Kornimate/medical-research-clean huggingface dataset:
evaluation of trazodone in osa-mci

Conditions: Mild Cognitive Impairment; Obstructive Sleep Apnea

Summary: alzheimer's disease (ad) is a progressive and multifactorial neurodegenerative disease. before progressing to ad, individuals may experience mild cognitive impairment (mci). while these individuals with mci have an increased risk of progressing to ad, emerging studies reveal that obstructive sleep apnea (osa) is a risk factor for both mci an well as ad. thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid mci and osa and ad. a randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sst2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid osa and mci. in this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.


Eligibility criteria:
inclusion criteria: * able to swallow trazodone capsules * stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening * a diagnosis of mild cognitive impairment (mci) * a diagnosis of obstructive sleep apnea (osa), and apnea-hypopnea index \> 5 * neuroimaging obtained during screening consistent with a clinical diagnosis of alzheimer's disease (ad) and without findings of significant exclusionary abnormalities * written informed consent to participate in the study provided by the patient exclusion criteria: * diagnosis of dementia, neurodegenerative condition, seizure disorder or other infectious, metabolic, or systemic disease affecting the central nervous system * vitamin b12 or folate deficiency * diagnosis of mental health disorders * nootropic drugs except for ad prescriptions stable for at least 30 days * suspected or known allergy to trazodone * intake of drugs or substances potentially involved in clinically significant inhibition or induction of cyp34a or p-gp-medicate drug interactions with trazodone within 4 weeks or 5 half-lives of the interacting drug prior to administration of trazodone and throughout the course of the study * previous exposure to anti-aβ vaccines * concurrent treatment with antipsychotic agents, antiepileptics centrally active antihypertensive drugs, sedatives, opioids, mood stabilizers, or benzodiazepines within 4 weeks of screening visit * patients who are receiving non-benzodiazepine hypnotics * clinically significant, advanced, or unstable disease that might interfere with outcome evaluations
early rehospitalization of persons aged 75 years or older admitted to a geriatric post-emergency unit.

Conditions: Early Rehospitalization of the Elderly

Summary: the older population is increasing, and one of the challenges is to prevent functional disability. longer hospital stays are a recognized factor in dependency. older subjects may present multiple complications, and therefore be frequently readmitted to hospital. readmission to hospital is a costly and iatrogenic event in terms of independence, and must therefore be limited. the most vulnerable older patients therefore require specific care to avoid these iatrogenic complications, and various innovative structures have been developed, such as mobile geriatric teams, carrying out assessments in emergency departments, or geriatric post-emergency units with a shorter length of stay to reduce the iatrogenic impact of hospitalization.in november 2022, a temporary hospitalisation unit based on this model was opened at the chu d'angers with 11 beds. the aim of this study is to estimate the rate of early rehospitalisation (\< 30 days) between december 2022 and september 2023, and the factors associated with it. once identified, these factors will allow us to further select patient profiles that are suitable for care in these very short stay units.


Eligibility criteria:
inclusion criteria: - patient admitted to the temporary geriatric hospitalization unit between december 1, 2022 and september 30, 2023 exclusion criteria: * patients moved to another medical, surgical or obstetrics department of the angers university hospital during their stay. * death during stay. * patient assigned to a unit other than the temporary geriatric hospitalization unit. * patient already hospitalized in the unit during the recruitment campaign. * opposition to data use
cetuximab re-challenge for colorectal cancer liver metastasis

Conditions: Colorectal Cancer; Liver Metastases; Cetuximab

Summary: for patients with unresectable colorectal cancer liver metastases, preclinical studies have shown that after the resistance of cetuximab, the treatment sensitivity can be restored by stopping cetuximab for a period of time. this is called the cetuximab re-challenge. and the circulating tumor dna (ctdna) test is reported a biomarker for the efficacy of cetuximab rechallenge. however, there is still no randomized controlled trial for verification. this study aims at patients after the first-line treatment of cetuximab has progressed. after the second-line non-cetuximab treatment has progressed, the effects of re-application of combined with cetuximab and chemotherapy alone are compared to verify the re-challenge effect.

patients with colorectal cancer liver metastases were ras wild type, received first-line cetuximab plus chemotherapy. after first-line progression, second-line non-cetuximab treatment were used. after second-line progression, ctdna is test, and patients with ras wild-type are enrolled in the study to compare cetuximab plus chemotherapy vs. chemotherapy alone as third-line treatment. treatment will continue until disease progression or unacceptable toxic effects. the primary endpoint is the disease control rate，which will be assessed by local multidisciplinary team with the use of contrast-enhanced ct or mri after 4 cycles and then every other 4 cycles up to 12 cycles.

