Kornimate/medical-research-clean huggingface dataset:
multimodal exercise training poststroke

Conditions: Exercise; Stroke

Summary: individuals poststroke with gait and balance impairment are typically less active and have low levels of physical fitness. improving fitness level while also improving gait and balance is very important. maximizing the exercise training benefit requires the appropriate level of effort is achieved. traditional exercise programs scale aerobic demand by increasing the walking speed or the slope of the treadmill surface. this may be difficult for individuals who experience decreased balance at faster speeds or on sloped surfaces and require the use of handrails to safely walk under these conditions. these exercise programs show limited improvement in walking ability after training. this project will test a novel approach, resistance-based treadmill walking, for maximizing improvements in fitness and ability to walk by individuals poststroke. the investigators previous research has shown that backward directed resistive force applied to the pelvis while walking is well tolerated by individuals poststroke. further, these forces can be used to effectively scale aerobic demand while walking in a controlled manner. with traditional treadmill training approaches handrail support is utilized to ensure safety. however, handrail support externally stabilizes the individual reducing training improvements in walking capacity and balance. for this pilot investigation a group that aerobically trains using a standard exercise treadmill training paradigm will be compared to a group that experiences progressive backward directed resistive forces applied to an individuals' pelvis while they walk at comfortable walking speeds without the aid of handrails. individuals will wear a fall harness that provides no external stabilization but prevents falls to the treadmill surface. this approach has the potential benefit of allowing individuals poststroke to meaningfully practice walking at safe speeds but against resistance thereby improving walking economy, dynamic balance, and walking speed. the proposed project is necessary to gather preliminary data for a much larger training study that has the potential to change the clinical approach for improving gait economy, balance, and walking speed for individuals poststroke.


Eligibility criteria:
inclusion criteria: * inclusion criteria: unilateral stroke that resulted in hemiplegia (\> 6 months post injury), older than 18 years of age, ability to walk independently, medically stable (controlled hypertension, no arrhythmia, stable cardiovascular status), and able to provide written informed consent. exclusion criteria: * history of serious cardiac disease (e.g., myocardial infarction), uncontrolled blood pressure, presence of cerebellar and brainstem deficits, severe cognitive disorder, inability to follow simple commands, uncontrolled respiratory or metabolic disorders, major or acute musculoskeletal problems.

Keywords: exercise multimodal balance resistance mobility
safety and efficacy of 9mw0813 in subjects with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: a multicenter, randomized, double-blind, parallel-controlled phase i trial comparing the safety, pharmacokinetics and efficacy of 9mw0813 and aflibercept (eylea®) after a single dose in patients with diabetic macular edema (dme).

this is a multi-center, randomized, double-blind, parallel controlled phase i clinical trial. the primary objective is to compare the safety of a single intravitreal injection (ivt) of 9mw0813 injection and aflibercept intraocular injection solution (eylea®) in dme patients. the secondary objectives are to comparing the pharmacokinetic profile, immunogenicity and efficacy of a single intravitreal injection (ivt) of 9mw0813 injection and aflibercept intraocular injection solution (eylea®) in dme patients.

