Kornimate/medical-research-clean huggingface dataset:
changes in the tricuspid valve complex induced by mitral valve annuloplasty

Conditions: Tricuspid (Valve); Deformity

Summary: the purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.

the proposed pathogenesis of functional tricuspid regurgitation (tr) in mitral valve disease seems incomplete. because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. this could lead to the development of functional tr, or to an increase in tr severity. to test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.

Eligibility criteria:
inclusion criteria: * all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty exclusion criteria: * concomitant tricuspid valve surgery * atrial fibrillation at the moment of surgery * poor echocardiographic windows

Keywords: cardiovascular diseases heart valve diseases mitral valve annuloplasty tricuspid valve insufficiency
quantra® system with the qstat® cartridge in trauma

Conditions: Trauma; Coagulation Defect; Bleeding

Summary: this is a prospective, single-center, observational study to assess the quantra qstat system in trauma patients.

this is a prospective, single-center, observational study to assess the performance of the quantra qstat system in trauma patients.

Eligibility criteria:
inclusion criteria: * subject is \> 18 years; children under the age of 18 are protected by adults under guardianship or by court order. * subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response according to site's level 1of trauma team activation criteria. * subject, or subject's legally authorized representative (lar), is willing to provide informed consent, either prospectively or by deferred consent. exclusion criteria * subject is pregnant. * subject is currently enrolled in a distinct study that might confound the result of the proposed study. * subject is not covered by social security.

Keywords: quantra qstat viscoelastic testing
long-term study on safety and immunogenicity of heplisav™ and engerix-b® in adults with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to determine the durability of seroprotection of heplisav™ and engerix-b® and the number of injections of each vaccine needed to maintain seroprotection in a cohort of chronic kidney disease (ckd) patients over time.

an observational study evaluating the long-term safety and immunogenicity of heplisav™ compared with engerix-b® in adults with chronic kidney disease who have previously received at least one hepatitis b vaccine series

Eligibility criteria:
inclusion criteria: a subject must meet all of the following inclusion criteria to participate in the study: * enrolled and completed heplisav or engerix-b treatment in: dv2-hbv-17 or dv2-hbv-18 and had anti-hbsag ≥ 10 miu/ml prior to or during dv2-hbv-18 * previously received a complete primary hepatitis b vaccine series in dv2-hbv-17 or prior to enrollment in dv2-hbv-18 * be otherwise clinically stable in the opinion of the investigator * be able and willing to provide informed consent exclusion criteria: a subject who meets any one of the following exclusion criteria is not permitted to participate in the study: * previously enrolled in dv2-hbv-18 and never obtained anti-hbsag ≥ 10 miu/ml * received hepatitis b vaccine off-study after enrolling in dv2-hbv-17 or dv2-hbv-18 * has known history of autoimmune disease * is unwilling or unable to comply with all the requirements of the protocol

Keywords: prevention of hepatitis b infection. end stage renal disease hepatitis b vaccination hepatitis b virus (hbv)
anti-inflammatory and anti-platelet effect of clopidogrel and aspirin vs aspirin alone in symptomatic polyvascular disease and in patients with multiple recurrent cardiovascular events

Conditions: Polyvascular Disease; Cardiovascular Disease

Summary: this is a monocentric, randomized, opened study to assess the anti-inflammatory and anti-platelet effect of clopidogrel and aspirin versus aspirin or clopidogrel alone in patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular events.


Eligibility criteria:
inclusion criteria: * patients with symptomatic polyvascular disease or recurrent cardiovascular events. in particular patients with established stable coronary artery disease associated with peripheral disease or cerebrovascular disease and patients with more than two acute cardiovascular events. exclusion criteria: * chronic treatment with anticoagulant drugs and the use of other antiplatelet therapy; * intolerance/allergy to aspirin or to clopidogrel * platelet counts outside the range of 125-450 10\^9/l * inflammatory or infectious disease * malignancies or immunologic or hematological disorders.

