Kornimate/medical-research-clean huggingface dataset:
chemoradiotherapy plus anti-pd1 in recurrent npc: a multicenter, open-label, randomised, controlled, phase iii trial

Conditions: Nasopharyngeal Carcinoma

Summary: this is a multicenter, open-label, randomized, controlled, phase iii trial. the purpose of this trial is to evaluate the efficacy and toxicity of anti-pd-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.


Eligibility criteria:
inclusion criteria: * diagnosed as local with or without regional recurrence after ≥1 year of radical treatment; * not suitable for surgery; * histologic diagnosis of npc (who ii/iii); * tnm stage rii-iva (ajcc/uicc 8th); * ecog 0-1 point; * no treatment to rnpc prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * no contraindications to immunotherapy or chemoradiotherapy; * adequate marrow function: wbc count ≥ 3×10e9/l, ne count ≥ 1.5×10e9/l, hgb ≥ 90g/l, plt count ≥ 100×10e9/l; * adequate liver function: alt/ast ≤ 2.5×uln, tbil ≤ 2.0×uln; * adequate renal function: bun/cre ≤ 1.5×uln or endogenous creatinine clearance ≥ 60ml/min (cockcroft-gault formula); * take effective contraceptions during and two months after treatment; * patients must be informed of the investigational nature of this study and give written informed consent. exclusion criteria: * treated with anti-tumor chinese medicine treatment; * have recurrence with local necrosis; * have ≥g3 late toxicities, except for skin, subcutaneous tissue or mucosa; * unexplained fever \> 38.5, except for tumor fever; * treated with ≥ 5 days antibiotics one month before enrollment; * have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); have a known history of human immunodeficiency virus (hiv), active hepatitis b (hbv-dna ≥10e3copiers/ml) or hepatitis c virus (hcv) antibody positive; have previously treated with pd-1 antibody or other immunotherapy for pd-1/pd-l1 pathway; * have new york heart association (nyha) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; * have known allergy to large molecule protein products or any compound of study therapy; * pregnant or breastfeeding; * prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; * have received a live vaccine within 30 days of planned start of study therapy has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial; * any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Keywords: locoregional relapse nasopharyngeal carcinoma chemoradiotherapy pd-1 antibody efficacy toxicity
observational study of keloids scars treated by shaving and cryosurgery

Conditions: Keloids Scars

Summary: treatment of keloids scars is difficult and controversial. these keloids have a functional and aesthetic impact. a lot of treatment are described with a lot of relapses and aggravation. authors report outcomes of the treatment with shaving and cryosurgery


Eligibility criteria:
inclusion criteria: * keloids scars * treatment of shaving and cryosurgery exclusion criteria: * immunosuppressive therapy * chemotherapy

Keywords: keloids shaving ears cryosurgery hypertrophic scars
vestibular therapy in alzheimer's disease

Conditions: Vestibular Diseases; Vestibular Disorder; Alzheimer Disease

Summary: nearly 2 out of 3 patients with alzheimer's disease (ad) experience problems with balance and mobility, which places such patients at increased risk of falling. the vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (vt) is well-known to improve balance function in healthy older adults. in this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with ad, in whom this treatment has never been studied.


Eligibility criteria:
inclusion criteria: * diagnosis of ad based on the national institute on aging-alzheimer association 2011 criteria that is mild-moderate (cdr=0.5-2). * age ≥ 60 years. * vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses). * able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and vt or active control. * able to give informed consent, as further detailed in the human subjects section. the investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in vt or active control. * presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. the caregiver must be able to participate in study procedures, specifically the text-messaging system. both the vt and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy. exclusion criteria: * diagnosis of severe ad (cdr≥3). * diagnosis of mild cognitive impairment or diagnosis of non-ad dementia, for example parkinson's disease dementia, dementia with lewy bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia. * deemed unable to participate in study procedures and vt or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.) * use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to vt. * lack of availability to participate in 8 weeks of vt or active control.
study of kb004 in subjects with hematologic malignancies (myelodysplastic syndrome, mds, myelofibrosis, mf)

Conditions: Myelodysplastic Syndrome (MDS); Myelofibrosis (MF)

Summary: this is a global, multicenter, open-label, repeat-dose, phase 1/2 study consisting of a dose escalation phase (phase 1) and a cohort expansion phase (phase 2). in both phases, kb004 will be administered by iv infusion once weekly as part of a 21-day dosing cycle.

