Kornimate/medical-research-clean huggingface dataset:
intraoperative monitoring to predict postoperative complications after thyroidectomy

Conditions: Endocrine Procedural Complications; Thyroid; Parathyroid; Deficiency; Laryngeal Injury

Summary: the goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (pth) to predict postoperative nerve morbidity and hypocalcemia.

intraoperative pth values and intraoperative continuous neuromonitoring will be collected prospectively in consecutive patients who undergo total thyroidectomy. postoperative parathyroid morbidity and recurrent laryngeal nerve morbidity will be evaluated within 1 week after total thyroidectomy and at 1 year postoperatively. other postoperative morbidity will be evaluated at 1 year postoperatively using validated classification.

Eligibility criteria:
inclusion criteria: * patients scheduled for total thyroidectomy in university of nancy (university hospital) exclusion criteria: * refusal to participate
confocal microscopy in barrett's esophagus

Conditions: Barrett's Esophagus

Summary: this data review will be done to evaluate the use of confocal microscopy imaging in patients who were seen for clinically indicated endoscopic surveillance and biopsies of barretts esophagus

this retrospective chart review will be done to evaluate the use of confocal microscopy imaging in patients who were seen at mayo clinic for clinically indicated endoscopic surveillance and biopsies of be. endoscopy reports and pathology results will be reviewed from 100 patients who have undergone endoscopy. these results will be correlated with images obtained with confocal microscopy at the time of the endoscopy. there will be no patient contact.

Eligibility criteria:
inclusion criteria: * patients who have undergone confocal microscopy at the time of surveillance endoscopy for barrett's esophagus

Keywords: barrett's esophagus confocal microscopy
cross-sectoral rehabilitation of older high-risk patients with hip fracture

Conditions: Hip Fractures; Rehabilitation; Recovery of Function

Summary: the goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip. the main questions aim to answer: * how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered * what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture participants age 65 and above with home address in frederiksberg municipality, living in own home, admitted and treated for at hip fracture at department of orthopedic surgery, bispebjerg hospital, will be asked for participation.

in addition to primary and secondary outcome measures some of the patients will be asked to respond to a interviewer-based questionnaire, about their experiences of the rehabilitation offered during their hospital stay and at the temporary municipality-based 24-hour setting / or at home during the first couple of months. furthermore, they will be interviewed about their expectations for rehabilitation in the municipality at time of discharge from the acute hospital.

Eligibility criteria:
inclusion criteria: undergone surgery for hip fracture and admitted to department m1, bispebjerg-frederiksberg hospital living in frederiksberg municipality and being admitted from own home, or a 24 hour temporary setting in the municipality exclusion criteria: living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting.
open-label extension (ole) study to assess safety and efficacy of evolocumab

Conditions: Hypercholesterolemia

Summary: the purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * completed week 80 of study 20120153 (nct01813422). exclusion criteria: * did not complete investigational product in the 20120153 parent study * have an unstable medical condition, in the judgment of the investigator * known sensitivity to any of the products to be administered during dosing * currently enrolled in another investigational device or drug study (excluding evolocumab (amg 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
facial mask tightness: a comparative study

Conditions: Anesthesia

Summary: a correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. most tight masks are actually sold but they have never been compared in studies. the aim of this study is to compare air leaks with standard facial mask and quadralite masks during preoxygenation and induction of anesthesia.


Eligibility criteria:
inclusion criteria: * edentulous patients * age \> 55 years exclusion criteria: * pregnancy or breast-feeding, patients on tutelage or guardianship * patient unable to understand the protocol * anesthesia in emergency or with full stomach

Keywords: anesthesia facial mask
value- vascular access laminate european experience. a post market surveillance study to assess the safety and effectiveness of vasq

Conditions: Arterio-Venous Fistula; Kidney Failure, Chronic; Kidney Diseases; Renal Failure Chronic; ESRD; Arteriovenous Fistula Thrombosis

Summary: this is a prospective single arm study enrolling patients who are scheduled for creation of a new brachiocephalic or radiocephalic av fistula. up to 80 patients will be enrolled, 50 with upper arm av fistula and 30 with forearm av fistula. all patients will be implanted with the vasq device, a subcutaneous arteriovenous conduit support for vascular access. the follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.


