Kornimate/medical-research-clean huggingface dataset:
treatment strategy of pancreatic radiolucent stone

Conditions: Chronic Pancreatitis

Summary: treatment strategy of chronic pancreatitis (cp) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. we aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.

1. treatment strategy of cp patients with large pancreatic stone： 1. . for patients with large radiolucent stone，ercp with balloon sphincteroplasty was performed directly to remove radiolucent stone. if ercp intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. eswl was performed in the following situations. frist, mpd strictures was so severe that dilation catheter can not be inserted during ercp. second, there was cystic dilatation in mpd and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. in the above cases, the naso-pancreatic catheterwas inserted during ercp, and then eswl would be performed with repeated injection of contrast medium. after eswl, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. for patients without mpd strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent. 2. . for patients with large radiopaque stone, repeated p-eswl sessions were performed, and ercp was routinely performed 48 hours after the last p-eswl. if ercp intubation failed, medication or surgery would be recommended. 2. a prospective cohort study was conducted in cp patients with large radiolucent stone. patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time. 3. the primary outcome was pain relief. the secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.

Eligibility criteria:
inclusion criteria: clinical diagnosis of chronic pancreatitis; with pancreatic radiolucent stones large than 5mm exclusion criteria: autoimmune pancreatitis; groove pancreatitis; pancreatic cancer diagnosed within 2 years after diagnosis of chronic pancreatitis
eculizumab therapy for chronic complement-mediated injury in kidney transplantation

Conditions: Kidney; Complications, Allograft

Summary: this study is designed to assess the effectiveness of eculizumab in recipients of kidney transplantation with donor-specific antibodies (dsa) and worsening kidney function and to assess if eculizumab improves endothelial cell injury in the kidney. the investigators hypothesize that complement inhibition with eculizumab will reduce allograft injury, resulting from less complement-mediated injury of endothelial cells and less endothelial cell activation.

this study will address the clinical challenge that currently exists in the management of kidney transplant recipients who have developed de novo dsa, have deteriorating graft function, yet have no established treatment alternative. this is a randomized, open-label, pilot intervention trial. post transplant patients with deteriorating renal function (defined as 20% reduction in gfr) will be screened for the development of dsa and biopsied for the presence of c4d deposition. all patients with dsa and those meeting inclusion/exclusion criteria will undergo protocol renal biopsy and will be assessed for c4d deposition. participants will be randomized to treatment with eculizumab plus standard of care (soc) or soc only. randomization will be stratified by c4d status (c4d+/c4d-) with 10 subjects (7 eculizumab, 3 soc only) in each stratum. eculizumab is an antibody that has been developed to inhibit the complement protein c5. eculizumab will be delivered via iv according to the following schedule: * eculizumab induction 600mg iv every 7 days for 4 doses * eculizumab 900mg iv 7 days later * eculizumab maintenance 900mg iv every 14 days for total of 26 weeks

Eligibility criteria:
inclusion criteria: * kidney transplant recipients greater than 6 months from the date of transplant * must be on standard immunosuppression: tacrolimus, mycophenolate mofetil, prednisone and have stable tacrolimus trough levels over past 3 months * deteriorating renal function, as defined by 20% reduction in gfr (mdrd calculation) * presence of dsa, as defined as mfi \> 1100 * renal biopsy demonstrating no diffuse, irreversible end-stage organ injury (i.e. stage iv fibrosis) * renal biopsy demonstrating c4d deposition (stratum 1) or no c4d deposition (stratum 2) exclusion criteria: * history of cmv, bk, hsv or other viral infections * history of chronic, recurrent bacterial infections * evidence of tubulitis on renal biopsy or other morphological features of acute cellular rejection or acute humoral rejection * renal biopsy demonstrating diffuse, irreversible end-stage organ injury * absolute gfr \< 25 (mdrd calculation) * inability to provide informed consent * history of poor vascular access * refusal to use double barrier contraception during study participation * patients actively enrolled in other clinical trials

Keywords: chronic kidney allograft injury complement protein eculizumab kidney transplantation
young adult hypertension feasibility study

Conditions: Health Behavior; Hypertension

Summary: this study was designed to evaluate the feasibility of a telephone-based health coach self-management intervention for young adults.

