Kornimate/medical-research-clean huggingface dataset:
sealed therapeutic shoe as treatment of diabetic foot ulcers

Conditions: Diabetic Foot

Summary: total contact casts (tccs) are effective treatment of plantar diabetic foot ulcers because they effectively offload the ulcer and are non-removable, resulting in high adherence to using the device. however, tccs are not widely used in clinical practice because they negatively impact gait and daily activities. a new treatment concept was invented, sealed therapeutic shoe, where a shoe with a custom-made insole offloads the ulcer, and the shoe is rendered irremovable to be worn day and night, like a tcc. in this multicenter randomized controlled trial (rct), 150 participants will be recruited and randomized to two treatment arms: tcc or sealed therapeutic shoe. the primary outcome is ulcer healing, secondary outcomes include (but are not limited to) skin complications, glycemic control, body mass index, gait function, balance, quality of life, physical activity, and health economics.

data for the primary outcome of 112 participants are needed but the aim is to recruit 150, if possible within a reasonable time frame, to take drop-out into account. participants are randomized (blocked randomization, stratified for ulcer site and study center) to either treatment with a sealed therapeutic shoe or total contact cast. each participant will be assessed by a cast technician during the treatment period (for ulcer healing and skin complications) and be assessed by a physiotherapist on five occasions: at baseline, approximately 4 weeks into treatment and 1, 6 and 12 months after treatment end. on these occasions the physiotherapist will perform different tests (gait, balance, ankle strength and flexibility, bone mass density in heel bone, etc) and participants will answer questionnaires and have their physical activity measured for 7 days with an activity monitor.

Eligibility criteria:
inclusion criteria: * diagnosed with diabetes mellitus (any kind) * foot ulcer under metatarsal heads exclusion criteria: * large ulcer (3-5 metatarsal heads) * critical ischemia (defined as toe pressure \<30 mmhg or tcpo2 \<30 mmhg) * uncontrolled infection (iwgdf infection grade 4, or grade 3 if not treatment against infection has been administered) * active charcot foot * foot deformities that necessitate custom-made shoes * inability to speak/read swedish. * people with increased risk that side-effects will not be discovered or reported (dementia, abuse of alcohol or drugs, intellectual disability, etc.) if the person do not have appropriate social support, will be excluded.

Keywords: wound healing casts, surgical shoes
best practice using rocuronium and reversal with neostigmine or sugammadex

Conditions: Muscle Weakness

Summary: this is an estimation study, prospectively evaluating the incidence of postoperative residual neuromuscular blockade (prnb) when a best practice protocol is implemented for a cohort of abdominal surgery and orthopedic surgery patients. the protocol is developed within the constraint of subjective monitoring, quantitative monitoring is not used, and use of rocuronium for paralysis and either neostigmine or sugammadex for reversal. the primary outcome is the incidence of prnb on arrival to the post-anesthesia care unit, defined as a train-of-four ration \<0.9.

this study estimates the incidence of postoperative residual neuromuscular block when rocuronium neuromuscular block is managed by protocol for qualitative monitoring and reversal with neostigmine or sugammadex. the study is an extension of the recently published study by thilen and co-workers which evaluated a protocol which used neostigmine as the sole reversal agent (doi: 10.1016/j.bja.2018.03.029). it demonstrated that use of a protocol was associated with a reduced incidence of severe residual paralysis, defined as normalized train-of-four (tof) ratio \<0.7 at time of tracheal extubation. it was also associated with a highly significant reduction in prnb as defined for several secondary outcomes, including non-normalized (i.e. raw) tof-ratio \<0.9 at time of arrival to the post-anesthesia care unit (pacu). the current study does not include a control group, only an intervention group. the investigators hypothesize that prnb can be prevented by adhering to a protocol which incorporates several current recommendations by experts. importantly, the protocol preserves a role for neostigmine when the pre-reversal assessment indicates that spontaneous recovery has progressed to a so-called minimal block which is defined as the subjective absence of fade in the adductor pollicis tof response. the investigators will study only abdominal surgery and orthopedic surgery patients. the primary outcome is incidence of prnb, defined as tof-ratio \<0.9 on arrival to the pacu. the investigators plan to enroll 120 patients, and if no more than one patient has prnb, the upper bound for the 95% confidence interval will be less than 5%.

