Kornimate/medical-research-clean huggingface dataset:
percutaneous punch biopsy for diagnosis of septic and aseptic prosthetic joint failure

Conditions: Wear of Articular Bearing Surface of Internal Prosthetic Joint; Infection Prosthetic; Infections Joint Prosthetic; Prosthetic Joint Infection; Prosthetic Pain

Summary: the aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation.

the main aim of the study is to demonstrate the superiority of a punch biopsy over a joint tap to rule out or prove septic prosthesis failure and thus establish a new diagnostic method. the subsequently calculated sensitivities of the previous and the procedure are used as the main indicator. in addition, we would like to prove that the total cost of diagnosing a septic / aseptic prosthesis failure using the proposed method has socio-economic advantages over the previous algorithm. one of the secondary objectives is the evaluation of the use of a punch biopsy for simultaneous a priori pathomorphological examination of periprosthetic soft tissue samples for the determination of wear particles. furthermore, the study is intended to demonstrate a shortening of the time span between the first suspected diagnosis of septic prosthesis failure and its reliable exclusion / detection.

Eligibility criteria:
inclusion criteria: * preceding implantation of a shoulder, hip or knee endoprosthesis * acute or chronic pain in the joint * periprosthetic fracture * instability of the endoprosthesis * indications of wear / insufficiency of the enclosed plastic spacers * indications of metal abrasion * primary misalignment of the implant exclusion criteria: * confirmed periprosthetic infection * proven allergy to fast-acting local anesthetics

Keywords: prosthetic joint infection wear particles prosthetic failure antibiotics biopsy joint tap
therapeutic drug use for ckd patients

Conditions: Chronic Kidney Disease

Summary: chronic kidney disease (ckd), characterized as renal dysfunction, is recognized as a major public health problem with high morbidity and mortality worldwide. this study aimed to analyze the common drug use and combinations of different stages and types of ckd patients. the study is a multicenter retrospective study involving three hospitals. investigators reviewed and analyzed all patients diagnosed with chronic kidney disease from july 1, 2020 to june 30, 2022. chronic kidney disease was defined as egfr less than 60 ml/min per 1·73 m(2) or the presence of albuminuria. the study selected seven types of drugs based on hospital electronic medical record data, including β receptor blockers, angiotensin converting enzyme inhibitor blockers, angiotensin ii receptors, dpp-4 inhibitors, glp-1 receptor agonists, sglt2 inhibitors, and calcium channel blockers. chi-square test, mann-whitney wilcoxon test, and kruskal wallis test will be used for statistical analysis. the main purpose of this study is to provide evidence for promoting rational drug use in ckd patients by describing the drug use. the secondary purpose of the study is to explore the efficacy, safety and economy of sglt-2 inhibitors in diabetes nephropathy (dn).


Eligibility criteria:
inclusion criteria: 1. visit time (based on admission time for inpatients) is from july 1, 2020 to june 30, 2022 2. any diagnostic type of the patient's visit includes ckd related diagnostics 3. age ≥ 18 years old exclusion criteria: 1. diagnosis includes malignant tumors 2. diagnosis includes uremia, hemodialysis, or peritoneal dialysis 3. diagnosis includes jaundice 4. incomplete clinical data

Keywords: chronic kidney disease diabetes nephropathy drug effectiveness drug safety drug economics
study in schizophrenic in-patients treated with quetiapine prolong or oral risperidone at flexible dose

Conditions: Schizophrenic Disorders

Summary: this pilot trial in finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (schizophrenia or schizoaffective psychosis or schizophreniformic psychosis)diagnostic and statistical manual (dsm - iv) with the first visits on days 1, 2, 4 or 5 and 7 ± 1.


Eligibility criteria:
inclusion criteria: * in the opinion of the investigator, requirement for treatment for an acute episode of schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to dsm-iv diagnostic criteria), positive and negative symptoms scale (panss) ≥ 65, cgi ≥ 4 exclusion criteria: * pregnancy or lactation * in-patients/hospitalized \> 7 days before enrollment * known intolerance or lack of response to quetiapine fumarate or risperidone, as judged by the investigator

Keywords: schizophrenia schizoaffective psychosis schizophreniformic psychosis pilot study quetiapine prolong risperidone
the effect of intermittent fasting on brain health

Conditions: Intermittent Fasting; Aging

Summary: the central hypothesis of this study is that closer adherence to time restricted eating (tre) will improve endothelial function, neurovascular (nvc) responses, resulting in improved cognitive performance, potentially through activation of sirt1-dependent vasoprotective pathways.

this hypothesis will be tested by assessing the effect of tre (not more than 10hr eating window each day for 6 months) in healthy older adults (55-80 years of age).

