Kornimate/medical-research-clean huggingface dataset:
targeted sensory reinnervation (tsr) in hand amputation

Conditions: Targeted Sensory Reinervation; Amputation; Phantom Pain

Summary: if a person has to have a part of their body amputated, in this case their hand, the patient then lacks information about the missing limb, which in many cases leads to pain that severely restricts their quality of life and participation in everyday life. this is usually phantom and/or neuroma pain. phantom pain is usually caused by many different mechanisms and occurs in 80-90% of patients. pain caused by terminal neuromas affects 13-32% of amputees and manifests itself as residual limb pain. a neuroma itself is a benign lump that can develop at the site of the defect after a nerve has been severed (neurectomy). in some cases the impairment is so severe that prosthetic tolerance, functional independence and quality of life can be severely affected. numerous treatment options for these types of pain are far from satisfactory for many patients and remain a major challenge for both the clinician and the person affected. it is often no longer possible for the patients to pursue a profession or hobby due to the pain as well as due to the pain medication required and its possible side effects. surgical intervention can therefore be considered for patients who do not (or no longer) respond to conservative pain treatment. in recent years, many surgical approaches have been introduced to treat or prevent post-amputee pain. one of these methods can make it possible to create an authentic feeling of the missing limb and thus reduce or eliminate phantom pain by means of targeted sensory reinnervation (tsr) of the lost body part. sensory reinnervation means that a nerve which enables a (sensory) perception associated with a sense is "redirected" to a new area of the body and can therefore fulfil at least part of its task again. in this case, an authentic feeling of the lost body part. the aim of this retrospective data-analysis is to evaluate data from patients with hand amputation (planned surgery or caused by accident/infection..) who have undergone tsr surgery to treat or prevent phantom and neuro-pain with regard to different parameters.


Eligibility criteria:
inclusion criteria: * patients with amputations of the hand * patient with programmed hand amputation * patients with treatment-resistant pain * patients with treatment-resistant phantom- and neuroma pain * patients with performed tsr surgery * aged at least 18 years * patient must be alive at the time of medical record review exclusion criteria: * patients enrolled in another interventional clinical trial * an injured skin area for reinnervation at the volar side of the forearm, as well as an injured median or ulnar nerve.

Keywords: nerves reinervation amputation hand phantom pain prevention novel methode
exploratory study of volatile organic compounds in alveolar breath

Conditions: Nutritional and Metabolic Diseases

Summary: the purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions.

individuals with metabolic disorders may sporadically produce malodors despite good hygiene. analysis of volatile organic compounds (vocs) helps to gain insights into medical conditions arising due to metabolic dysfunction as different metabolic pathways emit and or consume various vocs. these vocs can be detected via the exhaled breath collected and analyzed with a portable breath collection apparatus. voc profiles will be compared with self-reported symptoms and other observations of participating subjects.

Eligibility criteria:
inclusion criteria: * good general health * willing and able to travel to one of the participating sites exclusion criteria: * medical conditions that, in the opinion of the investigator, would prevent participation * elect not to participate in the study
study of efficacy, safety and tolerability of levodopa-carbidopa intestinal gel in levodopa-responsive parkinson's subjects

Conditions: Advanced Parkinson's Disease

Summary: the primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.

study s187.3.001 (nct00357994) and study s187.3.002 (nct00660387) were 2 identically designed, phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. these studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intestinal gel (lcig) in the treatment of levodopa-responsive subjects with advanced pd who had persistent severe motor fluctuations, despite optimized treatment with oral levodopa-carbidopa, concomitant with other available antiparkinsonian medications. participants were randomized to either lcig active gel + placebo capsules or levodopa-carbidopa immediate release (ir) active capsules + placebo gel. both treatment arms received the percutaneous endoscopic gastrostomy with jejunal extension (peg-j) procedure for gel administration, active lcig or placebo gel. data from these 2 studies were combined for analysis. the decision to combine the study data for analysis was made before enrollment was completed for both studies.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (pd) according to united kingdom parkinson's disease society (ukpds) brain bank criteria * levodopa-responsive participants who demonstrate some identifiable 'on response,' established by investigator observation * demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated exclusion criteria: * diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism * undergone surgery for the treatment of pd * contraindications to levodopa * subjects with any neurological deficit that may interfere with the study assessments