Eligibility criteria:
inclusion criteria: adult 18 years old or older, will undergo open or laparoscopic abdominal surgery or orthopedic surgery expected to last \<6 hours at harborview or univ of wash med ctr, have american society of anesthesiologists physical status i-iii, scheduled to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking drug for endotracheal intubation or intraoperative neuromuscular blockade. - exclusion criteria: allergy to neuromuscular blocking drugs, patients with neuromuscular disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-english speaking. -

Keywords: neostigmine sugammadex rocuronium neuromuscular blocking agents
enhanced recovery after surgery (eras) in gynecological surgery (erasgs-01)

Conditions: Gynecologic Disease; Gynecologic Cancer

Summary: enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. eras requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.the aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (eras) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

the study design is a two-arm, randomized, controlled trial. the control arm will consist of standard conventional perioperative care. the intervention arm will consist of a protocol-driven eras program. the investigators believe that this information will be very useful because although there is a national interest in creating eras protocols for gynecology, there currently is very little published on the subject. investigators hypothesize that those patients randomized to the eras protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. the investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Eligibility criteria:
inclusion criteria: * age \>18 and \<70 years old * patients candidated for elective gynecological surgery for benign pathology * patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery * signed consent form exclusion criteria: * contraindication to loco-regional anaesthesia * patients with ileus or subocclusive condition prior surgery * coagulation disorders * organ failure or severe disfunction (heart, renal, pulmonary, hepatic) * uncontrolled hypertension (\>180/95) * alcohol or drug abuser (current or previous) * psychiatric condition or language barriers * planned intensive care recovery

Keywords: preoperative / intraoperative/ postoperative management
phase 1/2a study of anpd001 in parkinson disease

Conditions: Parkinson Disease

Summary: this clinical trial is designed to test the safety and tolerability of injecting anpd001 cells that will mature into dopamine-producing cells into the brain of participants with parkinson disease. all participants will have anpd001 cells manufactured from their own previously collected cells.

participants will undergo a surgical implantation of cells that will mature into dopamine-producing neurons under general anesthesia into a part of the brain where dopamine production is decreased in patients with parkinson disease. the effect on parkinson disease symptoms, safety and tolerability, and cell survival are assessed for 5 years post-transplant (with mri and pet imaging scans of the brain). safety and tolerability are assessed annually for an additional 10 years via telephone call (total follow-up of 15 years)

Eligibility criteria:
inclusion criteria: * age 50-70 years of age at time of consent in the trial-ready cohort study anpd001-01 * met all eligibility requirements for inclusion in the trial-ready cohort in clinical study anpd001-01 * diagnosed with parkinson disease at least 4 years ago * unequivocal motor response to levodopa exclusion criteria: * prior brain surgery that, in the opinion of the neurologist or neurosurgeon, contraindicates administration of anpd001 * history of intracranial therapy for pd, including deep brain stimulation (dbs), focused ultrasound (fus), gene therapy or other biological therapy * history of cognitive impairment or dementia * history of clinically significant dopa dysregulation syndrome * history of epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological disease (other than pd), or poorly controlled cardiovascular disease * inability to temporarily stop anticoagulation or antiplatelet therapy for at least 2 weeks * history of malignancy (cerebral or systemic) within the prior 5 years, except treated cutaneous squamous or basal cell carcinomas * contraindication to mri and/or use of gadolinium * weight \> 300 lbs or body mass index (bmi) \> 35 * uncontrolled diabetes (hba1c \> 7.0%) or any other acute or chronic medical condition that would significantly increase the risks of a neurosurgical procedure * pregnancy or lactation * significant drug-induced dyskinesia (\>2 for any body part on the abnormal involuntary movement scale \[aims\]) * male or female with reproductive capacity who is unwilling to use barrier contraception for 3 months post-administration of the investigational product * unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments * any significant issue raised by the neurologist or neurosurgeon

Keywords: autologous induced pluripotent stem cells cell therapy dopamine regenerative medicine
stroke observatory of caen-normandie metropole

Conditions: Stroke

Summary: stroke observatory of caen-normandy metropole provides epidemiological data in prospective collection. the primary objective is to determinate incidence of stroke in this area. several data sources will be crossed to allow an exhaustive identification of the cases. no intervention will be carried. the data collected will correspond to those obtained in current practice. the number of participants is estimated at 800 per year. this observatory aims to become a qualified population register after three years, according to requirement of the french registry evaluation committee.

stroke is the second leading cause of death (the first in women in industrialized countries), the second cause of dementia and the third leading cause of disability. for a middle-aged person, the risk of developing a stroke is 1/5 in women and 1/6 in men over a lifetime. moreover, stroke is a disease that can be considered chronic. indeed, in france, the survival rate one month after a stroke is 80-90%. however, at least 50% of survivors retain a severe disability and almost all require long-term care. the medico-economic impact of stroke is therefore important in both the initial and chronic phases. nevertheless, none of the french stroke registries consider the burden of post-stroke disability. in addition, there is limited data available on the impact of geographic disparities on the prognosis of stroke. population studies are essential to accurately identify the incidence and burden of stroke, thereby supporting public health policy, guiding the allocation of resources, and evaluating the effectiveness of preventive strategies for a population. this is why we propose to create a norman observatory of stroke. it will include an urban and rural population and will aim to become a population register.

