bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
Condition: Delirium; Cognitive Impairment; Post-traumatic Stress Disorder; Depression; Anxiety
MeSH terms: Delirium; Emergence Delirium; Depression; Cognitive Dysfunction; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Haloperidol; Placebo
Intervention description: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: delirium; confusion; surgery; cognitive Impairment; post-traumatic Stress disorder; depression; anxiety

Summary:

      The purpose of this study is to investigate the effectiveness of a preventative low-dose of
      Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or
      thoracotomy.

      Delirium is state of severe confusion and some symptoms include:

        -  Cannot think clearly

        -  Have trouble paying attention

        -  Have a hard time understanding what is going on around them

        -  May see or hear things that are not there. These things seem very real to them.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least ≥ 18 years of age and older

          2. Undergoing a possible or scheduled thoracotomy

          3. English speaking

        Exclusion Criteria:

          1. History of Schizophrenia and Parkinson's disease

          2. History of Severe Dementia

          3. History of Alcohol Abuse

          4. On Cholinesterase Inhibitors or Levodopa

          5. Pregnant or Nursing

          6. Corrected QT interval > 550 milliseconds at the time of randomization

          7. History of Neuroleptic Malignant Syndrome or Haloperidol Allergy
Postsurgical Bupivacaine Extended-release Liposome Injection for Open-reduction Internal Distal Radius Fixation.
Condition: Distal Radius Fracture
MeSH terms: Radius Fractures; Wrist Fractures
Intervention: Exparel; Placebo
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      For patients undergoing open-reduction internal-fixaton (ORIF) of isolated distal radius
      fractures, administration of 66.5 mg of liposomal bupivacaine to operative field may decrease
      the need for post-operative narcotic pain medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Isolated distal radius fracture

        Exclusion Criteria:

          -  No Access to a telephone
Skin and Soft Tissue Infection (SSTI) Study
Condition: Skin Diseases, Infectious; Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections; Skin Diseases, Infectious; Skin Diseases
Intervention: Provodine; Incision and Drainage
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abscess; Antiseptic; Provodine; Povidone-Iodine

Summary:

      The purpose of this study is to determine if the use Provodine as an antiseptic and hand wash
      once daily for at least 7 days will have better healing, better health outcomes, fewer
      treatment failures and fewer infections themselves and among their household contacts than
      those who do not use Provodine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skin abscess

          -  Treatment requiring incision and drainage

        Exclusion Criteria:

          -  Unable or unwilling to provide informed consent

          -  Homeless, incarcerated, or living in a group home

          -  Abscess on the face or breast

          -  Abscess requiring surgical drainage in the operating room or requiring admission to
             the hospital

          -  Intravenous drug users

          -  Previous enrollment in this study

          -  Documented history of iodine sensitivity
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Truvada; Current HAART regimen
Intervention description: Truvada + NNRTI or PI.; Maintain baseline regimen
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV 1 Infection

Summary:

      This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected
      patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing
      highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose
      combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg [FTC/TDF]).
      Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease
      inhibitor (PI) at the same dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than
             or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol
             (LDL-CHO; > 1.6 g/L [4.15 mmol/L])

          -  Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to
             screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to
             screening
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
Condition: Bone Neoplasms; Pain, Intractable; Cancer
MeSH terms: Bone Neoplasms; Pain, Intractable
Intervention: Pregabalin; Placebo
Intervention description: Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).; Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in
      the adjunctive treatment of subjects with cancer-induced bone pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have a malignant, solid tumor that has been diagnosed as having
             metastasized to bone, and must have moderate to severe pain secondary to the bone
             metastasis at an identifiable reference site.

        Exclusion Criteria:

          -  The patient who has undergone diagnostic or therapeutic invasive interventions
             (angiography, biopsy, surgery) less than 15 days prior to study start that would
             impact their assessment of pain at the reference pain site or area, in the opinion of
             the investigator.
Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Joint Diseases
Intervention: etanercept; etanercept; Placebo
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 752.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Skin Disease; Joint Disease

Summary:

      The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for
      the treatment of skin and joint manifestations of psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  18 years of age or older at time of consent

          -  Active Psoriatic Arthritis

          -  Clinically stable, plaque psoriasis involving more than 10% of the body surface area

        Exclusion Criteria:

        Exclusion Criteria:

          -  Evidence of skin conditions other than psoriasis that would interfere with skin
             examinations.

          -  Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation

          -  Prior exposure to any TNF-inhibitor, including etanercept
EMD and/or Bone Substitute for the Treatment of Class II Furcations
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Intervention: EMD; βTCP/HA; Flap access surgery
Intervention description: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).; During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland); In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Regenerative therapy; Randomized clinical trial (RCT); Enamel matrix derivative; Hydroxyapatite-beta tricalcium phosphate; Buccal furcation

Summary:

      To clinically evaluate the treatment of mandibular class II furcation defects with enamel
      matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium
      phosphate/hydroxyapatite (βTCP/HA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, between 18-75 years of age;

          -  Presence of a mandibular molar with buccal class-II furcation defect, presenting PD ≥
             4mm, bleeding on probing (BOP), minimum (<1 mm) or no gingival recession after
             non-surgical therapy;

          -  Good general health;

          -  Minimum interproximal bone loss (< 2 mm).

