Kornimate/medical-research-clean huggingface dataset:
the effect of "mindfulness-based compassionate life training" for university students affected by the earthquake

Conditions: Earthquake; Trauma; Stress, Psychological

Summary: in this study, aimed to determine the effect of "mindfulness based compassionate life training" given to university students on coping with post-earthquake trauma stress and grief process. according to the experimental design with pre-test and post-test control group, the participants selected from the universe will be assigned to the experimental and control groups impartially. in this study, a priori power analysis will be performed to determine the sample size. for the independent groups, in which the effect of "mindfulness-based compassionate life training" on coping with post-earthquake trauma stress and grief will be compared, 80% power will be achieved at a significance level of 0.05 at a 95% confidence interval. a total of 68 participants will be reached by taking into account data losses and including 30% backup sample in the research. participants included in the study will be numbered from 1 to 68 and 34 experimental and 34 control groups will be created from www.random.org. pre-test data will be collected before applying to earthquake survivors in the experimental group and control group. 8 sessions of mindfulness based compassionate life training will be given to earthquake survivors in the experimental group. training sessions will be held online. for its effectiveness and continuity, each session will be held between 3 days and 7 days. one week after the mindfulness-based compassionate living training (after 8 sessions were completed), the "post-earthquake trauma stress level determination scale (nsstdbö)", "the grief scale" was administered to the earthquake survivors. the "self-compassion scale short form (sts-f)" post-test will be filled in by face-to-face interview. post-test data from the experimental and control groups will be obtained simultaneously.

research data will be collected face to face by researchers. 68 earthquake survivors who meet the inclusion criteria (to be studying at a university, to be affected by the earthquake, to be willing to participate in the study, to be open to communication and cooperation) will be included in the study. the descriptive features form consisting of 8 questions for data collection, "post-earthquake trauma stress level detection scale", "mourning scale". "self-compassion scale short form (sts-f)" will be used. research data will be collected as a pre-test and post-test for 1 month. those who do not regularly participate in the mindfulness-based compassionate living training will be excluded from the study. the research will be carried out with 68 participants, 34 in the experimental group and 34 in the control group.

Eligibility criteria:
inclusion criteria: * having a university nursing education * being affected by the earthquake * willingness to participate in the study * being open to communication and cooperation exclusion criteria: * not attending sessions regularly

Keywords: mindfulness self-compassion trauma psychological
wound biofilm detection kit development: validation of grading system with biofilm severity

Conditions: Chronic Wound; Wound Healing; Biofilm Infection

Summary: chronic wound is a leading health issue in current health care system. biofilm is a notorious risk factor of unhealed wound. although biofilm-direct wound care has been a prevalent strategy of wound care currently, diagnosis of biofilm still remained as an unmet clinical need. several advanced diagnostic tools of biofilm had been published in recent years, however, the evidence was still insufficient. in this study, we will enroll patients with chronic wounds, collect the wound debris, quantify the biofilm and validate with the signals of advanced diagnostic tools for biofilm detection, hoping to transform the tools which could only tell us whether the biofilm is present or not, into the severity of biofilm infection. the two tested tools includes of moleculight i:x and wound blotting and alcian blue biofilm detection kit.


Eligibility criteria:
inclusion criteria: * 1.age 18 or older * 2.has an unhealed wound and is scheduled for debridement surgery * 3.patients who are receiving wound care at this hospital (hsinchu branch) and are able to comply with follow-up wound monitoring exclusion criteria: * does not consent to provide remaining tissue from wound treatment for in vitro analysis. * allergic to nylon components. * under 18 years of age.

Keywords: chronic wound wound healing biofilm detection
tunnel access for horizontal alveolar ridge augmentation

Conditions: Bone Atrophy, Alveolar; Bone Loss; Bone Resorption; Alveolar Bone Loss; Alveolar Bone Resorption

Summary: minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. in the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. this approach preserves the blood circulation and does not damage the periosteum the purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .

several techniques have been introduced to minimize the invasiveness involved in oral bone regeneration, to prevent the coronal advancement of the flap, which in turn reduces postoperative discomfort, swelling, complications, and mobility. the tunnel technique involves making a vertical incision to access the bone defect and inserting the grafts. the significant benefit of this approach is that it may be closed without the need for periosteal incisions. several tunnel techniques have been described in the literature using various biomaterials including bovine bone, synthetic bone, bovine bone block, allograft block bone, hidroxiapatite. this clinical study assesses the efficiency of a minimally invasive surgical technique for horizontal ridge augmentation using biphasic calcium phosphate and acellular dermal matrix. this minimally invasive procedure aims to increase the horizontal volume of the edentulous ridge in both its bone component (through the use of biphasic calcium phosphate) and its mucosal component (through the use of acellular dermal matrix). compared to other traditional techniques, this procedure, performed through a tunnel approach, would significantly reduce the invasiveness of the treatment.