Eligibility criteria:
inclusion criteria: * any types of strokes (initial, recidivism) * place of residence in caen-normandie metropole * age higher than 30 days (exclusion of perinatal stroke) exclusion criteria: * none, unless patient opposition
developing and testing a spanish-language intervention to reduce cancer-related sleep disturbance

Conditions: Sleep Disturbance

Summary: the purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.


Eligibility criteria:
inclusion criteria: * located in the southern puerto rico area * able to speak and read spanish * have no documented or observable disabilities that would interfere with study participation * has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation) * has clinically significant sleep disturbance (i.e., \>/= 8 on the insomnia severity index) * is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy * has access to the internet and a digital device (e.g., smartphone) capable of using videoconference software exclusion criteria: * not able to read and speak spanish
application of the propofol precise infusion model

Conditions: Propofol Overdose of Undetermined Intent

Summary: propofol is one of the most commonly used anesthetics in the world. however, the dose-response of propofol was remarkable variety. herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug.

patients undergoing gastrointestinal endoscopy will be recruited. anesthesia is induced with propofol via tci at 1.5µg/ml, and increases 0.5µg/ml for every 3min until oaa/s score 0. during this period, oaa/s score will be evaluated every 1min until oaa/s score 0. at this moment, the blood concentration of propofol, the doses of propofol, the onset time and bis are recorded, and blood sample for gene polymorphism detection were required.

Eligibility criteria:
inclusion criteria: 1. patients who undergoing gastrointestinal endoscopy with anesthesia 2. age ≥18 years exclusion criteria: 1. hepatic or kidney function injured; 2. received hypnotic sedative drug regularly; 3. pregnancy, excessive drinking, or current smoker; 4. be allergic to propofol 5. patients who with difficulty communication
efficacy and safety of high absorption pad in split-thickness skin graft donor site wound

Conditions: Disorder of Skin Donor Site

Summary: high absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. the another will be cover on another half of split-thickness skin graft donor site wound. then, they will be covered with gauzes and bandage. time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.


Eligibility criteria:
inclusion criteria: * have split-thickness skin graft donor site wound on thigh * age 18-60 years * can read and write * can follow the study protocol * available on appointment date exclusion criteria: * systemic infection * chronic skin diseases * immune deficiency * allergic to cellulose, chitosan, sericin, and chlorhexidine * psychotic disorders * pregnancy or breast feeding
predictive markers in growth hormone deficiency (ghd) and turner syndrome (ts) children treated with saizen®

Conditions: Growth Hormone Deficiency; Turner Syndrome

Summary: the study aims at identifying the predictive markers after one month of saizen therapy in growth hormone deficiency (ghd) and turner syndrome children.


Eligibility criteria:
inclusion criteria: * one of the following diagnoses and candidacy for saizen® therapy: a) ghd: documented pre-established diagnosis of ghd with a growth hormone (gh) peak response of \<10 microgram per liter (mcg/l) with 2 gh stimulation tests, without priming with oestradiol. b) turner syndrome: documented pre-established diagnosis by karyotype. * prepubertal status according to tanner pre-established history of normal thyroid function or adequate substitution for at least 3 months. * weight for stature within the population specific normal range (\>5th and \<95th percentiles) for gender willingness and ability to comply with the protocol for the duration of the study. * parent's or guardian's written informed consent, given before any study related procedure that is not part of the subject's normal medical care, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given. exclusion criteria: * acquired ghd due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and history of irradiation or cranial surgery * previous treatment with gh, growth hormone-releasing hormone (ghrh), anabolic steroids or any treatment affecting growth. * previous treatment with corticosteroids, except in case of topical or inhaled corticosteroid administration for atopic disease. corticosteroids for hormonal substitution are also allowed if the condition and the treatment regimen have been stable for at least 3 months. * severe associated pathology affecting growth such as malnutrition, malabsorption, or bone dysplasia. * chronic severe kidney disease. * chronic severe liver disease. * chronic infectious disease. * acute or severe illness during the previous 6 months. * significant concomitant illness that would interfere with participation or assessment in this study. * active malignancy (except non-melanomatous skin malignancies that have undergone surgical excision and/or biopsy, diagnosis and treatment to resolution) * history or active idiopathic intra-cranial hypertension (benign intracranial hypertension or pseudo-tumor cerebri). * diabetes mellitus type i \& ii. * any autoimmune disease. * previous screening failure in this study. * use of an investigational drug or participation in another clinical study within the last three months.
satisfaction with an in-house developed nasal foreign body removal manikin