Keywords: symptomatic polyvascular disease multiple recurrent cardiovascular events
splenic function after spleen-preserving distal pancreatectomy with excision of splenic artery and vein

Conditions: Overwhelming Post-Splenectomy Infection

Summary: the spleen may be removed due to benign hematologic disorders, such as idiopathic thrombocytopenic purpura and hereditary spherocytosis, or malignancies, such as lymphomas and leukemias. splenectomy may also be performed due to splenic traumas or in association of some surgical procedures, when combined splenectomy will make the operations easier. the most well known procedure is distal pancreatectomy combined with splenectomy. in this research, there are two main goals. firstly, establish the data about the incidence of overwhelming postsplenectomy infection (opsi) in our country. currently, the western data of the incidence, morbidity rate and mortality rate of opsi is well established and vaccination along with prophylactic antibiotics is strongly recommended. since the incidence of opsi in our country isn't clear, most (\>95%) splenectomized patients in our hospital (national taiwan university hospital) did not have vaccination or prophylactic antibiotics. we'll try to determine the incidence of opsi by reviewing of our hospital charts and by structured interviews with patients. the spleen is a phagocytic filter. so asplenic patients have higher risks of getting infection and some spleen-preserving procedures are proposed. in our initial experiences, distal pancreatectomy with splenic artery and vein divided could be safely performed and greatly increased the possibility of preservation of spleen. however, when the spleen was preserved with dividing the splenic artery and vein, the blood supply to the spleen will be shifted from splenic artery to short gastric artery. although a substantial immunologic advantage exists if splenic tissue remains, this may not offer sufficient protection from encapsulated bacteria if splenic arterial blood flow is reduced because experimental animal studies have demonstrated that an intact splenic arterial system is necessary for optimal control of infection. thus, although the spleen is preserved in above mentioned procedure, the function of the preserved spleen is questionable and has never been studied of. our second object is to determine the splenic function after after spleen-preserving distal pancreatectomy with excision of splenic artery and vein by comparison of abdominal computed tomography and immunological function of patients before and after operation. besides, we'll designed an animal experiment to examine the rate of pneumococcal clearance by the spleen and to determine the relationship between splenic blood flow and splenic tissue mass in bacterial clearance from the blood when the splenic vessels were divided.


Eligibility criteria:
inclusion criteria: * all patients received splenectomy (patient list will be applied from dept. of pathology) at national taiwan university hospital in the last 20 years. exclusion criteria: * who rejected interview.

Keywords: opsi splenectomy
physiology of gip(1-30)nh2 in humans

Conditions: Glucose Metabolism Disorders

Summary: glucose-dependent insulinotropic polypeptide (gip) is a gut-derived incretin hormone that affects glucose, lipid and bone metabolism. secretion of gip into the blood stream from enteroendocrine cells is stimulated bu nutrients in the gut lumen and results in potentiation of glucose stimulated insulin secretion from the pancreas. the objective of this study is to investigate the physiology of gip(1-30)nh2 in humans with insulin secretion as the primary endpoint. furthermore the effects on on plasma/serum levels of glucagon, c-peptide, glucose, bone markers (ctx and p1np) will be measured.


Eligibility criteria:
inclusion criteria: * healthy men of northern european descent * bmi: 19-25 kg/m2 * stable body weight (±5%) in the last three months exclusion criteria: * treatment with medication or dietary supplements that cannot be paused for 12 hours * more than 14 units of alcohol per week or abuse of narcotics * established liver disease and/or plasma alanine aminotransferase (alt) ≥3 × normal value and/or inr outside the normal range * renal impairment (egfr \<60 ml/min/1.73 m2) * severe arteriosclerotic heart disease or severe heart failure (nyha group iii or iv) * low blood count (haemoglobin \<8.3 mol/l) * special diet or planned body weight change before the trial period * first-degree relatives with diabetes * participation in other clinical experiments with medication * any disease/condition that the investigators estimate disturbing for the participation in the experiment
erlotinib (tarceva) as a single agent or intercalated with combination chemotherapy in patients with egfr positive nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (egfr) pathway. the study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with egfr overexpression and/or egfr amplification.


Eligibility criteria:
inclusion criteria: * age \>= 18 * histologically or cytologically documented non-small cell lung cancer (nsclc) * eastern cooperative oncology group (ecog)performance status (ps)0, 1, 2 * radiologically measurable or evaluable disease no prior chemotherapy * 1 or 2 epithelial growth factor receptor (egfr) pathway markers positive at screening * tumor tissue block or fine needle aspirate exclusion criteria: * any concurrent anticancer therapy or radiation * other active malignancy * uncontrolled brain metastases * gi abnormalities * severe abnormalities of the cornea * significant cardiac disease * active infection

Keywords: nsclc erlotinib tarceva lung cancer
feasibility of specific anesthesia of the forefoot preserving the sensitivity of the heel for foot surgery

