Kornimate/medical-research-clean huggingface dataset:
anti-thrombotic and glucose lowering therapy in diabetic patients undergoing pci

Conditions: Type2 Diabetes Mellitus; Coronary Heart Disease

Summary: diabetes mellitus (dm) is one of the main risk factors for ischemic events in patients with coronary artery disease (cad) and diabetes is a factor in several post-pci (percutaneous coronary intervention) risk scores. however, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing pci. this study aims to describe the anti-thrombotic regimens, clinical outcomes and current diabetes medical treatment in an unselected consecutive population of patients with dm undergoing pci.

diabetes is one of the main risk factors for ischemic events in patients with coronary artery disease and diabetes is a factor in several post-pci risk scores (including the commonly used dapt score). however, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing pci. at large, results from randomized trials assessing the duration of dapt have produced conflicting results and there is uncertainty about the best anti-thrombotic strategy in patients with diabetes. further assessment of the patterns of use and their clinical effects, including those related to prolonged dapt is needed, in diabetic patients, especially in less selected "real world" populations.

Eligibility criteria:
inclusion criteria: * pci with stent implantation, performed in at least one major coronary artery in the context of stable coronary artery disease or acute coronary syndrome * type 2 diabetes mellitus (previously diagnosed or diagnosed at the index admission) * informed consent signed * patient not simultaneously participating in any interventional study exclusion criteria: * patients with type 1 diabetes mellitus * patients whose survival is expected to be lower than 1 year at hospital discharge * patients not whiling to participate

Keywords: pci-percutaneous coronary intervention diabetes mellitus dual antiplatelet therapy anti-diabetic drugs
volar locked plating versus bridging external fixation

Conditions: Distal Radius Fracture

Summary: a randomized, prospective comparison of volar locked plating versus hoffman ii bridging external fixation supplemented by k-wire fixation in patients with comminuted distal radius fractures, ao/ota type c2 \& c3. hypothesis: there is no significant difference in using volar plates compared to hoffman ii bridging external fixation supplemented by k-wire fixation in patients with comminuted distal radius fractures, ao/ota type c2 \& c3 as evaluated by a quick-dash score at 24 months follow-up.

we have designed a randomized, prospective study for comparison of volar locked plating versus hoffman ii bridging external fixation supplemented by k-wire fixation in patients with comminuted distal radius fractures, ao/ota type c2 \& c3. on the basis of power analysis a total of 140 patients are to be included in this project. the follow-up period is 2 years and evaluation is based on x-ray analysis, grip strength, range of movement, pain and various tools to measure quality of life and satisfaction with the treatment (eq-5d, sf-36, quick-dash).

Eligibility criteria:
inclusion criteria: * all patients admitted to ahus and lillestrom legevakt with a distal radius fracture are to be classified according to the system of the orthopaedic trauma association (ao/ota). * all patients between the age of 18 and 70 diagnosed with a c2- or c3-type fracture, or a dislocated c1-fracture, are eligible for inclusion. exclusion criteria: * gustillo-anderson type iii open fractures * previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity * dementia * congenital anomaly * bilateral radius fracture * pathological fracture other than osteoporotic fracture * congenital bone disease (for example osteogenesis imperfecta) * age below 18 and above 70 * disabling nury to other parts og the movement apparatus at the same time as the current injury
lansoprazole versus mosapride for functional dyspepsia

Conditions: Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome

Summary: functional dyspepsia is a common symptom complex with significant impact on quality of life. there is no standard treatment for functional dyspepsia but therapeutic efficacy of proton pump inhibitor (ppi) and prokinetic agent have been proved in subsets of patients. this study has two aims: * first is to compare the therapeutic efficacy of lansoprazole (a ppi) and mosapride (a prokinetic agent) for functional dyspepsia * second is to investigate whether different subgroups of functional dyspepsia (e.g., epigastric pain syndrome and postprandial distress syndrome) respond differently to ppi and prokinetic agent.

eligible outpatients with presentation of dyspepsia are enrolled if they fulfilled the criteria of rome iii criteria. a trained assistant helps the eligible patients to complete the rome iii standard questionaire, brief symptom rating scale (bsrs), and maudsley personality inventory (mpi). the enrolled patients are then randomized into either lansoprazole or mosapride group for 14-day treatment. before starting medication, right after completing the medication, and 1 month after the medication, the enrolled patients complete standardized severity questionnaire (hong-kong index) to evaluate severity of dyspeptic symptoms. symptom improvement is then determined.

