Kornimate/medical-research-clean huggingface dataset:
longitudinal outcomes of dbs in pd

Conditions: Parkinson Disease

Summary: vanderbilt university medical center is one of the largest-volume dbs centers in the country. from 2007 through october 2017, 265 parkinson's disease (pd) patients underwent deep brain stimulation (dbs), 168 of those implanted in subthalamic nucleus (stn) and 97 in globus pallidus interna (gpi). pre-operatively, each patient is extensively evaluated with a battery of validated motor, cognitive, and mood instruments. this information is stored in redcap, a secure online database platform. in an attempt to capture longitudinal outcomes in this population of interest, we will recruit all pd patients two years or more status post dbs who are receiving regular care at vanderbilt university medical center. study participants will undergo a condensed evaluation of motor function (unified parkinson's disease rating scale part iii), cognitive performance (mini-mental status examination), mood (beck depression inventory), and quality of life (parkinson's disease questionnaire-39). these results will be compared to baseline measures performed pre-operatively, allowing for assessment of interval change. stn and gpi dbs patients will be analyzed separately.

patients will be recruited from review of movement disorders neurologists' outpatient census. all patients with pd two or more years status post dbs will be contacted via phone and/or mailed letter. any interested patient will be mailed or e-mailed (via redcap) a copy of the study informed consent form. willing patients will present to the vanderbilt movement disorders clinic for an opportunity to inquire further about the study and sign the informed consent form in person. participants will have a single study visit, ideally coordinated with their regularly scheduled neurology follow-up. during the study visit, the following evaluations will be performed by a trained research assistant: video-recorded updrs iii bdi mmse pdq-39 in addition, current pd medications and number of falls in the past 6 months will be recorded. assessments will occur in the on-medication, on-dbs state. the video-recorded updrs iii will be reviewed and score at a subsequent date by a blinded rater (movement discord trained neurologist).

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * status post deep brain stimulation (dbs) implantation in the subthalamic nucleus (stn) or globus pallidus interna (gpi) at vanderbilt university medical center exclusion criteria: - unable to complete study assessments

Keywords: deep brain stimulation longitudinal outcomes subthalamic nucleus globus pallidus interna
lactacol 01 - impact of breast milk on the neurodevelopment of preterm newborns

Conditions: Prematurity of Fetus

Summary: the aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old. the investigators expect a difference of at least 5 points of development quotient (dq) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.


Eligibility criteria:
inclusion criteria: * maternal decision of breastfeeding * born between 28 and 34 weeks of amenorrhea * no important congenital pathology except prematurity * efficiency of the breastfeeding compatible with the research by the investigator * information and authorization of the parents or the parental authority exclusion criteria: * maternal decision of not breastfeeding * born before 28 weeks of amenorrhoea or after or at 34 weeks of amenorrhoea * important congenital pathology * efficiency of the breastfeeding incompatible with the research by the investigator * opposition from parents or the parental authority to participate to the research study

Keywords: preterm infant
mapping electrogram morphology recurrence for atrial fibrillation ablation

Conditions: Atrial Fibrillation

Summary: the overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (emr) mapping in patients with persistent atrial fibrillation (af) to locate areas of high electrogram morphology recurrence rate. the investigator believe that the emr mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow af. the investigator will test this technology on ten subjects undergoing a second ablation procedure. the investigator will map the af utilizing the emr to indicate locations of stable activity and ablate the area. the investigator believes that the study could produce acute af termination or af cycle length slowing. in addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from af following ablation of areas of high recurrence rates.


Eligibility criteria:
inclusion criteria: * male and female at least 21 years of age * persistent afib with one prior failed ablation for persistent or long standing persistent afib exclusion criteria: * inability to sign consent * patients with a life expectancy less than one (1) year * patients with chronic kidney disease with sufficiently low gfr that precludes either ct angiogram of the heart or contrast mri study * pregnant women and women that are breast feeding * patients with multiple (2 or more) prior failed ablations * patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Keywords: atrial fibrillation ablation
breathing training to improve human performance at high altitude

Conditions: Mountain Sickness Acute

Summary: individuals traveling to altitudes above 8,000 feet may suffer from impaired exercise and cognitive performance, and acute mountain sickness (ams). decreased barometric pressure, which leads to low blood oxygen levels, is the primary cause of these disorders. symptoms of ams are characterized by headache, nausea, vomiting, dizziness, fatigue, and difficulty sleeping. the goal of this research is to identify whether respiratory muscle training will improve physical and cognitive performance, and reduce the symptoms of ams, at simulated high altitude.


