bioihbjkbjnl/mcl2 huggingface dataset:
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Intervention: testosterone cypionate 200mg/ml
Intervention description: Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: Male
Minimum age: 42 Days
Maximum age: 108 Days
Healthy volunteers: No
Keywords: body composition; Klinefelter syndrome; XXY; sex chromosome variation; sex chromsome aneuploidy

Summary:

      This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about
      body composition (muscle and fat) and male hormones and look at the effect of testosterone
      shots on body composition. The Investigators know that older boys and men with Klinefelter
      syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but
      we do not know if this difference is present at birth or develops over time. The
      Investigators will learn if body composition and motor skills are improved with testosterone
      treatment in infants with Klinefelter syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male infants with 47,XXY karyotype

        Exclusion Criteria:

          -  Gestational age at birth <36 weeks

          -  Birth weight <5%ile or >95% for gestational age

          -  History of thrombosis in a first degree relative

          -  Exposure to androgen therapy outside of the study protocol.
Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy
Condition: Hysterectomy
Intervention: Bupivacaine; Liposomal bupivacaine; Saline
Intervention description: 0.25% bupivacaine for TAP block; Exparel for TAP block; Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to one of three study groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TAP block; Liposomal bupivicaine

Summary:

      The goal of this study is to evaluate the effectiveness of different formulations of
      bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain
      management after open abdominal hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective open abdominal hysterectomy with midline incision, age > 18 years, American
             Society of Anesthesiologist classification score (ASA classification) 1-3.

        Exclusion Criteria:

          -  Patient with a chronic pain condition, major unexpected surgical complication,
             unexpected prolonged intubation, patient refusal, local anesthetic allergy, any
             contraindication to regional anesthesia, greater than 2 attempts by resident and
             greater than 1 attempt by staff anesthesiologist for TAP block.
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Condition: Chronic Kidney Diseases; Hyperkalemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Intervention: Patiromer; Research Diet Menu
Intervention description: Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.; During the study, participants will be asked to consume only the foods provided in the research diet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic kidney disease, stages 3B-4

Summary:

      The purpose of this proof-of-concept controlled-feeding study is to determine whether
      patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum
      potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a
      plant-rich diet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stages 3B-4 CKD (estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73m2,
             not treated with dialysis)

          -  No prior treatment with patiromer

          -  Mild hyperkalemia (potassium 5.1 to <6.5 mEq/L) on one of the last two blood tests

          -  No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6
             months

          -  Deemed appropriate for the intervention by the patient's nephrologist, considering the
             patient's prognosis, cognition and pending treatments (e.g., dialysis)

        Exclusion Criteria:

          -  Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors,
             diuretics, β-blockers) in the last month

          -  Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery,
             short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic
             diarrhea)

          -  Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to
             study diets (excludes dietary restrictions on high-potassium foods)

          -  Pregnant (females) or planning to become pregnant (males and females) during the study
Continuous Wound Infiltration After Hallux Valgus Surgery
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Bunion
Intervention: Wound infiltration catheter; NaCl 0.9%; Ropivacaine 0.2%
Intervention description: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.; The catheter is connected to the perfusor line filled with saline 0.9% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours.; The catheter is connected to the perfusor line filled with Ropivacaine 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours.
Intervention MeSH terms: 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: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hallux valgus surgery; wound infiltration; pain

Summary:

      The aim of this study is to investigate the effect of continuous wound infiltration with
      ropivacaine in comparison to standard pain management after elective distal metatarsal
      osteotomy for postoperative pain control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing a distal metatarsal osteotomy (only Chevron or Scarf) and
             lateral release of the adductor halluces muscle with/without concomitant osteotomy of
             the proximal phalanx of the greater toe (Akin) for idiopathic hallux valgus deformity
             will be included.

