Kornimate/medical-research-clean huggingface dataset:
evaluation of community-based care for the frail elderly

Conditions: Chronic Disease; Frail Elderly Syndrome

Summary: the term frail chronic complex patient (ccp) is generally applied to subjects with heterogeneous conditions that may represent at least one of the following three traits: (i) the need for management by a number of specialists from different disciplines that often leads to high use of healthcare resources; (ii) fragility, which requires additional support either due to functional decline, social deficits and/or transient situations such as hospital discharge or, (iii) the need for highly specialised care with home technological support. the current protocol deals with the second category of patients, frail ccp, and addresses horizontal integration of community-based services. it is based in the city of badalona (216k inhabitants), within the metropolitan area of barcelona. badalona serveis assistencials (bsa) is the service provider of integrated care services for this population.

the study will assess three types of specific groups of patients: (i) early discharge group includes patients acutely admitted to the medical and/or surgical hospital wards and promptly discharged to receive home-based post-acute care and/or rehabilitation; (ii) home-based case management group includes complex chronic patients or patients receiving long-term care by a case management nurse; and (iii) geriatric residences group will include patients receiving acute support, post-acute or continued care for elderly people living in geriatric residences. it will be conducted by badalona serveis assistencials (bsa), an integrated care service provider located in the city of badalona (420k inhabitants) in the north-eastern part of the barcelona metropolitan area. the current study protocol aims to assess cost-effectiveness of the three types of interventions for frail patients, as well as to generate a roadmap for regional scalability of the service. the study design will consist of a prospective quasi-experimental case-control design wherein each intervention group will be compared with the corresponding usual care group (controls, 1:1 ratio), using propensity score matching. age, sex, gma (adjusted morbidity groups), socioeconomic status, number of hospitalisations during the previous year and polypharmacy will be used as matching variables.

Eligibility criteria:
inclusion criteria * age ≥ 65 years. * complexity: ≥ 2 chronic diseases * polypharmacy: ≥ 4 drugs * registered as complex chronic patient * ≥ 3 hospital or emergency room readmissions in the last year * having suffered a recent acute illness requiring continuous clinical and/or rehabilitative care by the home hospitalisation unit or primary care. * to be admitted in one of the geriatric residences of the territory of badalona, montgat and tiana. exclusion criteria * any neurological disease (e.g. severe-phase dementia with global deterioration scale (gds) ≥ 7) or psychiatrically severe enough not to allow the subject to respond to questionnaires. * subjects who do not agree to participate in the study.

Keywords: integrated care
ketamine for methamphetamine use disorder

Conditions: Substance Use Disorders; Substance Use; Methamphetamine Abuse

Summary: this study aims to determine whether treatment response with iv ketamine is superior to treatment response with iv midazolam in adults with moderate to severe mud. the study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (iv) ketamine against iv midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (mud).

effective management for methamphetamine use disorder (mud) remains elusive, despite widespread misuse of this stimulant. psychological interventions have demonstrated modest benefits, and relapse rates are high. there are currently no food and drug administration (fda)-approved pharmacotherapies for mud. this study explores the efficacy, safety, and feasibility for intravenous (iv) ketamine as a treatment for mud and will help to determine the effect size for a larger, multi-site trial of intravenous (iv) ketamine in mud. participants will receive either iv ketamine (0.50mg/kg) or iv midazolam (0.02mg/kg) over 45 minutes per infusion for a total of eight (8) infusions over six (6) weeks. medical management sessions with a study clinician will be provided to all participants once weekly (from weeks 1 through 6). the use of iv ketamine in this trial is consistent in dose (0.5 mg/kg) and duration of infusion (45-minute-long) to other studies of ketamine for psychiatric disorders (such as major depressive disorder and post-traumatic stress disorder, both of which are often comorbid in individuals with mud) and substance use disorder. however, iv ketamine has not been directly evaluated as mono-pharmacotherapy in those with mud yet. additionally, participants will be asked to participate in cognitive behavioral therapy (cbt) sessions once weekly (from weeks 1 through 12) on a non-infusion day.