Eligibility criteria:
inclusion criteria: * healthy * men, ages 18-45 who are able to achieve at least 3.5 watts/kg of body weight during the peak oxygen uptake test exclusion criteria: * less than 18 years old * greater than 45 years old * have a body mass index greater than or equal to 30 * have been recent smokers (tobacco or e-cigarettes) * current recreational or medical marijuana users * currently taking any medication (over-the-counter or prescription) or herbal supplements * participants who are unable to tolerate drinking only two, 6-ounce caffeinated beverages per day of the study * participants who are legally blind * participants who have been to altitudes above denver (1609m or 5280ft), including air travel, in the 3 weeks prior to the start of the study or with plans to do so during the study * participants who have suffered a significant head injury, have anemia or sickle cell trait or disease, have active peptic ulcer disease, diabetes, hypertension, heart disease, hiv/aids, glaucoma, kidney disease, liver disease/cirrhosis, adrenal gland failure, hyponatremia/hypokalemia, tuberculosis * participants who have a current herpes infection or any other current type of viral or bacterial infection * participants with seizure disorders or history of migraines

Keywords: exercise aerobic cognitive function
personalizing aspirin therapy in peripheral arterial disease patients

Conditions: Peripheral Arterial Disease

Summary: antiplatelet therapies are important to decrease the morbidity and mortality associated with peripheral arterial disease (pad) through the prevention of thrombus formation. aspirin (asa) is a readily available and affordable antiplatelet medication that can help reduce adverse cardiovascular events by up to 25%. however, 25-60% of pad patients are "asa insensitive" having a lower than normal ability to inhibit platelet aggregation after standard aspirin dosing. in a previous study conducted by our lab, we were able to demonstrate a methodology for personalizing antiplatelet therapy using two platelet function tests, platelet function analyzer-100 (pfa 100) and light transmission aggregometry (lta). to investigate this methodology further, we would like to conduct a pilot study on two cohorts of patients, one population continuing with their current medications (81mg asa), and a second group who will get personalized antiplatelet therapy using our methodology (81-325mg asa). in this study, 150 pad patients taking 81mg aspirin therapy presenting for clinical follow-up, or in-patient intervention, in vascular clinics or the emergency room, will be recruited to our study. 75 patients will be randomly assigned undergo platelet analysis using pfa-200 and lta, and will have their antiplatelet therapy personalized. patients will then be followed up in order to see if the patients with personalized therapy have better platelet inhibition. this study will allow us to help personalize antiplatelet therapy in pad patients, allowing for better patient outcomes and decreased adverse cardiovascular events.


Eligibility criteria:
inclusion criteria: * self-reported intake of either 81 mg of aspirin per day for 3 or more days * diagnosed with peripheral arterial disease exclusion criteria: * alcohol ingestion 24 hours prior to blood draw * patients receiving glycoprotein (gp) iib/iiia antagonists * ingestion of a non steroidal anti-inflammatory drug 3 days prior to blood draw * history of bleeding disorders * gastrointestinal bleeding * hemorrhagic stroke * allergy to aspirin or ticagrelor * pregnancy, thrombocytopenia anmia or leukopenia

Keywords: aspirin
local delivery of silk fibroin and chlorhexidine

Conditions: Periodontal Pocket

Summary: the current study is a prospective randomised split mouth study to evaluate the effect of silk fibroin as drug delivery system while simultaneously assessing the efficacy of silk fibroin in comparison to chlorhexidine.

fifteen healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. a detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. all patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.all the patients underwent scaling and root planing. following randomization, the site will be assigned to one of the three study groups. 1. group i (srp+ silk fibroin) 2. group ii (srp+ chlorhexidine) 3. group iii (srp+ combination of fibroin and chlorhexidine) periodotal pack was placed and patient was recalled after 21days, 1 month and 3 month for the follow up.

Eligibility criteria:
inclusion criteria: 1. patient with age between 30-50 years. 2. patients with stage i/ ii with grade a/ b periodontitis according to 2017 world workshop classification of periodontal disease will be considered. 3. patients with localized periodontal pockets. 4. patients willing to participate in the study. exclusion criteria: 1. patients with known systemic diseases. 2. non complaint patients. 3. patients who received any surgical or nonsurgical therapy 6 months before the start of the study. 4. pregnant or lactating females. 5. use of systemic antibiotics in the past 6 months.
feasibility of interval debulking surgery by laparoscopy for peritoneal carcinosis in chemosensitive patients

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cavity Cancer

Summary: this prospective nonrandomized multicenter phase ii study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.


