Kornimate/medical-research-clean huggingface dataset:
an observational study to evaluate the safety and efficacy of humacyte's hav for arterial replacement or reconstruction in ukrainian patients with life or limb-threatening vascular trauma

Conditions: Trauma; Trauma Injury; Trauma, Multiple; Trauma Blunt

Summary: humacyte provided havs as humanitarian aid to ukraine. this retrospective observational study is designed to collect data from patients in whom the havs have already been implanted on a humanitarian basis between june 2022 and may 2023.


Eligibility criteria:
inclusion criteria: * patients with an hav implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity. * aged 18 to 85 years old, inclusive. * patient or legal representative is able, willing, and competent to give informed consent. exclusion criteria: • employees of the sponsor or patients who are employees or relatives of the investigator.

Keywords: extremities arterial replacement arterial reconstruction
kinetics of etheric oils, smart textiles vs. ointment

Conditions: Common Cold

Summary: the purpose of the study is to determine whether the application form of etheric oils (camphor, cineol and menthol) causes changes in the concentration of this agents in the exhaled air. the second aim of the study is to determine differences in the subjective convenience of the application forms. we will test an commercial ointment application vs. smart textiles. smart textiles are new high-tech products with the unique possibility to combine the textiles with functional products e.g. pharmaceutical agents.

on the first appointment recruitment investigations will take place. after the person is enrolled to the study, the first determination of substances concentration in exhaled air and the convenience grade of the application form being exposed to will be achieved (study day 1). after a 7 days lasting washout phase on study day 2 newly determination of substances concentration and convenience grade of the other application will be assessed. each study day will have an approximate duration of 11 h. during this time 9 samples of the persons exhaled air will be collected.

Eligibility criteria:
inclusion criteria: * caucasian * broca-index: between -20 and +25% * who are willing and capable to confirm written consent to enrolment after ample information has been provided * who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study. exclusion criteria: * subjects with any major relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs) * subjects with any major clinically relevant laboratory abnormality. * subjects who participated in another trial with any investigational substance within the last 4 weeks * subjects who smoke more than 15 cigarettes per day * subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol during the active study phase * subjects who adhere to a diet or lifestyle (incl. competitive sports and weight lifting) that might interfere with the investigation * subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy * subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed

Keywords: common cold organic chemicals menthol cineole camphor etheric oils alternative medicine smart textiles
prompting and encouraging community hydration through education

Conditions: Frailty

Summary: parched (prompting and encouraging community hydration through education) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. the investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty. parched will randomise four areas in cwm taf university health board to receive one of four different interventions. individuals will receive an intervention based on which area they live in, each participant will take part in the study for 12 weeks.

parched is a cluster feasibility randomized control trial (rct) exploring the potential of an innovative prompting cup and education as person-centred and holistic tools to empower nursing leadership to reduce frailty in a catheterised community-dwelling population. this project will investigate interventions to improve hydration as potentially economically viable solutions to reducing frailty in a vulnerable population. interventions have been developed using behaviour change theory and techniques. 80 participants will be recruited and will receive one of three interventions or usual care for a period of 12 weeks, data will be collected at baseline, 4 weeks and 12 weeks. questionnaires, semi-structured interviews, and routine hospital records will be collected or accessed as part of the study.

Eligibility criteria:
inclusion criteria: * parched will recruit district nurse patients at medium or high risk of dehydration (using the g, u and l of the gulp tool1), * with a urinary catheter, * living at home in community or residential care, * aged 18 years or above exclusion criteria: * inability to provide informed consent, * medical conditions or dietary restrictions that would substantially limit ability to complete study requirements (i.e. intravenous fluid intake, inability to lift cup), * living in nursing care setting, * end of life pathway, * diagnosed swallowing difficulty, * inability to communicate in english or welsh.

Keywords: hydration fluid intake frailty feasibility study
a study evaluating the safety and tolerability of qrl-201 in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the primary objective of this study is to determine the safety and tolerability of multiple doses of qrl-201 in people living with als

this first-in-human, phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (pk) of qrl-201 administered intrathecal (it) to participants with amyotrophic lateral sclerosis. two dose escalation cohorts of 8 participants each, followed by an additional 48 participants, receiving the study drug in a 6:2 ratio of qrl-201 to placebo.

