Kornimate/medical-research-clean huggingface dataset:
validation of the psason ultrasound scores in patients with psoriatic arthritis undergoing treatment with apremilast

Conditions: Psoriatic Arthritis

Summary: the main purpose of this study is to validate the ultrasound scores psason22 and psason13 in patients with active psoriatic arthritis undergoing a treatment with apremilast.

this is a prospective, multicentre, phase iv trial assessing the value of the ultrasound scores psason22 and psason13 in differentiating between clinically active and inactive patients with psoriatic arthritis, following a treatment with apremilast for up to 24 months. additionally, convergent construct validity, inter/intra-reader reliability, sensitivity to change and differences in change in certain patients will be tested for the ultrasound scores.

Eligibility criteria:
inclusion criteria: 1. male or female patient ≥18 years and \<90 years of age 2. psa according to caspar criteria 3. peripheral manifestation (arthritis, tenosynovitis, dactylitis and/or enthesitis) 4. active disease as defined by a dapsa \>14 and clinical indication for treatment with apremilast (as per approved indication for psa, including failure to methotrexate) 5. written informed consent exclusion criteria: 1. inability to perform us at any site included in the psason22 or psason13 score (f.e. due to complete destruction of a joint) 2. planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography. 3. contraindication to apremilast (as per patient information leaflet) 4. current severe medical illness requiring hospitalization 5. pregnancy or lactation 6. inability of the patient to follow the treatment protocol 7. fulfillment of the mda criteria or dapsa≤14 8. current treatment with any investigational drug 9. current treatment with glucocorticoids at a prednisone equivalent \>10mg 10. intra-articular glucocorticoid injection in one of the joints to be investigated clinically or by sonography, or intra-muscular glucocorticoid injection within 8 weeks before baseline 11. change, including dosage changes or discontinuation, of csdmard treatment (with the exception of leflunomide) in the last 4 weeks before baseline 12. change, including dosage changes or discontinuation of leflunomide treatment in the last 8 weeks before baseline. (exception: if patients stop leflunomide and complete an 11 day treatment with cholestyramine (8g, 3 x daily), prior to the baseline visit, they may enter the study.) 13. current bdmard, tsdmard treatment 14. prior bdmard or tsdmard treatment without a minimal washout period before baseline (the minimal washout period is twice the half-life of the respective drug)

Keywords: ultrasound psoriatic arthritis outcome measures apremilast disease activity
the auxiliary effects of fucoidan for locally advanced rectal cancer patients

Conditions: To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT

Summary: this is a double-blind, randomized, placebo-controlled, parallel study. the main goal is to investigate the auxiliary effects of fucoidan for the patients with locally advanced rectal cancer who receive neoadjuvant ccrt before surgery. the quality of life is our primary endpoint for this study. the study is an observational study.


Eligibility criteria:
inclusion criteria: 1. age was more/equal to 20 year-old and less/equal to 80 year-old 2. diagnosed as locally advanced rectal cancers by pathological biopsy and image study. 3. ecog performance status within 0 to 2 points 4. excepted life remaining at least 4 months 5. females with fertility are willing to use effective contraception during the period of study 6. willing to follow the test procedures and tracking procedures 7. sign the inform consent form exclusion criteria: 1.suffering from other primary malignant tumors 2.females who are pregnant, planning to become pregnant, or breastfeeding 3.participate in other interventional clinical trial within the first 30 days 4.suffering from major mental illness such as mental retardation and mental disorders 5.unable to understand and answer research questions (oral or written) 6.abnormal laboratory data within 14 days before joining the study 7.evidence that subject has a severe or uncontrolled disease -
study evaluating the safety, pharmacokinetics, and pharmacodynamics of sam-531

Conditions: Alzheimer Disease

Summary: to assess the safety and tolerability of ascending multiple oral doses of sam-531, an investigational drug, in healthy japanese young male and elderly subjects.to provide the pharmacokinetics (pk) and pharmacodynamics (pd) profiles of multiple oral doses of sam-531 in healthy japanese young male and elderly subjects.


