Kornimate/medical-research-clean huggingface dataset:
mindfulness based dementia care study

Conditions: Caregiver Burnout

Summary: mindfulness based stress reduction (mbsr) refers to a particular type of attention focused on the present moment, non-judgmental awareness, and acceptance of that experience with openness and curiosity. mindfulness training was designed to enhance the range and use of coping skills, decrease levels of stress, improve mood, and reduce tendencies to react in maladaptive ways 1-3. investigators are evaluating a new program, called the mindfulness based dementia-care (mbdc) in caregivers (cg) for dementia, which combines the traditional approaches with education. the overall objective of this study is to evaluate the program and explore the potential benefits of the mindfulness based dementia-care (mbdc) program. investigators are conducting a prospective, pre-post, observational study with members participating in the mbdc program.


Eligibility criteria:
inclusion criteria: * must be ages ≥ 18 years * must be able to read and understand english * participant of the mindfulness based dementia care (mbdc) program exclusion criteria: * there is no exclusion criteria for this study

Keywords: mindfulness dementia
adapt monorail carotid stent system: a postmarket clinical follow-up study

Conditions: Carotid Artery Disease; Carotid Stenosis; Stroke

Summary: the purpose of this study is to get outcomes data for the adapt monorail carotid system used in conjunction with the filterwire embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

according to the world health organization, 15 million people suffer stroke each year. of these, 5 million die and another 5 million are permanently disabled. predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. the primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.

Eligibility criteria:
inclusion criteria: * high-risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis, via angiography or is asymptomatic and has ≥ 80% stenosis, via angiography * target lesion located in the common carotid artery (cca), internal carotid artery (ica), or carotid bifurcation * arterial segment to be stented has a diameter between 4mm and 9mm * age ≥ 18 years * life expectancy \> 12 months from the date of the index procedure exclusion criteria: * contraindication to percutaneous transluminal angioplasty (pta) * severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system * lesions in the ostium of the common carotid artery * occlusion of the target vessel * evidence of intraluminal thrombus * known sensitivity to nickel-titanium * known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies * uncorrectable bleeding disorders, or will refuse blood transfusions * history of prior life-threatening contrast media reaction * previous stent placement in the target vessel * evolving stroke or intracranial hemorrhage * previous intracranial hemorrhage or brain surgery within the past 12 months * clinical condition that makes endovascular therapy impossible or hazardous

Keywords: carotid artery stenting high risk patient carotid artery stenosis stroke carotid artery disease asti study adapt carotid stent system filterwire ez embolic protection system
non-systemic treatment for patients with low-volume metastatic prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are conventionally treated with androgen deprivation therapy. however, in patients with limited metastatic load, the time to progression might be. subsequently, active surveillance of these patients until progression might defer the start of androgen deprivation therapy (adt) for several months to years. as an alternative, salvage treatment of the limited number of metastases with either surgery or radiotherapy might postpone the start of adt even longer. the current trial hypothesizes that adt might be deferred longer following salvage treatment as compared to active surveillance.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of prostate cancer (pca) * biochemical relapse of pca following radical local prostate treatment * n1 and m1a/b disease on imaging, with a combined maximum of 3 synchronous lesions. * world health organization (who) performance state 0-1 * exclusion of local relapse * age \>=18 years old * signed informed consent exclusion criteria: * serum testosterone level \<50ng/ml * symptomatic metastases * psa rise while on active treatment with luteinizing hormone-releasing hormone (lhrh)-agonist, lhrh-antagonist, anti-androgen, maximal androgen blockade, oestrogen * previous treatment with cytotoxic agent for pca * treatment during the past month with products known to influence prostate specific antigen (psa) levels (e.g. fluconazole, finasteride, corticosteroids,...) * disorder precluding understanding of trial information or informed consent
erector spinae plane block vs quadratus lumborum block for laparoscopic nephrectomy

Conditions: Kidney Diseases; Kidney Failure

Summary: ultrasound (us) guided quadratus lumborum block (qlb) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the l1-l2 level. as there are modifications of the block generally local anesthetic is given between quadratus lumborum (ql) and psoas major (pm) muscles (anterior qlb). the qlb provides a sensory block between t7 - l1. therefore, qlbs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries. us-guided erector spinae plane block (espb) is performed at the level of the t11 transverse process. after visualization of the erector spinae (es) muscle and the transverse process, local anesthetic is injected under the es muscle. espb provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs. this study aims to compare the effectiveness of us-guided espb and qlb on postoperative pain control after laparoscopic nephrectomy.

