Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity study of traveler's diarrhea vaccine patch

Conditions: Diarrhea

Summary: the purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of e. coli (lt) patches or placebo, with or without alcohol swabbing


Eligibility criteria:
inclusion criteria: 1. a female or male 18-64 (inclusive) years of age; 2. in good health as determined by medical history and screening exam; 3. females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at day 0 and agree not to become pregnant for the duration of study. exclusion criteria: 1. abnormalities at physical exam \[as determined by the toxicity grading scale (grade 1-4)\]; 2. laboratory abnormalities \[as determined by the toxicity grading scale (grade 1 4)\] at screening; 3. participated in research involving investigational product within 30 days before planned date of first vaccination; 4. ever received investigational enterotoxigenic e. coli, lt, or lt (r192g) or nasalflu, berna biotech, ltd; 5. women who are pregnant or breastfeeding; 6. clinically significant underlying enteric, pulmonary, cardiac or renal disease; 7. current seizure disorder; 8. current use of immunosuppressive therapy (inhaled steroids are allowed); 9. known or suspected alcohol abuse or illicit drug use within the last year; 10. positive serology for hiv-1, hiv-2, hbsag, or hcv; 11. known allergies to any component of the vaccine including adhesives; 12. an employee of the study site; 13. an employee of intercell (global) or an immediate family member; 14. visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; 15. receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.

Keywords: prevention of travelers' diarrhea
study combining zevalin with high-dose chemotherapy prior to autologous stemcell transplant in patients with relapsed, refractory, or transformed non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this aim of this study to evaluate the safety and efficacy of combining a single course of yttrium 90 ibritumomab tiuxetan, a radiolabeled monoclonal antibody ( zevalin ), with high-dose beam chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed non-hodgkin's lymphoma.

relapse rates after chemotherapy for relapsed, refractory or transformed non-hodgkin's lymphoma (nhl)remain very high. nhl is a radiosensitive tumor. we hypothesize that targeted radioimmunotherapy combined with high-dose chemotherapy may increase response and survival rates in a safe and reliable manner.

Eligibility criteria:
inclusion criteria: 1. age \>=18 to \<=70 years 2. relapsed or refractory stage iii or iv, grade 1,2, or 3 follicular lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, waldenstrom's macroglobulinemia, or diffuse large b-cell lymphoma as defined by the who and: * expressing the cd 20 antigen * ecog performance 0-2 * written informed consent 3. prior collection of at least 2.5x10\^6 cd34-positive peripheral blood stem cells/kg. exclusion criteria: 1. abnormal renal function (creatinine \>2.5x upper limit of normal (uln) 2. abnormal hepatic function (bilirubin \>2xuln, alt/ast \>3x uln) 3. cardiac ejection fraction \<40% 4. severe defects in pulmonary function tests (dlco\<70% predicted, fev1, fvc\<60% predicted) or receiving continuous oxygen 5. a history of human anti-mouse antibodies (hama) or known type 1 hypersensitivity or anaphylactic proteins to any component of the zevalin therapy. 6. female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment 7. prior radiotherapy to \>25% of the bone marrow or \>20 gy to critical organ (lung, liver, kidney, spinal cord). 8. cns lymphoma 9. ongoing infection 10. prior treatment with radioimmunotherapy

Keywords: zevalin autologous one marrow transplant non-hodgkin's lymphoma
genetic study of sitosterolemia

Conditions: Lipid Metabolism, Inborn Errors; Sitosterolemia

Summary: objectives: i. identify the genetic defect and fine map the gene that causes sitosterolemia.

protocol outline: patients, family members, and normal volunteers provide blood samples for genetic studies and may fill out a general health and medication history. linkage analysis and microsatellite screening is performed on genomic dna, especially chromosome 2p21, between microsatellite markers d2s1788 and d2s1352. positive results may be reported to the patient and may influence future treatment.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of sitosterolemia presence of tendon and tuberous xanthomas premature atherosclerotic disease no family history of premature coronary artery disease normal or elevated plasma cholesterol levels or * family member of patient with sitosterolemia or * normal volunteer

Keywords: endocrine disorders inborn errors of metabolism rare disease sitosterolemia
clinical evaluation of the filmarray® meningitis/encephalitis (me) panel

Conditions: Meningitis/Encephalitis

Summary: the filmarray meningitis/encephalitis (me) panel (hereinafter referred to as filmarray me panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with filmarray systems. the filmarray me panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (csf) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.


