Kornimate/medical-research-clean huggingface dataset:
improved training program for fall prevention of war fighters

Conditions: Limb Injury

Summary: this study will train war fighters with lower extremity trauma to decrease fall risk.

eligible active duty service members, retired or veterans who participated in rehabilitation programs at department of defense advanced rehabilitation centers (walter reed national military medical center, center for the intrepid-san antonio military medical center and/or the naval medical center san diego) will be considered for enrollment in this study. this study will look at service members who have undergone transfemoral, transtibial or bilateral lower extremity amputation or limb salvage procedures. participants will receive fall prevention training on an instrumented treadmill (6, training sessions). participants will receive three performance assessments:-immediately following completion of the treadmill training and at three and six months following the completion of the training. post training, twice per month subjects will receive an email containing a follow up fall questionnaire monitoring if they have fallen and the circumstances surrounding their fall. if they do not have access to email, or if a timely response is not received from the email questionnaire which was sent out, subjects will be contacted by phone.

Eligibility criteria:
inclusion criteria: * eligible active duty and retired service members and veterans with lower limb trauma * transfemoral amputation, transtibial amputation, bilateral amputation and or limb salvage * participated in conventional rehab at one of the following rehab centers: walter reed national medical center, center for the intrepid brooke army medical center, naval medical center san diego * community ambulator * prosthesis / orthosis use daily * exclusion criteria: * dysvascular disease * excessive pain * neuromuscular problems preventing the performance of study protocol

Keywords: transfemoral amputation limb salvage bilateral amputation department of defense orthosis prosthesis rehabilitation military treatment facilities military injured lower extremity prevent falls trauma lower extremity service members retired service members active service members unilateral lower extremity trauma limb amputation limb preservation preserved limb trips slips transtibial amputation
rapamycin use in calcineurin inhibitor (cni)-free immunosuppression for stabilization/improvement of renal function after heart transplantation

Conditions: Heart Transplantation; Renal Failure

Summary: clinical problem: renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. current therapeutic approaches include cyclosporine reduction or discontinuation. it is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity? study design: heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression. read-out: renal function after 6 months; tolerability; and safety were assessed.

clinical problem: renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. current therapeutic approaches include cyclosporine reduction or discontinuation. it is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity? study design: heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression. read-out: renal function after 6 months; tolerability; and safety were assessed.

Eligibility criteria:
inclusion criteria: * heart transplantation (\> 6 months post-operation) * renal failure (serum creatinine stably \> 1.7 mg/dl * cyclosporine trough blood level \< 110 ng/ml exclusion criteria: * \< 18 years of age * rapamycin intolerability * active infection * pregnancy, breast feeding * major elective surgery planned in study period * thrombopenia \< 100,000/ml

Keywords: heart transplantation renal failure cyclosporine rapamycin
dose range finding study of bimagrumab in sarcopenia

Conditions: Sarcopenia

Summary: the purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. in addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.


Eligibility criteria:
inclusion criteria: * low muscle mass as confirmed by dxa; * low gait speed \<0.8 m/s * sppb score less than or equal to 9; * weigh at least 35 kg; * adequate dietary intake; exclusion criteria: * a lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management); * requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing, toileting). * intraocular surgery and laser procedures for refractive correction within 6 months prior to screening; * any underlying muscle disease including active myopathy or muscular dytrophy; * confirmed diagnosis of heart failure classified as new york heart association class iii or iv (e.g. dilated cardiomyopathy); * type i diabetes or uncontrolled type 2 diabetes; * chronic kidney disease \[estimated glomerular filtration rate (gfr) \< 30 ml/min\]; * history of confirmed chronic obstructive pulmonary disease with a severity grade \> 2 on the medical research council dyspnea scale; * confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids \>10 mg/d prednisone equivalent; * known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis); * myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening; * active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine cervix); * any chronic active infection (e.g., hiv, hepatitis b or c, tuberculosis, etc).

Keywords: sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed
immunotherapy in peripheral t cell lymphoma - the role of alemtuzumab in addition to dose dense chop

Conditions: Peripheral T Cell Lymphoma, Unspecified; Angioimmunoblastic Lymphadenopathy; Extranodal NK/T-cell Lymphoma

Summary: peripheral t cell lymphomas comprise 10-15% of all malignant lymphomas. the prognosis is significantly worse than that of aggressive b cell lymphomas. the prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. previous phase ii trials have demonstrated a significant activity of the monoclonal anti cd52 antibody alemtuzumab in primary and relapsed t cell lymphoma. the investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense chop-14 in patients with previously untreated peripheral t cell lymphoma.


