Kornimate/medical-research-clean huggingface dataset:
udall project 2 aim 2a&c

Conditions: Parkinson Disease

Summary: this protocol will leverage the novel (on-label, fda-approved) local field potential measuring capability of the medtronic percept™ pc dbs system to study the effects of globus pallidus internus and globus pallidus externus (gpi, gpe) dbs on: the wash-out and wash-in dynamics of motor behavior and local field potentials (lfps) and correlations between fluctuations in gait and lfps during activities of daily living (recorded over 4 weeks). these experiments will elucidate the relationships between gp lfps oscillations, lower limb function, postural control and gait performance.

this protocol will leverage the novel (on-label, fda-approved) local field potential measuring capability of the medtronic percept™ pc dbs system to study the effects of globus pallidus internus and globus pallidus externus (gpi, gpe) dbs on: the wash-out and wash-in dynamics of motor behavior and local field potentials (lfps) and correlations between fluctuations in gait and lfps during activities of daily living (recorded over 4 weeks). these experiments will elucidate the relationships between gp lfps oscillations, lower limb function, postural control and gait performance.

Eligibility criteria:
inclusion criteria: * receiving dbs therapy in gp for treatment of pd * implanted with medtronic percept dbs system * at least 3 months since initial activation of the neurostimulator exclusion criteria: * history of musculoskeletal disorders that significantly affects the ability to perform the motor tasks in the specific experiment in question * history of dementia or cognitive impairment * other significant neurological disorder as determined by the pi * post-operative complications or adverse effects (e.g. on stimulation dystonias) that affect patient safety or confound the experiment * lack of capacity to consent (as identified by ubacc)
comprehensive genetic assessment, risk and education in a mammography pilot

Conditions: Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8

Summary: researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.


Eligibility criteria:
inclusion criteria: * women participating in irb:18-010601 * aged 35 and over with a negative routine mammogram within 3 months. * qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by ibis version 8). * have an active email address for survey completion exclusion criteria: * not participating in the mayo clinic cedm pilot (irb: 18-010601) * known genetic cancer syndrome with test results available for review in mayo emr * known breast cancer * unable to understand or sign informed consent

Keywords: increased risk of breast cancer
gabapentin in reducing the need for pain medication in patients with bladder cancer undergoing radical cystectomy

Conditions: Bladder Carcinoma

Summary: this randomized phase ii/iii trial studies gabapentin in reducing the need for pain medication in patients with bladder cancer undergoing surgery to remove the bladder and nearby tissue and organs. gabapentin may reduce the amount of pain medicine required after surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.

primary objectives: i. to assess if perioperative gabapentin will decrease post-operative analgesic requirements within the first 48 hours after radical cystectomy (rc) in patients undergoing rc as measured morphine equivalents. secondary objectives: i. to assess patient self-assessment of postoperative pain on numeric pain scale (nps) at 24 and 48 hours. ii. to assess time to return of bowel function (robf). iii. to assess length of stay (los) following rc. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive gabapentin orally (po) thrice daily (tid) for 48 hours after surgery. arm ii: patients receive placebo po tid for 48 hours after surgery.

Eligibility criteria:
inclusion criteria: * diagnosis of bladder cancer * anticipated radical cystectomy with ileal conduit or orthotopic neobladder exclusion criteria: * presence of spinal cord injury including any form of paraplegia or quadriplegia * allergy to gabapentin * active alcohol dependence, defined as 2 or more positive questions on the cage alcoholism questionnaire * illicit drug use (excluding recreational marijuana) * chronic kidney disease with glomerular filtration rate \< 30 ml/min * pregnancy: all female patients \< 55 years old (yo) will be administered a urine pregnancy test prior to enrollment * non-english speaking patients * chronic gabapentin, or the similar drug pregabalin, use * chronic narcotic use (daily or near daily use for \> 90 days)
prevalence of hpv-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium

Conditions: Human Papilloma Virus Infection; Pterygium

Summary: prevalence of hpv-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium

the main purpose of this study is to evaluate the prevalence of hpv infection in primary and recurrent pterygium and the association of hpv types collecting from conjunctiva swab and urine. the second purpose is to compare a quantity of cytokines including il-6, il-18 and growth factor including vegf found in tears of patients with primary and recurrent pterygium to participants with free of ocular disease primary hypothesis - the prevalence of hpv infection in primary pterygium is difference with prevalence in recurrent pterygium patients. secondary hypothesis * ocular hpv infection has association with hpv genitalia infection. * tears cytokine and growth factor level (il-6, il-18 and vegf) are higher in pterygium hpv infection than non-hpv infection and also more than normal population

Eligibility criteria:
participants as primary and secondary pterygium group inclusion criteria: * age above 18 years old * presence of pterygium invading the cornea exclusion criteria: * other ocular inflammation that could affect the results of the study (such as conjunctivitis, keratitis, conjunctival tumor, etc) or would preclude the enrollment for safety reasons participant without ocular disease inclusion criteria * age above 18 years old exclusion criteria * presence of any ocular inflammation diseases

Keywords: hpv infection pterygium cytokine vegf auto-inoculation
an epidemiological study of acute coronary syndromes in the greek population. the target study

Conditions: Acute Coronary Syndromes

Summary: this is a multicenter, 2-phase observational study of acute coronary syndromes (acs) in greece, designed to provide real world data on the risk factors of patients presenting to a hospital emergency department with an index event, as well as to depict the current management practices and outcomes of these clinical conditions in greece.


