Kornimate/medical-research-clean huggingface dataset:
real-world effectiveness, safety and immunogenicity of chikungunya vaccination in populations at risk of severe or complicated forms: prospective study in la réunion

Conditions: Chikungunya Virus Infection

Summary: against the backdrop of a growing chikungunya epidemic in la réunion, this prospective study will assess the real-life efficacy, safety and immunogenicity of ixchiq® vaccine in vulnerable individuals (seniors, comorbid patients), defined by the french health autority (has) as at risk of severe or complicated forms and/or chronic disabling forms (chronic arthritis, chronic fatigue phenotypes). this study will also provide input for the preparation of a cluster randomized trial on a population scale.


Eligibility criteria:
inclusion criteria: * eligible for anti-chikungunya vaccination according to french health authority (has) * beneficiary of social security coverage * signature of informed consent form exclusion criteria: * pregnant women * vaccine contraindication for patients undergoing medical treatment * persons under guardianship, curatorship or safeguard of justice * anyone who has received immunoglobulin or a blood or plasma transfusion 3 months prior to vaccine administration

Keywords: prophylaxis, safety, efficacy, vaccine effectiveness, chikungunya
anticoagulation in stent intervention

Conditions: Atrial Fibrillation; Stroke

Summary: objective: the main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg / day + clopidogrel 75 mg / day) compared to the use of the triple regimen (acenocoumarol as control + acetylsalicylic acid 100 mg / day + clopidogrel 75 mg / day) in patients with atrial fibrillation, low-moderate risk of stroke (chads ≤ 2) who are undergoing pci-s. design: randomized, parallel, with two arms, blind evaluation by third parties. patients: 304 patients undergoing pci-s with atrial fibrillation, low-moderate risk of stroke (chads ≤ 2), which requires prevention of thrombosis


Eligibility criteria:
inclusion criteria: * patients of both sexes older than 18 years. * patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. patients with acute coronary syndrome or stable angina who are undergoing pci-s. * patients who have previously given their informed consent to participation in the study. exclusion criteria: * patients who can not be followed by the research team during the 12 months provided for monitoring. * patients with renal failure or serum creatinine above 2 mg • dl-1, neurological deficits, active ulcer or epigastric pain. * patients who continue regular treatment with nsaids or other analgesics or corticosteroids. * patients undergoing reoperation. * patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol. * pregnant women. * use of investigational agents or not registered within 30 days of entry into the study. * patients with a history of allergy to study drugs or excipients. * patients with severe valve disease. * patients with chads\> 2. * patients who can not use the study drug orally.

Keywords: atrial fibrillation coronary stent implantation low-moderate risk of stroke dual antiplatelet therapy anticoagulation
effect of plantar vibration in stroke

Conditions: Stroke

Summary: the aim of the study is to investigate the effect of plantar vibration on the ankle proprioception of patients with stroke.

the study, utilizing a randomized placebo controlled design, is planned to be conducted on a minimum of 34 patients with stroke who meet the inclusion and exclusion criteria. patients included in the study will be randomly assigned to receive plantar vibration or placebo plantar vibration interventions.

Eligibility criteria:
inclusion criteria: 1. two months or longer elapsed since the stroke, 2. a mini-mental state examination score of 24 or higher, 3. being between 45 and 75 years of age, 4. having a brunnstrom stage of 4 or above, 5. ability to stand independently for 20 seconds or more, 6. ability to walk independently for 10 meters, using assistive devices or orthoses if necessary. exclusion criteria: 1. the presence of severe osteoarthritis in the lower extremity, 2. the presence of cancer or diabetic neuropathy, 3. the presence of vestibular disorder, 4. the presence of lower extremity ulceration or amputation, 5. hemodynamic instability, 6. the presence of other neurological disorders (such as multiple sclerosis, parkinson's disease), 7. having experienced an acute lower extremity injury in the last six weeks, 8. history of lower extremity surgery, 9. alcohol consumption in the last 24 hours 10. posterior circulation stroke involving the basilar artery or cerebellum

Keywords: proprioception
incidence and predictors of opioid overdose and death among long-term users of opioid analgesics

Conditions: Opioid Overdose

Summary: retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.

the purpose of this study is to quantify risk, and predictors of risks for opioid overdose and for death associated with opioid overdose in persons who are or have been long-term recipients of prescriptions for schedule ii opioids. the study uses coded terms in large heath databases maintained by healthcare providers and health insurers, supplemented by overdose deaths identified from the national death index. the terms for overdose are combined following validated rules as developed in companion studies. the study is being conducted in parallel with a prospective questionnaire-based cohort study of the same risks.

