Kornimate/medical-research-clean huggingface dataset:
long-term impact of covid-19 among covid-19 patients with acute respiratory distress syndrome in brazil

Conditions: COVID-19; ARDS

Summary: the present multicenter prospective observational study aims to assess the long-term effects of covid-19 on patients with acute respiratory distress syndrome (ards). this is a hybrid design study with components of cohort and case-control designs. survivors of hospitalization due to ards caused by sars-cov-2, survivors of hospitalization due to ards caused by other etiologies not associated with sars-cov-2, and family controls without history of covid-19 or hospitalization will be followed up for a period of 6 months.


Eligibility criteria:
cohort of survivors of ards caused by covid-19 inclusion criteria: * age ≥18 years; * hospitalization due to covid-19; * positive polymerase chain reaction (pcr) test for sars-cov-2; * diagnosis of ards during hospitalization according to the berlin definition; * expected to survive and be discharged directly home from the hospital. exclusion criteria: * severe comorbidity with life expectancy less than 3 months; * unavailability to attend the study follow-up appointment; * death during hospitalization; * absence of proxy for patients with communication difficulties; * refusal or withdrawal of agreement to participate. cohort of survivors of ards caused by other etiologies not associated with covid-19 inclusion criteria: * age ≥18 years; * hospitalization; * diagnosis of ards during hospitalization according to the berlin definition; * expected to survive and be discharged directly home from the hospital. exclusion criteria: * severe comorbidity with life expectancy less than 3 months; * unavailability to attend the study follow-up appointment; * death during hospitalization; * history of sars-cov-2 infection within the last 12 months; * absence of proxy for patients with communication difficulties; * refusal or withdrawal of agreement to participate. family controls inclusion criteria: * age ≥18 years; * family member of a enrolled participant (either from the covid-19 ards cohort or from the non-covid-19 ards cohort) exclusion criteria: * severe comorbidity with life expectancy less than 3 months; * unavailability to attend the study follow-up appointment; * history of sars-cov-2 infection within the last 12 months; * history of non-elective hospitalization due to medical condition within the last 12 months; * refusal or withdrawal of agreement to participate.
clinical follow-up to evaluate the clinical usefulness of gentamicin-coated titanium nails in tibia fractures

Conditions: Tibia Fractures

Summary: this post market clinical follow-up is to confirm the clinical usefulness of the expert tibial nail (etn) protect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (eq5d, sf-12) instruments, disease-specific questionnaires (iowa ankle score, womac) and assessment of (non-)device related adverse events or complications.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or more * open or closed tibia fracture according to the surgical technique exclusion criteria: * women who are pregnant or breast-feeding or are planning to become pregnant during the study * patients with consumptive/ malignant primary disease and a life expectancy of \< 3 months * patients with a known allergy to aminoglycosides * physical or mental incapacity, which makes it impossible to obtain informed consent * history of drug and alcohol abuse * patient unlikely to cooperate * legal incompetence
cardiosecur connected electrocardiography in general care

Conditions: Heart Diseases; Connected ECG; Family Practice

Summary: heart disease symptoms are a frequent reason of consultation in general medical practice. only a few general practitioners are equipped with a 12 lead electrocardiography (ecg) whereas this test is extremely useful for diagnosis orientation in cases of cardiac diseases.cardiosecur allows the realization of a 15 or 22 leads ecg with only 4 electrodes connected to a smartphone or a tablet with an automatic interpretation function. the goal of the study is to evaluate the diagnostic value of cardiosecur device regarding cardiac symptoms in family practice.

this study will be a multicenter, single arm, non randomized trial testing the incremental diagnosis value of cardiosecur ecg regarding cardiac disease in general care. ten general practitioners will be given a cardiosecure active device with a tablet and perform an ekg to their consecutive patients who meet the inclusion criteria. inclusion criteria * recent cardiovascular symptom \< 7 days (chest pain, dyspnea, palpitation, heart failure or transient loss of consciousness) or physical examination leading in possible cardiac cause. * aged over 18 years * signed the informed consent * a questionnaire regarding the diagnosis orientation based on the patients' symptoms and physical examination will be given to gps before and after the ecg realization and automatic interpretation to evaluate whether the ecg modified the diagnosis. if the gp need further exploration to conclude or if the patient is oriented to an hospital or a specialist, the reference diagnosis will be defined at the end of these explorations. otherwise, the diagnostic will be defined at the end of the gp consultation. * a questionnaire regarding the ease of use of the cardiosecure device will be filled by the patients. * time for ecg realization will be recorded. * all the ecg and their automatic interpretation will be stored anonymously according to bioethics laws and then reviewed by 2 experienced cardiologists blinded to the results of the automatic interpretation. the interobserver reproducibility as well as the comparison with the cardiosecur automatic interpretation will be analyzed.