nephrectomy for renal transplantation is a commonly performed procedure. the laparoscopic live donor nephrectomy (lldn) is associated with many benefits and has become the gold standard for kidney retrieval surgery. as compared to open donor nephrectomy (odn), lldn has been shown to have less post-operative pain, shorter hospital stays, and faster recovery. even though lldn is less traumatic, some patients undergoing laparoscopic live donor nephrectomy still suffer significant postoperative pain require parenteral opioids, and have a risk for chronic pain. the postoperative pain mechanism of lldn is multifactorial - port pain, pain caused by incisions to retrieve the kidney, pelvic organ nociception, diaphragmatic irritation, and discomfort of a urinary catheter. opioids, epidural anesthesia, transversus abdominal plane (tap) block, and local infiltration of local anesthetics are used to prevent postoperative pain after lldn. in this study, the investigators aim to compare the effectiveness of us-guided espb and qlb on postoperative pain control after laparoscopic nephrectomy.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i-ii * scheduled for living donor laparoscopic nephrectomy under general anesthesia exclusion criteria: * history of bleeding diathesis, * receiving anticoagulant treatment, * known local anesthetics and opioid allergy, * infection of the skin at the site of the needle puncture, * pregnancy or lactation, * patients who refuse the procedure or participation in the study

Keywords: laparoscopic nephrectomy postoperative pain management erector spinae plane block quadratus lumborum block
effects of glp-1 analogue combined with metformin and metformin on gonadal and metabolic profiles in chinese overweight/obese pcos patients with hyperandrogenemia.

Conditions: Polycystic Ovary Syndrome

Summary: to study the effects of glp-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in pcos patients with bmi ≥ 24 in china. 60 cases of overweight pcos patients were collected from shengjing hospital. the intervention period was 3 months after intervention with met or met + glp-1. to evaluate the improvement of met or met + glp-1 in the treatment of hyperandremia, glucose metabolism, bmi, waist circumference, menstruation, hairiness and acne in pcos patients with different bmi.


Eligibility criteria:
inclusion criteria: 1. females 18 years to 40 years of age diagnosed as pcos by the 2003 rotterdam criteria 2. overweight/obesity (bmi≥24 kg/m2) 3. no pregnant plan in recent 6 months 4. written consent for participation in the study exclusion criteria: 1. type 1 or type 2 diabetes mellitus 2. subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, cushing's syndrome, thyroid diseases, and hyperprolactinemia 3. diagnosed with or have a family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) 4. serious systemic disease or malignant tumor 5. history of pancreatitis (chronic, acute or recurrent) 6. body weight change ≥10% at 3 months before treatment 7. used oral contraceptives or sex hormone drugs in the past 1 month 8. used oral glucocorticoids in the past 1 month 9. substance (alcohol or drug) abuse or dependence within 3 months 10. heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d) 11. subjects have a severe systemic disease, such as cardiovascular system, renal impairment (egfr\<60ml/min/1.73m2) 12. increase of transaminases up to \< 2.5 times of upper limit of normal value 13. have a history of thromboembolic disease or thrombotic tendency 14. subjects in pregnant or lactating or within 1 year after delivery 15. subjects have an allergic history to the drugs used in the study 16. subjects have participated in other clinical researches of medicine within 1 month prior to randomization 17. use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or otc) within 30 days before screening
evaluating the validity and acceptability of a fully-automated interview to diagnose insomnia disorder: a pilot study

Conditions: Insomnia Disorder

Summary: objective: to evaluate if a fully-automated diagnostic interview for insomnia disorder is suitable for clinical and research purposes (adequate sensitivity and specificity) and is acceptable to patients. study main outcomes: 1. concurrent validity (sensitivity and specificity) compared to a gold standard. gold standard: clinical diagnosis of a clinician using a validated structured clinical interview for the dsm 5 criteria of insomnia disorder 2. acceptability of the fully-automated interview. participants: volunteers to undergo the clinical and the automated interview will be recruited through non-probability convenience sampling from patients attending the sleep clinic at bordeaux university hospital between may 2023 and july 2023.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * being able to communicate and read in french * previous use a mobile phone exclusion criteria: * n/a

Keywords: insomnia disorder mobile health diagnosis
stomach cancer exosome-based detection

Conditions: Gastric Cancer; Gastric Adenocarcinoma; Gastric Cancer Stage; Gastric Neoplasm; Gastric Lesion; Gastric Cancer in Situ; Gastric Cancer Stage IV; Gastric Cancer Stage IIIB; Gastric Cancer Stage III; Gastric Cancer Stage IB; Gastric Cancer Stage IA; Gastric Cancer, Stage 0; Gastric Cancer Stage IIIA; Gastric Cancer Stage II; Gastric Cancer TNM Staging; Gastric Cancer Metastatic to Lung; Gastric Cancer Metastatic to Liver; Gastric Cancer Stage I; Gastric Cancer TNM Staging Primary Tumor (T) T2B

Summary: gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. this study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. however, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. accurate biomarkers could help identify patients with gastric cancer before it becomes incurable. this study aims to develop a non-invasive test to detect gastric cancer early. it consists of four phases: 1. discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue, normal tissue, and serum samples from patients with gastric cancer, as well as samples from people without the disease. 2. using machine learning to develop a combination "signature" of cell-free (cf) and exosomal (exo)-mirna in serum specimens from a training cohort. 3. a validation of this signature in an independent cohort to confirm its accuracy. 4. an evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease. in summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. by combining different genetic markers (cell-free microrna and exosomal microrna) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.