Eligibility criteria:
inclusion criteria: 1. patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study. 2. age 18-80 years 3. male and female participants 4. patients willing and able to attend follow up visits over a period of 12 months exclusion criteria: 1. patients with the planned index procedure being a revision surgery of an existing fistula. 2. target brachial artery smaller than 2.5 mm or larger than 6 mm or radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound 3. target vein outer diameter smaller than 2.5 mm by preoperative ultrasound 4. significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op ultrasound (scan should include the area between the planned anastomosis site and the axillary vein) 5. unusual anatomy or vessel dimensions (observed on pre-operative us or intraoperatively) and which preclude adequate fit of the vasq. 6. patients with prior central venous stenosis or obstruction on the side of surgery 7. depth of vein greater than 8 mm (on ultrasound) on side of surgery 8. known coagulation disorder 9. congestive heart failure nyha class ≥ 3 10. prior steal on the side of surgery as evident from the patient's medical history 11. known allergy to nitinol 12. life expectancy less than 18 months 13. patients expected to undergo kidney transplant within 6 months of enrollment 14. women of child bearing potential without documented current negative pregnancy test 15. inability to give consent and/or comply with the study follow up schedule
multi-modality mri study on prediction for mild cognitive impairment conversion

Conditions: Mild Cognitive Impairment; Alzheimer's Disease

Summary: the purpose of this study is to find the characteristics of mild cognitive impairment (mci) using technology of multi-modality mri , including structural mri, functional mri and diffusion tensor imaging(dti). then analyze the difference between progressive mci (mcip) and stable mci (mcis) and further construct the predictable classifier from mci to alzheimer's disease (ad) based on multi-modality mri characteristics of mci patients.

the cognition of mci is between normal healthy and ad, which is thought the transitional stage of ad. patients with mci have heavy risk to convert to ad, so in this study, the investigators focus on the exploration of the characteristics of mild cognitive impairment (mci) using technology of multi-modality mri, including structural mri, functional mri and dti. then the investigators further study the patients who convert to ad and explore their mri characteristics on baseline, in order to construct the predictable classifier from mci to ad. the investigators want to achieve the early diagnosis of ad and help clinicians interfere with the progress of this disease.

Eligibility criteria:
inclusion criteria: * age is between 55 to 75 years old * memory loss complaint and confirmed by an informant * cognitive impairment in single or multiple domains, adjusted for age and education * normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities * a clinical dementia rating (cdr) score is 0.5 and consistent with the boundary of neuropsychological scale * failure to meet the criteria for dementia * must be able to accept examination of mri, sight and hearing allow to complete test * right handedness exclusion criteria: * other diseases that cause cognitive impairment, such as thyroid disease, stroke and so on * people who have severe visual and hearing impairment
fungal ulcer treatment augmented with natamycin and cyclosporine a

Conditions: Fungal Keratitis; Corneal Ulcer

Summary: the goal of this clinical trial is to learn if adjunctive topical cyclosporine a eye drops combined with standard of care topical natamycin treatment improves vision outcomes in patients with fungal keratitis.

this is a randomized, masked, clinical trial of patients with documented fungal infections of the cornea. in this trial participants are treated with (standard of care) topical natamycin for a minimum of 48 hours and then randomized in a 1:1:1 ratio to receive either topical cyclosporine a (csa) 0.1%, or csa 2%, or placebo for 4 weeks. natamycin will be continued until the corneal ulcer has resolved. the primary outcome of this pilot trial is best corrected visual acuity (bcva) at 3 months. the specific aims of this trial are to: * to determine if early use of topical cyclosporine a is a beneficial adjuvant to natamycin in the treatment of mild to moderate fungal keratitis. * to determine if adjunctive 2% cyclosporine a demonstrates greater efficacy than 0.1% cyclosporine a in the treatment of fungal keratitis. * to determine which ulcer characteristics, predict the most benefit from the addition of early topical cyclosporine. in this study the investigators will partner with their cornea colleagues at the aravind eye hospital. this is because the incidence of fungal corneal ulcers is among the highest in the world in this location.