the purpose of phase 1 is to determine a maximum tolerated dose (mtd) for kb004 when administered to subjects with hematologic malignancies who meet the entry criteria. phase 1 has completed enrollment july of 2014, the recommended phase 2 dose is 250 mg. aml 20 mg cohort completed enrollment dec 2014. the purpose of phase 2 is to characterize preliminary clinical activity. the phase 2 portion of the study consists of two parts: * part a: subjects with aml or mds who meet the entry criteria * part b: subjects with mf who meet the entry criteria

Eligibility criteria:
key inclusion criteria (phase 1): - confirmed hematologic malignancy, including acute myeloid leukemia (aml), chronic lymphocytic leukemia (cll), chronic myelogenous leukemia (cml), acute lymphocytic leukemia (all), myelodysplastic syndrome (mds), multiple myeloma (mm), myelofibrosis (mf), myeloproliferative neoplasms (mpn) or mds/mpn overlap diseases. (once phase 2 has started subjects with aml will be eligible for inclusion in the phase 1 portion of the study only if their malignancy has been shown to have c-cbl mutation, trisomy 3, trisomy 11, inv(16), or elevated flt3. \[other aml and subjects with mds will no longer be eligible for inclusion in the phase 1 portion of the study\]). key inclusion criteria (phase 2): * part a: aml or mds patients with an acceptable level of epha3 expression * part b: mf patients with an acceptable level of epha3 expression key inclusion criteria (both phases): * confirmed hematologic malignancy refractory to or progressed following standard treatments, or subjects not considered medically suitable to receive standard of care treatment or who refuse standard of care treatment * acceptable level of epha3 expression * eastern cooperative oncology group (ecog) ≤1 * acceptable laboratory results key exclusion criteria (both phases): * for subjects with aml, more than 2 prior therapies for aml (induction and consolidation with or without a hypomethylating agent given in a maintenance setting are considered 1 therapy) * history of or current central nervous system (cns) involvement that may increase risk of bleeding * recent major surgery * ongoing surgical or wound healing complications * active clinically significant bleeding * uncontrolled hypertension * significant intercurrent illness * known history of prolonged bleeding times or platelet dysfunction * active infection requiring iv antibiotics, iv antifungals, or iv antivirals within 2 weeks prior to cycle 1, day 1

Keywords: hematologic leukemia malignancies myeloproliferative neoplasms
compare the oncological benefit of deep neuromuscular block in gastric cancer obesity patient

Conditions: Gastric Cancer; Obesity

Summary: this study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over bmi 25. the primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. the secondary endpoint is intraoperative bleeding, surgeons' satisfaction. the patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons * deep neuromuscular block group (98persons) * moderate neuromuscular group (98persons)

this study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over bmi 25. this is a randomized controlled trial comparing deep nmb with moderate nmb in laparoscopic subtotal gastrectomy in obese patients with gastric cancer. the design of the study is blinded (the surgical team and the research team are all blinded to the treatment); the attending anesthesiologist is not blinded. the primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. the secondary endpoint is intraoperative bleeding, surgeons' satisfaction. the patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons * deep neuromuscular block group (98persons) * moderate neuromuscular group (98persons) the patients are assigned to the deep nmb group or the moderate nmb group. the clinical research coordinator (crc) uses a computer randomization program to determine the degree of muscle relaxation of each patient. stratified block randomization is used to guarantee even distribution, which means that all participating hospitals are assigned moderate or deep nmb randomly in a 1:1 ratio. the crc notifies the anesthesiologist of the degree of muscle relaxation just before the operation. surgeons are blinded to the degree of muscle relaxation: they can enter the operating room after the muscle relaxation has been performed. a train-of-four (tof) monitor is placed out of the surgeon's visual field. the anesthesiologist injects sugammadex after confirming the absence of the surgeon. the ward staff members who evaluate patient outcomes are blinded to the degree of muscle relaxation.

