetic and
      aspiration of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with isolated tibial plateau fractures aged 18 years and older

          -  Patients with tibial plateau fractures and associated soft tissue complaints about the
             knee, not associated with a fracture outside of the tibial plateau

          -  Patients with bilateral tibial plateau fractures and no other noted fractures

        Exclusion Criteria:

          -  Any patient that does not wish to participate in the study or is unable to give
             consent at the initial encounter

          -  Patients under 18 years old

          -  Pregnant patients

          -  Patients who are unable to understand the study procedures

          -  Incarcerated patients

          -  History of allergic reaction to local anesthetics

          -  Emergent conditions requiring operations or airway protection

          -  Polytrauma patients

          -  Patients presenting for care greater than 24 hours following their injury.