Eligibility criteria:
inclusion criteria: * diagnosis of an acs (stemi, nstemi, ua). * informed consent exclusion criteria: * involvement in the planning and conduct of the study (applies to both astrazeneca staff and staff at the study sites). * participation in other clinical study in period between the index event and 6- month follow-up assessment with the exception of registering in registries or surveys not influencing the management of the acs.

Keywords: acute coronary syndromes epidemiology management of disease outcomes greece
early post transplant cardiac allograft vasculopathy

Conditions: Cardiac Allograft Vasculopathy

Summary: heart transplantation is an effective life-saving treatment for patients with end-stage heart disease. after a transplant, the new heart may develop narrowing in the arteries, causing heart failure, heart attacks and abnormal heart rhythms. this condition is known as cardiac allograft vasculopathy (cav). the disease is very common, affecting almost a third of heart transplant patients by 5 years after transplant. cav is a serious problem that causes the new heart to fail and is one of the main causes of death after transplant. early detection of cav is important as treatment options are poor once the disease is established. currently, available techniques to evaluate cav are limited by poor ability to detect disease early. the current tests usually focus on the large heart arteries and do not examine the smaller arteries that are also affected.

the objective of this study is to determine whether early abnormalities of the heart arteries after heart transplantation can predict the development of cav. we will use a combination of sophisticated imaging tools to examine in detail the early changes that occur in the arteries of a new heart. heart transplant patients from the university of ottawa heart institute and toronto general hospital will undergo a series of tests at 3 and 12 months after transplant. statistical analyses will determine whether results from the above tests at 3 months predict the development of early cav at 12 months after a heart transplant.

Eligibility criteria:
inclusion criteria: 1. heart transplant \<3 months. 2. age ≥18 years. 3. able and willing to provide informed consent. exclusion criteria: 1. contraindications to dipyridamole. 2. contraindications to aminophylline. 3. contraindications to nitroglycerin. 4. contraindications to iodinated contrast. 5. acute allograft rejection ≤1 month. 6. uncontrolled heart failure or myocardial infarction ≤7 days. 7. estimated glomerular filtration rate ≤30 ml/min. 8. combined solid organ transplantation.

Keywords: macrovascular disease microvascular coronary artery disease cardiac transplant rejection transplant; failure, heart intravascular ultrasound (ivus) optical coherence tomography index of microcirculatory resistance fractional flow reserve coronary flow reserve positron emission tomography endomyocardial biopsies
hydro-mechanical defragmentation of pulmonary embolism

Conditions: Pulmonary Embolism

Summary: evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy

in high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk. the first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. however a significant proportion of patients may not be a candidate for intravenous thrombolysis because of major contraindications. an alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited. percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by injection of 200 ml saline at high pressure using power injector can be used as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow.

Eligibility criteria:
inclusion criteria: * patients with angiographically confirmed acute high risk pulmonary embolism with shock index \>1. * pulmonary arterial occlusion with \>50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure \>25 mmhg) * patients with high risk pulmonary embolism who cannot receive fibrinolysis * patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe rv (right ventricle) dysfunction, or major myocardial necrosis) exclusion criteria: * patients with echocardiographically confirmed right sided thrombi. * patients with low-risk pulmonary embolism or intermediate-low risk acute pulmonary embolism with minor rv dysfunction, minor myocardial necrosis, and no clinical worsening * anaphylactic reaction to contrast media. * acute renal failure or severe chronic non-dialysis dependent kidney disease. * uncooperative patient
exert-bch exercise regimen to improve muscle mass after treatment of breast cancer

Conditions: Breast Cancer; Breast Carcinoma in Situ; Breast Cancer Female

Summary: the purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.

this protocol seeks to analyze patient outcomes of two standard of care, time-efficient, monitored group exercise regimens of high-load resistance training to improve hypertrophy in women who have been treated for ductal carcinoma in situ or invasive carcinoma of the breast. as part of the standard exercise program, patients will undergo a fitness evaluation at the ahnci exercise oncology and resiliency center before the start of the exercise program. this evaluation will be used to customize the patient exercise program. the exercise program consists of small group training sessions held approximately 3 times per week at the center for 12 weeks (3 months). the fitness evaluation and exercise program are standard of care. participation in this study will last the duration of the exercise program, about 3 months. all group exercise sessions will be closely monitored by the center staff who are certified strength and conditioning specialists (cscs).