        Exclusion Criteria:

          -  Pregnant or lactating;

          -  Required antibiotic pre-medication for the performance of periodontal examination and
             treatment;

          -  Suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral,
             diseases or diabetes);

          -  Had received antibiotic treatment in the previous 3 months;

          -  Were taking long-term anti-inflammatory drugs;

          -  Had received a course of periodontal treatment within the last 6 months;

          -  Smokers.
Phase IV Bioseal Study in Brain Tumor Surgery
Condition: Hemostasis; Meningioma Surgery
MeSH terms: Meningioma
Intervention: Bioseal Fibrin Sealant; Standard of Care (SoC)
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objective of this study is to observe the clinical utility and performance of Bioseal
      when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18 and 75 years of age

          -  Undergoing elective meningioma surgery and having a tumor cavity

          -  Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively
             by the surgeon requiring an adjunct to achieve hemostasis

          -  Able and willing to comply with procedures required by protocol

          -  Signed and dated written informed consent prior to any study related procedures.

        Exclusion Criteria:

          -  Subjects undergoing emergency surgery

          -  Subjects with any intra-operative findings that may preclude conducting of the study
             procedures

          -  Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than
             Bioseal on the Target Bleeding Site (TBS)

          -  Subjects with known intolerance to blood products or to one of the components of the
             study product or unwilling to receive blood products

          -  Subjects who have a history of traumatic head injury

          -  Female subjects who are known breastfeeding or pregnant or intend to become pregnant
             during the clinical study period

          -  The subject, in the opinion of the investigator, would not be suitable for
             participation in the study

          -  Subjects who participated in another trial within 30 days prior to the planned start
             of treatment.
A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Atrophy
Intervention: Memantine; Placebo
Intervention description: 10 mg tablets twice daily; Tablets twice daily
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 277.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Memantine; Neuroimaging; MRI; Brain atrophy

Summary:

      Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity
      associated with excessive glutamate release and calcium overload in neurons. Previous studies
      have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the
      rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go
      hand in hand with some of the symptoms of the disease. This suggests that memantine treatment
      in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of
      this study was to show whether memantine, in addition to providing symptomatic benefits, can
      slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients at least 50 years of age with a current diagnosis of probable AD of
             moderate severity (MMSE score between 12 and 20, inclusive) consistent with
             NINCDS-ADRDA criteria and MRI scans

          -  Patients must have had a knowledgeable and reliable caregiver to accompany them to all
             clinic visits during the study

          -  Patients were either on or off existing acetylcholinesterase inhibitor (AChEI)
             treatment provided that the treatment had been initiated >6 months prior to screening,
             had stabilised with respect to dose for >3 months, and remained fixed during the
             entire study. AChEI treatment could not be initiated or modified during the study

        Exclusion Criteria:

          -  The patient had evidence of clinically significant active disease (including recent
             myocardial infarction and uncompensated congestive heart failure [NYHA II-IV])

          -  The patient had evidence of any clinically significant neurodegenerative disease or
             neurological disorder other than AD

          -  The patient was contraindicated for MRI

        Other protocol-defined inclusion and exclusion criteria applied.
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: trospium chloride; oxybutynin IR; oxybutynin IR placebo
Intervention description: trospium chloride (60mg) once daily for 10 days; oxybutynin IR (5 mg) three times daily for 2 days; oxybutynin IR placebo three times daily for 2 days
Intervention MeSH terms: Mandelic Acids; Oxybutynin; Trospium chloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®)
      and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with
      overactive bladder and age associated memory impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient presents symptoms of overactive bladder

          -  Patient has age associated memory impairment

          -  No acute or unstable medical conditions

        Exclusion Criteria:

          -  History of alcohol or substance abuse within 1 year prior to study

          -  Has donated in excess of 500mL of blood or plasma in the 30 days prior to study

          -  Has known bleeding disorder (hemophilia)

          -  Previous abdominal bypass surgery for obesity
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
Treatment of Vitamin D Insufficiency
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: High Dose Vitamin D3; Low Dose Vitamin D3; Placebo
Intervention description: Yellow gel-cap vitamin D3 at 50,000 International Units daily for 15 days then two times a month for 350 days. Daily white placebo pills.; White gel-cap vitamin D3 at 800 International Units to take orally, daily for 365 days. Intermittent yellow placebo pills.; Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days. White gel-cap placebo pills once daily for 365 days.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 230.0
Sex: Female
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vitamin D; Cholecalciferol; Parathyroid Hormone; Calcium Absorption; Bone Mineral Density; Muscle Function

Summary:

      The purpose of this study is to answer the following questions: Does vitamin D increase
      calcium absorption, bone mass and muscle mass and function in women past menopause who have
      mildly low vitamin D levels? Do these benefits require prescription-strength vitamin D, or is
      an over the counter vitamin D dose enough?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Vitamin D insufficiency, defined as a serum 25(OH)D 16 to 25 ng/mL by high performance
             liquid chromotography assay

          -  Women ≥ 5 years past the date of last menses or bilateral oophorectomy, or ≥ 60 years
             old if they had prior hysterectomy without bilateral oophorectomy

          -  Total dietary and supplemental calcium intake < 600 mg daily but ≤ 1,400 mg daily,
             based on a food frequency questionnaire

        Exclusion Criteria:

          -  Women > 75 years old

          -  Hypercalcemia (serum calcium corrected for albumin > 10.4 mg/dL)

          -  Nephrolithiasis by medical record or patient report

          -  Inflammatory bowel disease, malabsorption or chronic diarrhea

          -  Stage 3, 4 or 5 Chronic Kidney Disease based on the Modification of Renal Diet (MDRD)
             formula

          -  Use of bone-active medications within the past 6 months including bisphosphonates,
             estrogen compounds, calcitonin, teriparatide, oral corticosteroids and anticonvulsants

          -  Allergy or intolerance to orange juice

          -  Allergy or intolerance to sunscreen

          -  Prior adult clinical fragility fracture of the hip, spine or wrist or a T-score below
             -2.5 at the lumbar spine or femur