Eligibility criteria:
main inclusion criteria： 1. diagnosed with type 1 or type 2 diabetes with hba1c ≤ 11.0%; 2. use etdrs chart bcva ≥ 19 letters and ≤ 73 letters (approximately equivalent to snellen chart equivalent 20/40 to 20/400); 3. central retinal thickness (crt) ≥ 300 μm, (using spectral domain optical coherence tomography); 4. bcva ≥ 24 letters in the non-study eye (approximately 20/320 equivalent on the snellen chart). main exclusion criteria: 1. with proliferative diabetic retinopathy (pdr), excluding inactive, fibrotic pdr; 2. vitreous hemorrhage within 30 days before the first administration; 3. structural retinal damage involving the fovea (such as retinal pigment epithelium (rpe) atrophy, retinal fibrosis, laser scarring, dense hard exudates), or the investigator believes that the study eye has other factors that may hinder vision after macular edema subsides increased retinal damage; 4. existing ophthalmic conditions other than diabetic retinopathy that cause macular edema or vision changes (such as retinal vein occlusion (rvo), choroidal neovascularization, retinal detachment, macular hole, macular retinal traction, epiretinal membrane, etc.) ; 5. there are iris neovascularization; 6. uncontrolled glaucoma (defined as intraocular pressure ≥ 25mmhg after anti-glaucoma drug treatment) or glaucoma-causing cup/optic disc ratio of the study eye \>0.8 or previous glaucoma filtering surgery (such as trabeculae); excision, sclerectomy, etc.); 7. the investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test; 8. aphakia (excluding intraocular lens) or posterior capsule defect (except for yag laser posterior capsulotomy after intraocular lens implantation within 30 days); 9. history of vitrectomy.

Keywords: aflibercept biosimilarity safety pharmacokinetics pharmacodynamics
microbiological molecular profile of the knee joint during primary reconstruction or revision surgery of the acl

Conditions: ACL - Anterior Cruciate Ligament Rupture

Summary: anterior cruciate ligament (acl) reconstructions are common surgical procedures, but a significant number fail for reasons that are not fully understood. silent infections have been shown to cause failure after other orthopedic surgical procedures such as fracture fixation and joint replacement. silent and subclinical infections, as well as disruptions in the knee joint microbiome, could therefore be potential causes of failure after ligament reconstruction. traditional infection diagnostic methods (microbiological cultures) are often inadequate to detect these silent infections due to a lack of sensitivity. new molecular techniques such as high-throughput sequencing or ngs (next-generation sequencing) overcome this sensitivity problem and have proven effective in diagnosing polymicrobial infections. increased sensitivity compared to traditional culture has been reported in numerous studies, with some demonstrating the ability of ngs to isolate the infectious organism(s) in up to 82% of culture-negative cases. these studies demonstrate the importance of advanced sequencing technologies for the diagnosis and management of infections after acl reconstruction, offering promising prospects for improving clinical outcomes. at the jean mermoz private hospital, acl reconstruction is performed using a graft that is previously immersed in vancomycin. in this context, this study will characterize the knee joint microbiome in the context of acl reconstruction with a graft treated with antibiotics.


Eligibility criteria:
inclusion criteria: * patient undergoing primary acl reconstruction or revision surgery * patient for whom access to the operative report of the primary acl reconstruction is available * patient affiliated with or beneficiary of a social security system * patient who speaks french and has signed informed consent exclusion criteria: * patients with preoperative signs or a history of knee joint infection * patients suffering from diabetes, cancer, or a chronic inflammatory disease * patients receiving immunosuppressive therapy * patients with elevated serum inflammatory markers * patients who have used intravenous drugs in the 3 months prior to surgery * patients who have used antibiotics in the 3 months prior to surgery * protected patients: adults under guardianship, curatorship, or other legal protection, persons deprived of their liberty by a judicial or administrative decision, persons under a protective measure, persons admitted to a health or social care facility for purposes other than research, and persons unable to express consent * pregnant or breastfeeding women
meniscus regeneration after meniscectomy and its clinical significance

Conditions: Meniscus Rupture; Regeneration

Summary: meniscus injury is common in sports-active population, and partial or total meniscectomy is standard surgery for meniscal tear. meniscus plays an important role in load transferring, shock absorbing, knee joint stabilizing and chondral protection. plenty of studies indicate that meniscus-deficiency increases the risk of oa and cause long-term poor outcomes. spontaneous human meniscus regeneration is rarely reported and whether regenerated meniscus is chondral-protective and can prevent oa progression remain unknown. during our clinical practice, we have encountered many cases with complete meniscal regeneration under arthroscopy. in this study, we will include all the patients who receiving meniscectomy and acl reconstruction and knee arthroscopy 2 years after primary surgery. patients demographic characters will be reviewed. the resected meniscus in the primary surgery and biopsied regenerated meniscus will be analyzed by histological and immunohistochemical method and their ultrastructure will be observed by electron microscope. patients will be followed at 2-, 5- and 10-year after the primary surgery and the cartilage degeneration and oa progression will be assessed.