Eligibility criteria:
inclusion criteria: 1. primary tumour was histologically confirmed colorectal adenocarcinoma; 2. clinical or radiological evidence of non-resectable liver metastases; 3. with at least one measurable tumor; 4. received first-line cetuximab (ras gene wild type) treatment and progressed 5. received second-line non-cetuximab treatment and progressed 6. received circulating tumor dna test and has ras gene wild type status; 7. performance status (ecog) 0\~1 8. a life expectancy of ≥ 3 months 9. adequate hematological function: neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hb ≥9g/dl (within 1 week prior to randomization) 10. adequate hepatic and renal function: serum bilirubin≤1.5 x upper limit of normal (uln), alkaline phosphatase ≤5x uln, and serum transaminase (either aspartate transaminase (ast) or alanine transaminase (alt)) ≤ 5 x uln(within 1 week prior to randomization); 11. written informed consent for participation in the trial. exclusion criteria: 1. patients with known hypersensitivity reactions to any of the components of the study treatments. 2. acute or sub-acute intestinal occlusion 3. pregnancy (absence confirmed by serum/urine β-hcg) or breast-feeding 4. other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix known drug abuse/ alcohol abuse 5. legal incapacity or limited legal capacity 6. pre-existing peripheral neuropathy.

Keywords: colorectal cancer liver metastases cetuximab re-challenge
a randomized controlled trial of stress reduction on cardiovascular morbidity and mortality in african americans

Conditions: Coronary Heart Disease; Cardiovascular Disease

Summary: this randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the transcendental meditation program will reduce all-cause mortality, myocardial infarction and stroke in african american patients with coronary heart disease. secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.

the overall objective of this randomized controlled trial is to conduct a long-term evaluation of the effects of the transcendental meditation (tm) program compared to health education (he) on secondary prevention of clinical events in african american men and women with coronary artery disease (cad). patients (n=201; mean age 59 yrs) were enrolled with documented cad (i.e., coronary angiogram showing at least one artery with \> 50% stenosis). patients were pretested at baseline and every 6-12 months for the duration of the study for incidence of clinical events, bp, bmi, medication usage, lifestyle behaviors, psychosocial stress factors and intervention compliance. subjects were followed for a maximum of 9.2 years (mean 5.4 years). the investigators hypothesize that a selected stress reduction intervention, the tm program compared with a health education control may significantly reduce risk for death, myocardial infarction (mi) and stroke in african american men and women with chd. if successful, the transcendental meditation program may be clinically useful in the secondary prevention of cardiovascular disease in a high-risk population.

Eligibility criteria:
inclusion criteria: african american men and women with documented coronary heart disease defined a coronary angiogram demonstrating the presence of one more coronary arteries with \> or = 50% stenosis. exclusion criteria: acute mi, stroke or coronary revascularization within the previous three months; symptomatic heart failure with ef \< 20%; dementia or other cognitive impairment determined clinically; and non-cardiac life threatening illness. -

Keywords: stress reduction transcendental meditation technique secondary prevention of coronary heart disease
high dose therapy followed by autologous transplantation for myeloma patients with severe renal impairment

Conditions: Multiple Myeloma; Renal Failure

Summary: multiple myeloma (mm) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. therapeutic intervention is recommended when at least one of the myeloma defining events occurs (crab features). renal impairment (ri) is one of the most common complications of mm, accounting for 20-30 % of mm patients at diagnosis and 40-50% of patients during the course of their disease. to date, there is no defined consensus for the management of myeloma patients with renal failure. it is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.

ri is associated with poor prognosis and short median survival (32 months vs 55 months for mm patients with normal renal function). thus, ri remains a major challenge for hematologists, including decisions on optimal anti-myeloma therapy, potential dialysis, supportive care and quality of life. the combination of a proteasome inhibitor and an immunomodulator is the preferred induction treatment for newly diagnosed transplant-eligible mm patients. after induction, high-dose therapy with autologous stem cell transplant (asct) is the standard of care for these patients. however, concerns related to management of comorbidities and treatment side effects question about therapeutic options for patients with severe renal damage. of interest, recent studies argued that high-dose therapy followed by asct could be a feasible and safe method for renal failure mm patients. yet, these observations on small sample size patients groups need to be confirmed with standardized conditions. this study proposes to evaluate the efficacy and the safety of this therapeutic strategy in mm patients with severe renal impairment.

