bioihbjkbjnl/mcl2 huggingface dataset:
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Blood draw for future biomarker analysis
Intervention description: Each participant was required to undergo blood draw for future genetic testing and biomarker analysis as mentioned in the informed consent form (ICF).
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To collect blood samples in a new cohort of Relapsing Forms of Multiple Sclerosis (RMS)
      participants who had developed immune thrombocytopenic purpura (ITP) after LEMTRADA
      treatment, for future Deoxyribonucleic acid (DNA) analysis as part of a global biomarker
      project assessing pre-identified candidate single nucleotide polymorphisms (SNPs) associated
      to the development of ITP after LEMTRADA treatment in RMS participants.
    

Eligibility criteria:

        Inclusion criteria :

          -  Male and female adult participants who had been treated with LEMTRADA, with
             development of ITP subsequent to treatment. Participants does not need to be currently
             on LEMTRADA treatment.

          -  Participants who had signed the study ICF.

        Exclusion criteria:

        - Not applicable

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
Condition: Cardiac Diagnostic Procedure; Cardiac Interventional Procedure; Femoral Access Site Closure
Intervention: Mynx Vascular Closure System; Manual Compression
Intervention description: MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.; manual pressure applied to your groin for approximately 5-10 minutes
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure
      following both diagnostic and interventional procedures as assessed by clinical and imaging
      criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients > 18 years of age scheduled for a percutaneous diagnostic or interventional
             procedure that have either a 5, 6, or 7F sheath placed in the common femoral vein.

        Exclusion Criteria:

          1. Patient has a history of a bleeding disorder

          2. Previous history of venous thrombosis or thromboembolism

          3. Patient is pregnant or lactating

          4. Patient has a known severe allergy to contrast medium

          5. Patient has a known allergy to PEG

        7. Patient is known to require an extended hospitalization or re-hospitalization (e.g.
        patient is undergoing coronary artery bypass graft (CABG) surgery) or patient is scheduled
        to have a CABG surgery <30 days following the procedure) 9. Multiple (>1) attempts at
        venous access were attempted in the target vein 10. Patient has intra-procedural bleeding
        around the access site prior to sheath removal 11. Critically ill patients requiring
        intravenous vasopressors for blood pressure stabilization 12. Ipsilateral femoral artery
        puncture or sheath insertion 13. Glycoprotein IIb/IIIIa use 14. Any bleeding or vascular
        access-site complication evident pre-venous closure
Misoprostol for Reduction of Blood Loss During Fibroid Surgery
Condition: Fibroids
MeSH terms: Leiomyoma; Myofibroma; Hemorrhage
Intervention: Misoprostol; Placebo
Intervention description: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.; 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Intervention MeSH terms: Pyridoxine; Vitamin B 6; Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: fibroids, leiomyomata, blood loss, misoprostol

Summary:

      The aim of this research work is to assess the impact of a single preoperative dose of buccal
      misoprostol in reducing blood loss during abdominal fibroid surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting for abdominal myomectomy with documented uterine fibroids on
             pelvic imaging (pelvic ultrasound or MRI) within in last 12 months

          -  Age ≥ 18 years and ≤ 50 years

          -  Pre-operative hemoglobin >8 g/dl

          -  Willing to have buccal administration of misoprostol or a placebo at least one hour
             pre-procedure.

          -  Ability to understand and the willingness to sign a written informed consent.

          -  Admissible medical/surgical history

          -  Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills

          -  Intraoperative use of vasopressin and uterine tourniquet is permissible

          -  Can have had prior Cesarean delivery

        Exclusion Criteria:

          -  Patients who have had a prior abdominal myomectomy

          -  Post-menopausal women

          -  Patients with known bleeding/clotting disorders

          -  Patients with a history of gynecologic malignancy

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to misoprostol

          -  Any cases converted to abdominal hysterectomy or other additional elective surgical
             procedures performed at time of abdominal myomectomy will be excluded from data
             analysis

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
Condition: End Stage Renal Disease; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Kidney Failure, Chronic
Intervention: 300mg glecaprevir/pibrentasivir 120mg
Intervention description: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
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: 40 Years
Healthy volunteers: No

Summary:

      In this study, individuals without hepatitis C infection who are on the kidney transplant
      waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be
      treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg /
      pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant
      procedure and continued for 4 weeks post-renal transplant.
    