        Exclusion Criteria:

          -  hallux valgus surgery other then mentioned above or concomitant other procedures

          -  denial to participate and give informed consent

          -  patients with neurological diseases that affect the sensory-motor function

          -  patients with any short-term (1 month) previous surgery on affected lower extremity

          -  allergies or other comorbidity that prohibits standardized pain regime (renal
             insufficiency, severe heart or liver impairment, uncontrolled asthma, history of
             peptic ulcera )

          -  patients unwilling to undergo surgery without general anesthesia
Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Intervention description: 2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic macular edema; Intravitreal injection

Summary:

      To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first
      year of treatment with aflibercept according to the EU Label.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or 2 diabetes mellitus

          -  Diagnosis of DME secondary to diabetes mellitus involving the center of the macula
             (defined as the area of the center subfield on OCT) in the study eye

          -  Decrease in vision determined to be primarily the result of DME in the study eye

          -  BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen
             equivalent of approximately 20/40 to 20/320.)

        Exclusion Criteria:

          -  Pregnancy and lactation

          -  Mismatch with inclusion criteria
The Effect of Brimonidine
Condition: Intraocular Pressure
Intervention: Brimonidine; Tropicamide; Phenylephrine Ophthalmic Product
Intervention description: 2 drops administered once in the left eye in both study arms; 1 drop administered at two different times points in both eyes in both study arms; 1 drop administered at two different time points in both eyes in both study arms
Intervention MeSH terms: Brimonidine Tartrate; Phenylephrine; Oxymetazoline; Tropicamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Brimonidine; Pupil Effects

Summary:

      This study will evaluate whether pre-treating patients with Brimonidine 0.2% before and/or
      after dilating the pupils will help to control the changes in intraocular pressure often seen
      when using dilating drops. The study will also evaluate the effects of different sequences of
      administering dilating drops along with Brimonidine on pupil size and reactivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy individuals

          -  Females of childbearing potential must agree to use a reliable method of birth control
             while participating in the study.

        Exclusion Criteria:

          -  Diabetic

          -  Have a history of glaucoma

          -  Have a history of iris trauma

          -  Have a history of eye surgery except for LASIK or PRK

          -  Pregnant

          -  Anisocoria (unequal pupils)
Effect of Ketamine on Postoperative Clinical Outcomes
Condition: Colorectal Surgery
Intervention: Placebo; Ketamine high-dose; Ketamine low-dose
Intervention description: Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate; Loading: 1 mg/Kg Infusion: 10 mcg/kg/min; Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: opioid; Fentanyl; Anesthetic adjuvant; Pain management; Perioperative outcomes; Constipation; Ileus; Colorectal

Summary:

      The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic
      adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management
      and on the later recovery after surgery in patients undergoing colorectal surgery.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients scheduled to undergo small and/or large partial bowel resection via
             laparotomy or laparoscopy

          2. Willingness and ability to sign an informed consent document

          3. No allergies to anesthetic or analgesic medications

          4. 18 - 80 years of age

          5. American Society of Anesthesiologists (ASA) Class I - III adults of either sex

        Exclusion Criteria

          1. Inability to comprehend the pain assessment tools

          2. Patients with known allergy, hypersensitivity or contraindications to anesthetic or
             analgesic medications

          3. Patients with clinically-significant heart disease including arrhythmias and
             significant hypertension, brain aneurysms, prior history of cerebral vascular accident
             (CVA), or chronic renal insufficiency

          4. Prior abdominal surgery

          5. History of abdominal carcinomatosis

          6. History of radiation enteritis;

          7. Patients with history of hepatic, renal, cardiac failure, organ transplant, or
             diabetes

          8. Patients with seizures

          9. Morbid obesity (body mass index >40)

         10. Pregnant or lactating women

         11. Subjects with a history of alcohol or drug abuse within the past 3 months

         12. Any other conditions or use of any medication which may interfere with the conduct of
             the study

         13. Prophylactic Nasogastric Tube (NGT) use

         14. Individuals with significant manic disorders including: schizophrenia, or bipolar
             disorder or psychosis

         15. Individuals with asthma and/or thyroid diseases
GrafixPL PRIME Evaluation Case Study
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Intervention: GrafixPL PRIME
Intervention description: GrafixPL PRIME
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40)
      that receive optimal treatment including serial wound debridement and off-loading with total
      contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data
      on other potential confounding factors that could affect healing such as medications,
      tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity.
      Wound healing, including wound size and adverse events will be evaluated. The objective of
      this study is to understand the use of this product to evaluate wound healing in 40 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  18-90 years of age

