Kornimate/medical-research-clean huggingface dataset:
targeted muscle reinnervation in the hand for the managment of symptomatic neuroma following digit and hand amputations

Conditions: Targeted Muscle Reinervation; Digital Amputation; Neuroma

Summary: neuromas are a common complication after digital and hand amputations, resulting in significant pain, discomfort, and functional impairment. various management methods are available, including surgical excision, nerve blocks, and nerve stump protectors, but these treatments may have limited success rates and potential complications. targeted muscle reinnervation (tmr) is a promising technique that involves surgically rerouting a severed nerve into a nearby muscle, which can prevent the formation of neuromas and provide improved muscle function


Eligibility criteria:
inclusion criteria: * arabic or english speaking individuals * an upper limb amputation distal to the wrist crease * a symptomatic neuroma within the hand or digits: defined as patient-reported localized pain consistent with a clinical exam of a neuroma pain.there must be a supporting tinel's sign on physical exam. exclusion criteria: * cognitive impairment for better assessment of patient reported outcomes and filling questionnaires and signing consents

Keywords: targeted muscle reinnervation neuroma amputation
posterior column fractures of tibial plateau

Conditions: Tibial Plateau Fractures

Summary: the goal of this observational study is to learn about the long-term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept. the main question it aims to answer is: does the internal fixation of posterior column fractures of tibial plateau according to three column concept has a good radiological and clinical outcomes in follow up for 1 year? participants already having internal fixation for their posterior column fractures will do x ray in their follow up visit and answer survey questions about their joint pain, rom for 1 year.

the goal of this observational study is to measure the radiological and clinical long term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept by using rasmussen score

Eligibility criteria:
inclusion criteria: * skeletally mature patients (18 - 60 years old). * tibial plateau fracture with posterior column involvement classified by x-ray and ct scan * fractures within 3 weeks of trauma exclusion criteria: * open fracture grade 3 gustilo anderson classification but not managed by internal fixation within 3 weeks of trauma * paediatric fractures. * pathological fractures
efficacy and safety of tv-1380 as treatment for facilitation of abstinence in cocaine-dependent subjects

Conditions: Cocaine Addiction

Summary: the primary objective of this study is to assess the efficacy and safety of tv-1380 \[recombinant human serum albumin (hsa) mutated butyrylcholinesterase (albubche)\] in facilitating abstinence in cocaine-dependent subjects.


Eligibility criteria:
inclusion criteria: * have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol. * male or female aged 18-60 years (inclusive). * meet diagnostic and statistical manual of mental disorders, fourth edition. * other criteria apply; please contact the site for more information. exclusion criteria: * meet criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, benzodiazepines, or marijuana or have physiological dependence on alcohol requiring detoxification. * are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 90 days preceding screening. * have one or more severe psychiatric disorders as determined by the mini international neuropsychiatric interview (mini) such as psychosis, schizophrenia, bipolar disease, major depression, or eating disorders in screening. * have one or more major neurologic disorders such as dementia or organic brain disease. * have other serious medical illnesses (including but not limited to uncontrolled hypertension, significant heart disease, respiratory disease including asthma, hepatic disease, renal disease, aids) or other potentially life threatening or progressive medical illness that may compromise subject safety or study conduct as determined by the site md. * other criteria apply; please contact the site for more information.

Keywords: cocaine addiction tv-1380 recombinant human serum albumin (hsa) mutated butyrylcholinesterase (albubche)
iodine-125 seed implantation therapy for locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study evaluates the application of 3d-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. half of participants will receive 3d-printed coplanar template, while the other half will receive 3d-printed non-coplanar template.

dosimetric verification was performed after implantation. pre- and postoperative d90, v100, and v150 were calculated. the success rate of iodine-125 seed implantation, dosimetric parameters, objective response rate (orr)，overall survival (os)，toxicities and quality of life of two treatment regimens and complications were analyzed and compared between the two groups.

