Kornimate/medical-research-clean huggingface dataset:
non-invasive nervus vagus stimulation in patients with covid-19 and ards

Conditions: COVID-19; ARDS; Cytokine Storm

Summary: critical ill covid-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. an imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. the nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. aim of this study is to evaluate whether nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.

introduction: critical ill covid-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. an imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. the nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. a method to stimulate the nervus vagus, is the non-invasive nervus vagus stimulation with auristim. aims: aim of this study is to evaluate whether nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients. methods: all patients admitted to icu at klinik favoriten with covid-19 and moderate to severe ards are asked to partcipate. after written consent, a randomisation in treatment-group (vagal nervus stimulation 4 times a day for each 3 hours until transfer to nomal ward or death) or non-treatment-group is done. in case of stimulation, side effects or intolerance are documented. after discharge or death of the patient, outcomeparameters are evaluated (need of mechanical ventilation, hospital stay, mortality, etc.) and compared between patients of treatment-group and non-treatment-group.

Eligibility criteria:
inclusion criteria: * positive sars-cov-2 rt-pcr * acute respiratory failure requiring non-invasive respiratory support (niv or high flow oxygen) * pao2/fio2 \<200 exclusion criteria: * age \<18 years * pregnancy (to be excluded using serum betahcg in women of childbearing age) * signs of infection, eczema or psoriasis at the application site * active malignancy * implanted cardiac pacemaker, deficrillator or other active implanted electrical devices * patient unable to consent * heart rate \<60/min * known vagal hypersensitivity * history of hemophilia

Keywords: nervus vagus stimulation covid-19 ards hyperinflammation cytokine storm
silver-coated endotracheal tube to reduce ventilator associated pneumonia (vap)

Conditions: Respiratory Failure

Summary: the purpose of this study is to determine if the use of a silver-coated endotracheal tube (ett) can reduce the incidence and/or delay the time of onset of vap when compared to a non silver-coated ett in patients who have been mechanically ventilated for \>= 24 hours.

nosocomial pneumonia is the leading cause of death from hospital-acquired infections.ventilator associated pneumonia (vap) develops in a significant percentage of patients who have been ventilated for at least 48 hours, and is associated with high morbidity, mortality,and financial costs. silver is a well-characterized antimicrobial agent, and is the active agent in multiple medical products used to reduce or control infection. bard has developed a proprietary antimicrobial ett, manufactured with a hydrophilic coating containing a fine dispersion of silver salts. this study compare the incidence and time to onset of vap in patients intubated for \>=24 hours with a proprietary silver-coated ett versus those intubated for \>= 24 hours with a standard non-coated ett.

Eligibility criteria:
inclusion criteria: * age \> 18 years * expected to be intubated for at least 24 hours * able to sign informed consent exclusion criteria: * symptoms of bronchiectasis * severe hemoptysis * history of cystic fibrosis * intubated \> 12 hours within previous 30 days * pregnancy * participating in a competing trial

Keywords: ventilator-associated pneumonia nosocomial pneumonia
safety and efficacy of zvs203e in the treatment of retinitis pigmentosa caused by rho gene mutation

Conditions: Retinitis Pigmentosa

Summary: this trial employs a single-arm, open-label seamless phase i/ii design, consisting of two stages: phase i dose exploration and phase ii dose expansion.the primary objective of this trial is to evaluate the safety, tolerability, and efficacy of subretinal injection of zvs203e solution.

zvs203e injection is administered via a single subretinal injection of raav8 vector carrying crispr/cas9 gene-editing tools to silence mutated genes, allowing retinal cells to express only normal functional proteins, thereby treating rho-adrp. this trial employs a single-arm, open-label seamless phase i/ii design, consisting of two stages: phase i dose escalation and phase ii dose expansion, with an anticipated total enrollment of 9 to 18 participants.

