Kornimate/medical-research-clean huggingface dataset:
international pancreatic surgery outcomes study - pancreasgroup.org

Conditions: Pancreatic Neoplasms; Pancreatitis

Summary: "snapshot" study worldwide over 3 months in 2021. provide a verified record of true morbidity and mortality. identify modifiable predicting factors of outcome. obtain pubmed citable co-authorship,

the pancreasgroup.org team is conducting a "snapshot" clinical study investigating the outcomes of pancreatic surgery worldwide. this "collaborative" model for snapshot clinical studies is a well-established approach for assessing current practice in a short period of time. there will be 3 months of prospective enrolment and 3 months follow up within a 12-month frame. the study will provide highly valuable data on outcomes after pancreatic surgery. the investigators are aiming at providing a verified record of true morbidity and mortality in consecutive unselected patients. this way the investigators will help identify relevant, modifiable predicting factors for outcome after pancreatic surgery.

Eligibility criteria:
inclusion criteria: * all indications (including benign and malignant) * open, laparoscopic or robotic. * elective or emergency. * partial or total pancreatectomies. * pancreatic tumour enucleations. * procedures with concomitant vascular or other organ resections. * pancreatic duct drainage procedures (e.g. frey, puestow, or beger) * adults 18 years of age or older. exclusion criteria: * pancreas or islet cell transplantation. * transcutaneous or transgastric imaging-guided ablation (e.g. rfa) or electroporation (e.g. nanoknife). * endoscopic (e.g. endoscopic retrograde cholangiopancreatography, stent or lithotripsy) procedures. * endoscopic transgastric and surgical necrosectomies excluded. * patients less than 18 years of age excluded.

Keywords: pancreatic surgery snapshot global surgery predictors outcomes
the post-operative effect of applying drainage on total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: this multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (tka) on post-operative performance.

this is a multicenter,open-label randomized controlled trail. a total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.

Eligibility criteria:
inclusion criteria: * ready to receive single-side tka * be evaluated as asa 1-2 degree before operation exclusion criteria: * coagulation disorder * peripheral vessel diseases * contraindication of surgery
multiple dose, double-blind, placebo and active controlled study of pharmacokinetics of diractin® as well as safety and efficacy for the treatment of muscle soreness

Conditions: Muscle Soreness

Summary: multiple-dose, double-blind, double-dummy, parallel, randomized, placebo and active controlled study of pharmacokinetics of diractin® as well as safety and efficacy for muscle soreness from exercise.


Eligibility criteria:
inclusion criteria: * understands nature and provision of the study * have been informed about the study by the investigator and gave signed and dated informed consent prior to participation * muscle soreness with a pain score of at least 3 on a 10 point categorical pain scale at 12-16h after exercise * male and female subjects * age 18-55 years * subjects in good health as determined by the investigator * woman of childbearing potential using reliable methods of contraception with a low failure rate (i.e. less than 1% per year), e.g. implants, injectables, combined oral contraceptives, reliable intrauterine-devices, vasectomised/ infertile partner or surgically sterile (uterus removed or both tubes tied) or postmenopausal (at least 2 years without periods) exclusion criteria: * 4.2.1 general exclusion criteria * investigator or any other team member involved directly or indirectly in the conduct of the clinical trial * subjects who are inmates of psychiatric wards, prisons, or other state institutions * participation in another clinical trial within the last 30 days and during the study * not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium) * pregnancy or lactation 4.2.2 medical history related exclusion criteria * history of dermal allergic reactions * known hypersensitivity or allergy (including photoallergy) to nsaid´s including ketoprofen, and ingredients used in pharmaceutical products * alcohol or drug abuse * malignancy within the past 2 years * skin lesions, dermatological diseases or tattoo in the treatment area * major surgery 3 months before enrolment * nsaid idiosyncrasy * impaired haematopoesis and coagulation * gastric and duodenal ulcer and gastrointestinal bleedings * systemic lupus erythematodes, mixed connective tissue disease * major heart disease / uncontrolled hypertension * hepatic failure with alt and/or ast \> 2.0 uln * renal failure with serum creatinine levels \> 1.5 milligrams/deciliter (mg/dl) * varicosis, thrombophlebitis and other vascular disorders of the lower extremities * major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs * hiv - infection * hepatitis b or c * asthma bronchiale * blood donation one month before screening and during study