Eligibility criteria:
inclusion criteria: * aged more than 20 years old * diagnosis of functional dyspepsia by fulfilling rome-iii criteria * outpatient exclusion criteria: * aged less than 20 years * organic lesions including ulcers, tumors, bleeding, vasculopathy or esophagitis as demonstrated on upper endoscopy * concurrent illness with malignancy, diabetes mellitus, liver cirrhosis, renal failure or porphyria * diagnosis of organic disease for dyspeptic symptoms by treating physicians * history of abdominal surgery * concurrent user of aspirin and nsaid * history of allergy or severe side effects to lansoprazole or mosapride * pregnant or lactating women

Keywords: functional dyspepsia epigastric pain syndrome postprandial distress syndrome proton pump inhibitor 5 ht-4 receptor agonist
effectiveness of nursing case management for lung cancer patients

Conditions: Lung Cancer

Summary: the study is to investigate the effectiveness of nursing case management for lung cancer patients in a taiwan medical center.

purpose: the study is to investigate the effectiveness of nursing case management for lung cancer patients in a taiwan medical center. the outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance, patients' satisfaction with healthcare, and staffs' satisfaction with case management. methods: the study will employ a quasi-experimental research design. the patients with new-diagnosed lung cancer and accepting case management will be assigned to the experimental group； the patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management will be assigned to the control group；the third group is the patients with non-new-diagnosed lung cancer and with accepting case management. the staffs are the doctors within the lung cancer medical team. the lung cancer case management database, patients' satisfaction questionnaire, and staffs' satisfaction questionnaire will be used to measure the effectiveness. statistical software spss for windows version 17.0 will be used to analyze the data. expected results: the research outcome will to confirm the impact of case management on the lung cancer patients and could be the reference data for future cancer case management model.

Eligibility criteria:
inclusion criteria: * patients with lung cancer exclusion criteria: * younger than 20 years old
echo flow versus (non-)invasive haemodynamics

Conditions: Cardiac Output, Low; Cardiac Output, High

Summary: rationale: diligent fluid management is instrumental to improve postoperative outcome, cost and quality of care. objective: to determine the accuracy of brachial, femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement, invasive and non-invasive pulse-contour analysis. study design: observational study - prospective clinical non-intervention measurement study. study population: adult asa 1-2 patients, scheduled for open upper gi surgery intervention (if applicable): not applicable. we will perform non-invasive ultrasound measurements of the femoral, carotid and brachial blood flow right before induction and under anaesthesia. main study parameters/endpoints: femoral, carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output, stroke volume variation, and pulse-contour analysis derived cardiac output (invasive or non-invasive) at the following time points during surgery; (limited for femoral site as it cannot be measured during surgery): (1) before induction of anaesthesia, (2) after induction, (3) 15 minutes after start of surgery, (4) before and (5) after (1-2 minutes) a fluid bolus, (6) before and (7) after start of vasopressors, (8) before and (9) after trendelenburg position and (10) after surgery before end of anaesthesia (figure 1). a fluid bolus will be performed as part of standard care (goal-directed fluid therapy). the vasopressor and trendelenburg position time points are optional measurements. we will also measure (continuous) invasive femoral blood pressure (sbp, dbp, map), non-invasive blood pressure, svv, central venous pressure (when available), heart rate, spo2, pfi, etco2.


Eligibility criteria:
inclusion criteria: * elective open gi surgery * invasive arterial blood pressure monitoring * informed consent exclusion criteria: * significant stenosis \> 30% or abnormal anatomy of aortic, femoral, carotid or brachial artery * cerebrovascular accident * atrial fibrillation * copd stage 3-4 * lobectomy / pneumectomy * active pneumonia * cardiac failure * severe heart valve regurgitation or stenosis * not able to measure brachial or carotid artery blood flow during surgery * contra-indications for femoral arterial catheter placement (e.g., vascular graft)
two warming methods in knee arthroplasty

Conditions: Hypothermia, Accidental

Summary: in this study two warming methods will be compared in knee arthroplasty surgery. barrier easywarm will be used in the study group and bairhugger upper body warming blanket in the control group. both groups will be prewarmed 30 minutes before spinal anaesthesia. in the operating room warming will be continued with the same warming method. primary end point is core temperature after arriving to post anaesthesia care unit. hypothesis is that barrier easywarm is not inferior to bairhugger in preventing inadvertent intraoperative hypothermia. few methods exist to measure the core temperature non-invasively. zero-heat-flux technique is used in this study. during the study we will test the accuracy of the 3m bairhugger temperature monitoring system by placing two sensors onto the patients (n = 30) fore head. after that the accuracy of the dräger tcore is examined by comparing it with the 3m bairhugger temperature monitoring system. so the patients (n=30) have both these different core temperature monitoring systems on their foreheads. this observational monitoring study is performed from the patient number 80 until the end.


