bioihbjkbjnl/mcl2 huggingface dataset:
Orphenadrine and Methocarbamol for LBP
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Orphenadrine; Methocarbamol; Naproxen; Placebo
Intervention description: Orphenadrine 100mg PO BID x 7 days; Methocarbamol 750mg 1-2 tabs po TID x 7 days; Naproxen 500mg PO BID x 7 days; 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days
Intervention MeSH terms: Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Orphenadrine; Methocarbamol; Cholinergic Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      Low back pain is a common cause of visit to emergency department. It is not clear if skeletal
      muscle relaxants are of benefit for patients with acute low back pain. This is a randomized
      study to determine if skeletal muscle relaxants, when combined with naproxen, improve
      outcomes more than naproxen alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  LBP duration <= 2 weeks

          -  No trauma to low back within previous month

          -  No radicular symptoms

          -  No history of low back pain or history of only infrequent episodes

        Exclusion Criteria:

          -  Medication allergies or contra-indications

          -  Not available for follow-up

          -  Chronic pain syndrome
The Use of Iron Therapy for Patients With Anemia After Caesarean Section
Condition: Postoperative Anaemia
MeSH terms: Anemia
Intervention: Ferinject; Ferrous fumarate; Placebo for ferrous fumarate; Placebo for ferinject
Intervention MeSH terms: Iron; Ferrous fumarate; Ferric Compounds
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postoperative; anemia; gynaecologic; surgery

Summary:

      The purpose of this study is to determine whether oral or intravenous iron is effective in
      the treatment of anaemia (iron-poor blood) after caesarean section.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gynecological surgery

          -  Hb 5-7 mmol/L

        Exclusion Criteria:

          -  Pregnancy

          -  Oncological operations

          -  Infections (PID)

          -  Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal
             testing; Hysteroscopies

          -  Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ),
             Conization,

          -  Small vulvar / vaginal operations such as (cysts, labia correction)

          -  Endometrial ablation

          -  Legal incapacity

          -  The patient has used pre-operatively an iron preparation and / or blood transfusion or
             during the surgery

          -  Hematologic disorders

          -  Erythropoiesis-stimulating agents &lt; 3months ago

          -  Myelosuppressive therapy in history

          -  Hepatitis

          -  HIV

          -  Alcohol abuses

          -  Not understanding Dutch

          -  Allergic reaction to iron therapy in past
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Condition: HIV; AIDS; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias
Intervention: Stribild
Intervention description: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atripla; stribild; dreams

Summary:

      Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep
      disturbances.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV+ subjects 18 years of age or older

          -  estimated Glomerular Filtration Rate > 70 mL/min

          -  must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral
             Load < 50 copies/mL

          -  no antiretrovirals prior to the initiation of Atripla

          -  baseline genotyping

        Exclusion Criteria:

          -  pregnancy

          -  unable to provide informed consent

          -  enrolled in another study
Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Condition: Incomplete Reversal of Neuromuscular Block
Intervention: Sugammadex; Neostigmine
Intervention description: Sugammadex will be given for reversal of neuromuscular blockade.; Neostigmine will be given for reversal of neuromuscular blockade.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study will compare patient recovery measures after reversal of neuromuscular blockade
      with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle
      strength, time to extubation and quality of recovery in the post anesthesia care unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be willing and able to provide written informed consent for the study

          -  Participant must be greater than or equal to 18 years of age

          -  Participant must be ASA (American Society of Anesthesiologists) class I, II or III

          -  Planned use of neuromuscular blocking drugs

          -  Planned use of endotracheal intubation

          -  Planned for extubation to occur in the OR

        Exclusion Criteria:

          -  ASA (American Society of Anesthesiologists) Class IV

          -  Age < 18 years old

          -  Inability to give oral or written consent

          -  Known or suspected neuromuscular disorder impairing neuromuscular function

          -  True allergy to muscle relaxants

          -  A (family) history of malignant hyperthermia

          -  A contraindication for neostigmine or sugammadex administration

          -  Serum creatinine level of greater than 2.0 mg/dL

          -  Surgery where the patient's arm is not available for neuromuscular monitoring

          -  A plan to extubate under deep anesthesia

          -  Pregnant
Functional Effects of Botox on the Brain Using MRS and fMRI
Condition: Healthy
Intervention: onabotulinumtoxinA
Intervention description: This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA .
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 30 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in
      a growing number of indications including disorders involving skeletal muscle (e.g.,
      strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g.,
      bladder), glands (axillary hyperhidrosis) and nociceptive pain (e.g. migraine) (Brin. 2014).
      Recently, several studies have suggested that peripheral BOTOX injections in the region of
      the glabellar lines (muscles around the eyes) may be effective in treating major depression
      and chronic migraine. However, the mechanism underlying the effect of peripheral BOTOX
      injections on the brain is not well understood. Therefore, the Investigators propose to
      further explore the functional effects of BOTOX injections on brain in healthy controls. The
      approach will involve the measurement of brain metabolites in the brainstem using MRS as well
      as an investigation of the functioning and connectivity between regions of the brain using
      resting state MRI and high resolution fMRI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females

          -  Ages 30-40 years of age

          -  Right-handed

          -  Normal or corrected-to-normal vision

          -  No history of psychiatric, neurological, or medical co-morbidities that might
             interfere with normal brain functioning

          -  Fluent in English

          -  Moderate to severe glabellar lines

        Exclusion Criteria:

          -  Pregnancy

          -  Ferrous metal, a pacemaker, or other battery-operated device implanted in the body

          -  Claustrophobia

          -  Known hypersensitivity to Botulinum Toxin

          -  Infection on the forehead or between the eyes

          -  Urinary tract infection
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Condition: HIV
Intervention: Raltegravir; Tenofovir; Emtricitabine
Intervention description: 400 mg twice daily; 245 mg once daily; 200mg once daily
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: HIV affected over 60 years old
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: HIV; Pharmatokinetic; 60 years old; Raltegravir

Summary:

      This is a phase IV, open label, prospective, one phase pharmacokinetic and observational
      study.

      Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy
      to:

        -  tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus

        -  raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24
           hour pharmacokinetic visit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV-1 infected males or females

          2. 60 years of age or greater*

          3. signed informed consent

          4. willing to switch therapy as per study protocol

          5. no previous exposure to raltegravir or HIV-1 integrase inhibitors

          6. plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the
             last 3 months

          7. currently receiving a stable antiretroviral regimen with no antiretroviral drug
             switches for at least 3 months

          8. no previous clinically-significant resistance documented on HIV-1 genotypic resistance

          9. subjects in good health upon medical history, physical exam, and laboratory testing

         10. BMI above or equal to 18 and below 32

         11. Male subjects who are heterosexually active must use two forms of barrier
             contraception (e.g., condom with spermicide) during heterosexual intercourse, from
             screening through completion of the study.

         12. Have local screening laboratory results (haematology and chemistry that fall within
             the normal range of the central laboratory's reference ranges unless the results have
             been determined by the Investigator to have no clinical significance * 50% of total
             enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged
             between 60 and 64 recruited, only subjects aged 65 or over will be eligible.

        Exclusion Criteria:

          1. current alcohol abuse or drug dependence

          2. positive urine drug of abuse screening

          3. active opportunistic infection or significant co-morbidities

          4. current disallowed concomitant medication
Effect of Epinephrine on Post-polypectomy Pain
Condition: Colonic Polyp
MeSH terms: Colonic Polyps
Intervention: Epinephrine
Intervention description: Epinephrine in the submucosal injection fluid
Intervention MeSH terms: Epinephrine
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
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Epinephrine is widely used in endoscopic mucosal resection of large polyps to prevent
      post-polypectomy bleeding. No previous studies looked at increase in immediate
      post-polypectomy pain with the use of epinephrine.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients aged 18 years and over

          2. Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps

          3. Able to sign informed consent

        Exclusion Criteria

          1. Patients previously enrolled in the study

          2. Pedunculated polyps

          3. Polyps not amenable to endoscopic resection

          4. Patients allergic or sensitive to epinephrine

          5. Patients with coronary artery disease who have had a myocardial infarction in the past
             year, or had coronary stenting in the past year, or had angina in the past year.

          6. Patients electing anesthesia other than monitored anesthesia care with propofol (MAC)
             for colonoscopy
Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion
Condition: Anesthesia; Urethral Obstruction
MeSH terms: Urethral Obstruction; Pain, Postoperative
Intervention: Placebo; Gabapentin
Intervention description: Placebo pill administered orally 1 hour before planned surgical procedure; Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind, Randomized, Placebo Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study's objective is to determine the efficacy of preoperative gabapentin in relieving
      postoperative pain, reducing opioid use and improving quality of recovery in subjects
      undergoing urologic surgery.