          -  Chronic foot ulceration below the ankle - persistent for 30 days or longer

          -  Ankle Brachial Index (ABI) >0.5 (Bedside ABI is acceptable for screening purposes as
             the formal imaging ABI may not be resulted prior to surgery)

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  <18 or >90 years of age

          -  History of poor compliance with follow-up visits

          -  Gangrene

          -  Untreated Osteomyelitis

          -  Widespread malignancy

          -  Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines

          -  Currently Pregnant or planning pregnancy during the course of intended participation
             in the study

          -  Is nursing or actively lactating
Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
Condition: Pain, Intractable; Breakthrough Pain; Chronic Pain
MeSH terms: Chronic Pain; Breakthrough Pain; Pain, Intractable
Intervention: Bupivacaine; Opioid
Intervention description: Patient-activated intrathecal bolus for incident pain; Patient-activated intrathecal bolus for incident pain
Intervention MeSH terms: Fentanyl; Morphine; Hydromorphone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 31 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the local anesthetic bupivacaine delivered
      intrathecally in small doses via PTM self-administered boluses significantly improves the
      breakthrough pain and functional status of patients with chronic intractable pain who are
      managed with an intrathecal drug delivery system.
    

Eligibility criteria:

        Inclusion Criteria

          -  Age more than 30 years implanted with an intrathecal drug delivery device.

          -  Intrathecal pump patients on stable dose for the last 3 months.

          -  Using on average more than 2 and less than 10 PTM doses per day

          -  Intrathecal medication admixture consisting of bupivacaine and another opioid
             (fentanyl or hydromorphone or morphine)

        Exclusion Criteria

          -  Using 10 or more PTM bolus doses per day or 2 or less PTM bolus doses per day

          -  Pending litigation or worker compensation claim

          -  Any recent (less than 3 month) procedures in spine (surgeries) or catheter
             adjustments.

          -  Recent pump dose adjustment within the past 3 months

          -  Pumps with medications other than bupivacaine/opioid combination.

          -  Pregnant or breast feeding
Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes
Condition: Healthy
Intervention: Placebo; Propofol; Thiopental
Intervention description: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.; A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.; A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
Intervention MeSH terms: Thiopental; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: N/A healthy volunteers

Summary:

      This study involves 60 healthy volunteers aged between 18 and 50 recruited from the general
      community. It involves doing a set of simple memory tests while inside a fMRI machine. The
      subject is given a very low dose of an anesthetic drug intravenously while in the scanner.
      The subject then sees a sequence of pictures on a screen, and presses a button if they
      remember seeing the picture before. While this is happening, the scanner will be capturing
      images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal
      and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will
      be altered by intravenous anesthetics such that suppression of hippocampal and amygdala
      activities will be dissociable. This dissociation pattern will be different between the drugs
      propofol and thiopental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age b/w 18 and 50

          -  right-handed

          -  minimum of high school education

          -  fluent in English

          -  normal vocabulary

        Exclusion Criteria:

          -  any significant medical/psychiatric comorbidity

          -  deficit in vision or hearing that would impede the study

          -  allergies to any of the study drugs, to soybeans, or eggs.

          -  history of head trauma

          -  family history of major psychiatric illness

          -  body mass index > 30 kg/m2

          -  claustrophobia

          -  prior exposure to IAPS pictures

          -  pregnancy

          -  permanent metal objects anywhere in the body

          -  a personal/family history of any porphyria
Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Liposomal bupivacaine; Placebo - injection
Intervention description: Extended-release local anesthetic; Injectable normal saline solution
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: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: liposomal bupivacaine; posterior repair

Summary:

      The specific aim of this randomized double-blind clinical trial is to evaluate the effect of
      intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy
      and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as
      measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ
      prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of
      injectable normal saline administered in a standardized technique into the posterior vaginal
      compartment at the time of posterior repair and/or perineorrhaphy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English-speaking women ages 18 and older undergoing posterior repair and/or
             perineorrhaphy at our institution for pelvic organ prolapse

        Exclusion Criteria:

          -  Planned regional anesthesia

          -  Allergy or contraindication to bupivacaine

          -  Allergy or contraindication to opioids

          -  Allergy or contraindication to non-steroidal medications

          -  Planned laparotomy

          -  Chronic pain diagnosis and/or chronic narcotic use