to address the unmet need for hypertension care in young adults, myheart (my hypertension education and reaching target), a multi-component hypertension intervention was developed. eligible patients were identified via the healthcare system's electronic health record. inclusion criteria included: 1. 18-39 years old at the start of the study, 2. previous hypertension icd-9 coded office visits and 3. uncontrolled hypertension (≥140/90 mmhg) based on the last ambulatory blood pressure reading. exclusion criteria included a pre-defined list of co-morbidities, in addition to planned or current pregnancy, any health condition that limits physical activity or dietary changes, current participation in another study, and planning to leave the area in the next three months. during the feasibility study, all participants continued to receive usual hypertension care from their primary care provider. the intervention involved health coach calls over a 3-month period using self-management modules. the order of the modules was guided by the participant's choice. all encounters were documented in the electronic health record. patient acceptability and home blood pressure monitoring survey data was acquired.

Eligibility criteria:
inclusion criteria: * 18-39 years old at the start of the study * previous hypertension icd-9 coded office visits * uncontrolled hypertension (≥140/90 mmhg) based on the last ambulatory blood pressure reading exclusion criteria: * chronic kidney disease (stage 4 or 5 or dialysis) * congestive heart failure, any etiology * activated healthcare power of attorney * skilled nursing facility or correctional facility residence * currently enrolled in case management or chronic disease management support services * sensitive condition diagnosis (e.g. hiv) * prescribed warfarin, novel oral anticoagulant, or insulin * diagnosis of sickle cell anemia or cystic fibrosis * prior stroke, myocardial infarction, coronary artery revascularization * syncope within past 12 months * prior or planned organ transplant * chemotherapy or radiation therapy within 6 months * severely impaired hearing or speech * current participation in another research study * pregnant/planning to become pregnant in the next 12 months * planning to leave the area in the next 3 months * any health condition that will limit physical activity or dietary changes * illegal drug use (other than marijuana) in the past 30 days (self-report) * unable to read or communicate in english

Keywords: young adult
a retrospective study for multiple endocrine neoplasia

Conditions: Multiple Endocrine Neoplasia

Summary: retrospectively review the clinical characteristics of patients with multiple endocrine neoplasia type i in national taiwan university hospital.

the investigators will retrospectively review the clinical characteristics of patients with multiple endocrine neoplasia type i in national taiwan university hospital.

Eligibility criteria:
inclusion criteria: * patients with multiple endocrine neoplasia exclusion criteria: * patients younger than 18 years old
comparison of the nociception monitoring devices during cardiac surgery.

Conditions: Cardiac Surgery

Summary: the purpose of this study is to compare the values of surgical pleth index (spi) and nociception level index (nol) measured simultaneously during cardiac surgery.

participants are given oral and written information about the course of the trial, associated risks and benefits and about the handling of the personal data on the day before the surgery by one of the investigators. participants are also given written information about patient's rights and insurance, the aim of the trial and its course. 40 adult cardiac surgery patients will be recruited for the study. nol and spi values will be measured during the cardiac surgery procedure. all patients receive oral premedication and standardized anesthesia.

Eligibility criteria:
inclusion criteria: * coronary artery disease of heart valve disorder qualified for the surgical treatment * participant understands the course of the trial and its aim * participant has given informed written consent exclusion criteria: * participant has not given consent * neurological or psychical disorders (psychiatric medication) * dementia * alcohol or substance abuse * central nervous system medication (medication for epilepsy or neuropathic pain)

Keywords: cardiac surgery pain nociception
3d vs 2d hd laparoscopy in inguinal hernia repair

Conditions: Hernia, Inguinal

Summary: inguinal hernia can be repaired laparoscopically. in the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. the three-dimensional laparoscopic systems are gradually entering the operating rooms. there are plenty of evidence of the benefits of 3d-system in laboratory conditions. however, no prospective randomized trials have been published in the clinical point of view. therefore, the purpose of this study is to investigate is there something to gain in changing into 3d laparoscopic system in the transabdominal pre-peritoneal (tapp) inguinal hernia repair.