Eligibility criteria:
inclusion criteria: * age: 18-80 years * cytologically or histologically confirmed pancreatic adenocarcinoma * inoperable locally advanced pancreatic cancer based on american joint committee on cancer (ajcc) staging system (8th ed) (without distant metastasis) * single tumor size≤ 6 cm * karnofsky performance score （kps）≥60 * estimated survival ≥3 months * without other several comorbidity * participants must have adequate organ function: * wbc≥3×109/l; hgb≥90g/dl; plt≥50×109/l * aspartate transaminase (ast)/alanine aminotransferase ( alt) ≤3 × institutional upper limit of normal * albumin≥3g/dl * total bilirubin ≤3mg/dl * pt≤3 × institutional upper limit of normal or inr≤2.3 * creatinine ≤1.5 × institutional upper limit of normal * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients with other malignant tumors * history of other anti-cancer therapy, including surgery,radiation, ablation and so on * pregnant or lactating women * patients with immunodeficiency disease * several heart disease, for example: new york heart association (nyha) class iii/iv congestive heart failure，active coronary heart disease and severe arrhythmia * uncontrolled hypertension * ongoing or active infection (\>grade 2 based on national cancer institute-common terminology criteria for adverse events (nci-ctcae) 4.0 edition) * active tuberculosis * chronic renal insufficiency * other organ failure * history of organ transplantation * history of severe mental illness

Keywords: iodine-125 three-dimensional printing brachytherapy template
optilume bph catheter system in benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hyperplasia

Summary: a post-marketing study using optilume catheter system for benign prostatic hyperplasia.

this is a post-marketing study for using optilume catheter system, which is a dilation drug coated balloon (dcb) catheter, to treat benign prostatic hyperplasia. participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (trus) to determine the eligibility to the study. participants will be followed up for 1 year after optilume treatment procedure.

Eligibility criteria:
inclusion criteria: 1. male subject with symptomatic bph note: symptomatic bph is defined as an international prostate symptom score (ipss) ≥ 13 and peak urinary flow rate (qmax) of ≤15 ml/sec 2. prostate dimensions suitable for treatment with the optilume bph catheter system in accordance with the approved instructions for use note: prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by trus 3. able to complete the study protocol in the opinion of the investigator exclusion criteria: 1. unable or unwilling to sign the informed consent form (icf) and/or comply with follow-up requirements 2. unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure 3. presence of an artificial urinary sphincter or stent(s) in the urethra or prostate 4. any prior minimally invasive intervention (e.g. tuna, balloon, microwave, rezūm, urolift) or surgical intervention of the prostate 5. confirmed or suspected malignancy of prostate or bladder 6. active urinary tract infection (uti) confirmed by culture 7. history of overt urinary incontinence requiring use of pads note: pad usage for post-micturition dribble is acceptable 8. presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.) 9. history of chronic urinary retention (e.g. pvr ≥300ml on two separate occasions, or catheter dependent drainage) 10. anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the optilume bph catheter system 11. significant obstruction from median lobe in the opinion of the investigator 12. disease or other health condition that is not suitable for this study

Keywords: optilume mist
study of ly573636-sodium in patients with metastatic non-small cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: the primary objective is to estimate the time to progressive disease for patients who receive ly573636-sodium (hereafter referred to as ly573636) after two previous treatments for metastatic non-small cell lung cancer. patients will receive an intravenous infusion of study drug once every 21 days. computed tomography (ct)-scans will be done before the first dose and then after every other treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic non-small-cell lung cancer * at least 18 years of age * have received 2 previous treatment regimens for metastatic non-small-cell lung cancer exclusion criteria: * serious pre-existing medical conditions * previous cancer (except skin cancer, excluding melanoma) * have received 3 or more previous treatment regimens for metastatic non- small-cell lung cancer * active treatment with coumadin
flotetuzumab expanded access program

Conditions: Acute Myeloid Leukemia; AML; AML, Adult Recurrent

Summary: the purpose of the expanded access program is to provide flotetuzumab to patients with acute myeloid leukemia (aml) for whom potential benefit justifies potential treatment risks.

macrogenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for macrogenics to supply flotetuzumab for single patient use.