Keywords: carbidopa levodopa-carbidopa levodopa levodopa/carbidopa suspension dyskinesia duodopa levodopa-carbidopa intestinal gel severe motor fluctuations duopa
mckenzie exercises for chronic neck pain: stabilization vs. non-stabilization

Conditions: Neck Pain; Cervical Pain

Summary: purpose: to compare the effects of mckenzie exercises plus stabilization exercise to those of mckenzie exercises alone on disability, pain, range of motion (rom) in patients with nonspecific chronic neck pain (nscnp). background: little is known about the efficacy of providing mckenzie exercises in addition to cervical and scapulothoracic stabilization exercises in people with nscnp. hypotheses we hypothesize that there will be no significant effect of adding stabilization exercises to mckenzie exercises than mckenzie exercises alone in patients with nscnp. research question: is there a statistically significant effect of adding stabilization exercises to mckenzie exercises on outcomes of patients with nscnp?


Eligibility criteria:
inclusion criteria: 1. ages between 30 and 50 years 2. localized chronic neck pain without an exact etiology 3. absence of any arm pain or discomfort that could be replicated by neck mobility or irritant assessment 4. pain exists in the dorsal area, between two horizontal lines: the first line passes through 5) the lower half of the occipital area, and the second line runs through the spinous process of the first dorsal vertebra exclusion criteria: 1. neck pain caused by any other complications, such as a neoplasm, neurological diseases, or vascular diseases 2. history of neck surgery or fracture 3. serious medical conditions that could affect participation in the study, such as cardiovascular disease, cancer, or autoimmune disorders 4. use of medication that could affect neck pain or exercise tolerance, such as opioids, muscle relaxants, or corticosteroids 5. participation in other treatments or interventions for neck pain during the study period 6. inability to understand or comply with study procedures or interventions, such as language barriers or cognitive impairment
once weekly infant corticosteroid trial for dmd

Conditions: Duchenne Muscular Dystrophy

Summary: the hypothesis tested here is that a lower dose of intermittent oral corticosteroids (5mg/kg/week) will be equally effective to the 10mg/kg/week dose.

the investigators know that the muscle destruction from duchenne muscular dystrophy (dmd) begins in infancy and we previously demonstrated that motor decline in infancy compared to typically developing infants reflects that destruction. because of the known side effects of daily corticosteroids, most physicians do not begin treatment until age 3-5 years. most side effects (cushingoid faces, linear growth arrest, and bone density loss) did not happen in infants and in ambulatory boys in two separate studies. however, in infants and young boys taking (10mg/kg/week), 56% of infants and young boys did have an increase in weight percentile compared to baseline. this study will test this lower dose of prednisolone (5mg/kg/week) in an unblinded study in infants and young dmd boys (ages 1 through 30 months) to determine if equal efficacy can be achieved with fewer side effects. the primary outcome for this study will be gross motor function. the study team will enroll boys from age 1 month through 30 months and follow each for two years. we will assess gross motor function using three outcome measures: the bayley-4 scales of infant and toddler development (bayley-4) and the newly developed neuromuscular gross motor outcomes (gro) and the northstar ambulatory assessment (nsaa). the one-year outcome will be the change in the bayley-4 scaled score and the two-year outcome will be the change in the gro score. this study will determine if a lower dose is equally effective and if that dose may lessen the weight gain seen in about half of the infants in the first study. both the bayley-4 and the gro allow assessment of gross motor function and are feasible in all boys with dmd under the age of 42 months. in addition, the gro allows continued assessment of motor function across a wide age span which will allow this cohort to be followed for two full years.

Eligibility criteria:
inclusion criteria: * subjects ages 1 month through 30 months * weakness consistent with duchenne on exam, creatine kinase ≥ 20 times the upper limit of normal, and genetic mutation known to be causative for dmd. exclusion criteria: * prior treatment with glucocorticosteroids

Keywords: duchenne muscular dystrophy dmd steroid muscular dystrophy
evaluation of swallowing in patients with obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.