Eligibility criteria:
inclusion criteria: * age ≥55 and ≤80 years of age * adequate hearing and visual acuity to participate in the examinations * ability to read and write in english * competence to provide informed consent. * mini montreal cognitive assessment ≥12 * mini nutritional assessment ≥12 exclusion criteria: * vision or hearing impairment that would impair the ability to complete study assessments * active cns disease including multiple sclerosis, uncontrolled seizures, active brain cancer * cerebrovascular accident other than tia within 60 days prior to visit 0 * major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse * diabetics prescribed sulfonylureas, meglitinides, and insulin * any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol

Keywords: intermittent fasting aging
evaluate the efficacy of disopyramide therapy in hypertrophic obstructive cardiomyopathy patients

Conditions: Cardiomyopathy

Summary: population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. tow echo examination, few hours apart, that includes strain rate will be done to each patient. the first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

tow echo examination, few hours apart, that includes strain rate will be done to each patient. the first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

Eligibility criteria:
inclusion criteria: * hypertrophic cardiomyopathy that treated with disopyramid exclusion criteria: * pregnancy * pacemaker

Keywords: hypertrophic cardiomyopathy, disopyramide,
superoxide dismutase (sod) as antioxidant treatment of age related macular degeneration (armd)

Conditions: Age Related Macular Degeneration

Summary: introduction: acting directly on the anti-radical enzyme chain, the superoxide dismutase (sod), a major enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in armd. its synthesis depends on the cellular oxygenated reactive species, and leads to the conversion of the superoxide ion (o2-) into hydrogen peroxide (h2o2). this compound is the cell watch guard continuously regulating a free radicals' detoxifying chain. subsequently, by increasing the production of h2o2, the administration of sod can trigger endogenous/internal antioxidant mechanisms. oral administration of sod is possible in its galenic form, glisodine. the purpose of this study was to evaluate the protective effect of sod on the bilateralization of the disease.


Eligibility criteria:
inclusion criteria: * unilateral neo-vascular armd exclusion criteria: * other pathology

Keywords: armd sod
a clinical assessment study of subjects with mucopolysaccharidosis iva (morquio syndrome)

Conditions: MPS IV A; Mucopolysaccharidosis IVA; Morquio A Syndrome

Summary: this multicenter, multinational, longitudinal study will quantify endurance and respiratory function in subjects diagnosed with mps iva and will better characterize the spectrum of symptoms and biochemical abnormalities in mps iva disease over time.


Eligibility criteria:
inclusion criteria: * willing and able to provide written, signed informed consent, or in the case of subjects age \< 18 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures. * documented history of reduced galns activity relative to the normal range of the laboratory performing the assay, or documented result of molecular genetic testing confirming diagnosis of mps iva. * willing and able to comply with all study procedures. exclusion criteria: * use of any investigational product or investigational medical device within 30 days prior to screening. * previous hematopoietic stem cell transplant (hsct). * concurrent disease or condition that would interfere with study participation or pose a safety concern.

Keywords: mucopolysaccharidosis iv type a mps iv type a mucopolysaccharidosis iva mps iva morquio a syndrome lysosomal storage disorder lsd n-acetylgalactosamine-6-sulfatase galactose-6-sulfatase galns enzyme replacement therapy ert
glucosamine periodontal adjunctive therapy

Conditions: Chronic Periodontitis

Summary: this study is the first evidence based work evaluated the systemic use of glucosamine as an adjunctive therapy to closed mechanical debridement in chronic periodontitis. the use of glucosamine sulphate was correlated with clinical outcomes and il1-β level in the gcf of patients with moderate to advanced chronic periodontitis

targeting the inflammatory response may be a rational approach to the medical treatment of chronic periodontitis. glucosamine sulphate (gs) was proven to have anti-inflammatory actions with minimal side effect profile. objectives; the main objectives of this study were to evaluate clinically the efficacy of gs; as a novel adjunctive host modulating agent in periodontal therapy and to investigate its effect on gingival crevicular fluid (gcf) level of il-1β. methods; forty patients with moderate to severe chronic periodontitis (cp) were included in this study. they were randomly divided into two groups. group i (g1) patients (n=20) received 500 mg gs capsules three times daily for 3 months following full mouth scaling and root planing (srp), while group ii (g2) patients (n=20) received a placebo for the same period following full mouth srp. clinical periodontal parameters and gcf il-1β levels were analyzed at baseline and 3 months following therapy.

