Kornimate/medical-research-clean huggingface dataset:
monoclonal antibody therapy in treating patients with advanced kidney cancer

Conditions: Stage IV Renal Cell Cancer; Recurrent Renal Cell Cancer

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them. purpose: randomized phase ii trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed.

objectives: i. determine the effect of monoclonal antibody vegf on time to progression, angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer. ii. evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen. iii. evaluate the toxicity of this regimen in these patients. protocol outline: this is a randomized study. patients are stratified by prior interleukin-2 therapy (yes vs no). patients are randomized to receive either placebo or one of two doses of monoclonal antibody vegf. following an initial loading dose, patients receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression. patients who are given placebo and experience disease progression are offered monoclonal antibody vegf and thalidomide if there are no contraindications. projected accrual: a total of 150 patients will be accrued for this study over 2 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- histologically proven unresectable advanced renal cell cancer measurable disease must have received or not be a suitable candidate for interleukin-2 therapy no papillary or collecting duct renal cell cancer no cns metastases --prior/concurrent therapy-- biologic therapy: see disease characteristics no prior thalidomide at least 4 weeks since other prior biologic therapy no other concurrent biologic therapy chemotherapy: at least 4 weeks since prior chemotherapy no concurrent chemotherapy endocrine therapy: at least 4 weeks since prior endocrine therapy no concurrent corticosteroid therapy radiotherapy: at least 4 weeks since prior radiotherapy no concurrent radiotherapy surgery: see disease characteristics --patient characteristics-- age: 18 and over performance status: ecog 0-2 life expectancy: at least 6 months hematopoietic: wbc at least 1,000/mm3 platelet count at least 75,000/mm3 no coagulation disorder, active bleeding, or wound healing problem hepatic: total bilirubin no greater than 2.0 mg/dl (for patients with gilbert's disease, direct bilirubin less than 0.5 mg/dl) sgot or sgpt no greater than 3 times normal renal: creatinine no greater than 2.0 mg/dl cardiovascular: no coronary artery disease other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no clinically evident preexisting peripheral neuropathy

Keywords: adult solid tumor body system/site cancer cancer kidney tumor kidney/urinary cancer recurrent renal cell cancer renal cell cancer solid tumor stage iv renal cell cancer stage, renal cell cancer
efficacy of sublingual midazolam in association with oral morphine in children analgesia after bone fracture

Conditions: Fractures

Summary: it is a randomized simple-blind monocentric study; the group a will receive oral morphine with placebo and the group b will receive oral morphine with sublingual midazolam. the aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

fracture is often responsible of pain in the paediatric emergency department (ed). this pain is very severe and needs effective drugs. during a study made at the ed of necker enfants malades hospital, it has been shown that the oral morphine had a limited action on this kind of pain. therefore it is interesting to increase the analgesia by making a drug association, for example with the midazolam witch is a benzodiazepine with a sedative and anxiolytic action, and which has got the mma for the intravenous and the intra rectal forms for children older than 6 months. the intravenous form has some disadvantages like an extra work and an increase of risk of side effects. that is why the sublingual form seems to be interesting in this context. even if some studies have shown the benefit of midazolam as a preanesthetic medication given to children scheduled for a surgical procedure, none has shown the interest of sublingual midazolam associated with oral morphine to relieve the pain due to a displaced fracture. the aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo. it is a randomized simple-blind monocentric study; the group a will receive oral morphine with placebo and the group b will receive oral morphine with sublingual midazolam . the pain will be quantified thanks to the visual analogical scale (vas)before and 30 minutes after the drugs administration, and we will try to show a difference of 15 points(on 100) of the vas at 30 minutes between the two groups. 60 patients aged from 5 to 16 years old and having a displaced fracture will be enrolled in this study which will last 1 year. patients having a contra-indication for morphine and midazolam won't be enrolled as patients with femoral fracture which needs a local anaesthesia.

Eligibility criteria:
inclusion criteria: * children between 5 and 16 years old * children with a disjoined bone fracture * children needed oral morphine analgesia * written informed consent from one or the two parents or legal pad exclusion criteria: * asa score \> 2 * concomitant administration of oral analgesia (level ii who classification) less than 6 hours * concomitant administration of benzodiazepine less than 24 hours

Keywords: midazolam sublingual oral morphine children bone fracture bone fracture with a deformed member
comparison of patella plating versus tension band wiring for the treatment of unstable patellar fractures

Conditions: Patella Fracture

Summary: this study aims to compare the efficacy and safety of patella anatomical locking plate fixation versus tension band wiring in the treatment of patellar fractures.