Keywords: pharmacokinetics of diractin® safety efficacy exercise
post-healing follow-up study in people with remission of a diabetic foot ulcer

Conditions: Diabetic Foot

Summary: to evaluate the benefit of multidisciplinary specific follow-up of patients with a healed diabetic foot ulcer at the rate of two annual consultation on wound recurrence.

diabetic foot ulcer is a major world health problem with a very high recurrence rate, 50% at two years. the main causes of diabetic foot ulcer recurrence are inadequate footwear, lack of podology care and lack of self-care. international recommendations call for regular podological monitoring to prevent recurrence of diabetic foot ulcer. the "remission foot" consultation assesses recommended items and is offered to any healed patient at the rate of two annual visit. a retrospective study on multidisciplinary specific follow-up may show a real efficacity on recurrence rate.

Eligibility criteria:
inclusion criteria: * patient with type 1 ou type 2 diabetes followed-up in centre hospitalier sud francilien, * discharge from hospital for diabetic foot ulcer between 2017 and 2019 and post-healing follow-up for two years, * 18 years of âge or older, * person not deprived of liberty, * person who was informed of and did not object to the study. exclusion criteria: - person refusing the study.

Keywords: diabetic foot ulcer recurrence prevention remission follow-up multidisciplinary team
women's-specific footwear with prosthetic feet

Conditions: Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury)

Summary: the purpose of this study is to address footwear challenges unique to women prosthesis users. comparing the effectiveness of different footwear and prosthesis combinations will help guide clinical decision making regarding the prescription of prosthetic devices, while keeping what the patient wants in mind. it is expected that these results will be used to generate new knowledge for the development of versatile prosthetic devices that accommodate a user's unique lifestyle while helping the patient to make good progress in rehabilitation. investigators will characterize perceived limitations in footwear among women prosthesis users. investigators think that women prosthesis users will be restricted in footwear choices and clothing choices due to the use of a prosthetic device. specifically, investigators expect perceived limitations in footwear will be greater for shoes with higher heels than shoes without heels.

the project involves development, distribution, and analysis of a questionnaire designed to address footwear use among women lower limb prosthesis users. responses from sixty women with a lower extremity amputation will be targeted. va participants will be identified by the mvahcs. these potential participants will receive the irb-approved survey via mail. eligible participants include women with unilateral or bilateral lower extremity amputations. the questionnaire will target the types of footwear worn by prosthesis users and the types of footwear desired to be worn. it will also capture the various types of prosthetic feet worn in each footwear category, amputation type, time spent walking in a prosthetic device, and general satisfaction with the prosthesis function during daily living when worn with shoes.

Eligibility criteria:
inclusion criteria: * woman veteran * age 18-80 * lower limb amputation (transtibial, through the knee, transfemoral) * eligible to receive care through the va health care system * ambulatory and currently using a prosthesis exclusion criteria: * syme's amputation * hip disarticulation

Keywords: limb prosthesis shoe self concepts
open versus laparoscopic dismembered pyeloplasty among adult patients with primary pelvi-ureteric junction obstruction

Conditions: Open; Laparoscopic; Dismembered Pyeloplasty; Primary Pelvi-Ureteric Junction; Obstruction

Summary: to prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (lp) and open pyeloplasty (op) patients.

pelvi-ureteric junction obstruction (pujo) is defined as a functionally significant impairment of the flow of urine from the kidney's renal pelvis into the proximal ureter. open pyeloplasty (op) has been the gold standard for pujo repair since the first successful reconstruction of an obstructed pujo was accomplished in 1892, and achieves success rates exceeding 90%. various open surgical techniques have been described based on the cause, location, and length of the pujo. the most popular repair is the anderson-hynes dismembered pyeloplasty, which has universal application and is accepted as the gold standard of treatment. now, laparoscopic dismembered pyeloplasty represents a minimally invasive alternative of gold standard open anderson- hynes technique that has a comparable successful outcome with open pyeloplasty while avoiding its co-morbidities. it is also better than endopylotomy as it deals effectively with the crossing vessel