Eligibility criteria:
inclusion criteria: * gastric cancer patients with laparoscopic subtotal gastrectomy * 19-75 years * body mass index(bmi) \> 25kg/m2 * american society of anesthesiologists i-iii exclusion criteria: * american society of anesthesiologists class iv * end stage renal disease (esrd) patient * patients with allergy to muscle relaxants * patients with diseases that may affect muscle relaxation
post-surgical mediastinitis within the chu brugmann hospital

Conditions: Mediastinitis

Summary: mediastinitis is an infectious complication that can occur after cardiac surgery. the incidence varies between 1 and 3% depending on the type of procedure and the patient's condition. the mortality of this severe postoperative complication rises from 10 to 35%, which makes it dreadful. the major risk factors reported are obesity, diabetes, and immunosuppressive therapy. there are other less important ones: age, coronary bypass grafting (especially if using the two internal mammary arteries), nosocomial pneumonia, dialysis, prolonged mechanical ventilation, long operative asepsis, undrained retro-sternally hematoma, prolonged pre-operative hospitalization...). prevention is very important. the principle of asepsis must absolutely be respected. the use of prophylactic antibiotic therapy is recommended. the most commonly encountered organisms are staphylococcus aureus, coagulase-negative staphylococci and gram-negative bacilli. there are several treatment modalities that vary between centers and may be different depending on the surgical team's experience and the depth or extent of the infection. the common principles of these treatments are: antibiotic therapy and surgical debridement (the timing of which may vary). the timing and modalities of wound closure are subject to variations: immediate sternal closure with placement of multiple or delayed drains. muscle flaps or large omentum transplant may be necessary if tissue loss is too important. the investigators propose to review their experience in the treatment of cardiac post-surgery mediastinitis at brugmann university hospital in the last 20 years in both adult and pediatric patients.


Eligibility criteria:
inclusion criteria: * post-cardiac surgery mediastinitis * patients of the chu brugmann (adults) and huderf (pediatric) hospitals exclusion criteria: - none
holter of movement in patients with multiple sclerosis in uncontrolled environment.

Conditions: Multiple Sclerosis

Summary: actisep is a multicentric academic study. ambulant patients with multiple sclerosis may be included on a voluntary basis. the investigators plan to include a group of approximately 80 patients with ms, fulfilling the mcdonald's 2017 criteria, of whom 40 of them show a progressive course according to the lublin classification. the investigators have planned two visits (at baseline and 1 year later). on both visits, participants will perform few tests (timed 25-foot walk (t25-fw), 9-hole peg test (9-hpg), 6-minutes walk test (6mwt), berg balance scale) and will answer to some questionaires (godin leisure time exercice questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, hospital anxiety and depression scale) after each visit, participants will wear actimyo for three months in daily living.


Eligibility criteria:
inclusion criteria: * confirmed ms diagnosis, * over 18 years old, * ambulant patients, * signed informed consent, * no clinical and / or radiological relapse within 3 months. * edss \< or = à 5,5, * treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion. exclusion criteria: * patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection. * any other previous or present pathology having an impact on motor function. * recent surgery or trauma (less than 6 months) in the upper or lower limbs

Keywords: actimyo accelerometry home monitoring
evaluation of the sofia sars antigen fia assay for covid-19

Conditions: SARS-CoV2 Infection

Summary: evaluating the performance of the sofia sars antigen fia

rt-pcr is the reference technique for the diagnosis of covid-19, as recommended by who, ecdc and the has college. serological tests to identify antibodies developed by the immune system following infection with sars-cov-2 are not currently recommended as a first-line test for the initial diagnosis of covid-19. however, they can be used in cases of negative rt-pcr and suggestive clinical presentation, or as a salvage test when rt-pcr could not be performed within 7 days of symptom onset. antigenic tests for the detection of sars-cov-2 can be used as a first-line test on nasopharyngeal swabs up to and including 4 days after the onset of symptoms. from the 5th day, only detection by gene amplification is indicated. given their excellent specificity and the current pandemic situation, it is not necessary to confirm positives with a gene amplification test. however, it is recommended to perform a gene amplification test when the antigenic test result is negative or uninterpretable in symptomatic patients older than 65 years or with at least one risk factor for severe covid-19. for contact persons detected in isolation or in clusters, it is also possible to use antigenic tests in the following cases * as soon as possible and then at 7 days for high-risk contacts (within the same household as an infected patient) ; * 7 days after exposure for other contacts (low risk). given the rapidity of antigenic test results (15 to 30 minutes), the good performance of the sofia sars antigen fia test in target populations and its traceability, it could be used as a first-line test in emergency rooms and screening centers and thus have a positive impact on the management of ambulatory patients and, by corollary, on viral transmission.