Eligibility criteria:
inclusion criteria: 1. good compliance with the plaque control instructions following initial therapy 2. each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm 3. teeth involved were all vital with score 0-1 mobility 4. availability for the follow-up and maintenance program; exclusion criteria: 1. no systemic diseases which could influence the outcome of therapy as evidenced by burket's oral medicine health history questionnaire 2. absence of periodontal treatment for the previous year 3. absence of systemic medication or antibiotic treatment for the previous six months 4. absence of a smoking habit. 5. post menopausal, pregnant or breast feeding women were excluded from participating in the study. patients with contraindications to glucosamine sulphate therapy e.g., hypersensitivity to any of the product's components or with inadequate compliance with the oral hygiene maintenance schedule were also excluded from the study.

Keywords: cytokines interleukin-1β chronic periodontitis host modulation glucosamine sulphate.
top-study (tacrolimus organ perfusion): treatment of ischemia reperfusion injury in marginal organs with an ex vivo tacrolimus perfusion

Conditions: Terminal Liver Disease; Ischemia Reperfusion Injury; Graft Dysfunction; Graft Failure; Poor Graft Quality

Summary: utilisation of extended criteria donors due to critical organ shortage contributes to increased ischemia reperfusion injury as well as mortality following liver transplantation. experimental data show protective effects on hepatic ischemia reperfusion injury (iri) using the calcineurin inhibitor tacrolimus applied intravenously or directly as a hepatic rinse. moreover clinical data indicate a protective role of a tacrolimus rinse in human liver transplantation when using normal, healthy grafts. the effects of tacrolimus on hepatic injury in extended donor criteria (edc) liver grafts remain unclear. therefore, the aim of the present study is to examine the effects of a tacrolimus ex vivo rinse (20 ng/ml) on cellular injury after transplantation of marginal liver grafts exhibiting 2 or more edcs according to eurotransplant's definition of edc grafts.


Eligibility criteria:
inclusion criteria: recipient: chronical terminal liver failure, age \> 18 years, first organ transplantation donor: * donor age \> 65 jahre * macrovesicular steatosis \> 40% (macroscopy or biopsy) * bmi \> 30 * sodium \>165 mmol/l * icu stay and ventilation \> 7 days * cold ischemia time \> 13 hours * ast \> 99 u/l * alt \> 105 u/l * bilirubin \> 3 mg/dl (\> 51 µmol/l) * application of epinephrine exclusion criteria: donor: • hepatitis b- or hepatitis c-infection recipient: * multi organ transplantation * high urgency listing * extrahepatic tumor disease * pregnancy

Keywords: liver transplantation edc iri graft survival graft function graft preconditioning tacrolimus rinse randomised multicenter trial
octreotide as palliative therapy for cancer-related bowel obstruction that cannot be removed by surgery

Conditions: Colorectal Cancer; Constipation, Impaction, and Bowel Obstruction; Extrahepatic Bile Duct Cancer; Gastric Cancer; Gastrointestinal Stromal Tumor; Nausea and Vomiting; Ovarian Cancer; Pancreatic Cancer; Peritoneal Cavity Cancer; Small Intestine Cancer

Summary: rationale: palliative therapy with octreotide may help patients who have bowel obstruction that cannot be removed by surgery to live longer and more comfortably. purpose: phase ii trial to study the effectiveness of octreotide as palliative therapy in treating patients who have cancer-related bowel obstruction that cannot be removed by surgery.

objectives: * determine the effectiveness of octreotide in the palliation of bowel obstruction secondary to cancer. * characterize the dose and tolerability of octreotide in this patient population. outline: patients receive octreotide subcutaneously or iv over 24 hours on days 2-5. patients who respond well to study may continue octreotide for palliative effects. projected accrual: a total of 9-25 patients will be accrued for this study over 9 months.

Eligibility criteria:
disease characteristics: * inoperable bowel obstruction secondary to cancer or * metastatic or primary abdominal cancer * patient presents with vomiting * percutaneous gastrostomy tube allowed patient characteristics: age: * over 18 performance status: * ecog 0-4 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no documented hypersensitivity to octreotide * not pregnant or nursing prior concurrent therapy: biologic therapy: * not specified chemotherapy: * prior chemotherapy allowed endocrine therapy: * concurrent steroids allowed radiotherapy: * prior radiotherapy allowed surgery: * not specified

Keywords: stage i colon cancer stage ii colon cancer stage iii colon cancer stage iv colon cancer stage i gastric cancer stage ii gastric cancer stage iii gastric cancer stage iv gastric cancer recurrent gastric cancer stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer recurrent pancreatic cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer stage i ovarian epithelial cancer stage ii ovarian epithelial cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer recurrent ovarian epithelial cancer small intestine adenocarcinoma small intestine lymphoma small intestine leiomyosarcoma localized extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer recurrent small intestine cancer constipation, impaction, and bowel obstruction peritoneal cavity cancer nausea and vomiting gastrointestinal stromal tumor
registry protocol for tracking trial subjects after vti-206 study completion

Conditions: Acute Liver Failure

Summary: vti-207 (nct01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol vti-206 (nct00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.

vital therapies, inc. (vti) is conducting clinical trial vti-206 in which subjects with acute on chronic hepatitis (aoch) and acute alcoholic hepatitis (aah) are treated with the elad system to assess the safety and efficacy of this therapy. the elad system incorporates cloned immortalized human liver cells (c3a cells). a hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with elad. the company is also collecting data related to whether a patient received a liver transplant and on survival.