Eligibility criteria:
inclusion criteria: * patients had to be healthy according to system of the american society of anesthesiology (asa) and aged 18 years or older * no general medical condition representing a contraindication to implant therapy * minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar * no periodontal disease (periodontal probing depth \<4 mm) or treated periodontitis * good oral hygiene (full mouth plaque index\<25%) * adequate control of inflammation (full mouth bleeding on probing\<25%) exclusion criteria: * smoking of more than 15 cigarettes a day • untreated periodontal disease * pregnancy or breastfeeding at date of inclusion • acute infections * keratinized mucosal tissue less than 2 mm.

Keywords: bone augmentation bone regeneration tissues augmentation ridge augmentation
multimodal platform combining vr and tens for stroke rehabilitation

Conditions: Stroke

Summary: stroke is a disabling medical condition annually affecting up to 15 million people worldwide. it leads to upper-limb impairments encompassing motor and sensory deficits together with cognitive self-body and space misrepresentation, overall limiting the functional independence of 70% of stroke survivors. on the motor side, stroke could account for hemiparesis (weakness or paralysis affecting the side contralateral to the brain lesion), muscle weakness, spasticity, loss of coordination, and others. on the sensory side, especially in the first stages after the stroke occurs, stroke could account for sensory loss, with the patient not being able to perceive what he's touching with the impaired arm.on a cognitive level, it has been shown that chronic stroke patients have distorted body representation and space representation. they perceive their impaired arm as shorter and the impaired hand as larger. despite initial evidence of the crucial role of sensory-motor integration toward a restored body representation to promote effective rehabilitation, conventional approaches suffer from the bias of prioritizing motor recovery, while disregarding stroke-induced sensory and body representation deficits. in this view, the creation of a virtual reality (vr) scenario in which the person is fully immersed, could potentially play a significant role in improving stroke patients' rehabilitation. taking this into consideration, this project aims to assess whether a multimodal platform combining vr with tens inducing full-body illusion toward a virtual avatar could positively impact motor performances, sensory assessments, and self-body and space representation of stroke patients. more into detail, the intervention will consist of the patient performing some task-oriented movement within the virtual reality and congruently tactile receiving feedback through transcutaneous electrical nerve stimulation. the subject will receive clear instruction within the virtual reality scenario to perform specific actions toward a final goal. these actions will be designed to make the subject repeat some crucial movements in their rehabilitation process. depending on the motor impairment of the patient, the investigators will adapt the characteristics and the difficulty of the task accordingly.


Eligibility criteria:
inclusion criteria: * ischemic or haemorrhagic stroke patient * at least 3 months after the stroke incident * 10 \<= fmue \<= 60 (motor function) exclusion criteria: * prior neurological or psychiatric disorders * severe cognitive impairment (moca score \<10) * epilepsy * pacemakers or other electronic implants * unable to give an informed consent form

Keywords: virtual reality tens stoke task-oriented rehabilitation multimodal intervention
comparison of paclitaxel-eluting coroflex please stent versus paclitaxel-eluting stent

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to assess whether the outcome of treatment with coroflextm please stent is not inferior to the outcome of treatment with taxus stent.

to establish the effectiveness and the safety of coronary stenting with the newly developed paclitaxel-eluting balloon expandable stent (coroflextm please stent, b. bran, melsungen, germany), compared to the conventional paclitaxel-eluting balloon expandable stent (taxus stent, boston scientific) in the treatment of coronary stenosis.