Eligibility criteria:
inclusion criteria: * male or female participants aged 18 to 80 years diagnosed with als * als symptom onset within 24 months of screening * slow vital capacity \>50% * clinical or electrodiagnostic evidence of lower motor neuron involvement * not pregnant and not nursing * willing and able to practice effective contraception * able to tolerate lumbar puncture * if on approved therapies for the treatment of als during the course of the study, must be on a stable dose (at the sponsor's discretion) exclusion criteria: * pathogenic variant, likely pathogenic variant, or variant of uncertain significance in the superoxide dismutase 1 (sod1) and/or fused in sarcoma (fus) genes * currently enrolled in any other clinical study involving either an investigational product (ip) or off-label use of a drug or device * prior exposure to stem cell or gene therapy products * any contraindication to intrathecal drug administration * abnormal laboratory values deemed clinically significant by the investigator * significant infection or known inflammatory process * any sign and/or history of neurological conditions and other neuromuscular disorders that could affect the electrophysiological recordings. * an eeg that shows signs of abnormal electrical activity (e.g., epilepsy)

Keywords: als, stathmin-2, stmn2, aso, antisense oligonucleotide
prognostic significance of fine-needle aspiration cytology features in papillary thyroid carcinoma

Conditions: Thyroid Neoplasms

Summary: the purpose of this study is to investigate the relationship between prognosis and fine needle aspiration cytology character of papillary thyroid cancer.

papillary thyroid carcinoma is the most common thyroid malignancy worldwide. the influence of clinicopathologic features on prognosis has been examined, but the relationship between cytologic features obtained by fine-needle aspiration (fna) and prognosis has been minimally studied. we retrospectively studied the cytologic features with computerized morphometry in 83 patients with usual-type papillary thyroid cancer and followed them for more than 10 years except for one with metastasis at diagnosis. the cytologic features of fna and recurrence of cancer were examined statistically.

Eligibility criteria:
inclusion criteria: * papillary thyroid cancer diagnosed in ntuh from 1977 to 2000 exclusion criteria: * patient without complete medical record
low pulse amplitude seizure therapy (lap-st study)

Conditions: Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Summary: this study assesses the feasibility of a full course of low pulse amplitude-seizure therapy (lap-st) (primary outcome).

this is hypothesized to increase stimulation focality, thus minimizing cognitive side effects compared to conventional ect. the study will enroll 22 patients recruited from the behman hospital, cairo, egypt. patients referred to ect service in the behman hospital who are clinically indicated to do ect for major depressive episode of a mood disorder or psychotic episode of a primary psychotic disorder will be approached. eligible participants who signed informed consent will be included to receive a course of right unilateral ultrabrief lap-st.

Eligibility criteria:
inclusion criteria: 1. ect clinically indicated 2. males or females over 22 to 80 years of age 3. use of effective method of birth control for women of child-bearing capacity 4. patient is medically stable 5. capacity of patient to fully participate in the informed consent process as evaluated by their clinician exclusion criteria: 1. current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ect 2. history of conditions that may make ect unsafe such as metal in the head, or a skull defect 3. female patients who are currently pregnant or plan to be pregnant during the study

Keywords: low pulse amplitude seizure therapy electroconvulsive therapy low pulse amplitude electroconvulsive therapy low pulse amplitude ect lap lap-st ect mood disorders psychotic disorders
open-label, 48-week extension study of elvucitabine in combination with background antiretroviral therapy (art) for participants who have completed study ach443-014a

Conditions: Human Immunodeficiency Virus (HIV)-1 Infection

Summary: to assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (art) in participants who completed study ach443-014a and meet the inclusion and exclusion criteria.

this study is an open-label extension study for participants who have completed 14 days of treatment in study ach443-014a and meet all inclusion and exclusion criteria. elvucitabine treatment (10 mg) will begin on day 1 (day 15 following completion of study ach443-014a) for all consenting participants in combination with background art as determined by the principal investigator. participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to week 48.