Eligibility criteria:
inclusion criteria * men aged 20 to 45 years, inclusive, at screening. * elderly men or women aged 65 years and above as of screening. * body mass index (bmi) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg. exclusion critereia * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ecgs, or clinical laboratory test results. alanine aminotransferase (alt) and aspartate aminotransferase (ast) levels should be below the upper limit of normal at screening. * tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.
prospective evaluation of interscalene nerve catheters vs. single injection blocks

Conditions: Pain

Summary: the primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status 1-3 * 18-79 years of age, inclusive * body mass index of \< 36 kg/m2. * the ability to understand local anesthetic related complications and care of a cpnb * presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis. * the ability to communicate with the practitioner managing the catheter. * residence within 2 hours of university of wisconsin hospital and clinics exclusion criteria: * any contraindication to a continuous interscalene catheter placement * clinically significant pulmonary disease * clinically significant cardiac disease * allergy to ropivacaine * peripheral or central nervous system disease * current (or planned) anticoagulation therapy or disease * local infection over area of catheter placement * renal or hepatic failure * history of opioid dependence * significant psychiatric disease * pregnancy or lactation (subjects will be asked if it is possible they could be pregnant. if a subject responds in the affirmative, a pregnancy test will be done.) * seizure disorder

Keywords: nerve block shoulder surgery physical therapy
effects of the humanitude® care methodology on health professionals' perception

Conditions: Delivery of Health Care; Education, Medical; Caregiver

Summary: healthcare professionals providing care for institutionalized older patients must deal with agitated behavior daily. such behavior alters the patient's quality of life and generates stress for the caregiver. humanitude® care methodology is an alternative to pharmaceutical approaches that has demonstrated benefits on care delivery. the present study aims to investigate the effects of this method on healthcare professionals' perception of competence and emotional state when dealing with difficult care situations.

this is a retrospective, multicentric, before / after study. data collected from a self-administered questionnaire to caregivers working in 32 continuous care units before and after participation in humanitude® care methodology training sessions in the ile-de-france region in france will be analyzed. data on the participants' perception of their own care competence and their emotional state when confronted with several difficult care situations will be collected. participants' well-being at work and adhesion to the humanitude® care methodology will be also evaluated.

Eligibility criteria:
inclusion criteria: * caregivers taken part in a humanitude® training course * caregivers agreeing to complete pre- and post-training questionnaires exclusion criteria: * caregiver not completing the questionnaire at one of the 2 stages of the assessment (before or after)

Keywords: humanitude care methodology agitated behavior quality of care health professional well being medical education
efficacy of intestinal decontamination in patients colonized by carbapenem-resistant klebsiella pneumoniae and colistin

Conditions: Patients Colonized by Klebsiella Pneumoniae.

Summary: the identification of all cases (44 patients) was carried out from the database of microbiology, university hospital reina sofía and the university hospital of jerez. for the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.


Eligibility criteria:
inclusion criteria: * patients with intestinal colonization by klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by klebsiella pneumoniae: * surgery in two weeks * transplant in two weeks * require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia) * recurrent or severe infections * institution admission * fragile patients at high risk of readmission. exclusion criteria: * the presence of an active infection for klebsiella pneumoniae. * concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.
psychological care of oncology patients with post-traumatic stress in the context of a covid-19

Conditions: Solid Carcinoma; Post Traumatic Stress Disorder; Covid19

Summary: in the context of the covid-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (ptsd). ptsd generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... the current health crisis also represents an increased risk of ptsd. after the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... in some people, ptsd can lead to more disabling problems such as (crowd) avoidance. in order to help patients with ptsd, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference. a study initiated at the françois baclesse centre during the first confinement, which included 735 patients from april to june 2020, made it possible to assess the impact of the pandemic linked to covid-19 on the care of cancer patients treated in day hospitals, but also to evaluate the ptsd experienced by patients, sleep difficulties, quality of life, cognitive complaints and confinement conditions using validated questionnaires. this study showed that 21% of patients had proven ptsd and 23% had insomnia problem. this study proposes to evaluate the value of adapted psychological care for patients with ptsd in relation to the pandemic on the improvement of ptsd, as well as on resilience, quality of life and sleep.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * patient treated or followed up for a solid tumour at the françois baclesse centre * patient with a score suggesting moderate or high posttraumatic stress symptoms (ies-r score ≥ 24) related to the covid-19 epidemic * the patient's state of health is compatible with the programme: psychological care for 6 months. * information note signed by the patient * any associated geographical, social or psychopathological conditions that might compromise the patient's ability to participate in the study exclusion criteria: * patient with no symptoms suggestive of moderate or high post-traumatic stress (ies-r score \<24) * patient deprived of liberty or under guardianship * patient already receiving psychological care * patient whose diagnosis of the disease was made within one month prior to the proposal for participation
multi-parametric mri/fluorine-18 fluciclovine pet-ct in glioblastoma