Eligibility criteria:
inclusion criteria: * residual cerebrospinal fluid samples after routine tests; * samples obtained by lumbar puncture; * sample volume is not less than 0.5 ml; * samples that have not been centrifuged; exclusion criteria: * samples from repeatedly enrolled patients; * samples that have not been preserved as required
application of icg in lymph node dissection during radical resection of rectal cancer with preserved autonomic nerves around lca and ima

Conditions: Indocyanine Green

Summary: indocyanine green nir imaging is valuable for lymph node dissection in d3 radical surgery for rectal cancer. it can guide the intraoperative improvement of lymph node dissection based on the preservation of lca and peripheral autonomic nerves of ima. this not only reduces the occurrence of postoperative complications and promotes rapid postoperative recovery, but also provides a more precise and individualized comprehensive treatment plan for patients after surgery. in addition，this trial also demonstrated that icg is safe and feasible for use in rectal cancer

the pathological data of 96 patients with rectal cancer from september 2020 - july 2022 were collected from the first hospital of qinhuangdao city.in 51 of these patients, icg was injected preoperatively via anoscope or anal dilator in the mucosal layer around the tumor, and surgical treatment was performed after visualization. the surgical approach was performed by laparoscopic radical rectal cancer with an intermediate approach step.the ima root is treated with low ligation of the ima, while lymph node dissection is performed while preserving the autonomic nerves around the ima. the other 45 patients were not injected with icg, and the procedure was performed as before.the occurrence of postoperative complications was recorded, and the detection of lymph nodes was also compared between the two groups, as well as the intraoperative situation and postoperative recovery.

Eligibility criteria:
inclusion criteria: 1. the preoperative colonoscopic pathological diagnosis was clearly rectal cancer and no malignant tumor in other sites. 2. good preoperative general condition, no serious cardiopulmonary, hepatic, renal or other major comorbidities before surgery 3. radical rectal cancer surgery with preservation of lca and peripheral autonomic nerves of ima in patients 4. no contraindications to surgery 5. no history of icg or iodide allergy exclusion criteria: -

Keywords: indocyanine green rectal cancer autonomic nerve inferior mesenteric artery left colic artery lymph nodes
genetics of cardiovascular disease

Conditions: Atherosclerosis; Coronary Heart Disease; Myocardial Infarction; Atrial Fibrillation

Summary: participants are being recruited at the inpatient department of the national medical research center of cardiology on a 'all-comers' basis. the enrolled participants will be divided into the main group (diagnosed with atherosclerotic cardiovascular disease (ascvd)) and control (not diagnosed with ascvd). the participants will have whole blood and serum collected at enrollment for further biobanking. a genome-wide association study will be carried out to determine the genetic determinants associated with atherosclerosis, coronary heart disease, acute coronary syndrome, etc., including a search for pathogenic variants.

this is a non-interventional case-control study aimed at identifying the genetic markers associated with various ascvd types or with the protective effect against them. participants are being recruited at the national medical research center for cardiology of the ministry of health of russia. the study will comprise at least 10,000 participants, 1 non-ascvd patient per 2 ascvd patients. the recruitment period started in september 2021 and will continue till december 2023. the study will be conducted for 29 months. observation will be carried out throughout the study. the participants of this study will be selected from the patients of the inpatient treatment at the national medical research center of cardiology. this study procedures will have no effect on the diagnostic and therapeutic procedures implemented by the attending physicians, based on the protocols and recommendations adopted in the russian federation. all participants will be divided into 2 groups: 1. patients with severe atherosclerosis (≥ 50% stenosis caused by atherosclerotic plaque) of various vascular beds (coronary vessels, carotid arteries, mesenteric arteries, lower extremities, and kidneys) 2. control group without clinically significant atherosclerotic lesions (≤49% stenosis). in each group, the known risk factors and the genetic determinants of ascvd will be investigated. based on the results of the analysis of all factors under consideration, the study should yield a panel of ascvd markers.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age; 2. informed consent; 3. an in-patient available for a comprehensive assessment for ascvd. exclusion criteria: 1. refusal to participate; 2. positive/negative ascvd impossible to confirm; 3. hiv, syphilis, hepatitis b and c; 4. any other criteria deemed reasons for exclusion by the principal investigator