Eligibility criteria:
inclusion criteria study participants must: 1. be 18 to 65 years old 2. be able to sufficiently understand, speak, and read english 3. be interested in reducing or stopping methamphetamine use 4. meet criteria for methamphetamine use disorder 5. use acceptable methods of contraception during participation in the study exclusion criteria study participants must not: 1. have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent 2. be currently in jail, prison, or inpatient overnight facility as required by court of law 3. have upcoming surgery planned or scheduled 4. be currently pregnant, breastfeeding, or planning on conception, if biologically female additional inclusion and exclusion criteria will be assessed by the study investigators at the screening visit.
longitudinal quantitative susceptibility mapping (qsm) in alzheimer 's disease

Conditions: Alzheimer's Disease

Summary: in this explorative longitudinal study 50 patients with alzheimer's disease (ad) and 50 age-matched control subjects will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 tesla magnetic resonance imaging (mri). regional differences of susceptibility and r2\* relaxation rates in deep gray matter and the neocortex will be evaluated in ad patients and controls and related to the patients´ cognitive status at baseline.

abnormally increased brain iron accumulation in deep gray matter is a common finding in alzheimer's disease (ad) and amyloid protein precursor and tau proteins were linked to disrupted iron homeostasis. validation studies showed that brain iron can be measured precisely by the novel magnetic resonance imaging (mri) technique quantitative susceptibility mapping (qsm) in vivo, thus, enabling reliable and precise longitudinal investigations. it is hypothesized that pathologic brain iron accumulation can be assessed with higher sensitivity with qsm than with current mri techniques such as r2\* relaxation rate mapping and that regional qsm is a predictor for cognitive decline and disability. this explorative longitudinal study is including 50 patients with ad and age-matched control subjects which will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 tesla mri. regional differences of susceptibility and r2\* in deep gray matter and the neocortex will be evaluated in ad patients and controls and related to the patients´ cognitive status at baseline. follow-up mri and clinical data with multivariate regression analysis serve to investigate the dynamics of ad-related changes of susceptibility, and their relation to cognitive functioning. in conclusion, this explorative longitudinal study in a patient cohort aims to clarify whether regional qsm changes are potential biomarkers for ad progression.

Eligibility criteria:
inclusion criteria: * diagnosis of dementia according to dsm-iv and nincds-adrda criteria * the patient lives either with the family or has less than 40h/week of external care * the patients is able to understand the role in this study and is willing to participate * the physician in charge of this study confirms that the patients understands the study and its aims according to cognitive and clinical testing exclusion criteria: * are other disorders * participation in a clinical drug trial (phase 1-3)
impact of increased immunoglobulin e to anti-herpes simplex virus -1 innate immune responses in atopic dermatitis patients with eczema herpeticum

Conditions: Atopic Dermatitis With a History of Eczema Herpeticum; Atopic Dermatitis Without a History of Eczema Herpeticum; Health Controls Without Atopy

Summary: this study investigates whether blood monocytes' surface bound- immunoglobulin e affects the innate immune responses against herpes simplex viruses in atopic dermatitis patients with eczema herpeticum.

some of atopic dermatitis patients (ad) have severe herpes simplex viral (hsv) infections, which could cause erosive skin lesions all over the body. this condition is termed as eczema herpeticum (adeh+). scientists have found that adeh+ patients have significantly increased blood immunoglobulin (ig) e compared to ad patients without eczema herpeticum and healthy people. increased ige in blood could bound to immune cells' surface, such as monocytes. since monocytes serve as the first line defense to fight viral infection, their surface-bound ige may interfere their anti-viral immune responses, and consequently results in more severe viral infections. the purpose of this study is to learn more about how increased ige affect body's immune ability to fight herpes simplex viruses. this study includes three groups: ad patient without eczema herpeticum complication(adeh-); ad patient with eczema herpeticum complication(adeh+) and healthy controls. study results will be compared between groups.