Conditions: Tumor, Brain

Summary: glioblastoma is the most common adult brain tumour with approximately 2000 new cases each year in the uk. optimal treatment consists of surgery followed by radiotherapy and chemotherapy but despite this survival is poor with only 10% of patients alive at 5 years. standard imaging (mri and ct) may not detect the full extent of tumours before treatment and it can be difficult to assess how the tumour is responding to treatment. the study aims to evaluate more advanced imaging techniques to see if they are better at mapping the whole tumour and assessing response to treatment. two different imaging techniques will be assessed: positron emission tomography - computed tomography (pet-ct) uses a mildly radioactive compound injected into the patient which is taken up into brain tumour cells and shows up as a bright spot on scans. brain tumours affect blood supply and how much fluid is in the brain tissue as well as how freely fluid can move around. advanced mr imaging known as multiparametric mri will be used to look at these additional features. this extra information may help improve planning of radiotherapy and assessing how tumours respond to treatment. twelve adult patients with glioblastoma undergoing radical treatment will be recruited over a 12 month period. each patient will have standard mr imaging before radiotherapy (after surgery) and 4-6 weeks following completion of radiotherapy. they will also have advanced mri and pet/ct before, during and after treatment. the aim will be to study if this is feasible and could potentially improve radiotherapy planning and response assessment. imaging will be interpreted by both imaging and brain tumour treatment experts.


Eligibility criteria:
inclusion criteria: * age ≥18 * who performance status 0-2 (appendix 1) * histologically proven gbm (who grade 4) * clinical decision made to proceed with radical treatment with surgery and chemo-radiotherapy * residual tumour following surgery as defined by the surgeons at the time of resection * able to provide fully informed written consent * able to lie flat for 1 hour * not be pregnant or breast feeding. female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be post-menopausal. exclusion criteria: patients with any of the following are not eligible for the study: 1. hypersensitivity to fluorine-18 fluciclovine 2. hypersensitivity to mri contrast media 3. acute renal failure or moderate renal impairment (estimated glomerular filtration rate \< 30 ml/min) 4. claustrophobia precluding imaging 5. non-mri compatible implantable device e.g. pacemaker 6. uncontrolled pain 7. urinary incontinence 8. female patients must not be pregnant and if of child bearing age using adequate contraception 9. breast feeding 10. serious psychiatric co-morbidity
traditional three incisions vs minimally invasive thoracol-laparoscopic esophagectomy for esophageal cancer

Conditions: Esophageal Carcinoma

Summary: this study is a multi-center, randomized, and open-label trial to compare the safety and feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic esophagectomy for esophageal cancer.


Eligibility criteria:
inclusion criteria: 1. histologic diagnosis of intrathoracic esophageal carcinoma of stage i to iii, which is potentially resectable judged by mdt 2. 18≤age≤75 3. ct1b-4a，n0-2，m0 confirmed by chest ct, eus, or eus-fna in four weeks; 4. ecog ps scores≤2 5. laboratory findings in 14 days before operation：normal blood test of basic metabolism panel 6. european clinical oncology group (ecog) performance status 0,1 or 2 7. more than 12 months of expected survival 8. tolerance of tracheal intubation and general anesthesia 9. written informed consent exclusion criteria: 1. carcinoma of the cervical esophagus or gastro-esophageal junction (gej) 2. prior thoracic surgery which may effect this study 3. pregnant or breast feeding 4. inability to tolerance of tracheal intubation and general anesthesia 5. ps \>2 6. unstable disease 7. poor compliance