Eligibility criteria:
inclusion criteria: 1. patients intending to undergo single-knee acl reconstruction at our institute of sports medicine. 2. the age of 18 \~ 50 years old at the time of operation. 3. both men and women. 4. bmi \< 24. 5. complete or partial meniscectomy was performed at the same time as acl reconstruction. 6. patients willing to undergo a second arthroscopic exploration 2 years postoperatively and to take the portal screws used to fix the ligaments during the initial surgery. 7. patients with preserved meniscus video during acl reconstruction. 8. the degree of knee osteoarthritis (koa) at the time of operation was \< ⅲ of kellgren laurence level. exclusion criteria: 1. patients with severe knee cartilage injury. 2. patients with koa≥klⅲ at the time of operation. 3. the patients cannot be followed up. 4. patients who refused the second arthroscopy and the removal of the internal fixation portal screw at the time of surgery. 5. patients with rheumatoid arthritis or other arthritis. 6. patients with other systemic diseases who take oral anti-inflammatory analgesics for years. 7. patients with multiple injections of drugs in the joint due to various reasons.

Keywords: meniscus regeneration meniscectomy
early intervention and prevention of non-alcoholic fatty liver disease in adolescents

Conditions: Non-alcoholic Fatty Liver Disease

Summary: this research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (nafld) in adolescents. potentially eligible adolescents who are seen at the university of wisconsin (uw) pediatric fitness clinic will be asked to join the study. patients who agree to participate in the study will be randomized into either the intervention group or the control group. the intervention group will follow a low-fructose diet. in addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.

this will be a prospective, randomized, controlled trial for obese adolescents. sixty obese youth (male and female), age 11-17 years with bmi \>95 %tile for age and sex and one parent/guardian will be recruited for inclusion into the study at an initial pediatric fitness clinic visit. consented subjects will be stratified by gender and ethnicity and randomized into low fructose or standard weight loss dietary intervention groups.

Eligibility criteria:
inclusion criteria: * 11-17 years of age * bmi \>95%tile for age and sex * being seen for an initial clinic visit at the uw pediatric fitness clinic * parent willing to participate in study exclusion criteria: * history of chronic disease that effects hepatic or renal function including: type 1 or type 2 diabetes mellitus, known liver disease or other chronic illness.

Keywords: non-alcoholic fatty liver disease adolescent
a community pharmacy-based program to improve management of diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: in this study the investigators aim to evaluate the impact of a community pharmacy-based program to educate type 2 diabetic patients about medications, life style and self-care.

diabetes mellitus type 2 is a progressive metabolic disorder that leads to several morbidities and increased mortality and costs. studies showed that strict control of blood glucose in diabetic patients reduces patients' risk of microvascular complications. community pharmacies are a well-placed healthcare facility located at the heart of the community with convenient access to pharmacists as health care professionals. some studies have shown effective interventions led by community and clinical pharmacist in developed countries. in developing countries, little evidence exists about feasibility of implementing community pharmacy-based services to promote medications adherence, self glucose monitoring and self-care in diabetic patients. this study is a 2 arm randomized controlled trial. eligible patients are referred to the community pharmacy from an endocrinologist's office. of 135 type-2 diabetic patients who will be recruited in the study,68 will be randomly allocated to the intervention arm using telephone balanced blocked randomization method. a community pharmacy-based program will provide training about medications, life style and self-care to the intervention arm. the control arm (67 patients) will receive usual care during the study period. the primary outcome of this study is measured as change in hemoglobin a1c pre and post intervention. as the secondary outcome, medications adherence, diabetes self-care activity, body mass index and blood pressure are measured.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients using oral anti diabetic medications. * hemoglobin a1c \> 7 within the previous month before recruitment * adequate literacy and ability to use the glucometer. * signing the informed consent exclusion criteria: * patients requiring adjunct insulin therapy. * patients with concurrent heart failure (stage 4). * patients who fast in ramadan. * patients receiving diabetes education in other programs.