patellar fractures are a common injury that can cause significant pain and disability. conventional treatment options frequently include tension band wiring (tbw) with or without axial k-wires or through cannulated screws. however, tension band wiring does have its issues, including implant prominence and frequent reoperation rates, especially for comminuted patella fractures. more recently, plate fixation has become increasingly more prevalent in the past decade. initially, this began with small fragment or mini-fragment plates; which progressed to mesh locking plates and now, anatomical locking patella plates. biomechanical studies have shown greater loads to failure, less fracture gapping or fracture displacement with locking plate fixation compared to tbw. its low profile construct and round edges may be more tolerable to patients and less prominent than tbw. furthermore, another possible advantage of plate fixation is the avoidance of quadricep and patellar tendon insertion scarring, as they do not need to be dissected or passed through for fixation as in tbw. this is the first randomized controlled trial comparing anatomical locking plate fixation and conventional tension band wiring for patella fractures to be performed. this study aims to compare the efficacy and safety of these two methods in the treatment of patellar fractures.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * diagnosed with an isolated closed injury, displaced, unstable fracture with displacement \>2mm (ao/ota classification 34-b and c with surgical indication) * able to give consent exclusion criteria: * history of previous knee surgery * poly trauma, * ongoing malignancy * pre-existing severe knee osteoarthritis (\>kl stage 4) * stroke * other neurological conditions/injuries to the lower limb * unfit for surgical anaesthesia * non-ambulatory * unable to consent or follow commands

Keywords: trauma knee injury tension band wiring patella fracture anatomical locking plate fixation
tibulizumab systemic sclerosis understanding and response evaluation (tibusure)

Conditions: Systemic Sclerosis (SSc); Scleroderma

Summary: the study is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (period 2)


Eligibility criteria:
inclusion criteria: * male or female, 18 to 70 years of age * body mass index between 18.0 and 35.0 kg/m² * fulfills classification criteria for ssc according to acr/eular 2013 criteria * has diffuse cutaneous ssc, defined as mrss \>0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis * has had ssc (defined as the first non-raynaud's phenomenon (rp) symptom or sign attributed to ssc) for ≤5 years * meets at least 1 of the following based on duration since ssc onset: * \<2 years from ssc onset (first non-rp symptom or sign attributed to ssc): mrss ≥15 and ≤45 at screening * ≥2 years from ssc onset (first non-rp symptom or sign attributed to ssc): mrss ≥20 and ≤45 at screening, and either: * rna polymerase iii negative, or * evidence of recent disease progression as defined in the protocol * fvc \>50% predicted * diffusing capacity of the lungs for carbon monoxide (dlco) ≥40% predicted (corrected for hemoglobin) exclusion criteria: * has any of the following complications: * left ventricular failure * pulmonary arterial hypertension * renal crisis within previous 6 months * gastrointestinal dysmotility within previous 3 months * digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months * current rheumatic disease other than ssc that could interfere with assessment of ssc * lung disease requiring continuous oxygen therapy * evidence or suspicion of active or latent tuberculosis * active crohn's disease or ulcerative colitis

Keywords: scleroderma systemic sclerosis (ssc) tibulizumab cutaneous interstitial lung disease (ild) autoimmune diseases immune system diseases systemic sclerosis interstitial lung disease (ssc-ild) skin diseases
functional recovery of patients undergoing resection and reconstruction of the lower limbs for bone tumor.

Conditions: Bone Neoplasm; Rehabilitation

Summary: the aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved.

retrospective observational study will be conducted. the evaluation of the patients clinical recovery progress will take place at three different times: during the hospital stay postoperative, at 3 and 6 months after surgery. different outcome measures will be considered in order to provide a complete picture of the patients functional recovery and their change.

Eligibility criteria:
inclusion criteria: * all participants undergone lower limb resection and reconstruction with localisation of the disease to the pelvis, femur femur, tibia and foot bones. * all participants undergone soft tissue resection surgery on the of the lower limb * all types of oncological diagnoses will be taken considered: osteosarcoma, ewing and others. exclusion criteria: * participants who undergo at our institute only the surgical treatment while continuing adjuvant treatment at other centres * participants for whom no rehabilitation treatment has been activated during adjuvant treatment at our institute

Keywords: bone tumor physiotherapy functional recovery
exploration of the parameters influencing the effort limitation of patients suffering from homozygous sickle cell anemia

Conditions: Analyze the Results of Cardiorespiratory Stress Tests; Resting and Stress Echocardiography; Capillary Lactatemia Measurements at the Ear

Summary: the cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. the hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients.. recent studies have shown a paradigm shift in the use of physical activity. hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. as a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population. it's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.

the cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. the hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients. recent studies have shown a paradigm shift in the use of physical activity. hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. as a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population. it's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.