Keywords: atherosclerosis; coronary heart disease; myocardial infarction; atrial fibrillation; polygenic risk panel; multi-omics study
understanding the need and feasibility of transitional care training program among family caregivers of geriatric stroke survivors in pakistan

Conditions: Stroke; Stroke, Ischemic; Stroke Hemorrhagic

Summary: the main intention of the study is to understand the need and feasibility of transitional care training program among family caregivers of geriatric stroke survivors in pakistan

the purpose of the study is to explore the training needs of family caregivers of caring their elderly stroke patients at homes in pakistan. secondly the study aims to develop transitional care training program based on the identified needs for family caregivers of geriatric stroke survivors. furthermore; the study intends to evaluate the feasibility/efficacy of transitional care training program among family caregivers of geriatric stroke survivors.

Eligibility criteria:
inclusion criteria: * family caregivers of both genders geriatric stroke survivors will be included * family caregivers who care patients both with the ischemic/hemorrhagic stroke * caregivers who have taken care of the patient at least with 1-time hospitalization * family caregivers who have taken care for at least 1-weeks at home. exclusion criteria: * family caregivers who are not willing to participate in the study * caregivers who has taken with any training regarding the stroke transitional care

Keywords: stroke geriatrics family caregivers needs assessment nursing home care
short-term effect of intravitreal dexamethasone implant in refractory diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (idi) in patients with refractory diabetic macular edema. the main question it aims to answer is: how fast does the diminishing in central retinal thickness has statistical significance after idi in patients with refractory diabetic macular edema? patients will be evaluated by oct before and after the implant.

patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post idi

Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes * diabetic macular edema involving the foveal center with crt \>300 μm measured by oct * at least 3 and maximum 9 monthly intravitreal injections of anti-vegf exclusion criteria: * uncontrolled diabetes (blood glucose ≥ 250 mg/dl at any time * previous idi * any condition precluding adequate fundus visualization * uncontrolled glaucoma * papillary excavation ≥ 0.7

Keywords: diabetic macular edema ozurdex dexamethasone intravitreal implant
evaluation of the healthy lifestyle program on cognitive outcomes

Conditions: Obesity

Summary: the goal of this study is to conduct a program of pilot research aimed at evaluating the effect of an intensive lifestyle intervention on cognitive functioning in older adults with obesity and or obesity and sarcopenia.

detailed description: the national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. the overarching goal of this study is to conduct a program of pilot research aimed at evaluating the effect of a intensive lifestyle intervention on cognitive functioning in order adults with obesity and or obesity and sarcopenia. while some degree of cognitive decline is common during the normal aging process, epidemiological evidence suggests that obesity can promote its acceleration. it is unclear the effect that intensive lifestyle changes could have on cognitive functioning in older adults with obesity. study timeline: may 2019 to may 2023 goal: conduct a study to evaluate the effects that intensive lifestyle program has on cognitive functioning in older adults with obesity and or obesity and sarcopenia. participation duration: participants will meet weekly for 17 weeks. cognitive assessments will take place at baseline and 17 weeks.

Eligibility criteria:
inclusion criteria: * english speaking * age ≥65 years * body composition body fat \>25% for men * body composition body fat \>30% for women * participating in the dartmouth hitchcock weight and wellness center (wwc) healthy lifestyle program (hlp) * willing and able to give informed consent exclusion criteria: * unable to perform measures * individuals unwilling/unable to provide consent * severe mental or life-threatening illness * history of bariatric surgery

Keywords: weight loss cognition sarcopenia obesity lifestyle
short term low dose corticosteroids for management of post covid19 pulmonary fibrosis

Conditions: Covid19

Summary: a randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates

: the study included patients with covid-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 polymerase chain reaction (pcr) swab negative for covid-19, and have persistent radiological changes in follow-up chest computed tomography (ct) chest, patients with normal ct chest at discharge, patients on chemotherapy, patients \<18years old, patients with known interstitial lung disease and patients with rheumatoid arthritis or systemic lupus erythematosus were excluded from the study. study patients were randomly assigned to either steroid group or control group and were followed up for 14 days, and ct chest was done at end of 14 days and was evaluated by a radiologist how was blinded for study arm, ct chest was graded either very minimal infiltrates including reticular shadows, hallow sign, and ground glass s (ggo), infiltrates \ 25%. the steroid group received 20 mg/day prednisolone for 14 days in addition to symptomatic treatment; the control group received symptomatic treatment without steroids data collected included patient demographics, symptoms, and its duration at baseline, cbc, ferritin and d-dime, ct chest at discharge, and after 14 days of inclusions in the study.