Eligibility criteria:
inclusion criteria: * bmi 25-40 * asa class i-iii * elective primary unilateral kneearthroplasty * spinal anaesthesia exclusion criteria: * asa class \> iii * unstable coronary artery disease * revision surgery, bilateral arthroplasty * general anaesthesia * decreased mental status

Keywords: inadvertent, intraoperative hypothermia, prewarming core temperature monitoring
effectiveness of an individualized program of muscular strength and endurance program for improving germ cell cancer

Conditions: Testicular Germ Cell Cancer

Summary: background: patients with testicular germ cell cancer (gcc) have a high cure rate, however impaired muscle function and fatigue are the most common complications among patients with gcc undergoing treatment with chemotherapy. although exercise is widely recommended, information about physiopathological effects of cancer therapy in skeletal muscle is very limited. methods/design: the present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. all variables will be measured at the beginning and at the end of a 8-week intervention by the same evaluator, who will hide the disposition of participants to each group. besides, it will be monitoring during de following 6 months (24 weeks) after training for all outcome variables.

background: patients with testicular germ cell cancer (gcc) have a high cure rate, however impaired muscle function and fatigue are the most common complications among patients with gcc undergoing treatment with chemotherapy. although exercise is widely recommended, information about physiopathological effects of cancer therapy in skeletal muscle is very limited. our aim is to evaluate the effects of an individualized exercise program with aerobic training in water running on cancer-related fatigue. methods/design: the present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. the investigators will conduct this trial in patients undergoing chemotherapy, recruited by the departament of oncology of virgen de la victoria hospital (málaga). patients will be included and evaluated before the first cycle of chemotherapy and assigned experimental or control group randomly. all variables will be measured at the beginning and at the end of a 8-week intervention by the same evaluator, who will hide the disposition of participants to each group. besides, it will be monitoring during de following 6 months (24 weeks) after training for all outcome variables.

Eligibility criteria:
inclusion criteria: * patients programmed to chemotherapy exclusion criteria: -

Keywords: testicular cancer germ cell cancer physical exercise cancer-related fatigue chemotherapy clinical rules metabolomics
safety, effectiveness and operability of using the new tissue containment system during laparoscopic ovarian cystectomy

Conditions: Ovary Neoplasm; Surgery

Summary: the study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystectomy. premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.


Eligibility criteria:
inclusion criteria: * premenopausal woman patient age 18-45 years * women with regular period * women with ovarian neoplasm (size: 3-10cm) * laparoscopic surgery required * body mass index 18.5-27.9kg/m2 * subject able to comprehend and give informed consent for participation in this study * signed informed consent form exclusion criteria: * patient is not considered suitable for a laparoscopic ovarian cystectomy procedure * the ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free * women with polycystic ovary syndrome * baseline amh less than 0.5ng / ml * known to have participated in any other clinical trials or hormone therapy within 3 months * women during pregnancy and lactation * women in acute stage infection of reproductive system or other parts * women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery * women with known or suspected poor compliance who cannot complete the trial * those who can not sign the informed consent
microbiome therapy in covid-19 primary care support

Conditions: SARS-CoV Infection; Corona Virus Infection

Summary: this double-blind, randomized, placebo-controlled study aims to investigate whether a throat spray containing probiotic bacteria (i.e. microbiome spray) can reduce the symptoms and complaints of the sars-cov-2 virus in patients with mild to moderate symptoms. in addition, the aim is to investigate whether the microbiome spray can prevent transmission of the sars-cov-2 virus to household members.


Eligibility criteria:
inclusion criteria: * patients in primary care with a positive sars-cov-2 test based on pcr * instructed during screening and agreed not to use other probiotic nutritional supplements outside of the study during the study period * sign the consent form exclusion criteria: * antibiotic use at baseline and during the study * vaccinated against sars-cov-2 at start of the study (both for index patients and household members that participate) * pregnant women * history of use of probiotic supplements in the past two weeks * current diagnosis of cancer or immunosuppressive therapy within the past 6 months * acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis) * clinically significant bleeding disorder * any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial

Keywords: lactobacilli probiotics throat spray
ft596 in combination with r-chop in subjects with b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma; Transformed Indolent Non-Hodgkin's Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma

Summary: this is a phase i study of ft596 in combination with two different schedules (standard or alternate) of r-chop in subjects with b-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. the study will consist of a dose-escalation stage followed by a dose-expansion stage.

this is a phase i study of ft596 in combination with 2 different schedules (standard or alternate) of r-chop in subjects with b-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. the study will evaluate both the clinical benefit of ft596 when combined with r-chop given on a standard or alternate schedule. subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. after safety and tolerability have been assessed to define the maximum tolerated dose (mtd) (or the maximum assessed dose \[mad\] in the absence of dose limiting toxicities \[dlts\] defining the mtd) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of ft596 in combination.