Eligibility criteria:
inclusion criteria: * age ≤ 66 years-old * patients with symptomatic, measurable and newly diagnosed multiple myeloma associated: * severe renal failure at the time of transplantation (creatinine clearance \< 40 ml/min/1.73m², ckd-epi: chronic kidney disease epidemiology collaboration) * partial response after induction treatment * for patients who undergo autologous transplantation, absence of known contraindication for transplantation * absence of amylose * patient affiliated to a social security regimen or beneficiary of the same * signed written informed consent form exclusion criteria: * patient without at least a partial hematological response following the induction stage * medical history of previous malignancy * patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. l.1121-6, l.112-7, l.1211-8, l.1211-9) * pregnant or breastfeeding woman * declining participation

Keywords: multiple myeloma renal failure autologous hematopoietic stem cell transplantation (asct) melphalan
monitor system for the safety of dabigatran treatment

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine whether dabigatran is associated with higher risk of bleeding in asia area especially in china clinical practice and whether it need to set up a monitor system.

dabigatran is administered in a fixed does without laboratory monitoring and is being compared with warfarin (international normalized ratio, but only hundreds of evidence from asia events in several multicenter, prospective, randomized trails. it remains unclear that whether dabigatran is safety in china clinical practice and no need of monitor test. we identified participants as those diagnosed as having nonvalved atrial fibrillation, and who initiated dabigatran after diagnosis.we followed up each individual from the first prescription of dabigatran until discontinued use or switch of anticoagulants, death, or other outcomes or until one year later. we categorized bleeding events as major and minor events according to anatomical position. we defined time to bleeding as days between the first dabigatran prescription and the date of the bleeding event. we analyzed the time to the first bleeding event, as well as the time to the first major hemorrhage, intracranial hemorrhage, gastrointestinal bleeding, hematuria, vaginal bleeding, hemarthrosis, hemoptysis, and epistaxis.

Eligibility criteria:
inclusion criteria: 1. age\>18 y at entry 2. af documented as follows: the patients has a symptomatic episode of paroxysmal or persistent af documented by 12-lead ecg, rhythm strip, pacemaker/implantable cardioverter-defibrillator electrogram, or holter ecg 3. in addition to documented af, patients must have ≥1 chads2-vas scores 4. we identified participants as those diagnosed as having af, and who initiated dabigatran after diagnosis 5. written, informed consent exclusion criteria: 1. history of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease) 2. severe, disabling stroke, or any stroke within the previous 14d 3. acute coronary syndrome within 1 year in af patients 4. conditions associated with an increased risk of bleeding 1. major surgery in the previous month 2. history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding 3. gastrointestinal hemorrhage or hematuria 5. severe renal impairment (estimated creatinine clearace≤30ml/min) 6. severe liver dysfunction 7. alcohol abuse or drug addiction 8. patients who have received an investigational drug at this time 9. patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trail

Keywords: atrial fibrillation anticoagulation dabigatran
intravitreal bevacizumab for diabetic macular edema

Conditions: Macular Edema; Diabetic Retinopathy

Summary: diabetic macular edema is a common cause of visual loss among diabetic patients. studies have demonstrated the role of vascular endothelial growth factor (vegf) in the pathogenesis of edema. this study designed to evaluate the effect of intravitreal injection of a recombinant monoclonal anti-vegf antibody, bevacizumab, for treatment of diabetic macular edema.


Eligibility criteria:
inclusion criteria: * diabetes mellitus * clinically significant macular edema * possibility of performing macular oct * consent of patient for inclusion in the study exclusion criteria: * history of macular photocoagulation in less than 6 months of inclusion in the study * necessity of surgical intervention * rejection of the remaining in the study by patient
evaluate the use of optical frequency domain imaging (ofdi) for celiac disease in children, adolescents and young adults

Conditions: Celiac Disease

Summary: the goal of this research is to conduct a pilot clinical study to image celiac disease characteristic mucosal lesions and compare optical frequency domain imaging (ofdi) images to histologic evaluation in children, adolescents and young adults with suspected celiac disease.

the optical frequency domain imaging(ofdi) catheter will be used in conjunction with a standard pediatric endoscope. the endoscopist will introduce the ofdi imaging catheter through the biopsy channel of the endoscope already in place. the catheter will be passed into the view of the endoscope so that the tip of the catheter can be directly visualized throughout the procedure. the catheter will be placed adjacent to the bowel wall in the vicinity of the target locations. once the ofdi probe is in place, ofdi imaging will start and data will be continuously collected during helical pullback scanning of the inner catheter drive shaft over a predetermined length of approximately 3 cm. it is expected that the total experimental procedure including the insertion of the ofdi catheter, ofdi imaging, and removal of the catheter will add approximately 10 minutes to the total length of the procedure.