Eligibility criteria:
inclusion criteria: * age \> or = 18 years * performance status who \< 2 * epithelial ovarian, fallopian tubes or primary peritoneal carcinoma (histologically confirmed) * unresectable disease because of figo stage iv disease proven by imaging (ct scan or pet ct) and/or diffuse extensive carcinosis considered unresectable for advanced figo stage iiic; or patients unable to support a radical primary surgery because of age, comorbidities or altered general condition. * no previous debulking surgery before neoadjuvant chemotherapy. * patients treated with a minimum of 3 cycles of platinum-based neoadjuvant chemotherapy. * response to chemotherapy was radiologically confirmed (scan-tap) prior to interval surgery: no evidence of peritoneal supra-mesocolic carcinomatosis ; residual pelvic masses smaller than 10 cm ; absence of suspect supra-centimeter retroperitoneal lymphadenopathy * able to read, write and understand french. * member of a social security scheme. * written informed consent. exclusion criteria: * patient unable to support laparoscopy * psychiatric condition or social or geographic situation that would impede appropriate study participation * concomitant participation in another clinical trial evaluating surgical treatment (interfering with the evaluation of the main endpoint)

Keywords: laparoscopy, interval debulking surgery
ellipse intramedullary nail high tibial osteotomy study

Conditions: Osteoarthritis; Varus Malalignment

Summary: this study further evaluates the safety profile and efficacy of the ellipse im hto nail system in subjects with osteoarthritis and varus malalignment of the knee. all subjects will receive treatment with the ellipse im hto nail system and followed for six months.

the ellipse im hto nail is intended for open wedge proximal tibial osteotomies. the ellipse im hto nail is an intramedullary nail that operates on the principles of distraction osteogenesis. the ellipse im hto nail is used in valgizing hto procedures to correct varus malalignment. the ellipse im hto nail is surgically placed in the intramedullary canal of the tibia. it is lengthened telescopically using the non-invasive external remote control.

Eligibility criteria:
inclusion criteria: 1. patient has standing varus malalignment benefitting from high tibial osteotomy correction 2. patient is diagnosed with current osteoarthritis of the knee 3. patient is eighteen years of age or greater 4. patient is a candidate to be implanted with an ellipse im hto system 5. if female of childbearing potential, patient presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study 6. patient understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements 7. patient signs informed consent for the use of their personal private data exclusion criteria: 1. patient declines to sign informed consent for the use of their personal private data 2. varus deformity greater than 10° 3. flexion contracture greater than 15° 4. knee flexion under 90° 5. medial/lateral tibial subluxation over 1 cm 6. medial bone loss of over 3 mm 7. inflammatory arthritis 8. arthritis in the lateral compartment 9. patella baja 10. weight over 114 kg 11. severe patellofemoral symptoms 12. unaddressed ligamentous instability 13. fixed flexion contracture 14. known or suspected osteoporosis or osteopenia based on medical history and radiographic images 15. current use of nicotine products. 16. requires other surgical procedures at the time of the hto surgery
total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension in patients with pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: this prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse


Eligibility criteria:
inclusion criteria: * women with symptomatic pelvic organ prolapse stage ii or higher (according to the international continence society pelvic organ prolapse quantification system - popq) in anterior and/or apical (central) compartment that require surgical management exclusion criteria: * patients that are not candidates for general anesthesia or laparoscopy * inability to consent * history of hysterectomy * history of anterior or apical pelvic organ prolapse surgery * history of urinary incontinence surgery * pregnancy or breast-feeding during the study period * suspicious adnexal masses or other factors that may indicate pelvic malignancy

Keywords: lateral suspension laparoscopic hysterectomy pelvic organ prolapse sacrocolpopexy
dardar nutrition study in hiv breastfeeding women

Conditions: Low Birth Weight

Summary: this study being conducted in dar es salaam, tanzania, to determine if a protein-calorie supplementation (pcs) and micronutrient supplement (mns) will have an impact on health outcomes for hiv-infected pregnant women and their infants.

in resource poor regions of the world where hiv is endemic, especially countries in sub-saharan africa, nutrition plays a critical role in hiv disease. nutrition affects the health of hiv-infected women and children, and may influence the risk of mother to infant transmission of hiv through breast milk. nutrition influences the risk of tuberculosis (tb) and tb disease severity. existing research has focused on the role of micronutrients in hiv disease outcomes but has not addressed the role of protein calorie supplementation (pcs) in subpopulations of patients with hiv disease at high risk, specifically, hiv-infected women who are either breast feeding or have active tb. our hypotheses are that administration of a culturally acceptable pcs is a practical, sustainable and effective strategy to: 1) decrease hiv viral load in plasma and breast milk of breast feeding women, enhance passively transferred immune mediators in breast milk, and improve hiv outcomes in women and their breast-fed infants and, 2) decrease hiv viral load, enhance tb-specific t cell immunity, and improve outcomes in women with hiv and active tb.