Eligibility criteria:
inclusion criteria: * diagnosis of obstructive sleep apnea syndrome exclusion criteria: * other causes of dysphagia * pharyngeal surgery * prior treatment for obstructive sleep apnea

Keywords: sleep apnea, obstructive deglutition disorders manometry endoscopy
an open label, prospective, one arm, feasibility, study for the use of halevy kit for the treatment of perianal fistulas in patients with crohn's disease

Conditions: Crohn Disease; Fistula

Summary: today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. the currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. the injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. the use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. this study was design to test the use of halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. in this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.


Eligibility criteria:
inclusion criteria: * male and female age greater than 18 * patients suffering from crohn's disease * patients with any number of simple or complex fistulas who require surgical intervention, requiring the insertion of a drain (seton) into the fistula tract, and/or injection of biologic adhesive, or an anal fistula plug * able and willing to sign an informed consent * patient will be available for follow up. exclusion criteria: * pregnant or lactating woman. woman of childbearing potential will undergo a pregnancy test at the beginning of the trial * known immunodeficiency. * exclusion criteria for injecting biologic adhesive: * known allergy to fibrin glue or one of its components. * an undrained perianal abscess, diagnosed by a physical examination or imaging methods. * known alcohol or drug abuse

Keywords: crohn fistula surgery fibrin glue seton drainage
postoperative analgesic effect of nefopam

Conditions: Stomach Neoplasms

Summary: nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (tiva). the investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.


Eligibility criteria:
inclusion criteria: * early or advanced gastric cancer exclusion criteria: * refusal * use of preoperative analgesic drugs * pregnancy * recurred gastric cancer * seizure * cardiac disease * monoamine oxidase inhibitor * urologic disease * previous intrabdominal surgery * body mass index \> 30 or \< 16
myval transaxillary transcatheter aortic valve replacement multicenter clinical registry

Conditions: Aortic Valve Stenosis

Summary: study goal is to determine the feasibility, procedural success, safety and potential benefit of the myval transcatheter heart valve (thv) in patients undergone transaxillary (tax) transcatheter aortic valve replacement (tavr).


Eligibility criteria:
inclusion criteria: * patient has been treatet transaxillary (tax) with myval transcatheter aortic valve replacement * bmi \<35 kg/m2 * ability to give informed consent exclusion criteria: * history of coronary artery bypass graft and a patent left internal mammary artery (lima) * age ≤18 years * patients presenting with pregnancy * patients without informed consent * expected life expectancy \<2 years
efficacy and tolerance of hypertonic sodium chloride (nacl 5%) eye drops without preservatives in corneal edema

Conditions: Corneal Edema

Summary: corneal edema is frequently found in clinical practice as a common sign of acute corneal disease due to different etiologies that cause an accumulation of extracellular fluid in the cornea. the present unicentric clinical trial aims to evaluate the efficacy and tolerance of an ophthalmic solution of hypertonic sodium chloride (nacl 5%) without preservatives in participants suffering from symptomatic corneal edema.


Eligibility criteria:
inclusion criteria: * age over 18 years * clinical diagnosis of symptomatic corneal edema related to chronic epithelial, secondary to corneal dystrophies, controlled infectious and inflammatory pathologies and surgical trauma already resolved. * no need for keratoplasty in the 6 months following the start of the study exclusion criteria:. * visual acuity less than 1/20 in both eyes * corneal edema caused by the following acute etiologies: trauma, infection, inflammation or stevens-johnson syndrome. * glaucoma or uncontrolled hypertension. * known allergy to any of the ingredients of the product.

