Kornimate/medical-research-clean huggingface dataset:
treatment of fecal incontinence and functional defecation disorders using non-instrumental biofeedback

Conditions: Fecal Incontinence; Outlet Dysfunction Constipation

Summary: background. rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. these treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs. hypothesis. a cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders. aim. to prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques. selection criteria. patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment. intervention. in separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. one session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. a visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. in addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome. biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. patients will be instructed to perform the same exercises daily at home in scheduled times. placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home.


Eligibility criteria:
inclusion criteria: incontinence studies * patients who have at least 4 episodes of fecal incontinence during the last 14 days. * patients able to follow instructions and attend study visits. dyssinergic defecation studies * patients with constipation who present less than 3 complete spontaneous bowel movements per week and/or who have bristol 1 or bristol 2 type stools in more than 25% of the bowel movements in the 2 weeks prior to the study * patients able to follow instructions and attend study visits. exclusion criteria: * patients with organic digestive diseases such as inflammatory bowel disease, celiac disease, gastro-duodenal ulcer... * patients with neurological diseases (spinal cord injury, multiple sclerosis, parkinson's disease). * patients with previous of active colon and/or rectal cancer. * patients with rectal fistula. * patients with rectal prolapse. * patients with total colectomy. * patients who have had any radiation to the pelvis in the last month.
haic versus systemic chemotherapy for unresectable icc

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (haic) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * the diagnosis of icc * patients must have at least one tumor lesion that can be accurately measured according to mrecist criteria. * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * without distant metastasis, but intrahepatic lymph node metastasis is allowed * the following laboratory parameters: platelet count ≥ 50,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 6 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: intrahepatic cholangiocarcinoma systemic chemotherapy hepatic artery infusion chemotherapy
continuous glucose monitoring to aid weight loss in prediabetes

Conditions: Weight Loss; PreDiabetes

Summary: the primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.

continuous glucose monitoring (cgm) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. this proposal will test the hypothesis that intermittent cgm will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.

Eligibility criteria:
inclusion criteria: * overweight/obese (bmi 25-40 kg/m2) * prediabetes (fasting glucose 100-125 mg/dl and/or hba1c 5.7-6.4%) exclusion criteria: * on glucose-lowering medications (e.g., metformin) * on weight-loss medications
safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of lc350189

Conditions: Hyperuricemia; Gout

Summary: this will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. adverse events, physical examinations, vital signs, ecg and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.


Eligibility criteria:
inclusion criteria: 1. healthy male subjects between the ages of 20 and 50 years at screening 2. subjects with body mass index (bmi) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ bmi (kg/m2) = body weight (kg)/ {height (m)}2. 3. subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an institutional review board (irb) - approved informed consent prior to performing any of the screening procedures. 4. findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
myofascial release in shoulder pathologies

Conditions: Humerus Fracture; Rotator Cuff Injuries

Summary: shoulder pathology has a high prevalence in the field of musculoskeletal diagnoses, as well as being a common etiology in cases of disability. passive and active-assisted kinesitherapy are used in the physiotherapy protocol. these techniques sometimes lead to feedback of fear and increased sensation of pain on the part of the patient that can slow or hinder the optimal recovery. a randomized clinical trial is intended to demonstrate that techniques for myofascial release of muscles important in the biomechanics of the shoulder, it is more effective than kinesitherapy in improving myofascial and also by eliminating the aforementioned unwanted effects and, therefore, improving the recovery of these processes.

the purpose of this study was to compare the efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization. design prospective, single-blind randomized controlled trial. setting inpatient department of a secondary university hospital. participants shoulder pain patients (n=44) were consecutively recruited and randomly assigned to an intervention or control group. interventions patients were randomly assigned to a control group, to which conventional kinesitherapy was applied, or to the intervention group to which a myofascial therapy protocol was applied. both groups completed a therapeutic exercise program based on specific mobilization and strengthening exercises. main outcome measures the quickdash questionnaire was the primary outcome, visual analog scale and the passive range of motion of the shoulder joint, grades were the secondary outcomes. the outcomes were evaluated at baseline (t0) and at 4 (t2),

Eligibility criteria:
inclusion criteria: * be between 20 and 80 years old. * patients who have been immobilized due to the following diagnoses: suture of the rotator cuff or fracture of the proximal extremity of the humerus. * have signed the informed consent of acceptance in the participation of the study exclusion criteria: * present neurological pathology. * be subdued corticoid therapy. * have anticoagulant treatment or have had it less than a month ago. * insulin-dependent diabetic patients. * patients with hemophilia. * having diagnosed a psychological or psychiatric pathology. * non-intervened displaced humerus fractures.