Eligibility criteria:
inclusion criteria: * patients scheduled for laparoscopic inguinal hernia repair exclusion criteria: * some other surgical operation planned during tapp * expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis) * operating surgeon experience less than 5 3d laparoscopy operations
lidocaine spray on an endoscope to improve tolerance to endoscopy

Conditions: C.Medical Procedure; Digestive System; Disorder of Upper Gastrointestinal Tract; Tolerance

Summary: the investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone.

all the patients underwent upper gastrointestinal endoscopy were consecutively enrolled and assigned to case group treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation or control group with conventional pharyngeal anesthesia without further treatment. and the investigators compared their baseline characteristics, past history, sedation or not, and frequency of retching and belching were measured during the endoscopy.

Eligibility criteria:
inclusion criteria: * all the patients who underwent upper gastrointestinal endoscopy in endoscopy room, cheju hall general hospital. exclusion criteria: * advanced older or younger age (\> 90, or \< 15 years) * comorbidities scored greater than iii of american society of anestheiologists physical status classification system (asa) score * history of hypersensitivity reaction to lidocaine * he pregnant * therapeutic or emergency endoscopy

Keywords: upper gastrointestinal endoscopy pharyngeal anesthesia lidocaine belching retching tolerance
effect of the consumption of a fermented milk on common infections in children aged 3-6 years, attending day care centers

Conditions: Common Infectious Diseases

Summary: this multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic lactobacillus casei dn-114 001 (actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria) in children aged 3-6 years, attending day care centers.volunteers received either 200g/day of tested product (n=300) or control product (n=299) for 3-months, followed by a 1-month follow-up.


Eligibility criteria:
inclusion criteria: * subject whose parents/legal guardians had given written informed consent, * male or female, aged 3 to 6 years (upper bound excluded), * attending day-care centres or preschools 5 days a week in the moscow area, * subject found medically healthy (in particular, free of respiratory and gi tract symptoms), * subject who appreciated dairy products and multi-fruit flavour. exclusion criteria: * subject whose parents were not reading and writing russian, or not understanding informed consent or study protocol. * subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), or with any known food or respiratory allergy. * subject presenting a severe evolutive or chronic pathology (ex: cancer, tuberculosis, crohn disease, cirrhosis, multiple sclerosis, type i diabetes...) or any past or actual health condition that could interfere with the outcome of the study (ex: hiv, chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive...). * subject having experienced any infectious disease during the last 7 days. * subject with current diarrhoea or constipation subject who was frequently using laxatives or who had been using laxatives during the week prior his participation to the study. * subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study. * subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation...) or with eating disorders (anorexia, bulimia...). * subject currently receiving, or who had received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics, antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid antiinflammatory substances, immunosuppressant treatment... * subject already enrolled in another clinical study, or currently under an exemption period from a previous study. * subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Keywords: probiotic - lactobacillus casei dn-114 001 - dairy product - infections - children
prospective registry of european hemophilia b patients receiving benefix® for usual use

Conditions: Hemophilia B

Summary: this is an open-label multi-center registry in patients with hemophilia b receiving benefix. all patients who begin treatment with benefix in european union countries, will be eligible for participation. patient demographics will be collected at baseline for all patients. a baseline fix activity and bethesda assay for inhibitor based on historical data should be recorded if available. adverse events as defined in the protocol will also be reported on the appropriate forms. data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with benefix.


Eligibility criteria:
inclusion criteria: * patients with hemophilia b scheduled to begin treatment with benefix are eligible for registry enrollment exclusion criteria:

Keywords: hemophilia b
a trial to study if regn5837 in combination with odronextamab is safe for adult participants with aggressive b-cell non-hodgkin lymphomas

Conditions: B-cell Non-Hodgkins Lymphoma (B-NHL)

Summary: the study is researching an experimental drug called regn5837 in combination with another experimental drug, odronextamab (called "study drugs"). the aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2. the study is looking at several other research questions, including: * what side effects may happen from taking the study drugs * how much study drug is in the blood at different times * whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects) * to find out how well the study drugs work against relapsed or refractory aggressive b-cell non-hodgkin lymphomas (b-nhls)