Keywords: community pharmacy services pharmacists diabetes mellitus diabetes mellitus, type 2 self care randomized controlled trial
bone marrow sparing image-guided radiation therapy (rt) incorporating novel use of gcsf and fdg-pet imaging

Conditions: Cervix Cancer; Endometrial Cancer

Summary: this is a research study using granulocyte colony stimulating factor (gcsf) as a bone marrow stimulating agent for imaging to guide radiation treatment planning. g-csf is a type of growth factor. growth factors are proteins made in the body. g-csf is a type of growth factor that makes the bone marrow produce white blood cells to reduce the risk of infection after some types of cancer treatment. gcsf is being given to stimulate the bone marrow to identify the active (blood cell producing regions) to better spare during pelvic radiation treatment planning.

this is a phase 1/2 study. the phase 1 is a dose finding portion of the study and phase 2 will enroll additional patients at the dose found in phase i. patients in phase i and phase 2 will have the same treatment and follow-up. participants will undergo standard of care diagnostic imaging, complete blood count (cbc) with differential and chemistry labs initially. while receiving the gcsf, participants will have a cbc with differential checked a day after each dose and one day prior to first day of radiation. the treatment planning fdg pet/ct will be performed shortly after the gcsf. during chemoradiation, participants will have weekly cbc with differential checked and other labs as standard of care.

Eligibility criteria:
inclusion criteria: * gynecologic cancer patients receiving pelvic radiation and chemotherapy, specifically: 1) stage i-iiic1 cervix cancer, 2) stage i-iii primary vaginal cancer, 3) stage iiia-iiic1 endometrial cancer patients status post hysterectomy and lymph node assessment, and 4) recurrent endometrial cancer patients with pelvic confined disease no required para-aortic or extended field radiation * age \> 18 years * ecog performance status 0-2 * adequate kidney function (serum cr \ 50 mg/dl) * adequate bone marrow function (white blood cells \> 3.0 x 10\^9/l, platelets \>100 x 10\^9/l) * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * treatment for other cancer in the past 2 years * previous pelvic radiation * medical condition that prevents receiving chemotherapy
genomics and covid-19 vaccine adverse events

Conditions: Vaccine Adverse Reaction

Summary: vaccines routinely used are extremely safe; however, severe adverse events to vaccines do occur. as vaccination against covid-19 has begun, adverse events to the vaccine, particularly guillain-barré syndrome (gbs), vaccine-induced immune thrombotic thrombocytopenia (vitt)/thrombosis with thrombocytopenia syndrome (tts), and myocarditis/pericarditis, after covid-19 vaccination have been reported worldwide. study hypothesis: there are genetic factors that contribute to increased risks of particular covid-19 vaccine-induced adverse events. the objective of the study is to determine if there are specific genetic factors strongly associated with each of the covid-19 vaccine-induced adverse events (i.e., gbs, vitt/tts, and myocarditis/pericarditis).