Eligibility criteria:
inclusion criteria: * inclusion is based on presenting acuity, not ulcer size. * inclusion of 20/40 = 6/12 = 0.3 log mar and 20/400 = 3/60 = +1.3 log mar. * smear or culture positive for fungal keratitis, any length. * age 18 years. * willing to participate in study. exclusion criteria: * co-infection with bacterial or viral keratitis. * corneal perforation. * requiring therapeutic keratoplasty for fungal keratitis. * unwilling or unable to follow up (e.g., living too far from hospital). * presenting acuity better than 20/40 = 6/12 = 0.3 log mar or worse than 20/400 = 3/60 = +1.3 log mar. * subjects taking cyclosporine at any concentration on presentation. * acuity worse than 20/200 = 6/60 = +1.0 log mar in unaffected eye. * pregnant women. * penetrating keratoplasty. * presents with a 0-7 day history of topical steroid.

Keywords: corneal ulcer cyclosporine a fungal keratitis fungal corneal ulcer
breast cancer genome guided therapy study (beauty)

Conditions: Invasive Breast Cancer

Summary: the purpose of this research study is to better understand the reasons why or why not breast cancers are destroyed by standard chemotherapy. this information will be used to develop new and better cancer therapies.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * histological confirmation of invasive breast cancer. * confirmation of breast cancer lesion ≥ 1.5 cm in size by any clinical (physical examination measurement) or radiographic criteria (mammogram, ultrasound or mri) in the ipsilateral breast. * note: benign breast disease, lcis or dcis in the contralateral breast is allowed. contralateral invasive breast cancer is allowed if disease is of clinically lower stage and the higher stage lesion will be the study lesion for all biopsies and tissue samples. * note: disease in axilla only is not eligible. * note: patients that have a contraindication or inability to have an mri may still be enrolled on study and not participate in the mri at any of the study specific time points. * note: for patients with bilateral disease the higher clinical stage disease will be the study lesion that will undergo study biopsies and tissue samples from surgery and the contralateral lesion will not undergo research biopsies and tissue samples. * men or women who are to begin neoadjuvant chemotherapy for treatment of stage i-iii her 2 negative breast cancer with paclitaxel followed by either the combination of 5-fluorouracil, epirubicin and cyclophosphamide (fec) or the combination of doxorubicin and cyclophosphamide (ac). or men or women who are to begin neoadjuvant chemotherapy for treatment of stage i-iii her 2 positive breast cancer with paclitaxel followed by either the combination of 5-fluorouracil, epirubicin and cyclophosphamide (fec) or the combination of doxorubicin and cyclophosphamide (ac). mc1137 trastuzumab will be given concurrently with the taxane portion and can be given concurrently with fec (but not ac) at the discretion of the medical oncologist. * note: her2 positive disease is defined to be: her2 score of 3+ by ihc or her2 gene amplification by fish. * provide informed written consent. * willing to return to mayo clinic in rochester, mn, mayo clinic in arizona, or mayo clinic in florida for imaging correlative, surgery, and follow-up. * willing to provide blood samples for correlative research purposes. * willing to provide tissue samples for correlative research purposes. * ecog performance status ≤ 2. exclusion criteria: * receiving any investigational agent which would be considered as a treatment for the primary neoplasm. * other active malignancy ≤ 5 years prior to registration. exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix. * note: if there is a history or prior malignancy, they must not be receiving any other treatment for their cancer. * patients who are not planning to receive neoadjuvant chemotherapy. * biopsy proven stage iv disease. * patients who are pregnant or nursing.
examining the relationship between pain, upper extremity functionality and depression in individuals with chronic shoulder pain

Conditions: Shoulder Pain

Summary: the aim of the study is to examine the relationship between pain, upper extremity functionality and depression in individuals with chronic shoulder pain.


Eligibility criteria:
inclusion criteria: * have been suffering from shoulder pain for more than three months exclusion criteria: * people who have had shoulder surgery
bioequivalence study of two finasteride 5 mg tablet formulations under non-fasting conditions

Conditions: Healthy

Summary: the objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (dr. reddy's laboratories limited) with the reference formulation proscar® 5 mg tablet (merck \& co., inc.)under fed conditions in healthy adult male subjects.

this randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 5 mg finasteride tablets under fed conditions. the study was conducted with 26 (24 completed) healthy adults. the subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. there was a 7-day interval between treatments.