Eligibility criteria:
inclusion criteria: 1. patients with a clinical diagnosis of retinitis pigmentosa (rp) (aged 18 years or older); 2. rho (c.403c\>t, p.r135w) gene site-specific mutation was confirmed by genetic testing, and no other ophthalmic genetic diseases were complicated; 3. the researchers judged that the target eye had viable retinal photoreceptor cells and retinal pigment epithelial cells; 4. the best corrected visual acuity of the target eye is between 2.0 logmar and 0.5 logmar (including 2.0 logmar and 0.5 logmar, which is equivalent to a number of fingers to 60 letters); 5. the subject and his or her spouse agree to use effective contraception during the trial period and for at least 1 year after dosing; 6. voluntarily participate in clinical trials and sign informed consent, and can complete the whole test process according to the protocol requirements. exclusion criteria: 1. the researcher determined that the target eye currently has or had macular lesions such as macular hiatal hole or macular neovascularization; 2. have other eye conditions that may prevent surgery or interfere with interpretation of the study endpoint, such as glaucoma, diabetic retinopathy, eye or periocular infections, active endophthalmitis, etc. 3. within 3 months prior to enrollment, the study eye had received any intraocular surgery, such as phacoemulsification cataract extraction. 4. the study eye had undergone retinal reattachment or vitrectomy. 5. participants who had participated in any drug or medical device clinical trial within 3 months before enrollment; 6. previously treatment of either eye with gene therapy or stem cell therapy for rp and other ocular diseases, including but not limited to viral vector gene therapy, rna therapy. 7. treatment with medications that may affect the efficacy and safety evaluation of the investigational product within 3 months prior to enrollment (e.g., ranibizumab, bevacizumab, aflibercept, conbercept). 8. known allergy to the drug planned to be used in the study.

Keywords: gene editing zvs203e rho retinitis pigmentosa
pilot study of somatostatin receptor imaging in nasopharyngeal cancer

Conditions: Nasopharyngeal Carcinoma

Summary: hypothesis: to estimate the proportion of locally advanced, recurrent or metastatic nasopharyngeal cancer patients which show high somatostatin receptor density (suvmax \>10) on ga-68 dotatate imaging. galium-68 dotatate: pet imaging will be performed with a pet/ct scanner. galium-68 dotatate will be injected intravenously. scanning will be performed approximately 60 minutes after the injection. the standardized uptake value (suv) will be used in the interpretation of the ga-68 dotatate scans. the values gathered will be used as an estimate of the somatostatin receptor density. a patient will be considered to have an overall high somatostatin receptor density if the average suvmax of all the representative lesions is more than 10.


Eligibility criteria:
inclusion criteria: * locally advanced npc or metastatic npc or locally recurrent npc * \>21 years old * histological confirmation of npc exclusion criteria: * \<21 years old * pregnancy or breast feeding
liquid biopsy with immunomagnetic beads capture technique for malignant cell detection in body fluid

Conditions: Malignancy; Pleural Effusion; Pleural Diseases; Ascites

Summary: the purpose of the current study is to establish a liquid biopsy method (positive enrichment by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous effusions and to evaluate its sensitivity and specificity for clinical application.

a serous effusion is common event in metastatic carcinoma, but it also can be associated with other benign medical conditions. current standard method for detecting malignancy is by cytological examination. however, cytological examination is often low sensitive, often due to the large amount of fluid with relatively sparse tumor cells present and the presence of many normal cells such as mesothelial cell. the investigators have developed a new method, malignant cell enrichment with immunomagnetic beads capture followed by pap staining and ngs, to identify target malignant cells in body fluids. mcab nj001 is developed for malignant cell isolation with immunomagnetic beads capture technique. this is a prospective, multi-center, double-blind, statistically powered clinical trial that will enroll patients scheduled to undergo a procedure for removal of fluid from a serous effusion with or without clinical diagnosis of caner. the purpose of the current study is to compare the novel serous effusion detection assay using nj001 coated immunomagnetic beads capture followed by pap staining and ngs analysis with traditional cytologic evaluation.

Eligibility criteria:
inclusion criteria: * males or females \>18 years of age; * have a serous effusion; * scheduled for a diagnostic and/or therapeutic procedure to remove serous fluid ( puncture of serous cavity). exclusion criteria: * females known to be pregnant;

Keywords: malignancy pleural effusion pleural neoplasms ascites
validity and reliability of scim-sr

Conditions: Spinal Cord Injuries

Summary: to determine the validity and reliability of scim-sr, patients will fill out scim 3 and sr.

to determine the validity and reliability of scim-sr, patients will fill out scim 3 and sr. scım-sr turkish form has been created. patients with spinal cord injuries who applied to our physical therapy clinic filled out the form twice.