Eligibility criteria:
inclusion criteria: * in the primary analysis, persons known to have had at least six months of no opioid dispensing who subsequently receive at least 70 days of schedule ii opioid dispensed within a 90-day period and who have not previously experienced an opioid overdose. * in a secondary analysis, persons who have been long-term users of ir/sa opioids and who switch to a different schedule ii ir/sa opioid product or to an er/la opioid * in another secondary analysis, persons with at least six months of presence in the health insurance data who have not received opioids in the preceding 30 days, and have not previously experienced an opioid overdose exclusion criteria: • experience of opioid overdose in the six months preceding inclusion
model for prognosis of elderly gastric cancer patients

Conditions: Stomach Neoplasms; Aged

Summary: this study aims to develop and validate a random survival forest (rsf) model for predicting long-term survival in elderly patients following curative resection for gastric cancer. the study is a retrospective multi-center analysis involving patients aged 75 and above who underwent gastric resection from january 2009 to december 2018 at nine top-tier hospitals in china. an online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

this retrospective multi-center study focuses on the development and validation of a predictive model for elderly gastric cancer patients. data were collected from 16,344 gastric cancer patients, with 1,202 elderly patients ultimately included after applying exclusion criteria. patients were randomly divided into training and testing cohorts in a 7:3 ratio. the study was approved by the institutional review boards with a waiver of informed consent due to the use of anonymized secondary data. the analysis employs the random survival forest (rsf) method, incorporating variable importance and minimal depth techniques to select key variables for predicting overall survival (os) and disease-free survival (dfs). the study also implements rigorous data handling procedures, including multiple imputations for missing data. the development of an online prognostic tool based on the rsf model is part of the project, designed to provide real-time survival predictions through a user-friendly interface for clinical application.

Eligibility criteria:
inclusion criteria: * patients aged 75 years or older. * histologically confirmed diagnosis of gastric cancer. * patients who have undergone curative gastrectomy. exclusion criteria: * patients with non-primary gastric malignancies. * pathological confirmation of metastatic disease (m1). * incomplete follow-up data or loss to follow-up.

Keywords: stomach neoplasms prognosis elderly prediction model
physical and cognitive exercises in nursing homes: is frailty reversible?

Conditions: Physical Activity; Elderly

Summary: elderly in residential care spend 97% of their time sedentary. moreover, exercise therapy often takes place in a poorly stimulating environment which is less motivational for the elderly to undertake regularly. exercise is however necessary to preserve their physical capabilities and to limit their care dependence. the aim of this study is to investigate the most motivating and stimulating exercise modality for prefrail and frail elderly in nursing homes with which they can reach sufficient training volume. to study this, elderly will exercise in 3 different ways on an ergometer or motomed (according to their physical capabilities): 1) in an environment without other visual stimuli 2) in front of a television with national geographic images 3) with the interactive software program memoride with which participants can exercise in real life on a virtual manner. memoride (activ84health) uses google street view images. the starting point is a connection between an exercise bike and a tablet with a pedalling sensor. this way, pedal frequency is sent to the tablet and as a result, images continue when pedalling. the forth modality is the control modality, in which participants are instructed to rest (supine) during 30 minutes. based on objective training parameters and metabolic parameters e.g. glucose, insulin, brain-derived neurotrophic factor (bdnf) and lactate, (via a blood sample with a venous catheter) the training modality which offers the best training results will be studied. secondly, also subject experiences (motivation and emotions) will be evaluated by using questionnaires and observation scales.


Eligibility criteria:
inclusion criteria: * men and women with an age of at least 70 years at the start of the study; * staying for at least one month in wzc st. elisabeth hasselt at the start of the study; * being frail or prefrail (according to the criteria of fried); * being available to participate in the study during 4 consecutive weeks; * being able to actively exercise on an exercise bike (if necessary from a wheelchair) during at least 5 minutes; * understand simple instructions. exclusion criteria: * any neurological or orthopedic disease which makes it impossible to exercise by bike actively e.g. stroke with hemiparesis of the lower limbs, amputations of the lower limbs,...; * any disease which makes it impossible to exercise actively e.g. heart failure; * any neurological or orthopedic disease from which progression (e.g. hip prosthesis, acute stroke) due to active recovery or decline (e.g. als (amyotropic lateral sclerosis), ms) due to the disease process can be expected on short term (1-2 months); * being blind or visually impaired; * any acute disease on the moment of the intervention which makes it impossible to exercise by bike during 30 minutes (e.g. hyper- or hypoglycemia) (reported by the caregiver)
a study of kct-0809 in patients with dry eye syndromes

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate the efficacy and safety of kct-0809 compared to placebo in patients with dry eye syndromes.