Eligibility criteria:
inclusion criteria: * all risk groups of peripheral t cell lymphoma * performance status ecog 0-2 * written consent * measurable disease exclusion criteria: * stage i n without bulky disease * already initiated treatment * serious accompanying disorder or impaired organ function * bone marrow involvement \>25% * hiv positivity * leukemic manifestation of lymphoma * simultaneous participation in another trial * platelets \< 100 000/ mm, leukocytes \< 2500 /mm

Keywords: t cell lymphoma
utility of restrata with split thickness skin graft to reconstruct the forearm donor site

Conditions: Wound Heal

Summary: understand association between use of restrata (acera surgical inc., st. louis, mo) in forearm flap reconstruction with donor site healing and function


Eligibility criteria:
inclusion criteria: 1. all patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap. 2. photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient. exclusion criteria: 1. active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications or medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc). 2. diabetes mellitus with most recent hemoglobin a1c ≥10.0 within 30 days prior to surgery. 3. morbid obesity (bmi \>40). 4. inability to maintain wrist immobilization for full planned period. 5. severe malnutrition (prealbumin levels \<10 mg per dl within 30 days prior to surgery or bmi \<15 (very severely underweight). 6. other conditions felt to significantly impair wound healing per surgeon discretion.
become of patients from the permanent access to care (pass) in cayenne, french guyana, suffering from a chronic disease (high blood pressure - diabetes) in the common law schemes

Conditions: Access to Health Services; Health Disparity, Minority and Vulnerable Populations; Chronic Disease; Social Security

Summary: it is an observational research, conducted at the cayenne hospital about the future of hypertensive and/or diabetic patients after their follow-up at the permanent access to care (pass). the pass is a medico-social structure that allows access to medical monitoring and support towards common law. the main objective of the study is to evaluate the use of the common law system by these patients. then the goal is to study the relationship between integration into the system and socio-demographic, medical characteristics, and understanding of health monitoring. data will be collected by guided telephone interviews and the review of medical records.

the problems of social inequalities in access to care are major public health issues as recalled by the regional health agency (ars) of french guiana in the regional health project (prs). french guiana has high precariousness indicators with half of its population living below the poverty line. in addition, health indicators are often more degraded in precarious populations. thus, in french guiana, there is a higher rate of premature mortality, partly attributable to obesity, sedentary lifestyle, diabetes and hypertension than in mainland france. despite an increased need for follow-up of chronic pathologies, the precarious population faces many difficulties in accessing care. the permanent access to health care (pass) in cayenne is a medico-social system, created to respond to these problems. the pass allows access to monitoring of chronic diseases and support towards the common law healthcare system. although the phenomenon of non-use of care studied in the precarious population of western french guiana seems primarily attributable to the absence of social security. the main objective is to evaluate the use of the common law system in hypertensive or diabetic patients treated at the pass in cayenne. in addition, the investigators want to study the relationship between integration into the system and the socio-demographic, medical characteristics, understanding of health monitoring.

Eligibility criteria:
inclusion criteria: * be 18 years or older * past follow-up by the pass of the cayenne hospital for at least one chronic pathology identified as follows: hypertension, diabetes. * the discharge and reorientation to general practitioner have happened between 1 month and 1 year prior to this study. exclusion criteria: * patient with a psychiatric condition * refusing the study

Keywords: health care system vulnerable populations chronic disease social security french guiana
a prospective longitudinal breast cancer study

Conditions: Breast Cancer

Summary: the purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.

the study objectives are described below: 1. obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. specimens will be used to evaluate ca 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease. 2. to store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of ivds, including additional ca 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.

Eligibility criteria:
inclusion criteria: * males and females, age≥ 18 years * histologic/pathologic confirmation of breast cancer * any stage of disease: newly diagnosed, stable, disease progression, surveillance * any treatment time point: treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring. * individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible. * able to understand and willing to provide informed consent exclusion criteria: * males and females, age \<18 years * no histologic/pathologic confirmation of breast cancer * any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer. * treatment plan with fewer than three visits expected in 3 years' time * unable to provide informed consent
pinloc versus hansson pins in the treatment of femoral neck fractures.

Conditions: Femoral Neck Fractures

Summary: a prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (hansson pinloc system, swemac linköping, sweden) versus 2 parallel pins with hooks (hansson pins, swemac linköping, sweden).

patients, who are to be treated with internal fixation due to a femoral neck fracture, will be randomized by the surgeon to pinloc or hansson pins using an on-line randomization system. the patients will be followed up at open visits at 3 months and 1 year. at two years the patients will be contacted by phone and medical records studied in order to detect any fracture complications.