Eligibility criteria:
inclusion criteria: * weight of at least 17 kilograms * cd123-positive hematologic malignancy * adequate organ reserve * provider and site are trained on study protocol using flotetuzumab exclusion criteria: * aml that meets inclusion criteria for study cp-mgd006-01 (nct02152956) * primary induction failure * early relapse (less than 6 months after first complete remission ) * three prior lines of therapy, including maximum of 1 prior salvage attempts
efficacy and safety of finerenone in heart failure with reduced ejection fraction

Conditions: Heart Failure With Reduced Ejection Fraction; Diabetes Mellitus; Diabetic Nephropathies

Summary: finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (mra), nowadays it's widely used in type 2 diabetes (t2dm) patients with chronic kidney disease (ckd), the newest trial shows finerenone improve the cardiovascular outcomes among patients with t2dm and ckd especially reduce the risk of hospitalization for heart failure. in patients with diabetic nephropathy, finerenone resulted in lower risks of ckd progression and cardiovascular events. finerenone shows great potential therapeutic effect in chronic heart failure (chf) patients with or without t2dm and ckd compared to eplerenone, but there is still no real world study on finerenone in patients with heart failure with reduced ejection fraction (hfref) and it's unclear about the effect of finerenone in chf patients without t2dm and ckd. the investigators will conduct a study to demonstrate the efficacy and safety of finerenone in hfref patients compared to other mras.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * new york heart association(nyha) functional classification ii - iv * lvef measured by the echocardiogram ≤ 45% * egfr\>25ml/min/1.73m² exclusion criteria: * lvef measured by the echocardiogram \> 45% * history of allergic or hypersensitivity to drugs involved in the trial. * patients with a known history of cancer, angioedema, significant congenital heart disease or rheumatic heart disease. * patients diagnosed with myocarditis. * probable alternative diagnoses could account for the patient's hf symptoms e.g., copd, bronchial asthma, primary pulmonary hypertension. * systolic blood pressure (sbp) ≥180mmhg or diastolic blood pressure (dbp) * 120mmhg at visit, dbp≤90mmhg or symptomatic hypotension. * patients with cardiac pacemaker * pregnant woman * egfr≤25ml/min/1.73m² and not accept long-term hemodialysis therapy. * serum potassium \>5.2 mmol/l at visit * fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate\>150 bpm in af patients. * obvious stenosis (≥50%) of bilateral renal arteries.
effects of mirror therapy and cognitive therapeutic exercise in stroke patients

Conditions: Stroke; Hemiparesis

Summary: this is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum functionality of the affected upper member,

objective: to assess the effect at 3 months of the of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, applied for 30 days in the functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and quality of life in stroke patients. design and setting: a randomized clinical trial of three parallel groups. population: 152 patients with residual hemiparesis due to ischemic or hemorrhagic stroke will be included, selected by consecutive sampling at the neurological service and stroke unit of the university hospital of burgos (hubu). measurements and intervention: functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and health-related quality of life will be evaluated. the intervention groups will receive a treatment based either on mirror therapy or on congnitive therapeutic exercise, both combined with task-oriented motor learning for 30 days. no additional intervention with the participants of the control group will be completed.

Eligibility criteria:
inclusion criteria: * diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke, * movements of the affected upper members classified between stages ii and iv on the brunnstrom scale * score on the montreal cognitive assessment (moca) scale equal to or over 26 exclusion criteria: * heminegligence * wernicke's aphasia * visual deficits (homonymous hemianopsia)

Keywords: stroke upper member neurorehabilitation mirror therapy therapeutic cognitive exercise perfetti
response and clearance of viral dna following administration of live attenuated varicella vaccine.

Conditions: Varicella; Transplants

Summary: varicella zoster virus (vzv) can lead to significant morbidity and mortality in transplant recipients. current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. this four week waiting period can result in delayed transplant, rejection of an optimal organ, or missed opportunity to vaccinate. however, these recommendations are not evidence based. this is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease. investigators will evaluate: 1. the time at which vzv dna becomes undetectable in blood and saliva by pcr after vaccination in children with chronic liver disease and 2. the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.


Eligibility criteria:
inclusion criteria: * 6 months to 21 years * no history of varicella, zoster or prior varicella vaccination exclusion criteria: * acute liver failure * liver transplant anticipated within 28 days * prior history of receiving blood products or immunoglobulin within 5 months prior to vaccination * fever * pregnancy * immunocompromised status * receiving immunosuppressive meds
safety and efficacy of simtuzumab (sim, gs-6624) in adults with advanced liver fibrosis but not cirrhosis secondary to non-alcoholic steatohepatitis (nash)

Conditions: Liver Fibrosis Due to NASH

Summary: the primary objective of this study is to evaluate whether sim (formerly referred to as gs-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with nash. it will consist of 2 phases: * randomized double-blind phase * open-label phase (optional)