Conditions: Hallux Valgus and Bunion (Disorder); Morton Neuroma; Metatarsal Fracture; Ingrown Nail; Foot Wound; Foot Infection

Summary: foot surgery is a painful surgery that is usually scheduled in outpatients. a good management of analgesia is the crucial point. regional anesthesia (ra) is the gold standard, that provides good anesthesia and a long duration of analgesia. the sciatic nerve block (or its branches) is the most adapted analgesic technique. limitation of proximal sciatic block is the motor block of the ankle and results in the impossibility, for the patient, to walk during the early post-operative period. distal block of the sciatic nerve (tibial and fibular nerve blocks), at the level of the ankle, has been proposed to maintain the mobility of the ankle, to make deambulation with crutches easier. nevertheless, the lack of sensibility of the heel remains a limitation for early walking, even with adapted shoes (ie : barouk). a specific anesthesia of the distal part of the foot, respecting the heel, could be the best option to provide an early deambulation and a suitable analgesia. ultrasound identification and specific anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves) could meet this dual objective : good anesthesia and suitable analgesia for early deambulation. this study is a feasibility study of a specific block of the plantar branches of the tibial nerve, to preserve the sensibility of the heel, in case of foot surgery. the safety of the procedure will be assessed according to the rate of postoperative dysesthesia.

block of the medial and lateral plantar branches of the tibial nerve will be performed under the medial malleolar-calcaneal axis (mmca) in order to preserve the calcaneal nerves. blocks of the deep peroneal nerve (dpn) and the superficial peroneal nerve (spn) will be added to provide an adequate anesthesia. every block will be performed under ultrasound using a 27-gauge, 5-cm, short bevel needle. 5 ml of 0.375% ropivacaine will be injected for each block. the sensory blocks will be assessed by pinprick test and cold test every 10 minutes for 40 minutes in the following locations: calcaneal nerves, lateral plantar nerve and medial plantar nerve. the extent of sensory block will be graded as follows: 2: normal sensation; 1: decreased sensation; and 0: no sensation (complete block).

Eligibility criteria:
inclusion criteria: * patients undergoing a foot surgery * consent for participation * affiliation to the french social security system exclusion criteria: * patient's refusal * existence of major spontaneous or acquired haemostatic disorders * infection at the point of puncture * allergy to local anesthetic or analgesic * pregnant or likely to be pregnant * patients under protection of the adults (guardianship, curator or safeguard of justice) * patients whose cognitive state does not allow assessment by the scales used * neuropathic disease

Keywords: foot surgery regional anesthesia regional analgesia ultrasound distal block plantar nerve block
prevention of phantom limb and stump pain using ambulatory continuous peripheral nerve blocks: a pilot study

Conditions: Amputation; Phantom Limb Pain; Stump Pain

Summary: the purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.

specific aim 1: to determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain. hypothesis 1: following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment. hypothesis 2: following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Eligibility criteria:
inclusion criteria: * undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively * currently without phantom limb and/or stump pain in a previously-amputated limb * ages 18 years or older * desiring perineural infusion for up to 6 days * willing to have an ambulatory infusion following hospital discharge exclusion criteria: * hepatic or renal failure * allergy to the study medications * pregnancy * incarceration * possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Keywords: pain amputation phantom limb stump pain catheter nerve block peripheral nerve block ucsd post-amputation phantom limb or stump pain
the effect of yoga and stabilization exercise in patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain.

44 patients participating in the study were divided three groups. the patients in the stabilization exercise group were instructed to perform hotpack, trans-cutaneous electric nerve stimulation (tens) and spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. the patients in the home exercise group were instructed to perform stabilization exercise. the severity of the pain evaluated through visual analog scale, functional status and quality of life evaluated through oswestry disability index(odi), nottingham health profile (nhp), respectively. assessments were repeated before and after the treatment.

