bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Condition: Genetic Risk for Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: donepezil HCL; Placebo
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study examines the sensitivity of functional MRI to detect brain changes caused by
      donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for
      Alzheimer's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal general cognitive function

          -  High Risk Group Only: Family history (1st degree relative) of AD

          -  Low Risk Group Only: No family history (1st or 2nd degree relative) of AD

          -  Visual and auditory acuity adequate for neuropsychological testing

        Exclusion Criteria:

          -  Current or past history of

          -  neurological illnesses/conditions

          -  head trauma with significant loss of consciousness

          -  medical illnesses/conditions that may affect brain function

          -  severe psychiatric disorder

          -  substance abuse

          -  unstable or severe cardiovascular disease or asthmatic condition

          -  history of stroke or transient ischemic attack
Regional Block for Postoperative Free Flap Care
Condition: Pain Management
Intervention: ropivicaine 0.2%
Intervention description: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia
      for head and neck patients undergoing microvascular free flap reconstruction.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age > 18

          -  Able to consent for themselves

          -  Undergoing a head and neck surgery at UAB with reconstruction using either a forearm
             free flap or a fibula free flap

        Exclusion criteria:

          -  Age < 18

          -  Unable to consent for themselves

          -  Non-English speakers

          -  Non-resectable tumor

          -  Have a known opioid tolerance, or are on a home opioid regimen for a chronic
             condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new
             cancer diagnosis will be allowed).

          -  Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by
             standard of care labs drawn within 30 days of enrollment
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Condition: Anesthesia, Local
Intervention: Ropivacaine 0.75%; Ropivacaine 0.75% + 300 mcg Buprenorphine; Ropivacaine 0.75% + 75 mcg clonidine; Ropivacaine 0.75% + 8 mg dexamethasone
Intervention description: Only ropivacaine 0.75% is administered for this arm of the interscalene block; Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block; Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block; Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Intervention MeSH terms: Dexamethasone; Clonidine; Buprenorphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Brachial Plexus Block; Clonidine; Dexamethasone; Buprenorphine

Summary:

      This is a prospective randomized controlled triple-masked study looking at the duration of
      nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and
      clonidine) plus ropivacaine versus plain ropivacaine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have or are:

               1. Orthopedics service patients having shoulder surgery

               2. ASA(American Society of Anesthesiologists) class I, II, or III.

               3. Patients at least 18 years old but less than 71 years old.

               4. Patients giving informed consent.

               5. Non-Emergency Surgery

                  Exclusion Criteria:

          -  Patients who have or are:

               1. An inability to cooperate during the block placement.

               2. Neuropathy of the planned extremity to block

               3. Diabetes

               4. Documented Kidney Disease

               5. Documented Liver Disease

               6. A lack of or inability to give informed consent.

               7. Currently incarcerated.

               8. Pregnant
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Condition: Type 2 Diabetes Mellitus; Inadequate Glycaemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Saxagliptin; Glimepiride; Placebo for dapagliflozin; Placebo for saxagliptin; Placebo for glimepiride
Intervention description: 10 mg, orally Green, plain, diamond-shaped, film-coated tablet; 5 mg, orally Plain, yellow, biconvex, round, film-coated tablet; 1, 2, or 4 mg, orally Opaque gray capsule; Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet; Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet; Does not contain active ingredient, orally. Opaque gray capsule
Intervention MeSH terms: Dapagliflozin; Glimepiride; Saxagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 939.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus Type 2,; metformin,; saxagliptin,; dapagliflozin,; glimepiride,; inadequate glycaemic control

Summary:

      This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as
      an addition to metformin is effective and safe in treating patients with type 2 diabetes when
      compared to glimepiride (sulphonylurea) as an addition to metformin treatment.
    

Eligibility criteria:

        Inclusion Criteria: Main Inclusion Criteria:

          1. Is male or female and ≥18 and <75 years old at time of informed consent.

          2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with
             individual need for therapy escalation.

          3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of
             metformin therapy for at least 8 weeks prior to Enrolment visit.

          4. Has a BMI of ≤45 kg/m2 at Enrolment visit.

          5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on
             central laboratory results from Visit 1.

        Main, Exclusion Criteria:

          1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes
             of the young (MODY), or secondary diabetes mellitus or known presence of glutamate
             decarboxylase 65 (GAD65) antibodies.

          2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or
             volume depletion that may affect the patient's safety and/or the interpretation of
             efficacy or safety data.

          3. Clinically significant cardiovascular disease or procedure within 3 months prior to
             Enrolment or expected to require coronary revascularization procedure during the
             course of the study.

          4. Concomitant treatment with loop diuretics
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: Garamycin Sponge (Gentamicin-Collagen sponge); Systemic Antibiotic
Intervention description: Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base); Antibiotics options per protocol:
Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
Intervention MeSH terms: Anti-Bacterial Agents; Gentamicins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen
      sponge) in combination with antibiotics is safe and effective in treating moderate and severe
      diabetic foot infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is aged ≥ 18.

          -  Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.

          -  Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located
             on or below the malleolus that presents with the following clinical manifestations of
             a moderate or severe infection based on the Infectious Disease Society of America
             (IDSA).

          -  Has received appropriate surgical intervention to remove all necrotic and infected
             bone if diagnosed with osteomyelitis

          -  Meets certain minimal laboratory criteria.

        Exclusion Criteria:

          -  Has an ulcer infection which, based upon the patient's known history of
             hypersensitivity cannot be appropriately treated with at least one of the empiric
             systemic antibiotic regimens per protocol.

          -  Has received > 48 hours of potentially effective antibiotic therapy and the wounds are
             clinically improving. If a patient has received an antibiotic within 72 hours, but is
             not improving or deep-tissue culture results indicate that the infecting pathogen is
             not susceptible to that antibiotic, the patient may be enrolled.