Eligibility criteria:
inclusion criteria: 1. males, 18-65 years of age (inclusive). 2. a body mass index (bmi) of 18-30 kg/m2 inclusive as calculated according to novum standard operating procedures. 3. good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. 4. signed and dated informed consent form, which meets all criteria of current fda regulations. exclusion criteria: 1. female. 2. history of allergy or sensitivity to finasteride, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 3. significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 4. presence of gastrointestinal disease or history of malabsorption within the last year. 5. history of psychiatric disorders occurring within the last two years that required hospitalization or medication. 6. presence of a medical condition requiring regular treatment with prescription drugs. 7. use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing. 8. receipt of any drug as part of a research study within 30 days prior to dosing. 9. drug or alcohol addiction requiring treatment in the past 12 months. 10. donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing. 11. positive test results for hiv, hepatitis b surface antigen, or hepatitis c antibody. 12. positive test results for drugs of abuse at screening.

Keywords: bioequivalence finasteride crossover
effect of cumulative chloride dose on development of acute kidney injury in critically ill children

Conditions: Acute Kidney Injury

Summary: the investigators would like to investigate the effect of chloride dosing on the development of acute kidney injury in critically ill patients. the investigators hypothesis is that administering intravenous fluids with higher chloride content are more likely to lead to acute kidney injury.

retrospective chart review from 2008-2012 evaluating chloride dosing and serum chloride levels and their effects on acute kidney injury in the pediatric icu. patients will be included for the first seven days of their picu stay.

Eligibility criteria:
inclusion criteria: * age less than 18 years * picu admitting diagnosis of sepsis, respiratory failure, or hepatic failure. exclusion criteria: * hyponatremia or hypernatremia at picu admission * preexisting diagnosis of end-stage renal disease or renal transplant * presence of neurologic comorbidities.
home based adaptive arm training for children

Conditions: Hemiplegia

Summary: twenty pediatric patients aged 5-17 years with acquired brain injuries (abi) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks. the specific aims of this proposal are to: aim 1: introduce home-based targeted upper limb training in children with hemiplegia from abi (acquired brain injuries) using a bimanual-to-unimanual training approach it is hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater compliance and improved motor outcome on the fugl myer scale compared to a conventional home training program. aim 2: improve the understanding of the pattern of recovery of isolated joint movements in the pediatric population with hemiplegia following abi. it is hypothesized that individuals receiving device-based bimanual-to-unimanual training will show improvement in active range of motion across upper limb joints compared with a conventional home training program.


Eligibility criteria:
inclusion criteria: * acquired brain injury at least 3 months prior to enrollment. * unilateral hemiparesis * history of compliance with home exercise programs in the past. exclusion criteria: * any social or medical problem that precludes compliance with the protocol * comorbid seizure disorder or other neurological disease * treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment * implanted neuromodulatory or electronic device or other complicating illness * lack of capacity to consent

Keywords: children pediatrics arm upper limb bimanual training physical training
study on seroprevalence and risk factors of coxiella burnetii (q fever) in the south of reunion island

Conditions: q Fever

Summary: emergent and infectious diseases are a public health priority on reunion island. amongst public health threats, the infection due to coxiella burnetii (q fever) seems to have appeared on reunion island in 2007 with two hospitalised confirmed cases (one death) and one probable case with a goat farmer. according to the investigator, the diffusion of c. burnetti is more ancient and such diagnosis have been made in the last 30 years with 80 positive serologies identified between 2005 and 2011. considering the high epidemic power of this disease, its often silent clinical expression and its life-threatening condition, the principal investigator wishes to perform a sero-epidemiological study in order to establish or to reject the risk of emergence of q fever in reunion island. the study will be performed on pregnant women because q fever is responsible for particular complications during pregnancy and because the number of pregnancy followed on reunion island is stable from one year to the other. the pregnant women population presenting the same exposure criteria as the general population, this population will be used to extrapolate to the general population of the island.


Eligibility criteria:
inclusion criteria: * all pregnant women coming to the two maternity hospitals located in the south of reunion island during inclusion period who have been informed and gave consent to participate to the study. exclusion criteria: * women aged less than 18 years old. * women who did not give their consent * women for whom it is not possible to perform the blood sample.