Eligibility criteria:
inclusion criteria: * recent cardiovascular symptoms \< 7 days (chest pain, dyspnea, palpitations, heart failure or transient loss of consciousness) or physical examination suggesting cardiac disease. * patients aged over 18 years * signed the informed consent exclusion criteria:
chronic kidney disease-related sarcopenia with poor prognosis

Conditions: Chronic Kidney Diseases; Sarcopenia

Summary: chronic kidney disease (ckd) has become a global public health priority over the past few decades, affecting 10-12% of the adult population and has received increasing attention. sarcopenia describes a generalizes degenerative skeletal muscle disorder involving the loss of muscle mass, muscle function and/or physical performance. indeed, sarcopenia is a condition with many causes and it can be considered "primary sarcopenia" when no other cause is evident but ageing. while in the clinical practice, it also occurs in patients with chronic diseases, such as chronic kidney disease, which can be considered "secondary sarcopenia". notably, the occurrence of sarcopenia in ckd patients is not only related with ageing, the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and oxidative stress also contribute to the muscle depletion. moreover, sarcopenia increased risk of falls and fractures, impaired ability to perform activities of daily living, disabilities, loss of independence and increased risk of death. hence, it is of great significance to prevent the occurrence and development of sarcopenia in patients with ckd. the purposes of this project were to investigate the prevalence of sarcopenia, further explore the risk factors for sarcopenia and detect the relationship between sarcopenia and outcomes in ckd patients.


Eligibility criteria:
inclusion criteria: * 1.aged ≥18 years and \<80 years 2.egfr\<60ml/min/1.73m2 or had received maintenance dialysis for at least 3 months. exclusion criteria: * 1.patients with neuromuscular diseases: such as muscular dystrophy, amyotrophic lateral sclerosis, spinal cord injury, stroke, and myasthenia gravis; 2.patients with neurodegenerative diseases: such as alzheimer's disease, parkinson's disease and huntington's disease; 3.patients with advanced malignant tumors; 4.patients with acute infectious diseases in the past 3 months; 5. patients with serious cardiovascular or cerebrovascular disease; 6.moderate to severe edema; 7.patients with rheumatoid arthritis, multiple sclerosis, or acute gout that limit joint mobility; 8.pregnant ; 9.patients identified to be unsuitable for enrollment by the study physician
pre-vitrectomy intravitreal ranibizumab for patients with proliferative diabetic retinopathy combined with diabetic macular edema

Conditions: Proliferative Diabetic Retinopathy; Diabetic Macular Edema

Summary: to investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in pdr-dme patients receiving vitrectomy.

primary objective: to investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in pdr-dme patients receiving vitrectomy. secondary objective:to investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in pdr-dme patients receiving vitrectomy. study design: this study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for pdr-dme patients.

Eligibility criteria:
inclusion criteria: 1. age≥18 years old; 2. type i or ii diabetes mellitus, clinically diagnosed as diabetic macular edema 3. diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (ppv) is required to undergo due to non-absorbent vitreous hemorrhage (vh), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (trd); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of ppv at the investigator's discretion 4. ability to provide written informed consent and comply with study assessments for the full duration of the study. exclusion criteria: 1. pregnancy or lactation; 2. history of stroke, peripheral vascular disease, angina or myocardial infarction within six months 3. intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline; 4. clinically confirmed intraocular pressure (iop) \>=21 mmhg, uncontrolled glaucoma or iris neovascularization in either eye

Keywords: pdr dme ranibizumab vitrectomy
study of changes in skeletal muscle after caloric restriction

Conditions: Obesity

Summary: research has shown that fat stored within muscles affects the muscle's sensitivity to insulin and ability to handle blood glucose. the purpose of this study is to examine the effects of weight loss surgery-induced caloric restriction on the accumulation and types of fats within skeletal muscle, as well as the effects of such caloric restriction on insulin sensitivity and inflammatory responses in skeletal muscle. the investigator proposes that caloric restriction will result in decreases in diacylglycerols enriched with saturated fat and increases in diacylglycerols enriched with monounsaturated fats.