purpose: reduce the risk of covid-19 vaccine-induced adverse events (i.e., gbs, vitt/tts, and myocarditis/pericarditis) through improved understanding of the biology underlying these severe adverse events and the genetic contribution to their cause research design: * prospective case-control study designs will be performed to investigate the genetic associations of guillain-barré syndrome (gbs), vaccine-induced immune thrombotic thrombocytopenia (vitt)/thrombosis with thrombocytopenia syndrome (tts), and myocarditis/pericarditis strongly associated (or ≥ 3.0) with covid-19 vaccination. * determined cases of specific covid-19 vaccine-induced gbs, vitt/tts, and myocarditis/pericarditis, and vaccinated controls without these adverse events will be included. * saliva dna samples from eligible adverse event cases and vaccinated controls will be collected. * candidate gene and genome-wide association studies (gwas) approaches will be conducted. * genomics analyses will be stratified by severity, age, sex, vaccine, and other critical covariates as determined by the gvdn work group for each adverse event and as adequately powered analyses allow. * to complement gwas, particularly in protein-coding regions, additional whole-exome sequencing (wes) will be performed on the most severe patients who are categorized as brighton collaboration level one case of covid-19 vaccine-induced adverse events to identify the most possible disease-causing mutations.

Eligibility criteria:
inclusion criteria: * case: any patient who received covid-19 vaccines and developed gbs, vitt/tts, or myocarditis/pericarditis after vaccination * control: any participant who received covid-19 vaccines and does not experience gbs, vitt/tts, or myocarditis/pericarditis. exclusion criteria: * individuals who have not received a covid-19 vaccine * individuals who are unable to provide informed consent

Keywords: genomics covid-19 vaccine adverse event guillain-barré syndrome (gbs) vaccine-induced immune thrombotic thrombocytopenia (vitt) thrombosis with thrombocytopenia syndrome (tts) myocarditis pericarditis
nox-e36 multiple ascending dose study in healthy volunteers and patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the primary objective of this trial is to evaluate the safety and tolerability of multiple intravenous doses of nox-e36 in healthy subjects and patients with type 2 diabetes mellitus. a secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic response at the level of inflammation, metabolism as well as ongoing diabetes complications (e.g. impaired cardiovascular, liver and renal function). thus, the study is designed to provide sufficient safety and dose-response data for a planned phase iia proof of concept study with nox-e36 in patients with multiple complications of type ii diabetes mellitus.


Eligibility criteria:
inclusion criteria: * group a: healthy male and female subjects * group b-d: patients with type 2 diabetes mellitus according to ada definition; gfr \> 60 ml/min; hba1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria exclusion criteria: * history of or presence of clinically significant diseases with the exception of diabetes (groups b-d) * concurrent illness that may affect blood glucose other than diabetes * supine blood pressure at screening, after resting for 5 min, of \>140 mmhg systolic or \> 90 mmhg diastolic (group a) or \> 160 mmhg systolic or \> 95 mmhg in diabetes mellitus patients (groups b-d) * clinically significant abnormal ecg at screening * any kidney disease not caused by diabetes or hypertension * type 1 diabetes mellitus
mortality, gravity predictive factors and clinical evolution of older covid-19 patients in short geriatric services.

Conditions: COVID-19

Summary: since the beginning of the year 2020, clinical characteristics of a new disease as the global covid-19 epidemic has spread in france. people over 70 years of age are the more concerned by this virus in proportion and in gravity with some atypical first symptoms compared to younger patients. evolution of the disease is variable from forms with few symptoms to severe forms sometimes quickly lethal. gericovid lyon is a descriptive analysis of all patients over 70 years of age hospitalised for covid-19 in short geriatric unities of university hospital of lyon this study will allow more comprehension about covid-19 in older people. the role of predictive factors, pre-existing comorbidities and the nature and frequency of complications in a short period will be investigate. treatments practices will be analysed too.


Eligibility criteria:
inclusion criteria: * patient over 70 years of age. * patient hospitalized in short geriatric units in university hospital of lyon. * patient diagnosed with covid-19 (positive polymerase chain reaction or a high presumption of covid-19 based on clinical and/or scannographic evidence). * patient informed and non-opposed to the research (patient informed of the study by his medical doctor during hospitalization or by post, thanks to a generic information sheet dedicated to covid-19 researches). exclusion criteria: * patient opposed to the research.

Keywords: elderly covid-19