Eligibility criteria:
inclusion criteria: * age 7 years and above undergoing upper endoscopy for evaluation of celiac disease * clinical history, physical findings, family history, or serologic evaluation suggestive of celiac disease * parents/guardian available to sign informed consent exclusion criteria: * patients with a history of hemostasis disorders * use of nonsteroidal anti-inflammatory drugs(nsaids) within ten days preceding initiation of the study * use of any oral anticoagulation medication within one month preceding initiation of the study * any known blood coagulation disorder

Keywords: celiac disease duodenal oct imaging
the effects of montelukast on smokers with asthma

Conditions: Asthmatic Smokers; Non-asthmatic Smokers

Summary: the purpose of this study is: 1. to compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers. 2. to elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.

many smokers have insufficient control of their symptoms due to inefficacy of ics in this subpopulation of asthmatics. cigarette smoking has been shown to stimulate production of cyslts. cyslts could activate production of il-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics. ltras are felt to be less efficacious than ics in smokers with asthma. however, ltra's unique mechanism of action could be particularly efficacious in preventing worsening symptoms and lung function for smokers with asthma. given this, along with the fact that ics are less effective in smokers, targeting cyslt could lead to significant clinical benefits for asthmatic smokers. data from this study may possibly serve as crucial data for the significant clinical benefits for asthmatic smokers and determination of the mechanism of corticosteroid resistance in smokers with asthma.

Eligibility criteria:
inclusion criteria: asthmatics: * clinical history of asthma for at least 1 year * with evidence of reversible airway obstruction, * two documented fev1 between 60-85%, * pc20 \< 4mg/ml by methacholine challenge test * and average baseline β-agonist use of 2 puffs/day smokers: * smoke 1/2 to 2 packs a day * with a smoking history of 5-30 pack years non-smokers: * non-smokers will have either never smoked or have stopped smoking cigarettes over 5 years ago exclusion criteria: * positive hcg (for females) * have a respiratory tract infection or need oral corticosteroids within the preceding 6 weeks * history of copd or respiratory disorder other than asthma * history of psychiatric illness * allergy to fluticasone propionate, salmeterol, montelukast or any of their components * significant, unstable medical condition other than asthma * history of life-threatening asthma exacerbation requiring intubation and mechanical ventilation in the last ten years

Keywords: asthmatics smokers inhaled corticosteroids leukotriene receptor antagonists
stone and laser therapies post-market study (salt)

Conditions: Benign Prostate Hypertrophy(BPH); Renal Calculi; Ureteral Stones, Kidney Stones; Calculi, Urinary; Urinary Tract Procedure

Summary: the objective of the salt study is to obtain post-market safety and device performance data for boston scientific's stone and bph study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (bph) treatment.

the salt study is a multi-center, open label, non-randomized, prospective observational study to document on-going post-market safety and device performance data of bsc commercially available study devices that are used in diagnostic and/or therapeutic urinary tract procedures or surgical treatment for bph. enrolled subjects undergoing diagnostic or therapeutic procedures using study devices will be followed for 1 year after the index procedure is complete.

Eligibility criteria:
inclusion criteria: for urinary tract procedure cohort: 1. subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified bsc device(s) 2. subject is willing and able to complete all follow-up visits for bph cohort: 1. subject is ≥ 40 years of age 2. subject with a diagnosis of benign prostatic hyperplasia (bph) with lower urinary tract symptoms 3. subject intends to undergo bph treatment with qualified bsc device(s) 4. subject is willing and able to complete all follow-up visits exclusion criteria: for urinary tract procedure cohort: 1. subject requires simultaneous surgical treatment for bph 2. unwilling or unable to provide consent 3. any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.) for bph cohort: 1. subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi) 2. unwilling or unable to provide consent 3. any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)

Keywords: bph benign prostatic hyperplasia lithotripsy renal calculi renal calculus boston scientific kidney stone urinary tract procedure