Keywords: shoulder pathology myofascial release clinical trial
the effect of double injection erector spinae plane block on postoperative pain following breast surgery

Conditions: Postoperative Pain; Breast Cancer

Summary: postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. erector spinae plane block (esb) is a new defined regional anesthesia technique for thoracic analgesia.main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection esb in breast surgery.


Eligibility criteria:
inclusion criteria: * 25-70 years of age * asa i-ii * undergoing elective breast cancer surgery exclusion criteria: * obesity (body mass index \>35 kg/m2) * infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * coagulopathy * recent use of analgesic drugs.

Keywords: erector spinae plane block breast surgery postoperative pain
tick-borne encephalitis and borrelial antibodies in serum

Conditions: Tick Borne Encephalitis

Summary: in slovenia, tick-borne encephalitis and lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected ixodes ricinus tick. in clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. patients with lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest lyme neuroborreliosis. patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for lyme neuroborreliosis, are often being treated with antibiotics in several european countries due to the possibility of double infection. the investigators hypothesise that such patients do not benefit from antibiotics. such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.


Eligibility criteria:
inclusion criteria: * 18 years or older * clinical picture compatible with tick-borne encephalitis, * clear cerebrospinal fluid, * cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid \>5 x 106/)l, * positive serum immunoglobulin m (igm) and immunoglobulin g (igg) antibodies against tick-borne encephalitis virus, * positive serum igg antibodies against lyme borreliae. exclusion criteria: * isolation of b.burgdorferi sensu lato from cerebrospinal fluid, * positive intrathecal borrelial antibody production index, * seroconversion of borrelial igg antibodies, * presence of erythema migrans and/or borrelial lymphocytoma in the last month, * bannwarth syndrome.
precision tms treatment guided by personalized brain functional sectors (pbfs) for asd

Conditions: Autism Spectrum Disorder

Summary: this study will evaluate the efficacy and safety of pbfs-guided tms treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.

autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. broad cognitive control function deficit in asd suggested cognitive control function as a potential phenotype and treatment target. using the personalized brain functional sectors (pbfs) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional mri data. the tailored tms intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (dlpfc) will be selected for each participant by a blinded researcher. the participants will be equally randomized to the active itbs to the cognitive control function network, and sham itbs at a ratio of 2:1. each participant will receive 5 days of treatment per week for 12 weeks. functional mri data under sedation will be collected pre-and post-treatment. three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.

Eligibility criteria:
inclusion criteria: * nearest age 6-30 years old * have the diagnosis of autism spectrum disorder * ados-2 score is higher than the asd cut-offs * capacity to follow the study procedures, including fmri scan under sedation, assessment, and rehabilitation training * participant's parent or other legal guardian give informed consent exclusion criteria: * current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder * severe self-injury or suicidal behavior presented in the last one year * severe visual, auditory, or motor disability that interferes with any study procedure * current or history of seizure * known severe physical diseases, such as congenital heart defect, traumatic brain injury * metal implantations, which are contradicted by mri or tms, such as artificial cardiac pacemakers, stents, cochlear implants * received tms, tcs, fus, or other neuromodulation treatment in the last 3 months * currently participating in other clinical trials

Keywords: tms personalized medicine asd fmri
evaluating system accuracy of blood glucose monitoring systems for self-testing in managing diabetes mellitus

Conditions: Diabetes

Summary: in this clinical trial an evaluation of a blood glucose monitoring system (bgstar) and several poct (point-of-care testing) devices against two laboratory methods will be performed. this evaluation will be performed according to iso (international organization for standardization) 15197 system accuracy.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * people with diabetes typ 1 or typ 2 and people without diabetes * for bg adjustment people with diabetes typ 1 or typ 2 * informed consent exclusion criteria: * pregnancy or lactation period * severe acute diseases * severe chronic diseases