Eligibility criteria:
inclusion criteria: * histological diagnosis of stage i, ii, iii, iv gastric cancer (tnm classification, 8th edition) (cases). * received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment. * confirmed cancer-free status at the time of study inclusion (non-disease controls). exclusion criteria: * lack of written informed consent. * systemic therapy before sampling. * synchronous gastric and non-gastric cancer diagnosed at or before surgery.
evaluation of a specialized yoga program for persons with spinal cord injury (sci)

Conditions: Spinal Cord Injury

Summary: the purpose of this randomized controlled study is to evaluate psychological variables, mindfulness, and pain in the context of a specialized yoga program for individuals with sci. participants will be randomized to either a wait-list control condition or to a specialized yoga program condition.


Eligibility criteria:
inclusion criteria: 1. have an sci or a spinal related condition, 2. be 18 years of age or older, 3. be able to speak and read english, 4. commit to two weekly, one hour yoga classes for six weeks, 5. be referred from a clinician on the inter-disciplinary team, 6. have a sitting tolerance of one hour, 7. be able to participate in gentle physical activity in that time, 8. be aware of and understand his/her health contraindications (is able to practice safely), 9. provide a note from their physician indicating that it is safe for them to participate in a physical activity intervention, such as yoga. exclusion criteria: 1. are not medically stable, 2. have pre-existing medical contraindications, 3. have cognitive limitations or language comprehension issues that would impact participation (determined by care team), 4. have had a regular yoga practice in the last six months.

Keywords: spinal cord injury yoga psychological flexibility mindfulness pain
long-term follow-up of tx200-tr101 (steadfast long term)

Conditions: Kidney Transplant Rejection; End Stage Renal Disease

Summary: this long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating tx200-tr101.

this is long- term follow up observational trial for patients who participated previously to a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor t regulatory cells (car-treg) in hla-a2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk. the aim is for this observational long-term follow up study (tx200-kt03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating tx200-tr101.

Eligibility criteria:
inclusion criteria: 1. subjects who enrolled in the phase i/iia study tx200-kt02, received a transplanted kidney and have either completed or withdrawn from that study. 2. willing and able to provide written informed consent (ic) in accordance with local regulations and governing independent ethics committee (iec)/institutional review board (irb) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study. exclusion criteria: * n/a

Keywords: regulatory t-cells genetically modified cells chimeric antigen receptor long term follow up t-regs cell therapy
dose escalation study of kw-3902 on diuresis in subjects with congestive heart failure (chf).

Conditions: Heart Failure, Congestive

Summary: the purpose of this study is to evaluate the safety of kw-3902iv compared to placebo and to determine the diuretic effect of kw-3902iv compared to placebo in patients hospitalized with volume overload due to chf who are refractory to high dose diuretic therapy.


Eligibility criteria:
inclusion criteria: * history of chf for greater than 3 months, * receiving oral/iv diuretic therapy * hospitalized for therapy for hf and edema that has not responded to diuretic therapy. * signs and symptoms of ongoing volume overload exclusion criteria: * myocardial infarction in past 14 days * clinical evidence of acute coronary syndrome causing worsening of hf, * pregnant or breast-feeding, * severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy, * automated implanted cardiac defibrillator (aicd) or synchronization device implanted within the preceding 7 days, * require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment, * deterioration due to an acute or superimposed condition requiring therapy other than diuretics * symptomatic ventricular tachycardia, * severe concomitant primary hepatic disease, * severe pulmonary disease, * any other concomitant life-threatening disease, * cva in the preceding 6 months, * hypotension, * participated in another clinical trial within 30 days, * acute contrast nephropathy, * admitted for heart transplant surgery or have had a heart transplant.

Keywords: heart failure, congestive diuretic
comparative study of new classification and traditional classification of radioactive oropharyngeal mucositis

Conditions: Head and Neck Cancer; Radiation-Induced Mucositis

Summary: radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. however, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. to solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) scattered erosion type; (3) fusion erosion type; (4) ulcer type. we intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors, and it needs to be treated according to the severity of mucositis to reduce symptoms and improve quality of life. however, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency, which seriously restricts doctors' correct evaluation and treatment of mucositis patients. to solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) scattered erosion type; (3) fusion erosion type; (4) ulcer type. we intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

Eligibility criteria:
inclusion criteria: * voluntarily sign informed consent; * age 18 or older on the date of signing the informed consent; * histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy. exclusion criteria: * they also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose \> 1.5× the upper limit of normal), mental illness, and a history of severe allergies

Keywords: radiation oropharyngeal mucositis head and neck cancer