Eligibility criteria:
key inclusion criteria: * diagnosis of b-cell lymphoma (bcl) as described below: * histologically documented bcl * previously untreated or no more than one prior systemic therapy for bcl * at least one bi-dimensionally measurable lesion * subjects with \>1 measurable lesion agreement to undergo a biopsy * capable of giving signed informed consent * age ≥ 18 years old * stated willingness to comply with study procedures through study duration * contraception use for women and men as defined in the protocol * negative serum pregnancy test within 7 days of treatment for women key exclusion criteria: * prior anthracycline therapy * females who are pregnant or breastfeeding * eastern cooperative oncology group (ecog) performance status ≥2 * evidence of insufficient organ function * currently receiving or likely to receive systemic immunosuppressive therapy * receipt of allograft organ transplant * known active central nervous system (cns) involvement by malignancy * non-malignant cns disease such as stroke, epilepsy, cns vasculitis, or neurodegenerative disease * clinically significant cardiovascular disease * positive hiv test * positive hepatitis b (hbv) or hepatitis c (hcv) test * live vaccine \<6 weeks prior to start of conditioning * allergy to human albumin or dimethyl sulfoxide (dmso)
colorectal cancer screening in average-risk population: immunochemical fecal occult blood testing versus colonoscopy

Conditions: Colorectal Cancer; Colorectal Neoplasm

Summary: aims: 1. to compare the efficacy of biennial immunochemical fecal occult blood test (ifobt) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population. 2. to determine the compliance and complications associated with both strategies. methods: multicenter, randomized, controlled study in 8 spanish regions (aragón, canarias, catalunya, euskadi, galicia, madrid, murcia and valencia). study groups: * group i: ifobt (oc sensor®) in one stool sample, followed by colonoscopy when a positive result. * group ii: colonoscopy. sample-size calculation: 27,749 subjects in each study group (total: 55,498).


Eligibility criteria:
inclusion criteria: * men and women aged 50-69 years exclusion criteria: * personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease * family history of colorectal polyposis, lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60) * severe comorbidity * previous total colectomy * not signed informed consent to participate

Keywords: colorectal cancer screening prevention fecal occult blood test colonoscopy colorectal neoplasm randomized clinical trial
awareness about breast cancer screening

Conditions: Breast Cancer

Summary: breast cancer is the most common cancer in french women, with 52000 new cases each year. shift work and night work is recognized by international agency for research on cancer as a potential risk factor. epidemiological studies find, for most of them, an increased risk of breast cancer compared with general population. physiological hypothesis rely on the melatonin role in defense against tumorigenesis. according to high authority of health clinical good practice guidelines, the risk does not justify more screening than the organized screening. we do not have information about awareness level of workers in health structures, specially in the hospices civils de lyon. investigators would like to know how employees take part to breast cancer screening, specially in night workers. this study, as a survey, is a first step to evaluate the need for specific actions to increase the participation to breast cancer screening.


Eligibility criteria:
inclusion criteria: * employees hcl * women exclusion criteria: * \<18 years old
vara (virtual and augmented reality applications in rehabilitation): motor rehabilitation protocol with grail for patients affected by hemiparesis

Conditions: Hemiparesis

Summary: the main goal of the study is to verify the efficacy of the grail system in respect to the walking pattern improvement in a population of hemiparetic subjects. in particular, the specific goals will be: * increase in walking symmetry and a better distribution among the time of stance and swing. * kinematics and kinetics correction, with incentive of more corrected activation timing. * recruitment of the muscles most involved by the paresis, with the help of visual feedback. * walking speed increase (but with the priority of the walking pattern) * increase in the resistance * stregthening of the support reaction


Eligibility criteria:
inclusion criteria: * hemiparetic patients as a consequence of acquired brain injury exclusion criteria: * excessive muscular spasticity or contractures. * recent (under 6 months) lower limbs surgery * cognitive or emotional/relational obstacles to the therapy

Keywords: grail children rehabilitation virtual reality hemiparesis