we hypothesize that in a setting of surgically-induced weight loss decrements in select dags result in improved glucose utilization, altered insulin signaling and decreased inflammatory responses. we propose to examine the impact of molecular dag species accumulation on glucose utilization, insulin signaling and inflammation in skeletal muscle from morbidly obese subjects before/after 10% weight loss facilitated by roux-en-y gastric bypass (rygb). we will compare these results to those from a control, normal weight cohort the detected differences in dag molecular species, insulin action, inflammatory responses between normal and obese subjects (before/after weight loss) will emphasize pathways coordinately altered as a consequence of adiposity and rygb surgery. the primary endpoints for this study will be: insulin sensitivity (glucose rd, insulin levels, dag mass, dag species amounts).secondary endpoints will be: ffa levels, inflammatory cytokine production, and insulin signaling in skeletal muscle.

Eligibility criteria:
inclusion criteria: * for normal weight subjects: * age 21-65 years * bmi of 21 to 27 kg/m2 * normal glucose tolerance as determined by ogtt on day of screening * no family history of diabetes * for morbidly obese subjects: * age 21-65 years * bmi of 30 to 65 kg/m2 * scheduled for roux-en-y gastric bypass at vanderbilt medical center * insulin resistant as determined by ogtt on day of screening exclusion criteria (for all subjects): * clinically significant heart disease * clinically significant hepatic or renal disease * pregnancy * breastfeeding * any abnormality that would preclude safe completion of study * use of statins * use of thiazide or furosemide diuretics, beta blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless subject has been on stable dose of such medications for the past 3 months before entering the study

Keywords: obesity insulin sensitivity inflammation
an extension protocol for the extended use of talimogene laherparepvec for eligible patients who participated in study 002/03 (nct00289016)

Conditions: Melanoma

Summary: the primary objective of this extension study was to further assess the safety and tolerability of talimogene laherparepvec. secondary objectives were to assess objective tumor response rate and survival.

this was an extension study to the multicenter, open-label, phase 2 study 002/03 (nct00289016). participants who had received the maximum 24 treatments under study 002/03 and met the inclusion and exclusion criteria were eligible to enroll. participants continued to receive talimogene laherparepvec until discontinuation criteria were met. the discontinuation criteria were complete response, clinically significant progressive disease that rendered further dosing futile, receipt of 24 treatments or 12 months on treatment (whichever was longer), occurrence of an unacceptable toxicity, death, investigator determination that other treatment was warranted, or another criterion for withdrawal from treatment (participant request, noncompliance with study procedures, or sponsor request).

Eligibility criteria:
inclusion criteria: 1. previously participated in study 002/03 and met 1 of the following: 1. received the maximum 24 treatment injections in study 002/03 and had not yet achieved a complete response (cr) and whose response to oncovex\^gm-csf indicated that treatment beyond 12 months was warranted, or 2. did achieve a cr in study 002/03 and developed disease progression within 12 months of achieving a cr, or 3. terminated treatment in study 002/03 to allow for treatment of brain metastases. treatment for brain metastases was no longer ongoing and the patient was able to return to oncovex\^gm-csf injections within 3 months of completing treatment for brain metastases. 2. eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: 1. prior common toxicity criteria for adverse events (ctcae) grade 3 or 4 toxicity related to oncovex\^gm-csf of any organ system (with the exception of injection site reactions, fever and vomiting); 2. history of grade 3 fatigue lasting \> 1 week while on oncovex\^gm-csf treatment; 3. history of grade 3 arthralgia/myalgias while on oncovex\^gm-csf treatment; 4. history of ≥ grade 2 autoimmune reactions, allergic reactions or urticaria or other oncovex\^gm-csf-related non-hematological toxicities while on oncovex\^gm-csf treatment that required a dose delay or discontinuation of oncovex\^gm-csf therapy; 5. symptomatic malignant disease progression that required alternative melanoma treatment; 6. primary malignancy disease progression despite treatment with oncovex\^gm-csf; 7. patient requested to be withdrawn from or was unable to comply with the demands of study 002/03. 8. patient was withdrawn from study 002/03 at the discretion of the investigator.
ocular assessments in patients treated with tivdak® in recurrent or metastatic cervical cancer

Conditions: Cervical Cancer

Summary: tivdak is used for the treatment of cervical cancer that has come back after chemotherapy. chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. this is done either by killing the cells or by stopping them from growing. the purpose of this study is to learn about possible side effects of tivdak, specially to any side effect that is related to the eye. a side effect is anything a medicine does to your body that is not part of how the medicine treats disease. * this study is seeking for participants who: are willing to take all the required eye tests * have not received tivdak before * do not have any active eye issues. participants will receive tivdak once every 3 weeks as an infusion that will be injected into the vein. participants will visit an eye care provider at 3 stages: * before starting the treatment, * before each of the first 9 infusions * then monthly for 3 months after they stop taking tivdak. treatment with tivdak will continue until it is not working anymore against the participant's cancer.