Eligibility criteria:
inclusion criteria: * adult patient (\> or = 18 years of age) * patient with symptoms of covid-19 (rhinitis, throat pain, nasal congestion or other signs of local manifestation of the disease in the upper respiratory tract, including loss of taste, with or without additional systemic symptoms such as fatigue, fever, muscle pain...) whose health condition does not require hospitalization (mild to moderate disease) * patient with these symptoms for 5 days or less with a median of 3 to 4 days. * patient with consent to participate in the study exclusion criteria: * patient with an age below 18 years * patient under legal protection (guardianship, curatorship) * patient without upper respiratory tract symptoms * patients with symptoms for more than 5 days * patient with previous covid-19 diagnosed by rt-pcr * patient vaccinated against sars-cov-2 (1 or 2 injections) * hospitalized patient * refusal to participate

Keywords: sars-cov2 infection assessment eia diagnosis
efficacy of ranibizumab in combination with photodynamic therapy for wet age-related macular degeneration

Conditions: Macular Degeneration; Visual Acuity

Summary: the purpose of the investigators study is to look at the visual outcomes of ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.

the main cause of severe vision loss in patients with age-related macular degeneration (amd) is the development of choroidal neovascularization (cnv). this debilitating form of amd affects the macula lutea, the central part of the retina, which is responsible for high resolution visual acuity. characteristic findings in neovascular amd include the development of new, abnormal blood vessels in the choroid layer beneath the macula otherwise known as cnv. current treatment options for this condition have included include laser therapy, photodynamic therapy (pdt), and intraocular injections (different types of anti-vascular endothelial growth factors) alone or in combination. while current treatments were demonstrated to slow the progression of vision loss, neither therapy was shown to significantly improve visual acuity. given their different modes of action, it is believed that combination therapy of ranibizumab with pdt may lead to better visual outcomes and may result in an improved effect in treating amd and therefore may help decrease the need for monthly ranibizumab injections. after the first injection, regardless of which group the patient has been assigned to, they will receive ranibizumab injections at 4 week intervals if clinically indicated. the purpose of the this study is to evaluate the visual outcomes of intraocular ranibizumab injections in combination with photodynamic therapy with verteporfin for the treatment of neovascular amd.

Eligibility criteria:
inclusion criteria: * diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization * must be 50 years of age or older * have a lesion whose total size is no more than 5400micrometres in greatest linear dimension in the study eye * cnv that is more than 50% obscured by blood * have best corrected visual acuity of 20/50-20/320 (snellen equivalent) * have been assessed with the use of early treatment diabetic retinopathy study charts exclusion criteria: * previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment * any permanent structural damage to the central fovea

Keywords: ranibizumab verteporfin
bk329 and body fat reduction

Conditions: Obesity and Overweight

Summary: this clinical trial aims to determine whether bk329 reduces body fat in adults with overweight or obesity and to assess its safety. the main questions are: * does bk329 reduce body fat in participants? * what side effects occur when participants take bk329?

researchers will compare bk329 to a placebo to evaluate its effectiveness in reducing body fat. participants will: * take bk329 or a placebo daily for 12 weeks. * visit the clinic every six weeks for checkups and tests.

Eligibility criteria:
inclusion criteria: * individuals with a body mass index (bmi) between 23 and 30 kg/m2. * individuals who have provided written consent on the consent form. exclusion criteria: * subjects with severe cerebrovascular disease (e.g., stroke, cerebral hemorrhage), heart disease (e.g., angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within the last 6 months. (however, subjects with a history of these diseases who are clinically stable may participate at the investigator's discretion.) * uncontrolled hypertensive patients (blood pressure ≥160/100mmhg, measured after 10 minutes of rest). * diabetic patients with poor blood glucose control (fasting glucose ≥160mg/dl). * subjects undergoing treatment for hypothyroidism or hyperthyroidism. * subjects with creatinine levels ≥ 2 times the upper limit of the research institution's normal range. * subjects with aspartate transaminase or alanine transaminase levels ≥ 3 times the upper limit of the research institution's normal range. * subjects experiencing severe gastrointestinal symptoms such as heartburn or indigestion (lactose intolerance). * subjects who have taken weight-altering drugs (absorption inhibitors, appetite suppressants, obesity-related supplements, psychiatric drugs, beta-blockers, diuretics, contraceptives, steroids, or female hormones) within the last month. * subjects who have participated in commercial weight loss programs within the last 3 months. * subjects who have participated in or plan to participate in another clinical trial within the last month. * alcohol abusers. * subjects who quit smoking within the last 3 months. * pregnant or breastfeeding women or those planning pregnancy during the trial period. * subjects with allergies to any components of the study foods. * subjects deemed inappropriate for the study by the investigator for other reasons.