Eligibility criteria:
inclusion criteria: * participants who have completed 14 days of treatment in study ach443-014a and who, in the investigator's judgment, remain candidates to receive elvucitabine together with background art. exclusion criteria: * failure to meet inclusion criteria

Keywords: extension study to study ach443-014a
an open-label study of a gene therapy product (vebeglogene autotemcel) in transfusion dependent beta-thalassemia

Conditions: Beta-Thalassemia

Summary: this is an interventional study to evaluate the safety and efficacy of autologous hematopoietic stem and progenitor cells (hspcs) transduced with lentiviral vector encoding functional hemoglobin subunit beta (hbb) gene in patients with transfusion-dependent beta-thalassemia.

the participant's autologous hspcs will be transduced with the self-inactivating lentiviral vector, carrying the functional hbb gene. study duration per participant is approximately 27 months including an approximately 30-day screening/baseline period, an approximately 60-day mobilization and product manufacture, an approximately 10-day myeloablative conditioning, 1 treatment day, and an approximately 24-month study observation period. the endpoints will be used to assess the safety and efficacy profiles in patients with transfusion-dependent beta-thalassemia.

Eligibility criteria:
inclusion criteria: * patients or parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedules. * diagnosis of beta-thalassemia and a history of rbcs transfusions. * documented baseline, or pretransfusion, hb≤7 g/dl. * availability of an adequate and well-documented transfusion history. exclusion criteria: * active bacterial, viral, fungal, or parasitic infection. * a white blood cell (wbc) counts\<3×10\^9/l, and/or platelet counts\<100×10\^9/l not related to hypersplenism. * uncorrected bleeding disorder. * presence of severe diseases that judged not compatible with the study procedures, such as severe hepatic disease, kidney disease, lung disease, and/or cardiovascular disease. * uncontrolled seizure disorder. * any evidence of severe iron overload that, in the investigator's opinion, warrants exclusion. * prior autologous hematopoietic stem cell transplantation. * prior receipt of gene therapy.
to evaluate the efficacy of alirocumab for neoatherosclerosis by using oct, in comparison with standard statin therapy

Conditions: Coronary Artery Disease Progression

Summary: the aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.

the investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. the investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group. the investigators compare these two group for outcomes.

Eligibility criteria:
inclusion criteria: 1. the age at the time of consent acquisition is 20 years old or over. 2. oct images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent 3. lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed. 4. baseline oct was scheduled to be revisited within 6 to 12 months, or already performed. 5. document consent has been obtained from the subject person to this research. exclusion criteria: 1. patients who have received treatment with pcsk 9 inhibitor in the past 2. patients whose treatment was interrupted before follow-up catheterization during the observation period 3. patients underwent ldl apheresis. 4. in the case that the researchers judges it as inappropriate as the object of this research.

Keywords: in-stent neoatherosclerosis alirocumab
cancer as a complication in recipients of autologous hematopoietic stem cell transplantation for autoimmune disease indication treated in france and canada?

Conditions: Autoimmune Diseases

Summary: autologous hematopoietic stem cell transplantation (ahsct) is a treatment option for several types of autoimmune disease (ad) in patients who remain active despite disease modifying therapies. in this setting, ahsct was shown to improve overall survival, event free survival and quality of life, with a grade a level evidence for systemic sclerosis (ssc) and multiple sclerosis (ms) patients and its benefit varies according to the ad type and the patient status for the other indications. the number of ahsct for ad has increased in the past twenty years at each country level in europe and also in canada. information about cancer after ahsct for ad is scant, although the ad patients population per se has an increased rate of cancer. this cancer risk can be explained in part by the long term use of immunosuppressive drugs or by other risk factors related to the ad (as in ssc or crohn) or to the patient. in addition to pretransplant potential risk factors for cancer in ad patients, the use of conditioning regimen, which may vary from low, medium or high immunosuppressive to myeloablative chemotherapy when irradiation is added to the proecedure, may favor the onset of cancer after ahcst. updated analysis and review of the literature until march 2023 led us to identify only twenty-two cases of cancer or hematological malignancies reported after ahsct recipients for an ad. the incidence of cancer after ahsct for ad was never considered as a primary endpoint in any previous study. in this context, the aim of this study is to describe the incidence of cancer after autologous hematopoietic stem cell transplantation (ahsct) for auto-immune diseases (ad) in the french mathec (french scientific network for ad and cellular therapies) and the ottawa and calgary patients cohorts from day 0 until twenty years follow up after ahsct.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years at ahsct 2. underwent first ahsct for any ad indication 3. included in the french mathec-sfgm-tc registry or the canadian ottawa and calgary databases 4. ahsct between january, 1st, 2000 and december, 31st, 2022 5. informed consent for data registration in the respective original registry/database exclusion criteria: none