Keywords: smbg (self-monitoring of blood glucose) poct system accuracy
magnetic compressive technique for pancreatic intestinal anastomosis

Conditions: Pancreatic Neoplasms; Pancreatitis, Chronic

Summary: in recent five years, the investigators have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during whipple. this study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.

magnetic anastomosis has been attempted in continuous connection between bowel and bowel, vessels and vessels, biliary and gastrointestinal tracts, as well as in recanalization of the biliary stricture, and bilioenteric anastomotic stricture. during the past 15 years, the investigators have designed different types of magnets, and attempted these magnets in vascular, intestine, and biliary anastomosis in preclinical studies. in recent five years, we have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during whipple. this study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.

Eligibility criteria:
inclusion criteria: * patients with pancreatic neoplasm who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy * patients with dilated pancreatic duct secondary to chronic pancreatitis who needs frey's procedure * patients with pancreatic injury who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy exclusion criteria: * woman during pregnancy or lactation or anyone with mental disorder * the wall of pancreatic incision is too thick so that the attractive force of magnetic device cannot meet the requirements of compression * any foreign body has been implanted in body, such as heart pacemaker. * surgical contraindication, including child-pugh c with hepatic encephalopathy, and anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery

Keywords: magnamosis; magnetic anastomosis; pancreaticojejunostomy
evaluation of the stability of sulfur volatile compounds from exhaled air for halitosis diagnosis

Conditions: Halitosis

Summary: halitosis or bad breath is a problem affecting 30% of the world's population. there are many causes, and oral pathologies, including periodontitis, are the main etiology. in order to make a diagnosis, a clinical interview is necessary to distinguish true halitosis from psychological halitosis. in addition, a measurement of volatile sulfur compounds (vsc), the main molecules involved in bad breath, is necessary. this is done during the consultation by measuring the concentration of vscs in exhaled air. however, few private practices or hospitals have the necessary equipment to measure vsc. as a result, patients are often obliged to travel long distances to obtain a consultation including this specific vsc analysis. the aim of this study is to evaluate the stability of vsc values obtained in gaseous samples up to 7 days after sampling, in order to assess the clinical relevance of analyzing samples at a distance from sampling. the clinical aim is to determine whether self-sampling by the patient at home and extemporaneous analysis could be considered in the diagnosis of halitosis.


Eligibility criteria:
inclusion criteria: * adult, male or female * subject affiliated with a social health insurance plan * able to understand the objectives and risks of the research and to give dated and signed informed consent * subject presenting for consultation for diagnosis and treatment of periodontal pathology exclusion criteria: * subject under safeguard of justice * subject under guardianship or curatorship * pregnancy or breast-feeding * impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.) * subject currently included in another clinical research protocol or in an exclusion period
circle game collaborative--freddie the frog

Conditions: Cognitive Impairment; Physical Disability

Summary: families who have children with disabilities experience more challenges in interacting with their children than families who have children without disabilities. this increased level of burden results in higher rates of emotional stress and hardship for those families. motivated by the idea of making deeper connections between children with disabilities and their parents, our gaming platform is designed around two key concepts - human touch and collaborative play. using wearable sensors, conductive fabrics, microcontrollers, and wireless communication, our gaming platform will register and interpret "touch" as a way to interface with game apps and the devices they are installed on. in other words, touch is translated into player input. thus, rather than interact with an ipad directly, children and their parents interact with each other instead. our platform engages both parents and children with disabilities equally in order to better focus on their shared physical expression. as touch can be registered from any part of the body, our platform can be used with children with any type of disability and allows for both active and passive participation by children with a severe disability.


Eligibility criteria:
inclusion criteria: group 1: children without disabilities between the ages of 5-9 years. any parent/caregiver to the child group 2: adolescents with mild to moderate physical or cognitive disability between the ages of 10-17 years. any parent/caregiver to the child group 3: adolescents with moderate to severe physical and/or cognitive disability between the ages of 10-17 years. any parent/caregiver to the child exclusion criteria: all groups: * parents who do not understand and speak english * parents with a disability

Keywords: children with disabilities parent family games technology collaborative game