Eligibility criteria:
key inclusion criteria: 1. have documented cd20+ aggressive b-nhl, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-cd20 antibody and an alkylating agent, as described in the protocol. 2. measurable disease on cross sectional imaging as defined in the protocol 3. eastern cooperative oncology group (ecog) performance status 0 or 1 4. adequate bone marrow, renal and hepatic function as defined in the protocol 5. availability of tumor tissue for submission to central laboratory is required for study enrollment. archival tumor tissue for histological assessment prior to enrollment is allowed 6. during dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant. key exclusion criteria: 1. prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-cd20 x anti- cd3 bispecific antibody, such as odronextamab 2. diagnosis of mantle cell lymphoma (mcl) 3. primary central nervous system (cns) lymphoma or known involvement by non-primary cns lymphoma, as described in the protocol 4. treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol 5. standard radiotherapy within 14 days of first administration of study drug, as described in the protocol 6. continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab 7. co-morbid conditions, as described in the protocol 8. infections, as described in the protocol 9. allergy/hypersensitivity: known hypersensitivity to both allopurinol and rasburicase note: other protocol defined inclusion / exclusion criteria apply

Keywords: aggressive b-cell non-hodgkin lymphomas relapsed or refractory
ao multicenter intervention trial for prevention of surgical site infection

Conditions: Surgical Site Infection

Summary: this study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. the intervention consists on the implementation of the aot ssi prevention bundle. d

during the first phase of the study, 4,238 patients will be recruited and the baseline incidence of surgical site infection at each participating site will be determined. at the beginning of the third year, the bundle will be implemented and data on 4,238 additional patients will be collected. the incidence rate on surgical site infection before and after the intervention will be compared. we hypothesize that this intervention will reduce the infection rate within the first 3 months after surgery from 6% to 4.5% (5% to 3.75% in closed fractures and from 10% to 7.5% in open fractures).

Eligibility criteria:
inclusion criteria: * • age \> 18 years * recent fracture (\< 10 days) located in femur, tibia or humerus * any type of open or closed fracture * produced by high or low energy trauma * primary fracture treatment with surgery and use of any of the following: * intramedullary or extramedullary devices including cases in which a temporary external fixator is used * joint replacement * informed consent obtained (if required by local ec/irb), i.e.: * ability to understand the content of the patient information/icf * willingness and ability to participate in the clinical investigation according to the clinical investigation plan (cip) * signed and dated ec/irb approved written informed consent exclusion criteria: * pathologic fracture secondary to tumors, infection or cysts * patients with an underlying chronic, bone and joint infection or prior history of a bone and joint infection * refracture and non-union * peri-implant fractures * patients with terminal illness * pregnancy or women planning to conceive within the study period * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
exercise therapy for people with a diabetic foot ulcer - a feasibility study

Conditions: Diabetic Foot Ulcer; Diabetic Foot; Wound Healing Disorder; Ulcer Foot; Ulcer Healing

Summary: the aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future rct. the primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.


Eligibility criteria:
inclusion criteria: * adults aged 18 years or above * diabetes mellitus * non-surgical ulcer located distal to the malleoli * willingness to participate in a 12-week supervised exercise therapy intervention twice a week * prescribed with a therapeutic shoe, orthopaedic specialist shoe from the outpatient clinic or a specialized podiatrist. exclusion criteria: * dementia or other reasons that cause inability to give informed consent * people that are wheelchair-bound * people with a prescribed cast or walker boot * unable to understand danish. * diagnosed with or awaiting evaluation of suspected acute phase charcot arthropathy or osteomyelitis
detailed phenotypic and genotype study to correlate rb1 mutations relating to primary ocular tumors and secondary extra-ocular metastasis.

Conditions: Retinoblastoma Bilateral; Retinoblastoma Unilateral; Retinoblastoma, Extraocular; Retinoblastoma, Recurrent; Retinoblastoma

Summary: the goal of this observational study is undertake a detailed phenotypic and genotypic study of patients with ocular and secondary cancers due to mutations in the rb1 gene. our research sequencing approach will allow advanced insight to for further detailed genotypic understanding of parent-of-origin for valuable insight into the genotype-phenotype relationship of this cancer syndrome.


Eligibility criteria:
inclusion criteria: * patients with molecularly proven retinoblastoma due to rb1 or a typical clinical retinoblastoma phenotype with genetic screening pending. * able to give consent/parent or guardian able to give consent. exclusion criteria: * patients unable or unwilling to undertake consent or clinical testing. * patients unwilling to donate a saliva or blood sample in order to establish the genetic cause of their condition.

Keywords: retinoblastoma parent-of-origin