Keywords: autoimmune diseases hematopoietic stem cell transplantation cancer
optimization of the surgical care pathway for kidney tumors by digitizing perioperative nursing coordination (uroccr 126)

Conditions: Digitizing Perioperative Nursing Coordination

Summary: the project proposes to evaluate the interest of the uroconnect remote monitoring medical device (dm) to optimize patient support and nursing coordination

kidney cancer represents 2 to 3% of solid cancers in adults. worldwide, an estimated 431,288 people a year are diagnosed with kidney cancer. each year, in france, 13,500 patients undergo total or partial nephrectomy. the development of minimally invasive surgical techniques and the structuring of innovative care pathways for the management of renal tumors in enhanced rehabilitation after surgery (raac) and even on an outpatient basis have led to a significant reduction in the length of stays. the physiognomy of the course of care for patients operated on for a renal tumor is completely modified and generates for the patient a feeling of deterioration in the quality of care and disruption of medical follow-up. the objective is to deploy a model for coordinating the perioperative care pathway of patients who have undergone nephrectomy for renal tumor in several french centers in order to assess the impact for patients, caregivers and the health system. this coordination would lead to the formalization of a nurse coordinator job profile adapted to the specificities of oncological surgery and the tools necessary for its implementation. the uroconnect device has a "patient" interface for presenting self-questionnaires and access to a library of educational content and a "caregiver" interface to rationalize and optimize the nurse's activity of perioperative coordination in his task.

Eligibility criteria:
inclusion criteria: * planned surgical management by total or partial nephrectomy for kidney tumor, * affiliation or beneficiary of the french social security * expressed consent for integration of the uroccr cohort, * expressed consent to participate in the dipru study. exclusion criteria: * difficulties understanding and expressing oneself in french * participant under guardianship or curatorship * pregnancy at the time of surgery * no internet access

Keywords: kidney tumor digital tool care pathways cost analysis health economic evaluation
acute microbial switch

Conditions: Insulin Sensitivity; Glucose Metabolism Disorders (Including Diabetes Mellitus); Hyperinsulinism

Summary: in this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.

in this project the investigators aim to test whether it is possible to precisely measure the changes in fermentation gas patterns after supplementation of a complex fibre mixture over a 36-hour period in both lean normoglycemic and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo. additionally, the investigators will investigate whether changes in fermentation patterns will be directly related to changes in carbohydrate and fat oxidation and to microbial composition or related metabolites and hormones in blood, faeces, and urine.

Eligibility criteria:
inclusion criteria: * lean normoglycemic individuals: * lean (bmi ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 ); * normal fasting glucose (plasma glucose \< 5.6 mmol/l) and a homa-ir\< 2.2 individuals with overweight/obesity and prediabetes/insulin resistance: * overweight/obesity (bmi ≥ 28 kg/m2 and ≤ 40 kg/m2 ); * insulin resistance (homa-ir\>2.2) and/or impaired fasting glucose (ifg: plasma glucose ≥ 5.6 mmol/l) for both subject groups: * aged 30 - 75 years; * normal blood pressure (systolic blood pressure 100-150mmhg, diastolic blood pressure 60-100 mmhg); * weight stable for at least 3 months (± 2 kg) exclusion criteria: * t2dm (defined as fasting plasma glucose ≥ 7.0 mmol/l) * gastroenterological diseases * abdominal surgery affecting the gi tract; * cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years; * abuse of products; * alcohol (\> 15 standard units per week) * drugs * excessive nicotine use defined as \>20 cigarettes per day; * plans to lose weight or following of a hypocaloric diet * regular supplementation of pre- or probiotic products, use of pre- or probiotics three months prior to the start of the study; * intensive exercise training more than three hours a week; * use of most medications that influence glucose or fat metabolism, like some lipid lowering-drugs (e.g., ppar γ or pparα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g., anti-inflammatory\* or immunosuppressive drugs) and anti-oxidants; * regular use of laxatives; * use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition). * veganism * lactose intolerance * for women: pregnancy or lactation

Keywords: microbiota insulin sensitivity fiber