Keywords: traditional three incisions minimally invasive thoracol-laparoscopic esophagectomy mie esophageal cancer
platform study of jdq443 in combinations in patients with advanced solid tumors harboring the kras g12c mutation

Conditions: KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small Cell Lung; Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Colorectal Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Tumors; Neoplasms, Colorectal

Summary: this is phase ib/ii, multicenter, open-label adaptive platform study of jdq443 with select therapies in patients with advanced solid tumors harboring the kras g12c mutation.

jdq443 will be considered "backbone" treatment in this trial and combined with selected therapies, or "partner(s)". the combination of a backbone and a partner will constitute a treatment arm. after dose escalation, treatment arms that reach a maximum tolerated dose /recommended dose and are determined to be safe may, but are not required to, proceed to phase ii to further explore safety, tolerability, and anti-tumor activity.

Eligibility criteria:
inclusion criteria: dose escalation: - patients with advanced (metastatic or unresectable) kras g12c mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy. phase ii: * patients with advanced (metastatic or unresectable) kras g12c mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy * patients with advanced (metastatic or unresectable) kras g12c mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy. all patients: * ecog performance status of 0 or 1. * patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. exclusion criteria: * tumors harboring driver mutations that have approved targeted therapies, with the exception of kras g12c mutations * prior treatment with a kras g12c inhibitor is excluded for patients in a subset of groups in phase ii. * active brain metastases, including symptomatic brain metastases or known leptomeningeal disease * clinically significant cardiac disease or risk factors at screening * insufficient bone marrow, hepatic or renal function at screening other protocol-defined inclusion/exclusion criteria may apply

Keywords: kras g12c targeted therapy nsclc crc advanced solid tumors jdq443 trametinib ribociclib cetuximab
welchol® and insulin in treating patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to see how safe and effective and tolerable the use of welchol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs


Eligibility criteria:
inclusion criteria: * ages 18 - 75 years, inclusive * diagnosed with type 2 diabetes * stable insulin therapy for 6 weeks * stable dose of any other antidiabetic medications for 90 days * hemoglobin a1c value between 7.5% to 9.5% * c peptide greater than 0.5 ng/ml * prescribed ada diet exclusion criteria: * history of type 1 diabetes or ketoacidosis * history of pancreatitis * uncontrolled hypertension * allergy or toxic response to colesevelam or any of its components * serum ldl-c less than 60 mg/dl * serum tg greater than 500 mg/dl * body mass index (bmi) greater than 45 kg/m2-

Keywords: diabetes mellitus
mind diet and cognitive function in middle-aged and older adults

Conditions: Cognitive Function; Dementia

Summary: a 12-month cluster-randomized controlled trial designed to test the effect of the mediterranean-dash intervention for neurodegenerative delay (mind) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years.

mediterranean-dash intervention for neurodegenerative delay (mind) diet and cognitive decline in middle-aged and elderly people is a 12-month cluster-randomized controlled trial designed to test the effect of the mediterranean-dash intervention for neurodegenerative delay (mind) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. the proposed mind diet for this study is a hybrid of the mediterranean and dash diets but with selected modifications based on the most compelling evidence in the diet-dementia field and chinese dietary guidelines 2022. specifically, the proposed mind diet education will emphasize the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafood, beans and legumes, nuts, olive and seed oils, and green tea, and restrict red and processed meats, animal fat, fried foods, and sweets and pastries. the trial will employ a cluster randomization design comparing the effects on cognitive change of the mind intervention diet education among 1200 adults aged 40-69 years. secondary outcomes will include dietary behavior changes, health status changes, etc. the proposed study is sited at taian, shandong, china.

Eligibility criteria:
inclusion criteria: * normal chewing function, able to eat hard foods such as nuts. * willing to participate and sign an informed consent form. * able to understand research procedures and adhere to them throughout the entire study period. exclusion criteria: * participation in or have participated in other clinical trial studies within the past year. * medication to treat alzheimer's or parkinson's disease. * diagnosis of severe chronic diseases, such as cancer.

Keywords: cognitive function dietary pattern