Eligibility criteria:
inclusion criteria: * sci \>1 month * 18-70 years * agree to participate * give written consent exclusion criteria: * not read turkish, * not write turkish, * cognitive problems
impact of hypnosis for performing lumbar infusion tests

Conditions: Hypnosis; Hydrocephalus; Anxiety; Pain

Summary: infusion tests are now the gold standard for the diagnosis of chronic adult hydrocephalus (cah), also known as normal pressure hydrocephalus. it is an invasive procedure using the same approach as a lumbar puncture. once the intrathecal puncture is performed, the intracranial pressure is measured in lateral decubitus via a pressure head. dynamic tests (injection of 0.9% nacl at a constant flow rate) are performed after recording the basal pressure. this type of test lasts 30 to 45 minutes in lateral decubitus. patients with cah have cognitive-behavioral disorders that can alter the gesture and its interpretation in case of movements or contractures. movement artefacts lead to a longer recording time. the longer the test, the more the patients' tolerance tends to decrease. moreover, the patient's feeling towards this test is important because it may have to be repeated. pain, anxiety and patient comfort are essential parameters to consider. non-medicinal techniques (hypnosis, music therapy) have shown a tendency to reduce anxiety in pediatric and adult populations with an impact on instantaneous anxiety but also on personality-related anxiety. most studies are focused on specific pathologies, primarily in palliative care, or on pediatric application. the use of these techniques in an elderly population with mild cognitive-behavioral disorders has not been explored. the objective is to evaluate the impact of hypnosis on anxiety, pain and comfort during the lumbar infusion test.


Eligibility criteria:
inclusion criteria: * patient over 65 years old undergoing assessment for suspected cah in day hospitalization for a lumbar infusion test * no major cognitive impairment (mmse\>20) exclusion criteria: * patient less than 65 years old * major cognitive impairment (mmse\<20) * history of lumbar surgery * contraindication to lumbar puncture or infusion test * hearing impairment

Keywords: hypnosis infusion study hydrocephalus anxiety pain
use of compression bandages in the prevention of post-mastectomy lymphoceles

Conditions: Lymphocele

Summary: lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery. this can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer. there is no consensus regarding the management of lymphocele. the placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences. this would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.


Eligibility criteria:
inclusion criteria: * patients over 18 years old, * undergoing mastectomy-type surgery with or without axillary dissection for breast cancer * affiliated with a health insurance plan exclusion criteria: * recurrence of breast cancer, * mastectomy with rmi (immediate breast reconstruction) at the same time of operation * anticoagulant treatment at curative dose * arteritis obliterans of the upper limbs, * other cancer during treatment, * decompensated heart failure, * acute infectious episode (cellulitis, erysipelas, lymphangitis) * acute deep vein thrombosis upper limb ipsilateral to mastectomy, * cutaneous atrophy of the upper limb, * bullous dermatoses, * hyperalgesia of the shoulder * inability to submit to the constraints of the protocol, * impossibility for the patient to achieve self-restraint at the thoracic level * pregnancy, * feeding with milk * bmi\> 35 * adult protected by law (guardianship, curatorship and safeguard of justice). * anyone who is not in a position to give their consent in writing

Keywords: mastectomy
omega-3 fatty acids to combat sarcopenia

Conditions: Sarcopenia

Summary: the purpose of this study is to determine how omega-3 fatty acids influence muscle protein metabolism and mitochondrial physiology in the context of human aging.


Eligibility criteria:
inclusion criteria: * age 18-35 or 65-85 years exclusion criteria: 1. current use of omega-3 nutritional supplements 2. fasting plasma glucose ≥126 mg/dl 3. active coronary artery disease 4. participation in structured exercise (\>3 times per week for 30 minutes or longer) 5. smoking 6. medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants) 7. renal failure (serum creatinine \> 1.5mg/dl) 8. chronic active liver disease (bilirubin \> 17mmol/l, ast\>144iu/l, or alt\>165iu/l) 9. anti-coagulant therapy (warfarin/heparin) 10. inr \>3 11. use of systemic glucocorticoids 12. chronic use of nsaids or aspirin 13. pregnancy or breastfeeding 14. alcohol consumption greater than 2 glasses/day 15. hypothyroidism 16. fish or shellfish allergy
open-label placebo in manual therapy

Conditions: Low Back Pain, Recurrent

Summary: to investigate the effects of placebo in patients affected by low-back pain.


Eligibility criteria:
inclusion criteria: adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included. -patients will need to have a diagnosis of low back pain made by a physician exclusion criteria: * pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases. * pregnant women * patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial * diseases that may affect the interpretation of results such as fibromyalgia * patients currently being treated by other specialists or other manual therapists

Keywords: placebo placebo effect open-label trial
intravenous acetaminophen use with bariatric surgery on morbidly obese patients

Conditions: Obesity; Pain

Summary: bariatric patients usually require the use of either intravenous or oral opioid medications. the use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. this study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.


