bioihbjkbjnl/mcl2 huggingface dataset:
Intrathecal (IT) Baclofen Drug Distribution
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Intervention: Baclofen bolus injection
Intervention description: A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location.
Intervention MeSH terms: Baclofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: spinal cord injury; cerebral palsy; stroke

Summary:

      The goal of this pilot study to determine whether there is a significant therapeutic
      advantage to place the ITB catheter within the cervical, thoracic or lumbar region of the
      spine. It is also a goal of this pilot study to determine whether the origin of spasticity
      influences the effect of Lioresal Intrathecal (baclofen injection) on ITB catheters located
      in the cervical, thoracic or lumbar regions of the spine. The investigators propose to study
      the impact of catheter location on the reduction in spasticity within a group of patients who
      are scheduled for ITB trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients with spasticity from spinal origin (spinal cord injury)

          2. Adult patients with spasticity of cerebral origin (cerebral palsy and cerebrovascular
             accident)

          3. Adult women of child bearing age with a negative pregnancy test

        Exclusion Criteria:

          1. Patients with spasticity from Multiple sclerosis

          2. Pregnant women

          3. Patients under the age of 18 years

          4. Patients over the age of 50

          5. Patients who are unable to have an MRI scan of the total spine

          6. Patients with spinal deformity that would prevent easy access to the lumbar
             intrathecal space

          7. Patients who have an allergic reaction to IT baclofen

          8. Patients who have significant headache from CSF withdrawal

          9. Patients who have intradural blockage that prevents advancing the IT catheter to the
             level of C4
Pancreatic Enzyme Supplementation for Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Intervention: pancrelipase
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pancreatic enzyme supplementation

Summary:

      The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic
      enzyme supplementation will improve symptoms in individuals with celiac disease who suffer
      persistent symptoms despite a gluten free diet. This protocol specifically aims to:

        1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of
           gastrointestinal symptoms in patients with celiac disease on a gluten free diet.

        2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme
           supplementation in patients with celiac disease on a gluten free diet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven celiac disease.

          -  Age 18-80.

          -  Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in
             period.

          -  Subject must be following a gluten free diet.

          -  tTG < 40 units at screening.

        Exclusion Criteria:

          -  Taking prescription or over the counter enzyme supplements for 1 month prior to
             enrollment.

          -  Pregnant, breastfeeding or planning pregnancy. Woman using acceptable methods of
             contraception will be included. Acceptable methods of contraception include oral
             hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide,
             condoms, intra-uterine device, abstinence, and male partner vasectomy.

          -  Patients with a pork allergy or who are unwilling to consume pork products.

          -  English proficiency unsuitable for completion of surveys.

          -  Known severe pancreatic disease.

          -  Known history of prior cancer (except squamous or basal cell skin cancer).

          -  Patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2
             tablespoons) of whole milk per day.

          -  Clinically significant abnormality in safety lab values (i.e. CBC and BMP) at
             screening that may impact subject safety or the scientific integrity of the study.

          -  Other known active GI condition including but not limited to inflammatory bowel
             disease, small intestine bacterial overgrowth, and obvious FODMAP intolerance.

          -  History of all major gastrointestinal surgery other than appendectomy or
             cholecystectomy.

          -  Comorbid condition that in the opinion of the investigator would interfere with the
             subject's participation in the study or would confound the results of the study.
Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery
Condition: Arthroscopic Knee Surgery
Intervention: Hyperosmolar Saline; Normal saline
Intervention description: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.; Lactate Ringer's (LR, 273mOsm/L)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An isotonic solution, such as saline (0.9%, 300mOsm/L) or lactated ringer's (273 mOsm/L), is
      commonly used and safely proven for joint irrigation during arthroscopy. Arthroscopic fluid
      is usually pressurized to enable visualization through dilation of the joint or bursa and
      prevent bleeding from the microvasculature. It has been recommended that this pressure be
      maintained at 49mmHg or less below the systolic blood pressure to preserve the clarity of
      view. The combination of large amounts of pressurized irrigation solution and lengthy
      arthroscopic procedures may cause substantial tissue fluid retention. Thus, extravasation of
      irrigation fluid into the periarticular tissues is inevitable and may create technical
      difficulties as well as patient morbidity and complications. Previous investigators have
      reported complications including tracheal obstruction, post-operative airway edema and
      compromise leading to prolonged intubation, excess weight gain, neurologic injuries, skin
      necrosis, and fluid overload associated with excessive fluid extravasation and tissue
      retention. Furthermore, it has been shown that fluid accumulated during the operation is
      slowly released back into the systemic circulation. Although there is not a rapid change in
      circulating volume, there may be implications for elderly patients and those with multiple
      comorbidities during prolonged arthroscopic surgery. Therefore the investigators seek to
      determine if a hyperosmolar solution, similar to what is used in head trauma patients, can
      reduce the degree of fluid extravasation in knee arthroscopy. The investigators also seek to
      determine if a hyperosmolar solution has any effect on post-operative knee pain compared to
      the standard isotonic solution. The third objective is to determine if a hyperosmolar
      solution has any effect on post-operative pain medicine consumption compared to the standard
      isotonic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (18 years of age or greater) undergoing arthroscopic knee surgery who
             are willing and able to consent.