Keywords: corneal edema sodium chloride single-dose
decision making tool for firearm storage

Conditions: Dementia, Mild; Depression

Summary: this is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.

this pilot study will test the feasibility and acceptability of a decision aid about safe firearm storage with firearm-owning persons with early dementia and/or depression

Eligibility criteria:
inclusion criteria: * medical record documentation of early dementia and/or depression * internet or mobile device access * access to firearm(s) exclusion criteria: • active suicidality
induction folfirinox followed by chemoradiation in locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: there is no a clear consensus regarding the optimal treatment strategy of locally advanced pancreatic cancer. there is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. the investigators evaluated the safety and efficacy of induction folfirinox followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer (lapc).

continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer. in all patients an accurate pre-treatment staging was performed, including multilayer ct scan, positron emission computed tomography (pet-ct) with 18f-2-fluoro-2-deoxy-d-glucose (fdg) and laparoscopy with peritoneal washing. patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this approach.the induction phase of the treatment plan was designed to administer folfirinox protocol (oxaliplatin 85 mg/mq and irinotecan 180 mg/mq plus leucovorin 400 mg/mq followed by bolus fu 400 mg/mq on day 1, then fu 2,400 mg/mq as a 46-hour continuous infusion) every 14 days for four cycles. in the combined phase of the treatment radiotherapy target volumes were established by ct scan and pet-ct scan. concurrent chemotherapy consisted of gemcitabine at the dose of 600 mg/mq weekly. four weeks after the completion of radiochemotherapy, restaging including ct scan and pet-ct scan was performed. tumor response was defined in accordance with the world health organization (who) definition through ct scan and pet-ct scan. surgery was considered in patients whose tumors were technically resectable. after resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years

Eligibility criteria:
inclusion criteria: * proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma; * borderline resectable or unresectable pancreatic tumours; * no previous radiochemotherapy to abdomen; * 0-i eastern cooperative oncology group (ecog) performance status; * adequate cardiac, liver and kidney function and a good bone marrow reserve. exclusion criteria: * resectable and metastatic disease; * previous or concomitant malignant disease; * one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, pa o2 \ 40 mmhg, mental disability.

Keywords: chemoradiation folfirinox
evaluation of diabetic retinopathy using ultra-widefield fundus images compared with two-field fundus images

Conditions: Retinal Diseases; Diabetic Retinopathy; Diabetes Complications; Diabetes Mellitus; Screening

Summary: this study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images. the hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus images.

as of 2030,9.7% (108.4 million) people in the china population have diabetes, and the total costs of diabetes in adults would reach $460.4 billion. diabetic retinopathy (dr) and diabetic macular oedema (dme) are the principal causes of adult vision loss. nevertheless,dr has few visual symptoms until dme occurs or the lessions located in the peripheral retina.thus,it is crucial to early diagnosis and treatment of dr patients,which will prevent vision loss and reduce the societal buren of diabetes. the early treatment diabetic retinopathy study (etdrs) standard 7-field 30° color fundus photography is a time-consuming examination requiring pharmacological pupil dilation,experienced photographers and image montage.to simplify the operation process and improve patient compliance,2-field 45° retinal photographs (1 macular-centered field and 1 disc-centerde field) was proposed in the eurodiab iddm complications study and widely used in dr screening.two-field 45° retinal photographs has been proven beneficial in reducing blindness resulting from dr,while may be neglected dr pathology in the peripheral retina.with the development of imaging technology, nonmydriatic ultra-widefield scanning laser opthoalmascopy (optomap) can obtain high-resolution,widefield images (180-200°) of the retina in only 0.25s. optomap had good agreement with 7-field etdrs in determining dr and dme severity and may be profitable in dr evaluation in research and clinical settings,espesially in predominantly peripheral lession(ppl). patients with dm, with or without known dr, will be imaged using the optomap and 2-field 45° retinal photographs imaging device both for diagnosis and screening purposes at ningbo eye hospital. internal validation and continuous quality control will routinely be conducted. according to the international clinical diabetic retinopathy disease severity scale, the data for the ungradable image rate, distribution of dr severity levels, and ppl will be evaluated and compared. statistics analysis will explore the agreement of dr severity levels between optomap images and 2-field photographs.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. diagnosis of diabetes mellitus. exclusion criteria: 1. diseases involving the posterior pole other than dr, such as age-related macular degeneration，retinal vein occlusion. 2. history of panretinal laser photocoagulation.

Keywords: diabetic retinopathy ultra wide-field imaging fundus photography screening