Eligibility criteria:
key inclusion criteria: * adults with chronic liver disease due to nash defined as macrovesicular steatosis involving \> 5% of hepatocytes on a liver biopsy with associated lobular inflammation * stage 3-4 fibrosis by ishak score on a liver biopsy * exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease * must have aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 10 x central laboratory upper limit of normal (cluln) * must have serum creatinine \< 2.0 mg/dl * a negative serum pregnancy test is required for females of childbearing potential * all sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during intercourse throughout the study and for 90 days following the last dose of study medication * lactating females must agree to discontinue nursing before starting study treatment * males, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion and for 90 days following the last dose of study drug. key exclusion criteria: * pregnant or breast feeding * cirrhosis of the liver * any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding * weight reduction surgery in the past 5 years * positive for hepatitis c virus (hcv) rna * positive for hbsag * alcohol consumption greater than 21oz/week for males or 14oz/week for females * positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening. * clinically significant cardiac disease * history of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening * major surgical procedure within 30 days prior to screening or the presence of an open wound * known hypersensitivity to the investigation product or any of its formulation excipients * history of bleeding diathesis within 6 months of screening * unavailable for follow-up assessment or concern for individual's compliance with the protocol procedures; * participation in an investigational trial of a drug or device within 30 days prior to screening * bmi \< 18 kg/m\^2 note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: nash noncirrhotic monoclonal antibody loxl2 simtuzumab nonalcoholic steatohepatitis nafld liver biopsy mre liver fibrosis ishak
auricular acupressure for hemodialysis patients with insomnia

Conditions: Insomnia Chronic

Summary: auricular acupressure therapy (aat) has been applied in mhd patients with insomnia in recent years and yielded favorable results. however, the effect and safety of aat for insomnia in mhd population still lacks high quality evidence. a randomized controlled clinical trial is planned to evaluate the effect and safety of aat in mhd patients with insomnia.

insomnia, a worldwide health problem, is much more frequently complained in maintenance hemodialysis (mhd) patients and impairs their quality of life and long term outcome. hypnotic sedative agents are often reluctantly prescribed with doses mounting up. patients are concerned about drug dependence and drug-related adverse effects. as a non-drug therapy, auricular acupressure therapy (aat) is attractive to both patients and practitioners and is widely used to treat many conditions in china. the investigators had been applying aat for mhd patients with insomnia in recent years and yielded favorable results. however, the effect and safety of aat for insomnia in mhd population still lacks high quality evidence. therefore, the investigators aimed to perform a randomized controlled clinical trial in mhd patients with insomnia to evaluate the effect and safety of aat.

Eligibility criteria:
inclusion criteria: * aged 18\~75 years * on regular dialysis ( 2 - 3 sessions weekly, 4 hours each session, total weekly dialysis hours ≥ 10 hours) for more than 3 months (but less than 10 years) * insomnia according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * global score of psqi \> 7 * informed consent. exclusion criteria: * presence of co-morbidities including cancer, congestive heart failure, connective tissue disease and hematologic diseases; * inadequately dialyzed, indicating by urea clearance index (kt/v) \< 1.20; * presence of severe physical symptoms such as bone pain, itchy skin, sleep apnea and restless legs which are obviously causative for insomnia; and weary condition caused by severe anemia (hemoglobin\<60g/l) or malnutrition (serum albumin\<30g/l). * infections of external ears or malformed ears.

Keywords: insomnia hemodialysis auricular acupressure randomized controlled trial
epidemiology of hepatitis b, c and delta in reunion island

Conditions: Hepatitis B; Hepatitis C; Hepatitis D

Summary: viral hepatitis b, c and δ represent a global public health problem for which france was very early mobilized. despite this, in its foreword, the dhumeaux report on "management of people infected with hepatitis b or hepatitis c viruses" identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the overseas territories. the specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland france. this study aims at improving our knowledge on the characteristics of patients with hepatitis b, c and δ in reunion island, their follow-up, their evolution and complications.


Eligibility criteria:
inclusion criteria: major patient * with confirmed hbsag and / or anti hcv positive ab * residing in reunion island * followed in one of the participating centers exclusion criteria: • patient carrying isolated anti hbc antibodies