Eligibility criteria:
inclusion criteria: * corneal and conjunctival damage * insufficiency of lacrimal secretion or tear film instability * ocular symptom exclusion criteria: * severe ophthalmic disorder * punctual plugs or surgery for occlusion of the lacrimal puncta

Keywords: dry eye syndromes corneal diseases conjunctival diseases
descartes-08 car-t cells in generalized myasthenia gravis (mg)

Conditions: Myasthenia Gravis, Generalized

Summary: this is a phase iib study to evaluate the safety and preliminary efficacy of descartes-08 car t-cells in patients with generalized myasthenia gravis


Eligibility criteria:
inclusion criteria: * patient must be at least 18 years of age. * patient must have generalized myasthenia gravis at the time of screening. * concomitant immunosuppressive drugs must be deemed necessary by the investigator. * seronegative patients are included exclusion criteria: * major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient. * patient is pregnant or lactating.

Keywords: descartes-08 cart car-t autoimmune auto-antibody auto antibody chimeric antigen receptor t cells mg gmg myasthenia gravis generalized myasthenia gravis
reduction of sperm dna fragmentation by oral ginger

Conditions: Infertility

Summary: this study is a randomized, double blind, controlled clinical trials assess the efficacy of the ginger oral treatment on sperm dna fragmentation, sperm parameters and male hormones.

sperm dna fragmentation is known to affect male fertility. previous findings have suggested the implication of oxidative stress in the etiology of this pathological condition. the present study was designed to find out dna fragmentation in ejaculated spermatozoa can be reduced by oral treatment with ginger extract. 71 men with unexplained or idiopathic infertility were randomized between a ginger treatment (500 milligram daily for 3months) group and a placebo group. sperm dna fragmentation was evaluated by terminal deoxyribonucleotidyltransferase-mediated dutp nick-end labeling assay (tunel) before and after treatment. no differences in basic sperm parameters were found between the ginger treatment and the placebo group before or after treatment. however, the percentage of dna-fragmented spermatozoa was markedly reduced (p\< .005) in the ginger treatment group after the treatment as compared with the pretreatment values). no difference in the pretreatment and post treatment incidence of sperm dna fragmentation was observed in the placebo group. these data show that sperm dna damage can be efficiently treated with oral ginger extract administered during a relatively short time period.

Eligibility criteria:
inclusion criteria: * men with idiopathic infertility or unexplained exclusion criteria: * history of varicocele, genitourinary inflammation or infection * history of cigarette smoking.

Keywords: sperm dna damage ejaculated spermatozoa ginger herbal drug herbal medicine
know how to position the saccule and utricule in scanning

Conditions: Otosclerosis

Summary: titanium pistons cause mri artifacts that prevent interpretation of the vestibule. this disadvantage is not present on ct but the vestibule is not visible. hence the interest in creating a model with 6 reference cuts in order to position the utricle and the saccule in the vestibule in ct. furthermore, the scanner has fewer contraindications, greater availability and a shorter examination time than mri.

the aim of the study is to analyze six normal sections chosen as reference in histology, high resolution t2 mri and ct in order to compare them with precise topographical landmarks to position the posterior membranous labyrinth in ct. then, apply the investigators' observations to cases of operated otosclerosis.

Eligibility criteria:
inclusion criteria: * adults (≥18 years old) and minors (≥ 6 years old) * subject having received an mri of the internal ear canals from the hus between 01/01/2018 and 01/01/2021 or a ct scan of the rocks between 07/01/2015 and 01/01/2021 * normal mri or ct on the side opposite the pathology. * normal tonal audiogram on the side opposite the pathology (peripheral facial paralysis assumed to be cold for mri and petrous fracture for ct). * subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research. * holders of authority who have not expressed their opposition, after information, to the reuse of their child's data for the purposes of this research exclusion criteria: * subject having expressed opposition to participating in the study * holders of parental authority who have expressed their opposition to the reuse of their child's data for the purposes of this research * imaging with artifacts * absence of pure-tone audiogram or its abnormality on the side of the ear studied * any malformation or pathology of the vestibule on imaging on the side of the ear studied * subjects under guardianship or curatorship

Keywords: otosclerosis vestibular dysfunction membranous labyrinth
endoscopic-vacuum assisted closure of intrathoracic postsurgical leaks

Conditions: Mediastinitis; Esophageal Neoplasms; Anastomotic Leakage

Summary: the purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.