Eligibility criteria:
inclusion criteria: all adult patients (above 18 years old) with primary pelvi-ureteric junction obstruction indicated for active intervention as * symptoms such as recurrent flank pain, recurrent urinary tract infection and rarely hypertension. * breakthrough urinary tract infections while on prophylactic antibiotics. * increasing renal antero-posterior diameter, or decreasing renal parenchymal thickness by ultrasound. * low or decreasing differential renal function, but above 10%. exclusion criteria: * patients having poor ipsilateral renal function \< 10%. * patients with previous pelvi-ureteric junction obstruction repair. * associated renal stones. * patients unfit for surgery according to american society of anesthesiologists classification. * contraindications for laparoscopy as (marked obesity, large ventral hernias, gross coagulopathy, abdominal wall sepsis, vertebral deformities...). * pediatric patients. * pregnant women. * vesicoureteral reflux. * congenital renal anomalies as (horse- shoe kidney, pelvic kidney, mal- rotated kidney ...). * single functioning kidney. * malignancy. * refusal of written consent.
cardiorespiratory and muscular rehabilitation of children and young adults with marfan syndrome.

Conditions: Marfan Syndrome

Summary: marfan syndrome (mfs) is a rare genetic disease (1/5000) characterized by the association of ocular impairment, cardiovascular disease and musculoskeletal disease. in some chronic conditions, physical activity and training have been shown to be effective in improving muscle strength and functional abilities but also fatigue and quality of life. we hypothesize that the implementation of a personalized exercise rehabilitation program (personalized training program) in children and young adults with mfs, by improving muscle mass, physical endurance, muscle strength, bone mass and quality of life of these patients. in order to test this hypothesis, investigators wish to carry out an interventional, prospective, monocentric study for the first time in children and young adults (\<25 years old) presenting an mfs.

marfan syndrome (mfs) is a rare genetic disease (1/5000) characterized by the association of ocular impairment, cardiovascular disease and musculoskeletal disease. chronic fatigue and decreased physical endurance are almost constant complaints of patients with mfs (90% according to some studies), and have an impact on activities of daily living and quality of life. the fragility of the connective tissues and the muscle deficit, responsible for increased stress on the musculoskeletal system, may be involved in this symptomatology. this deficiency in muscle mass is already present in young children and worsens in adolescents and young adults, as researchers have shown in a clinical study carried out in the toulouse mfs competence center. this muscle deficit may also explain, at least in part, the deficit in bone mass observed in children and adults. in some chronic conditions, physical activity and training have been shown to be effective in improving muscle strength and functional abilities but also fatigue and quality of life. investigators hypothesize that the implementation of a personalized exercise rehabilitation program (personalized training program) in children and young adults with mfs, by improving muscle mass, physical endurance, muscle strength, bone mass and quality of life of these patients. in order to test this hypothesis, investigators wish to carry out an interventional, prospective, monocentric study for the first time in children and young adults (\<25 years old) presenting an mfs.

Eligibility criteria:
inclusion criteria: * marfan syndrome according to ghent criteria. * for minors, signed informed consent of at least one of the holders of the parental authority. for majors, signed informed consent. * patient affiliated to a social security scheme or equivalent. exclusion criteria: - cardiac contraindications to personal training program: o severe aorta dilatation (aortic diameter\> 45 mm) o and / or left ventricular failure (left ventricular ejection fraction \<45%) o and / or severe mitral leakage ≥ grade 3 - pregnancy

Keywords: marfan syndrome personal training program cardiorespiratory rehabilitation muscular rehabilitation
effectiveness of nonpharmacologic therapies on pain after removal of chest drains in postoperative cardiac surgery

Conditions: Pain Management

Summary: the objective of this clinical trial is to determine the effectiveness of pain reduction between an experimental treatment and the usual one when removing thoracic drains in post cardiac surgery patients, in a cardiovascular critical patient unit, in temuco, between the years 2024- 2026. its safety will also be analyzed. the main questions to be answered are: - what is the effectiveness of non-pharmacological therapies in reducing pain in the removal of chest drains in post-operated patient of cardiac surgery, in cardiovascular critical patient unit, temuco, between the years 2024- 2026? participants: * two non-pharmacological therapies will be applied, to one group aromatherapy with lavender essential oils, which were previously submitted to oil property analysis. and another group with local cold therapy, there will also be a control group with the usual pharmacological therapy. * all the groups will receive the usual pharmacological treatment, the non pharmacological therapies will only be of support, in no case they will replace the usual medical therapy.