      Investigators hypothesize that subjects receiving gabapentin will have lower pain scores,
      less opioid consumption and better quality of recovery as compared to subjects who are given
      a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years to 75 years

          -  Patients with obstructive kidney stones undergoing elective ureteroscopy or cystoscopy
             with Ureteral stent placement

        Exclusion Criteria:

          -  Age less than 18 or more than 75 years

          -  Acetaminophen allergy

          -  Gabapentin allergy

          -  Hydromorphone allergy

          -  Chronic use of gabapentin

          -  History of chronic pain (Pain for > than 3 months)

          -  Chronic renal insufficiency (Creatinine > 1.3)

          -  Seizure disorder

          -  Psychiatric disorders (medically treated)

          -  Chronic use of anticonvulsants, antidepressants, antipsychotics (use > 3 months)

          -  Antacids ingested within 2 hours prior to surgery

          -  History of gastric or duodenal ulcer

          -  Pregnant or lactating

          -  Inability to communicate in English
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
Condition: Lumbar Spine Degeneration
Intervention: 5cc Vivigen and local autograft; Small kit rhBMP-2 with local autograft
Intervention description: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft; The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking description: The surgical team, including the surgeons, will be blinded to the treatment options until decompression/instrumentation have been completed. The patients and all staff, including hospital nursing staff, case management, and physical therapists, will be blinded as to which bone graft treatment the patient received.
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen,
      a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 or older;

          2. Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc
             disease with axial low back pain and neurologic symptoms, failed conservative
             treatment and eligible for a single level lumbar instrumented fusion;

          3. Willing to provide informed consent, participate in study, and comply with study
             protocol.

        Exclusion Criteria:

          1. Pregnant or contemplating pregnancy prior to surgery;

          2. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal
             infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);

          3. Surgery involving more than 2 vertebral levels;

          4. Worker's compensation or personal injury related to lumbar spine (treatment outcomes
             may be affected by patient's personal interests; could also run into potential issues
             with reimbursement).

          5. Lactating women

          6. Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem,
             Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin

          7. Immune compromised patients
Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Transepicardial with Transseptal CD 133+ Implantation
Intervention description: Transepicardial with Transseptal CD 133+ Implantation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CD 133+; Transepicardial with Transseptal Implantation; CABG

Summary:

      Heart Failure has several etiologies and one of them is coronary artery disease. Coronary
      artery bypass grafting (CABG) is one of revascularizations method which has been used for
      decades in coronary artery disease theraphy. However, data about coronary artery bypass
      grafting shows that post-CABG patients still have low ejection fraction. For the last decade,
      there have been a lot of studies about the using of stem cells to increase heart
      contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone
      marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells
      is given during CABG by injection transepicardial and transseptal. The purpose of this study
      is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem
      cells can improve myocardial perfusion in patient with low ejection fraction following CABG
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with coronary artery disease 3 vessels disease indicated for CABG

          -  LVEF < 35% which has been confirmed by MRI

          -  Patients with akinetic or hypokineic segment, and left ventricle myocardial
             hypoperfusion confirmed in MRI

          -  has signed informed consent

        Exclusion Criteria:

        Emergency CABG Ungraftable coronary artery Acute myocardial Infarct (<14 days) Valve
        disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia
        Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT >
        1,5 upper normal value Creatinine > 2 g/dl. Malignancy

        Drop out criteria :

        Aortic cross clamp >120 minutes and CABG total time >180
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Recurrence; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Placebo
Intervention description: Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.; Dose-matched placebo taken orally once daily.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 644.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Fetzima; Relapse-prevention; Placebo-controlled

Summary:

      This study evaluates the efficacy, safety and tolerability of levomilnacipran
      extended-release (ER) compared with placebo in the prevention of depression relapse in major
      depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria

          -  Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th
             edition) criteria for Major Depressive Disorder (MDD)

          -  The participant must have an ongoing major depressive episode of at least 8 weeks and
             no more than 18 months

          -  The participant must have at least 3 lifetime episodes of MDD (including the current
             episode)

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control

          -  Participants who are considered a suicide risk

          -  History of non-response to 2 or more antidepressants (after adequate treatment)

          -  Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or
             mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic
             disorder

          -  Panic disorder