Eligibility criteria:

        Recipient Inclusion Criteria

          -  Participants ≥ 40 years old

          -  On the deceased donor kidney waitlist at Johns Hopkins Hospital

          -  Awaiting a first or second kidney transplant

          -  No available living kidney donors

          -  On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease defined as a
             glomerular filtration rate <15 ml/min for ≥ past 90 days

          -  HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors
             for contracting HCV other than being on hemodialysis

          -  Calculated panel reactive anti-human leukocyte antigen antibody (cPRA) below 80%

        Recipient Exclusion Criteria

          -  Plan to receive a multi-organ transplant

          -  Plan to receive a dual kidney transplant (including en bloc)

          -  Prior solid organ transplant

          -  Participating in another study that involves an intervention or investigational
             product

          -  Plan to receive a blood type incompatible kidney

          -  History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B
             (HBV) infection, defined as being on active antiviral treatment for HBV, detectable
             hepatitis B surface Ag or detectable hepatitis B DNA

          -  Unable to safely substitute or discontinue a medication that is contraindicated with
             the study medication

          -  Psychiatric or physical illness that in the opinion of the investigator would make it
             unsafe to proceed with transplantation or interfere with the ability of the subject to
             participate in the study
Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Condition: Mild Hypercortisolism
MeSH terms: Cushing Syndrome; Adrenocortical Hyperfunction
Intervention: Mifepristone
Intervention description: All patients in the study will receive daily Mifepristone for 6 months and primary and secondary outcomes will be assessed before and after the 6 month treatment period
Intervention MeSH terms: Mifepristone
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
Keywords: mild hypercortisolism; Subclinical Cushing's Syndrome; Preclinical Cushing's Syndrome

Summary:

      The purpose of this study is to determine whether mifepristone is an effective treatment for
      hyperglycemia due to mild hypercortisolism.

        -  To test the hypothesis that GR blockade with mifepristone will decrease the severity of
           metabolic syndrome features as measured by waist circumference, lipid profile, body mass
           index, blood pressure and insulin resistance, measured by HOMA-IR score.

        -  To test the hypothesis that GR blockade with mifepristone will improve QoL, depression
           and anxiety scores, measured by validated assessments, in patients with mild
           hypercortisolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age

          -  Incidentally noted adrenal nodule <4 cm with benign imaging characteristics

          -  Evidence of mild hypercortisolism

          -  Evidence of diabetes or abnormal glucose tolerance

        Exclusion Criteria:

          -  contraindication to mifepristone

          -  Indication for unilateral adrenalectomy

          -  Evidence of other adrenal hormone hypersecretion

          -  lactating mothers

          -  women of childbearing age unwilling to use an effective, nonhormonal form of
             contraception
Anesthetic Techniques in EP Patients
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Intervention: Propofol; Ketamine; Remifentanil; Sevoflurane
Intervention description: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.; 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.; 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.; 1 general anesthesia group for VT ablations and afib procedures.
Intervention MeSH terms: Ketamine; Remifentanil; Propofol; Sevoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Electrophysiology; Anesthetics

Summary:

      The purpose of this study is to compare different combinations of anesthetic drugs (cause
      loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient
      comfort for cardiac electrophysiology procedures. In addition, the investigators are studying
      the different anesthetic combinations to determine the best approach in terms of
      identification and treatment of arrhythmias.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for cardiac electrophysiology procedures

          -  Patients ≥18 years of age

        Exclusion Criteria:

          -  Gastroesophageal reflux disease (GERD),

          -  pulmonary hypertension,

          -  severe pulmonary disease,

          -  obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)
Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint
Condition: Arthritis Multiple Joint
MeSH terms: Arthritis
Intervention: Botulinum Toxin Type A; Steroid - Triamcinolone Acetonide; Lidocaine
Intervention description: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule; Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution; Single injection of 1 - 3 mL of 2% Lidocaine
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carpometacarpal Joints; Osteoarthritis; Basal thumb joint arthritis; Trapeziometacarpal arthritis

Summary:

      Basal arthritis of the thumb is a common condition with increased prevalence in
      post-menopausal women, obese persons, and the elderly. Surgical options are varied and
      efficacious, but not all patients are candidates for surgery. The successes and pitfalls of
      previous, similar trials are carefully considered in the creation of our own. Though steroid
      injection is the standard of care in basal joint arthritis, current data does not support its
      efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin
      type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since
      efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal
      joint might be the next great tool in treating this common, debilitating disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radiographic evidence of basal joint arthritis

          -  Associated symptoms of basal joint arthritis including:

          -  Pain

          -  Decreased range of motion

          -  Decreased thumb strength

        Exclusion Criteria:

          -  Persons under the age of 18

          -  Women who are currently pregnant

          -  Incompetent persons or persons otherwise incapable of effectively communicating the
             subjective experience of pain

          -  Prior surgery on the joint

          -  Injection in the last 12 months
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Condition: Foot Dermatoses
MeSH terms: Onychomycosis; Skin Diseases; Foot Dermatoses
Intervention: Loceryl NL; Ciclopirox NL
Intervention description: Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.; Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
Intervention MeSH terms: Ciclopirox; Amorolfine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intra-individual study
Masking: Single (Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onychomycosis

Summary:

      The main objective of this study is to compare subject's compliance and satisfaction for two
      modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl
      NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to
             dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at
             screening visit,

          -  Subject with less than 80% of the nail surface area with disease involvement and
             without matrix involvement, no dermatophytoma, streaks (spikes) or subungual
             hyperkeratosis > 2mm,

          -  Subjects with positive mycological results (direct microscopy and culture) for
             dermatophytes and/or yeasts (including Candida) at baseline,

          -  Subjects with same number of affected toenails on both feet or no more than one
             additional affected toenail on one of the feet,

        Exclusion Criteria:

          -  Subject with a surgical, medical condition or clinically important abnormal physical
             findings, which, in the judgement of the investigator, might interfere with
             interpretation of the objectives of the study (i.e. lack of autonomy),

          -  Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other
             abnormalities of the nail unit, which could affect/influence the subject's compliance
             of the investigational products, or mask the effects of treatment (cure),

          -  Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
Condition: Low Back Pain; Lumbosacral Radiculopathy; Lumbar Disc Degeneration; Lumbar Disc Herniation; Stenosis; Spondylolisthesis; Spondylolysis; Deformity of Spine
MeSH terms: Intervertebral Disc Displacement; Spondylolisthesis; Intervertebral Disc Degeneration; Spondylolysis; Radiculopathy; Low Back Pain
Intervention: Exparel; Bupivacaine
Intervention description: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL; 30 mL bupivacaine 0.5% w/v solution
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to collect information about how patients feel when doctors
      manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine
      injected into the lumbar spine at the end of surgery, compared to the patients that doctors
      use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors
      determine which approach works best for patients who will receive surgery in their lumbar
      spine in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 or older;

          2. Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc
             degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or
             deformity requiring surgical intervention;

          3. Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or
             without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;

          4. Willing to provide informed consent, participate in study, and comply with study
             protocol.

        Exclusion Criteria:

          1. Hypersensitivity or allergy to local anesthetics;

          2. Pregnant or contemplating pregnancy prior to surgery;

          3. Previous surgery in lumbar spine (i.e. other than microdiscectomy);

          4. Prior treatment for alcohol, recreational drug, or opioid abuse;

          5. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal
             infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);

          6. Surgery involving more than 2 vertebral levels;

          7. Worker's compensation or personal injury related to lumbar spine (treatment outcomes
             may be affected by patient's personal interests [21]; could also run into potential
             issues with reimbursement).

          8. Lactating women

          9. Patients with end stage liver disease