Eligibility criteria:
inclusion criteria: * must be pain at least 3 months * must be visual analog scale rating 3 or more exclusion criteria: * history of any lumbar spine surgery * severe/progressive scoliosis * spinal stenosis * spondylolisthesis * cancer * diabetes * metabolic syndrome * history of exercise programs or yoga at least 12 weeks before the onset of study

Keywords: exercise, pain, yoga
performance and safety of the resorbable collagen membrane "ez cure"

Conditions: Oral Bone Defect; Maxillofacial Bone Defect; Periodontal Bone Loss; Alveolar Bone Loss

Summary: the evaluation of the clinical data has demonstrated the conformity of the resorbable collagen membrane (rcm), ez curetm, with the relevant essential requirements for its use in periodontal applications. the rcm is intended for guided tissue regeneration (gtr) and guided bone regeneration (gbr) procedures. it acts as a barrier against the migration of epithelial cells within the bone defect (performance) and thus complies with several surgical indications in the treatment of maxillofacial bone defects. it has been concluded that the risks associated with the use of this device are acceptable when weighted against the benefits to the patients. in order to improve the clinical data on the rcm, the manufacturer, biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. in this objective, the goal of this study will be to observe the following parameters: 1. tissue regeneration (mucosa health on the site of implantation) 2. safety (report of any adverse event) 3. radiographic analysis of periodontal tissues


Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 70 * periodontal defects (e.g. cyst, bone tumour, crest augmentation...) * aleveolar bone defect after tooth (teeth) extraction * non opposition form (consent of the patient) * patients affiliated to the french social security * patients not under guardianship or judicial protection exclusion criteria: * pregnancy of breastfeeding women * severe smoker (\>10 cigarettes per day) * acute infections * allergies to the material (if an allergy of any kind is suspected, adequate exams must be carried out in advance) * refusal of the patient to adhere to surgical follow-up and to the limit in activity level * fever and/or local inflammation * hiv positive known * history of uncontrolled diabetes (untreated or not stabilized by treatment) * history of treatments for previous corticosteroids, long-term (more than 6 months) and interrupted for less than 3 months * history of chemotherapy in progress or during the last three months * history of cervico-facial radiotherapy * history of bone disease with disorders of blood circulation which is defined as akbers-schönberg disease or paget's disease * known severe hyperparathyroïdism * history of severe immune deficiency

Keywords: periodontal defects alveolar bone preservation collagen membrane mucosa healing
platelet rich plasma vs. corticosteroid injection in the treatment of partial rotator cuff tears

Conditions: Rotator Cuff Tear

Summary: the purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. the specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (prp). subjects with partial thickness rotator cuff tears will be randomized to receive an injection of prp or corticosteroid. shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. subjects will be followed for one year to determine the outcomes for each treatment. the hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. prp injections for the treatment of partial thickness rotator cuff tears.


Eligibility criteria:
inclusion criteria: * shoulder pain for at least two weeks. * partial thickness articular sided rotator cuff tear diagnosed by mri and musculoskeletal ultrasound. exclusion criteria: * prior surgery to the injured shoulder * full thickness rotator cuff tear * pregnancy * cancer * current treatment with anticoagulation medication * steroid injection in the past 6 months in the injured shoulder * prior prp treatment to the injured shoulder

Keywords: prospective randomized controlled double blinded trial rotator cuff tear platelet rich plasma corticosteroid ultrasound
evaluating the efficacy and safety of of hsk44459 in people with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. the main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.


Eligibility criteria:
inclusion criteria: 1. diagnosed with idiopathic pulmonary fibrosis (ipf) prior to screening, patients must meet both of the following criteria: 1. ipf based on 2022 ats/ers/jrs/alat guideline as confirmed by the investigator based on chest hrct scan taken before or during screening period and if available surgical lung biopsy. 2. usual interstitial pneumonia (uip) or probable uip hrct pattern consistent with the clinical diagnosis of ipf, as confirmed by the investigator prior to screening. if indeterminate hrct finding ipf may be confirmed locally by (historical) biopsy. 2. percentage predicted forced vital capacity (ppfvc) ≥45% at screening period. 3. diffusion capacity of the lung for carbon monoxide (dlco) (corrected for haemoglobin \[hb\]) ≥ 25% of predicted normal at screening period. 4. patients have to be either: 1. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy. 2. on stable therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period. exclusion criteria: 1. clinically significant airways obstruction (forced expiratory volume in one second (fev1)/forced vital capacity (fvc) \< 0.7) at screening. 2. in the opinion of the investigator, other clinically significant pulmonary abnormalities. 3. acute ipf exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined). 4. lower respiratory tract infection requiring antibiotics within 2 weeks prior to screening and/or during the screening period. 5. major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (being on a transplant list is allowed). 6. history of malignancy within 5 years prior to screening. 7. any suicidal behavior within 2 years prior to screening (i.e. actual attempts, interrupted attempts, abandoned attempts, or prepared actions or attitudes).