Conditions: Satisfaction; Consumer Satisfaction

Summary: to overcome the issues regarding training in real persons, using a simulated manikin instead of an actual patient or simulated patient is another option with consideration to the training able to be held at any time periods and no issues about minor or serious complications needed to be concerned with. the aim of this study is to devise a low-cost manikin with a specific design to serve all possible needs of end users but still keep its function as necessary for training.


Eligibility criteria:
inclusion criteria: * physicians who hold a md degree exclusion criteria: * not want to complete questionnaires * no experience in a nasal foreign body removal

Keywords: manikin nasal foreign body
tolerability and safety study of recombinant human acid sphingomyelinase in acid sphingomyelinase deficiency patients

Conditions: Human Acid Sphingomyelinase Deficiency

Summary: to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of rhasm in adult patients with acid sphingomyelinase deficiency (asmd) following repeated-dose administration.


Eligibility criteria:
inclusion criteria: * patients with documented non-neuronopathic acid sphingomyelinase deficiency * the patient has a diffusing capacity of carbon monoxide (dlco) \>20% and ≤80% of the predicted normal value. * the patient has a spleen volume ≥6 multiples of normal(mn). a partial splenectomy will be permitted if performed ≥1 year prior to screening/baseline and residual spleen volume is ≥6 mn. * the patient who is receiving lipid lowering therapy should be on a stable dose and regimen of lipid-lowering therapy(ies) for at least 12 weeks prior to screening/baseline, with the patient expected to remain on the same dose and regimen throughout the 26-week treatment period. * the patient who is female and of childbearing potential must have a negative serum pregnancy test for β-hcg. exclusion criteria: * the patient is female and pregnant or lactating. * the patient has a body mass index(bmi)\>30. * the patient has received an investigational drug within 30 days prior to study enrollment * the patient has a medical condition or any extenuating circumstance that may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities. * the patient has had a major organ transplant * alt or ast \>250 iu/l or total bilirubin \>1.5 mg/dl. * the patient is unwilling or unable to abstain from the use of alcohol for 1 day prior to and 3 days after each rhasm infusion for the duration of the study. * the patient requires medications that may decrease rhasm * the patient is unwilling or unable to avoid the use of medications or herbal supplements that may cause or prolong bleeding, or have potential hepatotoxicity within 10 days prior to and 3 days after liver biopsy

Keywords: human acid sphingomyelinase deficiency
multi-center study to transplant hepatitis-c infected kidneys

Conditions: Renal Failure Chronic; Hepatitis C

Summary: open label multi center study for the donation of hcv positive kidneys to hcv negative recipients with interventional treatment to prevent hcv transmission upon transplantation.

the study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of hcv infection from donor kidney with known hcv infection (all genotypes) to an hcv negative recipient as evidenced by a negative hcv viral rna at 12 weeks post treatment.

Eligibility criteria:
recipient inclusion criteria: * estimated glomerular filtration rate(egfr) \< 15 ml/min/1.73 m2 * listed for an isolated kidney transplantation * able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent * no available medically acceptable, compatible living kidney donor * subject must agree to use an effective method of birth control per protocol specifications recipient exclusion criteria: * history of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant * female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study * history of hiv * hcv rna positive * hbv surface ag-positive or detectable hbv dna * primary focal segmental glomerulosclerosis (fsgs) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team * presence of clinically significant liver disease * transplant candidate requiring antibody desensitization protocol for transplantation * most recent calculated panel reactive antibody (cpra) \>80%. * prior recipient of a non-renal solid organ transplant donor organ inclusion criteria * deceased donor organ with kidney donor profile index (kdpi) ≤0.85 * hcv rna-positive donor organ exclusion criteria * known prior hcv treatment with direct acting antiviral medication * hiv rna-positive * hbv surface antigen-positive or hbv dna-positive

Keywords: hemodialysis renal failure kidney transplant