Eligibility criteria:
inclusion criteria: * age 16-65 years old, age, sex and race match among non-atopic, adeh- and adeh+. * participant and/or parent guardian must be able to understand and provide informed consent, and fits in one of the following conditions: 1. a history of ad with a history of eczema herpeticum, adeh+, as diagnosed using the atopic dermatitis research network standard diagnostic criteria. 2. a history of ad without a history of eczema herpeticum, adeh-, as diagnosed using atopic dermatitis research network standard diagnostic criteria, and no first degree relatives with a history of eh. 3. non-atopic as diagnosed using atopic dermatitis research network standard diagnostic criteria. exclusion criteria: * inability or unwillingness of a participant to give written informed consent or comply with study protocol * known or suspected immunosuppression * severe concomitant illness(es) * women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding * known sensitivity to study drug(s) or class of study drug(s) * patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) * use of any other investigational agent in the last 30 days

Keywords: atopic dermatitis eczema herpeticum immunoglobulin e herpes simplex virus
endovascular exclusion of taaa/aaa utilizing fenestrated/branched stent grafts

Conditions: Thoracoabdominal Aneurysm; Abdominal Aortic Aneurysm

Summary: the purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

the purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. the evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. not pregnant 3. willing and able to comply with two-year follow-up period. 4. willing and able to give informed consent prior to enrollment 5. no known allergy to stainless steel or polyester 6. no history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately. 7. life expectancy greater than two years 8. high risk candidate for open surgical repair exclusion criteria: see above
psychological intervention on burnout in icu caregivers

Conditions: Burnout; Anxiety; Depression

Summary: icu caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. they run a high risk of developing burnout that can impact on their welfare, performance, and patient care. burnout favours absenteeism and staff quitting their jobs, whereas the shortage of icu caregivers already started. no randomised controlled intervention aimed at reducing such distresses had been run until now. this study allowed finding a new method of psychological support applicable in the special environment of icu. our findings suggest that psychologists specifically assigned to treat icu caregivers might be beneficial on their burnout.


Eligibility criteria:
inclusion criteria: * all icu caregivers rrom the university hospital of geneva exclusion criteria: * refusals
efficacy and safety of colquhounia root tablet in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. the aim of the study is to evaluate whether colquhounia root tablet combined with methotrexate (mtx) might be better than mtx alone for patients with active rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: 1. subject understood the whole process of the trial and signed the informed consent voluntarily. 2. subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 acr/eular ra classification criteria. 3. subjects aged between 45-70years who were the males without fertility requirements or menopausal women. 4. subject has a das28 crp disease activity score greater than 2.6 and less than 5.1. 5. subject did not participate in any drug trials within 1 month before enrollment. exclusion criteria: 1. pregnant women, women planning to become pregnant or breastfeeding. 2. severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease. 3. active liver disease or abnormal liver function, alt and ast are more than 1.5 times the upper limit of normal. 4. renal impairment, serum creatinine greater than the upper limit of normal. 5. bone marrow hematopoietic dysfunction, peripheral blood leukocytes \<3.0×109/l, or definite anemia (hemoglobin less than 80g/l), or platelets \<80×109/l, or other blood system diseases. 6. active gastric and duodenal ulcers. 7. uncontrolled severe hypertension, metabolic diseases. 8. malignant tumors. 9. acute and/or chronic infectious diseases. 10. severe cardiac arrhythmia found on electrocardiogram. 11. mental illness, history of alcoholism, drug or other substance abuse. 12. diagnosed with other connective tissue disease. 13. those who have used immunosuppressants, biological agents, colquhounia root tablet or drugs containing tripterygium wilfordii within 1 month before enrollment. 14. those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control. 15. adverse reactions have occurred in the past using colquhounia root tablet or drugs containing tripterygium wilfordii.

Keywords: rheumatoid arthritis colquhounia root tablet methotrexate randomized controlled trial
romosozumab versus denosumab in giop: a 2-year extension study

Conditions: Osteoporosis; Glucocorticoids Toxicity

Summary: the investigators conducted an open-label randomized controlled trial (rct) in chronic glucocorticoid (gc) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (romo) for 12 months followed by denosumab (den) for 12 more months vs den for 24 months throughout. superiority of romo/den to den/den in raising the spine bone mineral density (bmd) was demonstrated at month 12 and month 24. the present study was to report the further bmd changes at 48 months (2 year extension) for those participants who were maintained on den treatment.