Eligibility criteria:
inclusion criteria: * subjects participating in the vti-206 clinical trial. exclusion criteria: * subjects not participating in the vti-206 clinical trial.

Keywords: liver liver failure acute liver failure elad alcoholic hepatitis acute on chronic hepatitis
investigation of skin pigmentation effect on performance of masimo pulse oximetry (inspire)

Conditions: Hypoxemia

Summary: the objective of this study is to evaluate the performance of masimo rd set® spo2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.


Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older. * subject is receiving care in an intensive care unit. * subject with an arterial catheter in place. * subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air exclusion criteria: * subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity). * subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.). * subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care. * subjects with nail polish or acrylic nails on the digits where sensor needs to be applied. * subjects with known allergic reactions to adhesive tapes. * subjects with arterial catheter placed in a lower extremity. * subjects not suitable for the investigation at the discretion of the investigator or the clinical team.
improving physical activity in young adult cancer survivors

Conditions: Physical Activity; Quality of Life

Summary: the primary goal is to conduct a 12 week pilot randomized controlled trial (rct) of the fitbit flex, a popular, affordable, wearable physical activity tracking device, and the fitbit mobile health (mhealth) app. the target population will be cancer survivors 18-39 years old recruited from the seattle cancer care alliance. for the intervention group, peer influences will be engaged via a private, social network (e.g. a facebook group) customized for survivors. measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). this pilot study will provide initial proof of concept and allow for further customization of the intervention for cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period. besides conducting exploratory analyses of primary and secondary outcomes for this pilot rct, we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39 years and between 1.0-5.0 years from the completion of active cancer therapy, (2) intervention participants wear the fitbit flex on the majority of all intervention days during the 12-week intervention period, and (3) ≥75% of all participants complete online questionnaire data collection at time 1 and time 2.


Eligibility criteria:
inclusion criteria: * does not meet recommended guidelines for physical activity (pa,150 min of moderate activity or 75 min of vigorous activity) * currently between 1.0-5.0 years from the completion of active cancer therapy * able to read and speak english * have a smart phone (or can borrow a study-provided ipod touch) and willing to use it for the mobile app and facebook group exclusion criteria: * pregnant or planning on becoming pregnant in the next year
intermittent pneumatic compression for treating lower limb lymphoedema

Conditions: Lymphoedema of Leg

Summary: the treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited nhs resources. intermittent pneumatic compression (ipc) represents an innovative treatment for this condition, however the efficacy of ipc as a treatment for lower limb lymphoedema needs to be investigated via robust clinical research.

the primary aim of this research is to evaluate the effectiveness of intermittent pneumatic compression (ipc) as a treatment for lower limb lymphoedema as a whole, and to compare the effectiveness of a new generation device, in this case the lymphassist (huntleigh healthcare), against older sequential models. the study methodology consists of a pilot randomised control trial of two groups - intervention group a will continue to receive their standard lymphoedema care but will also be provided with a lymphassist ipc device to use, mimicking manual lymph drainage therapy. participants in intervention group b will receive their standard care plus an ipc device that uses sequential therapy. each participant will act as a control for a 5 week period continuing with their standard treatment only. outcome measures include impact on limb volume, skin stiffness and elasticity score and impact on quality of life scores.

Eligibility criteria:
inclusion criteria: * age 18 or over, * able to provide written consent, * confirmed diagnosis of lower limb isl stage ii or iii. exclusion criteria: * • unable to provide written consent * severe congestive heart failure * severe skin problems, lower limb ulcers or wounds. * presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the ipc device safely or adhering to instructions/study protocol. * non-pitting chronic lymphoedema. * known or suspected deep vein thrombosis. * pulmonary embolism. * thrombophlebitis. * acute inflammation of the skin (erysipelas, cellulitis). * uncontrolled/severe cardiac failure. * pulmonary oedema. * ischaemic vascular disease. * active cancer diagnosis. * active metastatic diseases affecting the oedematous region. * oedema at the root of the extremity or truncal oedema. * severe peripheral neuropathy.