Eligibility criteria:
inclusion criteria: * morbidly obese and body mass index (bmi) of 35 * between ages 20-17 * candidates for laparoscopic bariatric surgery exclusion criteria: * know hypersensitivity to acetaminophen or opioids * impairment in liver function * renal dysfunction * mental retardation

Keywords: pain management
childhood passive smoking: cohort study of cardiac risk

Conditions: Cardiovascular Diseases; Heart Diseases; Lung Diseases; Coronary Arteriosclerosis

Summary: to determine the effects of long-term exposure to passive smoking on the cardiovascular and oxygen transport systems in pre-adolescent twins.

background: the adverse health effects of actively inhaled cigarette smoke include impaired pulmonary function, increased coronary and cerebrovascular disease, chronic pulmonary disease, and cancer. infants and young children of smoking parents are at increased risk for lower respiratory tract infections and small airways disease than are children of non-smoking parents. what is less clear is how the oxygen transport system of the growing child is affected by the long-term exposure to and passive inhalation of cigarette smoke and if this exposure represents a risk for the subsequent development of atherosclerotic heart disease. design narrative: a sample of 300 pre-adolescent twin pairs was recruited from an established population-based twin study. the three cohorts of twins and their parents were initially evaluated in a cross-sectional study and then followed longitudinally for up to three years. in the initial testing cycle the following data were collected: genotype; general health; anthropometric measures; resting and exercise noninvasive evaluation of hemodynamic parameters including blood pressure, heart rate, cardiac output, left ventricular mass, and oxygen consumption; hematocrit and blood levels of 2,3-dpg, cotinine, thiocyanate, and erythropoietin; spirometric and pulmonary flow data; lipid levels. there were three follow-up exams. the availability of repeated measures of oxygen delivery and its determinants in twins and their parents permitted both a unique analysis of genetic and environmental factors during the process of developmental change and measurements of the risks of accelerated atherosclerotic/ischemic heart disease and of the development of reactive airway disease. the following hypotheses were tested: genetic factors accounted for a significant proportion of the variation in the hematologic and cardiovascular determinants of systemic oxygen delivery; adaptive responses of the oxygen delivery system differed in the same individual before and after puberty; passive smoking in children was an incremental risk factor for the development of accelerated atherosclerotic/ischemic cardiovascular disease; passive smoking in children was a contributing factor in the development of reactive airway disease.

Eligibility criteria:
no eligibility criteria
a safety and efficacy study evaluating ctx112 in subjects with relapsed or refractory b-cell malignancies

Conditions: B-cell Lymphoma; Non-Hodgkin Lymphoma; B-cell Malignancy; Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL); Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Large B-cell Lymphoma

Summary: this is an open-label, multicenter, phase 1/2 study evaluating the safety and efficacy of ctx112™ in subjects with relapsed or refractory b-cell malignancies.

this is an open-label, multi-center phase 1/2 study of ctx112 in subjects with relapsed/refractory b cell malignancies. ctx112 is an is allogeneic cd19-directed chimeric antigen receptor (car) t cell immunotherapy comprised of allogeneic t cells that are genetically modified ex vivo using crispr-cas9 (clustered regularly interspaced short palindromic repeats/ crispr associated protein 9) gene editing components (single guide rna and cas9 nuclease).

Eligibility criteria:
key inclusion criteria: 1. age ≥18 years. 2. refractory or relapsed b cell malignancy. 3. eastern cooperative oncology group performance status 0 or 1. 4. adequate renal, liver, cardiac and pulmonary organ function. 5. female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after ctx112 infusion. key exclusion criteria: 1. prior allogeneic hematopoietic stem cell transplant (hsct). 2. active or history of central nervous system (cns) involvement by malignancy. 3. history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with cns involvement. 4. presence of bacterial, viral, or fungal infection that is uncontrolled or requires iv anti-infectives. 5. active hiv, hepatitis b virus or hepatitis c virus infection. 6. previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence). 7. concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to ctx112 infusion or with a nonbiological anticancer drug within 14 days prior to ctx112 infusion. 8. primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 9. women who are pregnant or breastfeeding.

Keywords: car t non-hodgkin lymphoma (nhl) lymphoma allogeneic