        Exclusion Criteria:

          -  Current pregnancy or breastfeeding

          -  Unable to give consent

          -  Prisoner

          -  Mentally Disabled
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
Condition: Kidney Failure; Secondary Hyperparathyroidism; Hyperphosphatemia; Hypercalcemia
MeSH terms: Bone Diseases; Renal Insufficiency; Hyperphosphatemia; Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Calcitriol; Paricalcitol
Intervention description: 3 times weekly; 3 times weekly
Intervention MeSH terms: Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this non-inferiority study is to compare the safety and effectiveness of a
      mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol
      in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO)
      parathyroid hormone targets.
    

Eligibility criteria:

        Inclusion Criteria:

        - All subjects will have been treated for at least three months on hemodialysis with IV
        paricalcitol. These subjects must have a most recent calcium level within the normal range,
        most recent phosphorus level < 8 mg/dL and a most recent PTH between 130-585 pg/mL

        Exclusion Criteria:

        Patients will be excluded if:

          1. age greater than 18

          2. active malignancy

          3. expected survival greater than 6 months

          4. high likelihood of renal transplant during the study period.

          5. Low calcium bath

          6. prior parathyroidectomy

          7. use of calcimimetics
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
Condition: Acute Coronary Syndromes
MeSH terms: Atrial Fibrillation; Acute Coronary Syndrome; Syndrome
Intervention: Apixaban; vitamin K antagonist; Acetylsalicylic acid; Acetylsalicylic acid placebo
Intervention MeSH terms: Aspirin; Vitamin K; Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 4614.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist
      given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial
      fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in
      the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors
      (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a
      comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K
      antagonist, such as warfarin, with or without aspirin.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Adults with either active or a history of non-valvular atrial fibrillation or flutter
             with the planned or existing use of an oral anticoagulant for prophylaxis of
             thromboembolism. In addition, subjects must have had an acute coronary syndrome or
             percutaneous coronary intervention with a stent within the prior 14 days

          -  Planned use of antiplatelet agents for at least 1 to 6 months

          -  Males and Females ≥ 18 years of age

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 24 hours prior to the start of study drug

        Exclusion Criteria:

          -  Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g.
             prosthetic mechanical heart valve)

          -  Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine
             clearance < 30 mL/min

          -  Patients with a history of intracranial hemorrhage

          -  Patients have had or will undergo Coronary arterial bypass graft (CABG) for their
             index acute coronary syndrome (ACS) event

          -  Patients with known ongoing bleeding and patients with known coagulopathies

          -  Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists
             or to aspirin
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
Condition: Placenta Accreta; Postpartum Hemorrhage; Cesarean Section; Tranexamic Acid
MeSH terms: Postpartum Hemorrhage; Placenta Accreta; Placenta Previa; Hemorrhage
Intervention: Tranexamic Acid; Placebo Drug
Intervention description: 50 cc Normal Saline IV
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is
      effective for reducing blood loss during high risk surgical procedures related to placenta
      previa and placenta accreta. TXA is currently used in other types of surgery for patients who
      are expected to have a large blood loss, such as orthopedic or open heart surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English and Spanish speaking pregnant women

          -  Any order pregnancy (singleton, twin gestation, etc)

          -  Suspected accreta based on ultrasound or MRI imaging studies

          -  All women evaluated for placenta accreta and deemed to be high risk for this disease
             (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal
             to 2 prior c-sections

        Exclusion Criteria:

          -  Women less than 18 years of age

          -  Women with a personal history of venous or arterial thrombosis (deep vein thrombosis,
             pulmonary embolism, myocardial infarction, or stroke

          -  Women with a personal history of a high risk clotting disorder, such as
             anti-phospholipid syndrome

          -  Women who do not have a good understanding of either English or Spanish will be
             excluded.