Eligibility criteria:
inclusion criteria: * hiv+ women * 2nd trimester of pregnancy * residency in dar for duration of breastfeeding * plan to exclusively breastfeed exclusion criteria: * high risk pregnancy (e.g., diabetes, pre-eclampsia) * women with allergy to components of pcs
neuromuscular cognitive training

Conditions: Injury;Sports

Summary: this project will utilize a quasi-experimental, multiple baseline pretest-posttest design where participants will complete postural stability assessments, physical performance assessments, and questionnaires to evaluate perceptions toward injury prevention before and after completing a 6-week neuromuscular-cognitive prevention program.

the i-thinc program will address aspects of cognition (i.e., reaction time/processing speed, working memory, cognitive flexibility, inhibitory control, attention, and dual-tasking) while completing common movement patterns utilized in tennis (i.e., lateral shuffle, rapid acceleration/deceleration, and postural stability). the proposed program will take place in the participants training facility. the program will be implemented twice per week for six weeks (12 sessions) with each session lasting 20 minutes. to add variety, there will be two complementary programs (a and b) comprising of four exercises increasing in complexity every two weeks. each week participants will complete program a during the first session and program b during the second session.exercises will progressively challenge cognitive and physical demand. exercises were designed to address the most common injuries in tennis.

Eligibility criteria:
inclusion criteria: * healthy adults from the university of kentucky varsity tennis programs exclusion criteria: * not medically cleared for participation

Keywords: injury prevention cognition physical performance postural stability neuromuscular
multihance at 3 tesla (3t) in brain tumors

Conditions: Brain Tumor

Summary: compare the efficacy of multihance and magnevist

the purpose of this study was to evaluate whether multihance is superior to magnevist in terms of qualitative and quantitative assessment of unenhanced mri and contrast-enhanced mri for the visualization of brain disease.

Eligibility criteria:
inclusion criteria: * was 18 years or older * provided written informed consent * scheduled for mri * confirmed or highly suspected to have brain tumor(s) and willing to undergo two mri exams within 14 days exclusion criteria: * pregnant or lactating females * allergy to one or more of the ingredients in the products or hypersensitivity to any metals * congestive heart failure, class iv * previous stroke in the past year * received another contrast agent within 24 hours pre and post each exam * investigational product * contraindications to mri * severe claustrophobia * surgery with 3 weeks prior * steroid therapy or radiosurgery between two exams
two different preparations of sevoflurane in induction

Conditions: Coughing on Induction; Vapors; Inhalation

Summary: in our study we aim to study the effects of two preparations of sevoflurane in vital capacity rapid inhalation induction.


Eligibility criteria:
inclusion criteria: * patients undergoing abdominal surgery exclusion criteria: * patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (bmi\>35) will be excluded from the study
does iv magnesium improve quality of recovery with eras protocols in laparoscopic colorectal surgery?

Conditions: Colo-rectal Cancer; Anesthesia

Summary: this study is a randomized, double blind controlled trial examining the impact of incorporating a single intraoperative intravenous magnesium bolus and infusion into a preexisting enhanced recovery after surgery (eras) protocol for colorectal surgery in place of preoperative oral pregabalin. these protocols are pathways designed with the goal of achieving early surgical recovery by utilizing a constellation of perioperative care techniques that include the use of opioid-sparing pain medications, minimally invasive approaches, and prevention of post-operative nausea and vomiting, among others. intravenous magnesium has shown to be an effective non-opioid analgesic in abdominal surgeries that decreases total opioid consumption, pain, and improves recovery. the purpose of this study is to evaluate whether or not the addition of intravenous magnesium to our institutional eras protocol will improve specific outcome measures, and provide additional benefits when compared to oral preoperative pregabalin. the primary outcome is the patient's quality of recovery based on the "quality of recovery - 40 questionnaire" (qor 40), and secondary outcomes will be opioid consumption, pain, shivering, sedation scores, acute kidney injury, gastrointestinal function, respiratory function, and hospital length of stay.


Eligibility criteria:
inclusion criteria: * elective laparoscopic colorectal surgery * age 18-75 * asa (american society of anesthesiologists) physical status classification 1-3 exclusion criteria: * current use of buprenorphine/suboxone or methadone maintenance treatment * known history of substance abuse * use of intra- and/or postoperative ketamine or lidocaine infusion * pre- or postoperative placement of epidural catheter * inability to speak english or communicate verbally * chronic kidney disease (ckd) stage 3 * hepatic cirrhosis * neuromuscular disease * heart block on ekg * uncontrolled diabetes with hba1c \> 8% * known allergies to study drugs