Eligibility criteria:
inclusion criteria: * the patient must be at least 18 years of age * significant de novo coronary artery stenosis (\>50% by visual estimation) * patients with stable (ccs class 1 to 4) or acute coronary syndromes (unstable angina pectoris braunwald class ib, ic, iib, iic, iiib, iiic or nstemi) or patents with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention * the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site exclusion criteria: * the patient has a known hypersensitivity or contraindication to any of the following medications: * heparin * aspirin * both clopidogrel and ticlopidine * sirolimus, paclitaxel * stainless steel and/or * contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. patients with true anaphylaxis to prior contrast media, however, should not be enrolled) * systemic (intravenous) sirolimus or paclitaxel use within 12 months * female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study * history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions * gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months * current known current platelet count \<100,000 cells/mm3 or hgb \<10 g/dl * an elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period * patients with ef\<25% * cardiogenic shock at entry * acute mi patients within symptom onset \< 12 hours needing primary angioplasty * creatinine level \> 3.0mg/dl or dependence on dialysis * patients with left main stem stenosis (\>50% by visual estimate)

Keywords: coronary artery disease stent
metabolic modulation as treatment in acute heart failure

Conditions: Acute Heart Failure

Summary: the primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure

acute heart failure is a serious disease that despite modern therapies carries a high mortality. inotropic drugs improve patient status but yield a higher risk of death. previous studies have shown that myocardial contractility improves when glucose fermentation is up regulated and decreases when free fatty acids are high. in a placebo-controlled design we wish to shift myocardial substrate metabolism towards increased glucose uptake and utilization and measure hemodynamics and biochemical markers of metabolism and prognosis.

Eligibility criteria:
inclusion criteria: * acute heart failure * nyha class iii - iv. * ejection fraction \<35 exclusion criteria: * age \ 85 år, * allergy * renal failure * recently developed brady- or tachy-arrythmias * serious infection * heart failure due to restrictive or hypertrophic cardiomyopathy or stenotic valvular heart disease * recent myocardial infarction (\<6 weeks) * pulmonary wedge pressure \>30 mm hg * diabetes mellitus treated with insulin * peptic ulcer * pregnancy

Keywords: acute heart failure metabolic modulation
kn035 in combination with trastuzumab and docetaxel in her2-positive breast cancer

Conditions: HER2-positive Breast Cancer

Summary: this is an open-label, single arm phase ii trial to evaluate the efficacy, safety and tolerability of kn035 in combination with trastuzumab and docetaxel. eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. tumor assessment will be performed according to recist 1.1 criteria.


Eligibility criteria:
inclusion criteria: * written informed consent * female subjects with age 18 to 70 (inclusive) years at the time of consent * lvef ≥50% at baseline * ecog performance status of 0-1 * have not received 1l treatment for recurrent or metastatic breast cancer * adequate organ function exclusion criteria: * history of exposure to the cumulative doses of doxorubicin \> 400 mg / m2 or equivalent * history of autoimmune diseases * active brain metastasis * concurrent diseases that compromise patient's safety

Keywords: her2-positive breast cancer pd-l1 immune checkpoint
bioequivalence study of tansulosine 0,4 mg capsule in health subjects -fed state

Conditions: Hyperplasia Prostatic

Summary: the purpose of this study is to compare the bioavailability (rate and extent of absorption) of two tansulosine 0,4 mg capsule formulations. an open, randomized, two-period crossover study with a seven-days washout interval was conduced in 32 healthy male volunteers. the plasma samples were obtained up to 72 hours after drug administration. a sensitive and specific lc-ms/ms method was developed and validated for the determination of tansulosine in human plasma. bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of cmax, auc 0-72h and auc 0--inf.

the study protocol was approved by local ethics committee (unicamp - campinas, brazil). the study was performed with 32 healthy male volunteers. they were within 10% of their ideal body weight. biochemical test and physical examination were carried out. their medical history was also obtained. . volunteers did not drink caffeine-containing drinks 48-hours before the study. the volunteers gave written informed consent to participate in study. the study was designed as two-single-dose, randomized, open-label, balanced, crossover study, with two periods separated by 7-days washout. in both periods after a standard breakfast volunteers were given a single dose of their formulation (reference or test) of tansulosine with 200 ml of water. blood samples (8 ml) were collected at 0 (pre-dose) and at 01:00; 02:00; 03:00; 04:00; 04;30; 05:00; 05:20; 05:40; 06:00; 06:20; 06:40; 07:00; 07:30; 08:00; 08:30; 09:00; 10:00; 12:00; 24:00; 48:00; 72:00h. these samples were centrifuged immediately and kept frozen at -20°c until the time of analysis. standard meals were served at 4 and 8h after administration. during hospital confinement, volunteers were always under medical supervision.