the investigators conducted a pilot open-label 24-month randomized controlled trial (rct) comparing the efficacy of romosozumab (romo) with denosumab (den) in moderate/high risk adult patients using long-term gcs (defined as a daily prednisolone dose of ≥5mg/day for ≥12 months). all patients had moderate to high risk of osteoporotic fracture as evidenced by at least one of the following: (1) a personal history of fragility/vertebral fracture; (2) dual energy x-ray absorptiometry (dxa) t score ≤-2.5 \[age ≥40 years\] or z scores ≤-3.0 \[age \<40 years\] at spine, hip or femoral neck; or (3) high risk of 10-year frax-estimated major fracture). of the 70 patients enrolled, 63 completed the study. at month 12, the spine bone mineral density (bmd) increased significantly in both the romo and den groups. the spine bmd gain from month 0-12 was significantly greater in romo-treated patients (p\<0.001). although the hip bmd at month 12 also increased significantly in the romo and den groups, the bmd gain was not significantly different between the groups. at month 24, the spine bmd continued to increase in both the romo and den groups, and the bmd gain remained significantly greater in romo-treated patients. as there are no long-term data on the sequential use of romo and den in patients with giop, the current 2-year extension study is planned to observe the bmd changes at the spine and the hip of patients in the two treatment groups at month 48.

Eligibility criteria:
inclusion criteria: 1. patients who are continued on 6-monthly subcutaneous injection of den in either the romo or den arms after month 24 in our original rct 2. those who are willing to have a repeat dxa assessment at the end of 4 years. exclusion criteria: 1. patients who refuse to be maintained on denosumab after month 24; 2. patients who are maintained on other anti-osteoporotic drugs after month 24; and 3. patients in whom prednisolone is planned to be tapered or discontinued after month 24.

Keywords: glucocorticoids osteoporosis fracture romosozumab denosoumab outcome
diaphragm function after reversal of rocuronium-induced neuromuscular blockade with sugammadex or neostigmine in children

Conditions: Neuromuscular Block, Residual

Summary: this study is to evaluate the recovery of diaphragm function and atelectasis after reversal of neuromuscular blockade with neostigmine and sugammadex using lung ultrasound and diaphragm ultrasound for children aged 2 to 7 who are scheduled for the surgical procedure under general anesthesia.


Eligibility criteria:
inclusion criteria: * patients between the ages of 2 and 7 who are scheduled for surgery lasting more than 1 hour under general anesthesia using a neuromuscular blocking agent exclusion criteria: * patients with a history of severe respiratory disease with a high risk of bronchoconstriction * patients with abnormal findings on preoperative chest radiography such as severe atelectasis, pneumothorax, pleural effusion, or pneumonia. * patients with severe renal or liver disease, or neuromuscular disease * patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine) * patients with significant bradycardia * patients scheduled for surgery where estimated blood loss during surgery is expected to be more than 30% of estimated blood volume, or cases where fluid imbalance is expected to be severe during surgery * patients scheduled for lung parenchyme/diaphragm/thoracic surgery * other researchers considered it inappropriate to participate in research.
oral microbioma and oral malignant disease

Conditions: Oral Cancer; Oral Squamous Cell Carcinoma; Premalignant Lesion

Summary: this case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.


Eligibility criteria:
inclusion criteria: * patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in case of no malignant disease * patients are (partially) dentate (≥20 teeth) * patients who have given written informed consent to participate in this study exclusion criteria: * patients with a history of radiotherapy in head and neck region * patients with a history of chemotherapy, immunotherapy or immunomodulating drugs * patients with a previous malginancy in head and neck region * edentulous patients (with or without implants) * patients with removable (partial) dentures
protein and rna expression patterns in predicting response to treatment in patients with lung cancer

Conditions: Lung Cancer

Summary: rationale: studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (dna and rna) and may also identify protein expression patterns related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study evaluates changes in dna, rna, and proteins with the goal of predicting response to treatment in patients with lung cancer.

objectives: * to determine protein and/or rna expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer. * to characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity. * to evaluate dna mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents. outline: patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. tissue samples are analyzed by a variety of techniques, including dna sequencing, rna sequencing and expression levels, protein assessment \[by immunohistochemistry, western blot, matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-ms\]). the goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. blood samples are also collected to obtain normal dna for analysis. after completion of study, patients will be followed until their death.

Eligibility criteria:
inclusion criteria * diagnosis of suspected lung cancer or lung cancer exclusion criteria * inability to undergo therapy

Keywords: lung cancer