Eligibility criteria:
inclusion criteria: * covid-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 polymerase chain reaction (pcr) swab negative for covid-19, and have persistent radiological changes in follow-up chest computed tomography (ct) chest exclusion criteria: * patients with normal ct chest at discharge, patients on chemotherapy, patients \<18years old, patients with known interstitial lung disease, and patients with rheumatoid arthritis or systemic lupus erythematosus

Keywords: covid-19 post covid-19 fibrosis low dos steroids
intraoperative hypocapnia in provhilo and probese

Conditions: Mechanical Ventilation Complication; Surgery; Pulmonary Complication; Intraoperative Complications; Postoperative Complications

Summary: to gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation, the 'protective ventilation using high versus low peep trial' (provhilo), and the 'protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (probese).

lung-protective intraoperative ventilation (lpv) has the potential to improve the outcome of surgery patients through a reduction in postoperative pulmonary complications. use of intraoperative ventilation strategies that use a low tidal volume could result in intraoperative hypercapnia. however, hypocapnia remains surprisingly common during intraoperative ventilation, possibly meaning that anesthesiologists continue to use high, if not too high respiratory rates or tidal volumes. previous studies suggested associations between intraoperative derangement of end-tidal carbon dioxide (etco2) and postoperative outcomes. indeed, two studies in highly selected patient groups showed associations of intraoperative hypocapnia with prolonged length of hospital stay, in patients undergoing pancreaticoduodenectomy, and in patients undergoing hysterectomy. to gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation; provhilo and probese.

Eligibility criteria:
inclusion criteria: * planned for major (abdominal) surgery. * at risk for postoperative pulmonary complications. exclusion criteria: * planned thoracic surgery or neurosurgery. * unscheduled surgery (i.e., urgent, or emergent surgeries) were excluded because these patients may have had metabolic abnormalities at the moment of surgery, i.e., metabolic acidosis, for which the anesthesiologist may have adjusted the intraoperative ventilator settings. this may have led to a 'compensatory' low etco2. * patients with etco2 recordings are missing from the study databases.

Keywords: postoperative complications intraoperative complications hypocapnia mechanical ventilation
mindful construal diaries: can the mcd increase mindfulness and mindful eating in bariatric surgery patients

Conditions: Obesity

Summary: the study aims to test the mindful construal diary (mcd- a mindful eating intervention) initially developed by mantzios and wilson. the diary aims to facilitate weight-loss, while also promoting a present centred awareness to current food consumption. there has yet to be any research testing the mcd in clinical populations.

(bsp = bariatric surgery patients) the mcd is an intervention that consists of 10 questions an individual must consider prior to eating, and revisit while eating. mindfulness refers to being consciously aware in the present moment and being accepting to emotions, and in practice, me can be defined as an awareness to thoughts, feelings and emotions related to current food consumption (e.g., portion size, feelings of hunger/satiety, and healthfulness of food). being underpinned by both concepts, the mcd intervention prompts individuals to consider aspects of their meal by generating a more focused perspective to the experience of eating. current applications of mindfulness in health-related settings are promising, benefits include long-term weight-loss, and decreases in symptoms associated with physical and psychiatric disorders. although the mcd is similarly associated with weight-loss, existing literature on its utility within the bariatric surgery population is scant. furthermore, as weight regain is often observed post-surgery, it is important to explore how the mcd can help bsp overcome this obstacles. furthermore, as the mcd is yet to be applied to bsp, this research will also establish whether the mcd is effective in promoting mindfulness, me and subsequent weight-loss in this population. the potential benefits of this research are broad, as it can help establish a novel approach to effective weight-loss in bsp, and equip health care practitioners with a cost-effective weight-loss intervention. this research will employ a mixed-method design, where participants will be asked to maintain use of the mcd when eating for a three month period, and at their usual care visit complete questionnaires and an interview. participants will be recruited from heartland hospital's bariatric clinic.

Eligibility criteria:
inclusion criteria: * 18 years old or above * bariatric surgery patients cared for at heartlands hospital * english speakers (reading and writing) * post bariatric surgery exclusion criteria: * under the age of 18 years old * a lack of capacity * not cared for at heartlands hospital * non-english speakers (reading and writing inc) * special communication needs * severe mental health illness

Keywords: post-bariatric surgery weight-loss diary