Eligibility criteria:
inclusion criteria: * they were within 10% of their ideal body weight. * biochemical test and physical examination were carried out. * no concomitant medications were allowed. * volunteers did not drink caffeine-containing drinks 48-hours before the study. * the volunteers gave written informed consent to participate in the study. exclusion criteria: * chronic disease * smokers

Keywords: bioequivalence tansulosine
omega-3 fatty acids and post traumatic stress disorder (ptsd)

Conditions: Posttraumatic Stress Disorder

Summary: an increasing literature shows that omega-3 fatty acids provide numerous health benefits, including a variety of psychiatric symptoms and disorders including stress, anxiety, cognitive impairment, mood disorders (major depression and bipolar disorder) and schizophrenia. omega-3 fatty acids may additionally represent a promising treatment strategy in patients with ptsd. moreover, given its beneficial cardiovascular effects, adjunctive omega-3 fatty acids may also benefit the general health status of these veterans, who frequently present with a variety of comorbid medical disorders.

see brief summary

Eligibility criteria:
inclusion criteria: 1. veterans 18-65 years of age, any ethnic group, either sex. 2. ability to participate fully in the informed consent process. 3. current diagnosis of ptsd . 4. no anticipated need to alter medications for the 10-week duration of the study. exclusion criteria: 1. serious unstable medical illness, history of traumatic brain injury (tbi) with loss of consciousness greater than 30 minutes, or history of cerebrovascular accident, prostate or breast cancer. 2. current active suicidal and/or homicidal ideation, intent or plan. 3. use of aspirin, warfarin or other anticoagulant therapy, as omega-3 fatty acids may increase bleeding time. other concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary. 4. regular use of omega-3 fatty acid supplementation within the last 3 months (cod liver oil, other fish oil, flaxseed). 5. regular consumption of more than one serving of fatty fish per week. 6. substance dependence within the last 4 weeks (other than nicotine dependence). 7. current diagnostic and statistical manual, fourth edition (dsm-iv) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than tbi. 8. female patients who are pregnant or breast-feeding. 9. known allergy to study medication.

Keywords: ptsd cognition fish oil omega-3 fatty acid
predicting location and extent of prostate cancer using micro-ultrasound imaging

Conditions: Prostate Cancer

Summary: the goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. the images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.


Eligibility criteria:
inclusion criteria: * scheduled for mr-us fusion prostate biopsy or radical prostatectomy * agree to consent to the study exclusion criteria: * does not agree to consent.
a multicenter, prospective, randomized controlled trial to evaluate the efficacy of pcsk-9 inhibitors in delaying the progression of calcified aortic valve disease

Conditions: Aortic Stenosis; PCSK9 Inhibitor; Calcified Aortic Valve Disease

Summary: the aim of this clinical trial is to understand whether the drug pcsk9 inhibitor can slow the progression of calcific aortic valve disease and to understand the safety of the drug. the primary objective of the study was to evaluate whether pcsk9 inhibitors could delay the progression of aortic stenosis in patients with aortic stenosis. secondary objectives: 1) to evaluate whether pcsk9 inhibitors can delay the progression of valve calcification in patients with aortic stenosis;2) to evaluate whether pcsk9 inhibitors can reduce long-term adverse events in patients with aortic stenosis;3) to evaluate the effect of pcsk9 inhibitors on circulating lp(a) levels in patients with aortic stenosis.


Eligibility criteria:
inclusion criteria: * voluntarily sign informed consent; * age ≥18 years old, gender unlimited; * patients with aortic stenosis diagnosed by echocardiography; * combined with atherosclerotic cardiovascular disease or * hypercholesterolemia ldl-c≥4.9mmol/l; * the blood lipids were not up to standard after the maximum tolerated dose of statins; exclusion criteria: * rheumatic aortic stenosis; * previous use of pcsk9 inhibitors or allergy to pcsk9 inhibitors; * left ventricular ejection fraction ≤35%; * patients planned to undergo aortic valve replacement or tavr in the near future; * complicated with other severe valvular diseases; * poor adherence to treatment and inability to take medication according to the trial protocol; * pregnant and lactating women; * combined with active malignant tumors, severe liver and kidney dysfunction and other life expectancy of less than 1 year; * participants who are participating in other interventional clinical studies; * patients who were judged by the investigator to be ineligible for participation in the trial