          -  Requires or is likely to require treatment with any concomitant topical product or
             wound therapy during the study period.
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: OnabotulinumtoxinA 100 Units
Intervention description: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:
• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Overactive Bladder; Botox/OnabotulinumtoxinA; Pain; OAB; Non-neurogenic Overactive bladder

Summary:

      The purpose of this research study is to help determine if 10 injections of Botox ® 100 units
      is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing
      urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse
      outcomes of 20 injections versus 10 injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female gender

          -  At least 18 years of age

          -  Have already decided to undergo intradetrusor Botox® injections for treatment of
             refractory overactive bladder.

          -  Able and willing to learn clean intermittent catheterization (or care provider is
             willing and able to perform intermittent catheterization).

          -  Understands and is willing to undergo follow up and complete questionnaires as
             described in this protocol

          -  Able to give informed consent

        Exclusion Criteria:

          -  Male gender

          -  Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to
             treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).

          -  Acute urinary tract infection

          -  Treatment with Botox® toxin for other conditions

          -  Allergy to Botox® toxin

          -  Hematuria that has not been worked up

          -  Known bladder malignancy

          -  Previous history of bladder augmentation

          -  Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or
             breastfeeding

          -  Currently taking aminoglycoside antibiotics

          -  Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization)
             prior to enrollment

          -  History of chronic pain or pain syndromes
Clozapine for Cannabis Use in Schizophrenia
Condition: Schizophrenia; Cannabis Abuse; Cannabis Dependence; Dual Diagnosis
MeSH terms: Marijuana Abuse; Schizophrenia
Intervention: Clozapine; Risperidone
Intervention description: Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day; Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day
Intervention MeSH terms: Risperidone; Clozapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Cannabis Abuse; Cannabis Dependence; Dual Diagnosis; Clozapine; Risperidone

Summary:

      Many individuals with schizophrenia also suffer from marijuana addiction that worsens their
      problems related to schizophrenia. Most of the medications prescribed for schizophrenia have
      no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical
      antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not
      commonly used due to its side effects and is reserved for people who do not respond to other
      antipsychotic medications.

      In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a
      cannabis use disorder will be randomized to a 12-week treatment course with either clozapine
      or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis
      that patient treated with clozapine will have decreased cannabis use as compared to patients
      treated with risperidone.

      Should this study indicate that clozapine will lessen marijuana use in persons diagnosed with
      schizophrenia more than risperidone, it will provide evidence needed to begin to shift
      clinical practice toward its use in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of schizophrenia

          -  Clinical diagnosis of a cannabis use disorder (abuse or dependence)

        Exclusion Criteria:

          -  Pregnant,trying to become pregnant or nursing

          -  History of a seizure disorder

          -  Current treatment with clozapine or risperidone

          -  Contraindication to treatment with clozapine or risperidone
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Condition: Exocrine Pancreatic Insufficiency (EPI)
MeSH terms: Pancreatic Neoplasms; Exocrine Pancreatic Insufficiency
Intervention: Pancrelipase; Placebo
Intervention description: Pancrelipase is administered orally as capsules with a meal or snack; Placebo is administered orally as capsules with a meal or snack
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency (EPI); Pancreatic Cancer; Creon; Pancrelipase

Summary:

      This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to
      pancreatic cancer. This study will include resected participants who are post pancreatic
      cancer surgery, and an additional cohort in non-resected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a
             life expectancy of at least 5 months at screening

          -  Participant's pancreatic cancer must involve the head and/or neck of the pancreas

          -  Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1
             (FE-1) ≤ 150 µg/g stool at screening

          -  A positive Sudan stain for participants without history of fat malabsorption (fat
             malabsorption is defined as clinical steatorrhea, or measured stool fat > 7 g/day, or
             positive stool results by Sudan stain) within 1 week of screening -- Positive stool
             results are defined as increased level of neutral OR total fats

        Exclusion Criteria:

          -  Participant has neuroendocrine pancreatic cancer

          -  Participant has fibrosing colonopathy

          -  Participant has any other malignancy within 1 year of screening

          -  Participant has uncontrolled gout, including those with a recent flare within 60 days
             of screening

          -  Participant has other significant organ or bone marrow abnormality within 60 days of
             screening
Octaplas Pediatric Plasma Exchange Trial
Condition: Adverse Effects in the Therapeutic Use of Plasma Substitutes
Intervention: Octaplas™
Intervention description: octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 2 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Octaplas

Summary:

      To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring
      serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs),
      thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric
      patients who require therapeutic plasma exchange.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients in whom therapeutic plasma exchange (TPE) is required.

          2. Patient is male or female ≥ 2 years to ≤ 20 years of age.

          3. Patient or patient's legal representative(s)/guardian(s) has /have given voluntarily
             written and signed informed consent before any study-related procedure is to be
             performed. If children are old enough (age usually deemed by each institution) to
             understand the risks and benefits of the study, they should also be informed and
             provide their written assent.

        Exclusion Criteria:

          1. Patient with known homozygous congenital deficiency of Protein S.

             Exclusion Criteria:

          2. Patient has a history of severe hypersensitivity reaction to plasma-derived products
             or to any excipient of the investigational product.

          3. Patient has an already known IgA deficiency with documented antibodies against IgA.

          4. Patient is currently participating in another interventional clinical study or has
             participated during the past 1 month prior to study inclusion. This is not applicable
             to non-interventional trials and does not exclude patients who have been exposed to
             Investigational Medicinal Product with a washout of at least 30 days from enrollment
             in LAS-213. Concurrent participation in a device study will be considered on a case by
             case basis.

          5. Patient is pregnant.

          6. Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the
             first infusion episode or planned used of these medications while on study.