Eligibility criteria:
inclusion criteria: age 20-89 years * women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast * women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. women undergoing active chemotherapy are not allowed on study. immunotherapy or targeted agent usage is allowed. exclusion criteria: * any current treatment with cytotoxic chemotherapy for breast cancer * inability to safely engage in group sessions of resistance training as deemed by study pi * severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by pi to be unsafe to engage in resistance training

Keywords: cancer carcinoma in situ hypertrophy exercise
telemedicine follow-up for bariatric surgery patients: what do patients prefer

Conditions: Obesity

Summary: this is a randomized clinical trial that will randomize bariatric patients undergoing laparoscopic sleeve gastrectomy or laparoscopic roux-en-y gastric bypass to receive either in-person or telemedicine post-operative follow-up within 30 days after surgery.

our current bariatric practice: bariatric surgery patients are expected to follow up with the bariatric surgery midlevel providers as well as with dietitians within 30-days after their bariatric procedure. the bariatric surgery midlevel providers are staffed and supported by our bariatric surgeons in case if they have questions or concerns. patients do not get billed for post-operative visits within 90-days of global surgery period; the same global surgery rules apply to both in-person and telemedicine visits. patients are required to follow-up after surgery as part of the metabolic and bariatric surgery accreditation and quality improvement program. adult (≥ 18 year-old) participants in the study will undergo primary roux-en y gastric bypass or sleeve gastrectomy and will randomized to telemedicine or in-person visit before their surgical procedure. patients who encounter unexpected intra-operative or post-operative complication or unexpected hospital course may not be offered telemedicine visits but will be included in our analysis. the performing surgeon will determine if a patient is illegible for telemedicine visit if unexpected course was encountered. however, analysis will be analysis to treat. all participants will be contacted via telephone and will be surveyed about their post-operative care visits within 7-14 days after that visit, which is typically performed within 30-days after surgery. the survey will be developed in coordination with the mayo clinic research survey center and will focus on the following aspects: baseline familiarity with technology, patients' satisfaction with the post-operative care they received, patients' preference of in-person vs telemedicine visits, patients' estimation of additional costs for their care outside of the direct medical costs, along with an open question that will ask patients to provide comments and feedback about their overall experience with their follow-up appointment.

Eligibility criteria:
inclusion criteria: patients \> 18 years of age having bariatric surgery; primary roux-en y gastric bypass or sleeve gastrectomy be in the united states at the time of their 30-day follow-up live 70 miles or further from mayo clinic downtown campus in rochester, mn access to wi-fi and electronic device (laptop, computer, tablet, smart phone, etc.) willing to consent for the study exclusion criteria: patients \< 18 years of age be outside the united states at the time of their follow-up undergoing revision of previous bariatric surgery unable to speak english unwilling or unable to provide consent for the study

Keywords: obesity
trial of irinotecan in combination with three methods of administration of fluoropyrimidine.

Conditions: Colorectal Neoplasms

Summary: this study compares in the first study period combination of irinotecan with three different methods of administration by fluoropyrimidine. (ie. infusion, bolus and oral). in the second period of study it compares folfiri \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[lv\] with infusional 5-fluorouracil (5-fu)\] + bevacizumab and mlfl + bevacizumab. measures of efficacy and safety will be reported.


Eligibility criteria:
inclusion criteria: * diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (stage iv distant disease) * present or past histological documentation of adenocarcinoma of the colon or rectum. the site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless: * an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease. * the primary cancer was a duke's a or b1. * physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases. exclusion criteria: * patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents). * patients cannot have concurrent malignancies at study entry. * exceptions: patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.
peak plasmablade 4.0 versus traditional electrosurgery in total knee replacement.

Conditions: Degenerative Joint Disease; Osteoarthritis

Summary: the objective of this clinical study is to evaluate the operative performance of the peak plasmablade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse events, and skin scarring following surgery; and compare these outcomes to the current standard of care (soc).

total knee replacement is a surgical procedure performed to replace the weight-bearing surfaces of the knee joint. the goal of total knee replacement is to improve a patient's mobility by improving the function of the the knee joint. the peak plasmablade® uses pulsed radiofrequency (rf) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. the plasmablade has received fda clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ent) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. it is hypothesized that this benefit may improve the post-operative outcome of patients undergoing total knee replacement.

Eligibility criteria:
inclusion criteria: 1. age between 21 and 80 years old 2. physically healthy, stable weight 3. requiring unilateral total knee arthroplasty (tka) 4. subject exhibits preoperative radiographic evidence of joint degeneration consistent with tka that cannot be treated in non-operative fashion 5. subject has severe knee pain and disability due to degenerative joint disease 6. subject must understand the nature of the procedure and provide written informed consent prior to the procedure. 7. subject must be willing and able to comply with all follow-up evaluations 8. subject must be willing to undergo tka using the signature knee system exclusion criteria: 1. age younger than 21 or greater than 80 years old 2. previous history of infection in the affected joint 3. peripheral vascular disease 4. revision procedures 5. bmi \> 35 6. valgus or varus deformity \> 15 degrees 7. flexion contracture \> 15 degrees 8. history of diabetes 9. anticoagulation therapy which cannot be discontinued 10. cognitive impairment or mental illness 11. severe cardiopulmonary deficiencies 12. known coagulopathy 13. immunocompromised 14. kidney disease (any type) 15. unable to follow instructions or complete follow-up 16. currently taking any medication known to affect healing 17. currently enrolled in another investigational device or drug trial

Keywords: total knee arthroplasty plasmablade electrosurgery peak surgical medtronic advanced energy medtronic