Eligibility criteria:
inclusion criteria: 1. must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy 2. treating physician has determined that treatment with tivdak is appropriate for the participant according to us prescribing information 3. must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate 4. must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site 5. must agree to use effective contraception according to the us prescribing information exclusion criteria: 1. active ocular disease at baseline per investigator assessment 2. previous treatment with tivdak 3. previous administration of an investigational drug within 30 days 4. any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator's judgment, increase the risk of study participation or make the participant inappropriate for the study. 5. patients who are breastfeeding, pregnant, or planning to become pregnant based on criteria as indicated in the us prescribing information 6. known allergies, hypersensitivity, or intolerance to tivdak or its excipients

Keywords: uterine neoplasms genital neoplasms female urogenital neoplasms neoplasms by site neoplasms uterine cervical diseases uterine diseases genital diseases, female female urogenital diseases female urogenital diseases and pregnancy complications urogenital diseases genital diseases uterine cervical neoplasms, tisotumab vedotin
assessment of intracerebral hematoma

Conditions: Intracerebral Hematoma

Summary: the study will assess acute intracerebral hematoma expansion within the first 48 hours from the onset using transcranial duplex sonography in patients who have acute intracerebral hematoma , and will also assess the correlation between the transcranial duplex sonography measurements and the clinical outcome of these patients .


Eligibility criteria:
inclusion criteria: 1. first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast ct brain 2. admitted within 24 hours of symptom onset exclusion criteria: 1. blood diseases, decompansated hepatic or renal impairment, or encephalopathy caused by electrolyte disturbance 2. on anticoagulant treatment 3. if devolped major complications during hospitalization ( e.g sever chest infection, hypoxia, or deep venous thrombosis ) 4. comorbid neurological or psychiatric disorders
immunogenicity of nd1.1 by delivery directly to the ileum

Conditions: Avian Influenza

Summary: the purpose of the study is to determine the safety and tolerability of nd1.1, an adjuvanted adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. the secondary objective is to evaluate the immune response (cellular and humoral) of two doses of nd1.1 oral vaccine.


Eligibility criteria:
inclusion criteria: * able and willing to complete informed consent * healthy, as established by medical history, physical exam, and laboratory assessments * has normal bowel movements * willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge exclusion criteria: * ability to donate up to 550 ml of blood over several months * exposure to any investigational drug or vaccine 8 weeks prior to study * has traveled to asia within 8 weeks of enrollment * abnormal ecg findings * history of irritable bowl or any other inflammatory gastrointestinal disorder * any individual with increased risk for bowl obstruction * radiation exposure above target values 50 msv within the past 30 days or a cumulative dose above 150 msv in the past 12 months * history of substance abuse * subject unwilling to use an approved method of contraception during study and for 2 months after study * positive for hcv, hiv, or hbv * presence of an implantable device that is sensitive to radio frequencies (e.g. pacemakers) * history of an autoimmune disorder, or an immunosuppressive disorder * stool sample with occult blood at baseline * any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator, is a contraindication to the compliance of the protocol or informed consent

Keywords: prevention of avian influenza
subconjunctival bupivacaine in strabismus surgery

Conditions: Anesthesia, Local

Summary: this study aimed to assess the effectiveness of the subconjunctival bupivacaine on postoperative pain in strabismus surgery under general anaesthesia.

40 patients will schedule for elective strabismus surgery under general anaesthesia and randomly allocated into two groups to receive subconjunctival 0.5%bupivacaine group(b) or subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.

Eligibility criteria:
inclusion criteria: * all patients aged 14 _30 years old with body mass index 18_28kg/m. * american anaesthesiologist association physical states i,ii. * singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia. exclusion criteria: * were patients with chronic pain. * ocular hypertension. * inability to communicate. * history of hematological disease. * allergy to local anesthetic drugs.

Keywords: subconjunctival bupivacaine. strabismus surgery. postoperative analgesia.