          -  Women with defective color vision (color-blindness)
Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
Condition: Insomnia; Bipolar Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Bipolar Disorder
Intervention: Suvorexant; Placebo
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of suvorexant, added to existing
      medications, for treatment-resistant insomnia in individuals with bipolar disorder. The
      investigators hypothesize that participants receiving suvorexant for one week will experience
      significantly greater improvement in sleep duration compared to participants receiving
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70),
             bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80),
             with concurrent insomnia related to bipolar disorder (307.42).

          2. Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents,
             anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for
             management of bipolar disorder.

          3. Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.

        Exclusion Criteria:

          1. Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total
             score ≥ 12.

          2. Current (past 6 months) alcohol or substance use disorder.

          3. Current psychosis.

          4. Patients who are actively suicidal or evaluated as being a high suicide risk.

          5. Women who are currently pregnant or breastfeeding.

          6. Clinically significant abnormalities on baseline laboratory tests (comprehensive
             metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential,
             thyroid stimulating hormone).

          7. Presence of any unstable and/or potentially confounding neurological and/or medical
             disorder.
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
Condition: Pain
MeSH terms: Pain
Intervention: IV Acetaminophen (Treatment A); Oral Acetaminophen (Treatment B); Placebo (Treatment C); Morphine (Treatment D)
Intervention description: Acetaminophen administered by intravenous (IV) infusion; Acetaminophen administered by oral tablets; Placebo administered by IV infusion or oral tablets; Morphine administered by IV infusion
Intervention MeSH terms: Acetaminophen; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: comparison

Summary:

      The purpose of this study is to evaluate two experimental pain models to see if they would be
      useful for comparing different products for reduction in pain intensity.

      The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental
      pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen,
      oral acetaminophen, placebo, and IV morphine.
    

Eligibility criteria:

        Inclusion Criteria

          1. Must have a health status of "healthy" assessed by the investigator and defined as no
             clinically significant deviation from normal medical history, physical examination,
             vital signs, and clinical laboratory determinations.

          2. Must be male, Caucasian, between 18 and 55 years of age (inclusive) at the time of the
             screening.

          3. Must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2 with a minimum weight of 110
             pounds (50 kg) at screening.

        Exclusion Criteria

          1. A positive test result for human immunodeficiency virus (HIV), hepatitis B (surface
             antigen), or hepatitis C virus antibody at Screening.

          2. A history of any drug allergy, hypersensitivity, or intolerance to acetaminophen,
             morphine, or capsaicin or to any of the excipients in the IV or oral formulations
             used.

          3. A positive test result for drugs of abuse, alcohol, or cotinine.

          4. Fitzpatrick Skin Type V or VI (based on a Skin Type score of greater than 30.

          5. A history of conditions which might be specifically contraindicated or require caution
             to be used during the administration of any drug in the study.

          6. Any other medical, psychiatric and/or social reason for exclusion as determined by the
             investigator.
Allergic Rhinitis Changes the Sinus Microbiome
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: QNASL; Placebo nasal spray
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that treatment with QNASL will reduce nasal mucosal
      inflammation induced by the allergy season and prevent the changes in the microbiome caused
      by the allergy season.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between 18 and 55 years of age.

          2. Two year history of seasonal allergic rhinitis.

          3. Positive skin test to grass and/or tree antigen.

        Exclusion Criteria:

          1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

          2. Pregnant or lactating women.

          3. Subjects treated with systemic steroids during the previous 30 days.

          4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom
             or Opticrom during the previous 30 days.

          5. Subjects treated with oral antihistamine/decongestants during the previous seven days.

          6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants
             during the previous 3 days.

          7. Subjects treated with immunotherapy and are escalating their dose.

          8. Subjects on chronic anti-asthma medications.

          9. Subjects with polyps in the nose or a significantly displaced septum.

         10. Upper respiratory infection within 14 days prior to study start.