Eligibility criteria:
inclusion criteria: * adult patient ≥ 18 years old * affiliated with a social security scheme (beneficiary or beneficiary's beneficiary) exclusion criteria: * pregnant or breast-feeding women * patients under guardianship, curatorship or legal protection * patient under ame * patient with a contraindication or unsuitability for physical activity on a cycloergometer
obesity hypoventilation syndrome prevalence study

Conditions: Obesity Hypoventilation Syndrome

Summary: this is an observational study to characterize the prevalence of obesity hypoventilation syndrome in patients referred to the sleep lab.


Eligibility criteria:
inclusion criteria: * greater than or equal to 21 yrs. of age * referred to sleep lab for diagnostic psg, initial titration psg or split night psg as routine clinical care * bmi greater than or equal to 30kg/m2 exclusion criteria: * acutely ill or medically unstable to participate per pi * current positive airway pressure(pap therapy)users * medical history of chronic obstructive pulmonary disease(copd) * incapable of providing own informed consent * bmi less than 30kg/m2
a clinical study on the efficacy and mechanism of tumor treatment vaccine (ttv) for recurrent and refractory advanced solid tumors

Conditions: Solid Tumors, Adult

Summary: this is a study of the clinical efficacy and mechanism study of tumor treatment vaccine (ttv, also known as neo-bcv) in patients with recurrent and refractory advanced solid tumors.

the study aims to explore the safety and effectiveness of neo-bcv in the treatment of advanced solid tumors.the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: 1. male or female aged 18-75 years; 2. asubjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy; 3. subjects have at least one measurable lesion according to response evaluation criteria in solid tumors (recist 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm); 4. ecog score of 0-2, lifespan \> 12 weeks; 5. women of childbearing age who have a negative pregnancy test within 7 days before treatment. female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug; 6. voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up. exclusion criteria: 1. the patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid); 2. white blood cell count ≥ 50×10\^9/ l or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle; 3. patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment. 4. hiv, hbv and hcv positive; 5. patients with diseases of the central nervous system or autoimmune central nervous system lesions, including stroke, epilepsy, dementia; 6. patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months; 7. patients are on anticoagulation or have severe coagulopathy (aptt\>70); 8. patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration; 9. patients were infected with covid-19 within 2weeks prior to investigational drug administration; 10. subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator; 11. subjects in other conditions that are considered unsuitable for this study by the investigator.

Keywords: tumor immunotherapy tumor vaccine advanced solid tumor
weight loss in patients with covid-19 and influenza in comorbidity with ncds: a pilot prospective clinical trial

Conditions: Clinical Trial

Summary: the goal of this study was to evaluate the effects of the fast weight loss on clinic and laboratory inflammation profile, metabolic profile, reactive oxygen species (ros) and body composition in patients with covid and influenza in comorbidity with ncds. primary endpoints: clinic/infectious/inflammation tests for covid and influenza; weight loss during 14 days. secondary endpoints: fasting blood glucose, hba1c, blood insulin; systolic/diastolic bp; blood lipids; alt, ast, chest ct-scan.

study design. a 6-week, open, pilot prospective clinical trial with the intention-to-treat principle. participants: the study enrolled 72 adult people (38 women) aged from 25 to 80 years with moderate-to-severe cases covid and influenza in comorbidity with ncds as t2d, hypertension, and nash. all patients with the ards had in comorbidity with one or more ncds. all patients refused for pharmacology therapy due to: either previous unsuccessful drug results; or an antimicrobial resistance profile; or drug allergy; or reluctance to take medication; or iatrogenic fear (iatrophobia); or a rich failed experience in drug treatment; and nash. all the patients were admitted into the out-patient department in 3-5 days after illness onset. the study was carried out in the republic of kazakhstan from november, 2020, through july, 2022 at university medical center (astana) and anadeto medical center.

Eligibility criteria:
inclusion criteria: * written informed consent form; * patients with fever * patients refused for pharmacology therapy * weight loss treatment for 12-14 days and +4 weeks follow-up (total 6 weeks) exclusion criteria: * patients with acute respiratory failure and assisted ventilation requirement * respiratory rate ≥ 30 times per minute * oxygen saturation ≤ 93% by finger oximetry at resting status

Keywords: covid-19 influenza non-communicable diseases (ncds) fast weight loss
early warning of intradialytic hypotension in hemodialysis patients

Conditions: Hypotension of Hemodialysis

Summary: in this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable ppg-based device. measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. the aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.


Eligibility criteria:
inclusion criteria: 1. patients with eksd undergoing chronic hemodialysis treatments for \> 3 months. 2. patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study. 3. patients must satisfy a medical examiner about their fitness to participate in the study. 4. patients must provide written informed consent to participate in the study. exclusion criteria: 1. patients with an inability to communicate well with the principal investigator (pi) and staff (i.e., language problem, poor mental development, or impaired cerebral function). 2. withholding the dialysis session for any reason prior to initiation. 3. minors under the age of 18.

Keywords: hemodialysis intradialytic hypotension remote monitoring