Eligibility criteria:
inclusion criteria: * femoral neck fractures where the preferred treatment is internal fixation. exclusion criteria: * unwilling to participate.
knowledge of cardiovascular risk factors in chronic kidney disease patients

Conditions: Chronic Kidney Disease(CKD); Renal Transplantation

Summary: the aim of this study is to assess knowledge of cardiovascular risk factors, physical activity levels, health literacy and perceptions of benefits and barriers to exercise in patients with chronic kidney disease and compare them with healthy people.


Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease * being aged 18-65 * voluntary participation in the study exclusion criteria: * having cognitive problems * being illiterate
glycemic control of biphasic insulin aspart 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this this trial is conducted in europe. the aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (biasp 30) alone or combined with insulin aspart(iasp) in patients previously treated with conventional biphasic human insulin 30/70.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months * hba1c (glycosylated haemoglobin) equal to or below 12% * willing and able to perform self blood glucose monitoring (smbg) exclusion criteria: * history of drug or alcohol dependence * mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * previous participation in this trial * receipt of any investigational drug within the last month prior to this trial * known or suspected allergy to trial products or related products
validation study in patients of a non-invasive blood pressure monitor for perioperative use

Conditions: Intraoperative Hypotension

Summary: collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring. this to see if the non invasive bloodpressure monitor can be validated for intraoperative use.

although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor. after data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by association for the advancement of medical instrumentation (aami) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use. the study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the flotrac system in the ev1000 monitor. this study is a substudy of a feasability protocol evaluating a new algorithm for the clearsight system.

Eligibility criteria:
inclusion criteria: * patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (flotrac). * patients older than 18, for elective general surgery. exclusion criteria: - patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures
comparison of three different assisting devices to power manual wheelchairs in patients with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to compare three assisting devices to propel personal wheelchairs (servomatic a©, servomatic b© and e.motion©) to the standard personal manual wheelchair in patients with spinal cord injury.

the objective of the study is to compare three assisting devices to propel personal wheelchairs (servomatic a©, servomatic b© and e.motion©) to the standard personal manual wheelchair in patients with spinal cord injury. the study consists of three distinct and independent phases: * phase 1: performance evaluation on wheelchair ergometer in order to compare the energy expenditure and kinetic characteristics in comparable situations with regard to speed and workload imposed to the wheelchair-patient couple. * phase 2: comparison of maneuverability and ease of crossing usual obstacles in outdoor and indoor paths with standardised obstacles. trajectories are to be recorded in order to allow analysis by independent experts. * phase 3: comparison of the autonomy of patients afforded by the devices by comparing the patient's ability to transfer from wheelchair to car seat and from car seat to wheelchair, as well as ease of wheelchair packing in car, in the context of a standard city transport involving a car and the wheelchair. the three phases are to be performed using the standard manual wheelchair and the three assisting devices in a randomized order. three different groups of patients are included in the three phases of the study.

Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 70 years * spinal cord injury c5-c8, paraplegic d1-d11, and d11 paraplegic below only for phases 1 and 2 phase 1 and 2 * spinal cord injury d1 and above only for phase 3 * having given free and informed consent * negative pregnancy test for women of childbearing age exclusion criteria: * no affiliation to a social security scheme * refusal to participate in the clinical trial * patient under guardianship * major cognitive disorders * bedsores * functional abnormality of the shoulder * history of cardiovascular disease * ecg to suspect coronary insufficiency * pregnant patients without effective treatment or contraceptive * acute complication or systemic organ

Keywords: spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device
a phase i study of g3139 subcutaneous in solid tumors

Conditions: Tumors

Summary: genasense® is currently administered to subjects in clinical studies as a multiple-day continuous intravenous infusion. subjects are treated on an outpatient basis and carry a pump that delivers the drug through a peripheral or central intravenous line. the route of administration limits the convenience of treatment, and catheter-related complications have been reported. this study is designed to evaluate the pharmacokinetics and safety of g3139 administered by subcutaneuous injection.


Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available. patients with a history of brain metastasis will be eligible if there is no evidence of cerebral edema or treatment with steroids. * adequate organ function as determined \< 7 days prior to starting study medication * eastern cooperative oncology group (ecog) performance status 0 to 2 * at least 3 weeks and recovery from effects of major prior surgery or other therapy including radiation therapy, immunotherapy, cytokine, biological, vaccine and chemotherapy exclusion criteria: * significant medical diesese * history of leptomeningeal disease * coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function. * use of any investigational drug within 3 weeks prior to starting study medication * known hypersensitivity to phosphorothioate-containing oligonucleotides * pregnancy/lactation

Keywords: ecog mrt nci ctc sae short intravenous infusion to patients with solid tumors