controlled clinical trial, randomized, single-blind, with a sample of 100 postoperative cardiac surgery patients who meet inclusion and exclusion criteria. the sample will be obtained by two nurses with more than 8 years of experience in cardiac intensive care and specializations, of these patients all will receive the usual pharmacological therapy, will be divided into three groups: 25 patients (local cold); 25 patients (aromatherapy); 50 patients (with usual pharmacological therapy, indicated by medical team, without adding tnf). data will be collected through a form. the database will be exported to stata corp18 software, where they will be analyzed. the ethical requirements of ezequiel emanuel will be considered. translated with deepl.com (free version)

Eligibility criteria:
inclusion criteria: * postoperative cardiac surgery patient with indication of the cardiac surgeon to remove chest drains within the first 24 hours postoperatively. * patient who follows orders and with vigil state of consciousness, temporally and spatially oriented. * usual analgesic treatment indicated by physician: paracetamol 1 g every 8 hours; or metamizole 1 g every 8 hours; ketoprofen every 8 hours, or pregabalin 75 mg every 24 hours, last administration at 07:00 am. * inr \ 50,000. exclusion criteria: * patient with psychomotor agitation * dependence on psychotropic drugs, alcohol, or with abstinence syndrome. * patient in postoperative course with cardiogenic shock, with need for 2 or more vasoactive drugs (vad). * older than 80 years old. * maintained with continuous infusion pump (cib) of analgesia. * refractory pain, with second line management: lidocaine patches, buprenorphine patches, patient controlled analgesia pump. * administration of anticoagulant at 07:00 am.

Keywords: cardiac surgery pain management chest drain non-pharmacological therapy
mechanistic clinical trial of colchicine in patients with peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: the goal of this mechanistic clinical trial is to test the effects of reducing inflammatory signaling in femoral artery atherosclerotic plaques. researchers will compare patients receiving colchicine to patients receiving placebo to determine the effect of colchicine on the inflammatory state of atherosclerotic femoral arteries.

patients with peripheral artery disease who will be undergoing femoral endarterectomy will be randomized 1:1 to receive colchicine (0.6mg oral) or placebo daily for 4 weeks prior to 18f-fdg pet/ct imaging. at the baseline visit, study procedures will be reviewed with eligible participants and the study team will obtain written informed consent. baseline blood samples for laboratory studies will be collected and assayed, as well as additional blood samples for research. participants will completed study questionnaires at baseline and at the imaging visit. participants will receive follow-up phone calls with the study team. all eligible participants will be approached for participation in an imaging visit. at the imaging visit, participants will repeat laboratory tests and undergo non-invasive molecular imaging to evaluate the effects of colchicine on the extent of atherosclerotic plaque macrophage activity as assessed by 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. diagnosis of peripheral artery disease 3. stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: 1. use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months 2. allergy to colchicine 3. presence of medication with drug-drug interaction 4. acute limb ischemia requiring emergent intervention 5. vascular connective tissue disorders 6. autoimmune/autoinflammatory disorders 7. systemic infection 8. blood dyscrasia 9. pregnant or lactating women 10. uncontrolled diabetes (a1c \>10%) 11. history of crcl \< 30 ml/minute or esrd (hd) 12. history of liver disease or chronically-elevated (\>3 months) alt/ast \> 3.0 x uln 13. claustrophobia

Keywords: colchicine atherosclerotic cardiovascular disease peripheral artery disease atherosclerosis inflammation
autologous mesenchymal stem cells from adipose tissue in patients with secondary progressive multiple sclerosis

Conditions: Autoimmune Diseases; Immune System Diseases; Demyelinating Diseases; Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System

Summary: the main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with multiple sclerosis (poser and mcdonald criteria). 2. secondary progressive ms patients with edss ≥ 5.5 and ≤ 9. 3. patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in edss progression. 4. patients with no ms relapse and no steroid treatment within the month prior to inclusion. 5. patients who give written consent to participate in the study. - exclusion criteria: 1. history of current pathology or current laboratory results indicative of any severe disease. 2. pacemaker or metallic implants that prevent mr imaging. 3. inability to complete questionnaires. 4. refusal to give informed consent. 5. predicted impossibility for a biopsy of at least 30 grams of fat tissue. 6. positive screening test for hiv, hepatitis b or hepatitis c. 7. history of malignancy. 8. having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline. 9. body mass index\> 40 kg/m2. 10. patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study. 11. pregnancy or lactation -

Keywords: multiple sclerosis mesenchymal stem cells autologous