intrathoracic leakage is a serious complication after esophageal surgery. the reported incidence of esophageal anastomotic leaks after gastrectomy and esophagectomy ranges from 5% to almost 30%. within the last 10 years endoscopic treatment has changed the approach to intrathoracic anastomotic leakages. application of metal clips, injection of fibrin glue and placement of self expanding metal or plastic stents (sems/seps) have been reported to successfully achieve closure of postoperative anastomotic leaks in approximately 66-100%. alternative endoscopically treatment modalities are welcome especially in cases of failure of the above mentioned endoscopic treatment modalities to prevent the necessity of surgical reintervention which is associated with high mortality or mutilating surgical outcome such as proximal diversion with cervical esophagostomy. vacuum-assisted closure (v.a.c.) is an established treatment modality for extensive cutaneous infected wounds. the v.a.c. system device is based on a negative pressure applied to the wound via a vacuum sealed sponge tissue. the sponge results in formation of granulation tissue, while the vacuum removes wound secretions and reduces edema and therefore improves blood flow, all together achieving consecutive wound closure. since its introduction in the late 1990´s the number of indications for the v.a.c. system has steadily increased. recently the endoluminal application of a vacuum assisted wound closure system for the closure of rectal anastomotic fistulas has been reported. our group reported the successful closure of intrathoracic anastomotic leaks in two cases by endoscopic placement of a vacuum assisted closure system. here we plan to study the efficacy, safety and long term outcome of e-v.a.c. to treat major intrathoracic postsurgical leaks.

Eligibility criteria:
inclusion criteria: * all patients at the medical school hannover that present with intrathoracic postsurgical leakage that can be intubated with a regular 9.2mm diameter endoscope (olympus gif-165, olympus * age over 18 years old * signed informed consent exclusion criteria: * small leakage that can be treated with clips * refusal to participate in study

Keywords: negative-pressure wound therapy endoscopic/endoluminal v.a.c. therapy esophagectomy anastomotic leakage anastomosis, surgical
treatment of social anxiety in youth

Conditions: Social Anxiety Disorder

Summary: this research is designed to determine the effectiveness of attention bias modification for socially anxious children and adolescents. over the course of 3 years, 50 youth will be enrolled in the trial.

the primary objective of this study is to develop an attention training (at) protocol for adolescents with social anxiety disorder (sad). attentional biases to threat have been shown to be associated with the development and maintenance of anxiety disorders, in both adults and youth. given these relations, at paradigms have been developed to modify these attentional biases. such paradigms have been shown to be promising in the treatment of adult anxiety. however, to date, only two small studies have examined the use of at with children, and no att protocol has been developed specifically for use with children or adolescents. this is important, given the complications and possible ineffectiveness of applying adult-designed therapies to youth. given this gap in the literature, the primary aims of the current study are intended to develop a treatment program to address attentional biases and anxiety in adolescents with sad, to collect preliminary data regarding the program's short-term efficacy and feasibility, and to explore attention biases as a mediator and moderator of initial treatment outcomes. it is hypothesized that the at protocol developed in the current project, compared to a placebo control comparator condition, will result in reductions in social anxiety among a sample of adolescents with sad. further, the at protocol is expected to reduce attentional biases to threat among those adolescents who possess such biases prior to treatment (not all adolescents are expected to show this bias yet at has been shown to be potentially effective with these youth; the presence/absence of attention bias will be explored as a moderator of change). the proposed study will be a pivotal step towards assessing the feasibility of an adolescent-focused at procedure for the treatment of sad. results will contribute to an emerging body of research exploring the ameliorating effects of experimental paradigms that target information processing biases in anxious youth. given emerging evidence regarding the use of at in adult populations, findings from this study may have implications for improving the current prevention and treatment options available for anxious adolescents.

Eligibility criteria:
inclusion criteria: * diagnosis of social anxiety disorder; * english speaking exclusion criteria: * suicide intent, * psychosis, * autism spectrum disorder
immunological memory induced by the 13valent pneumococcal conjugate(pcv13) and 23valent plain polysaccharide vaccine(ppv23) in hiv-infected patients

Conditions: HIV Infection

Summary: the purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (pcv13) and 23valent plain polysaccharide vaccine (ppv23) on the establishment of immunological memory in hiv-infected adults on art.


Eligibility criteria:
inclusion criteria: * cd4 t cell count \>200cells/μl * on art exclusion criteria: * no previously recorded allergy to pcv, ppv23 * no intravenous immunoglobulin (ivig) given within the previous 6 months * no other vaccine given within the previous 6 months
study to compare the efficacy and safety of olaparib when given in combination with carboplatin and paclitaxel, compared with carboplatin and paclitaxel in patients with advanced ovarian cancer

Conditions: Ovarian Cancer

Summary: to compare the efficacy of olaparib in combination with paclitaxel and carboplatin (auc4) when compared with carboplatin (auc6) and paclitaxel alone in patients with advanced ovarian cancer.


Eligibility criteria:
inclusion criteria: * diagnosed with serous ovarian cancer * patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment * at least one lesion that is suitable for accurate repeated measurements exclusion criteria: * patients receiving any systemic anticancer chemotherapy, radiotherapy (except palliative) within two weeks from the last dose prior to study treatment * hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin

Keywords: poly(adp ribose) polymerisation (parp) platinum sensitive advanced serous ovarian cancer olaparib parp inhibitors platinum sensitive advanced serous ovarian cancer