Kornimate/medical-research-clean huggingface dataset:
psychotherapeutic augmentation of brain stimulation effects

Conditions: Depression Chronic; Depression, Unipolar; Treatment Resistant Depression

Summary: this study aims to investigate effectiveness and feasability of a 15-week group psychotherapeutic intervention as continuation treatment after electroconvulsive therapy in severely depressed patients. feasibility and acceptance of the half-open manualized cbt intervention are assessed. depressive symptoms, quality of life and emotion regulation skills will be assessed before ect treatment, before and after the 15-week group cbt intervention and at a 6 months follow-up after treatment end and compared to depressed patients treated with ect who did not partake in group cbt. moreover, patients will attend two indidivual pre-group sessions with one of the group therapist and one individual post-group session

while electroconvulsive therapy (ect) is a highly effective anti-depressant treatment, a relevant number of patients experience recurrence of depressive episodes within 6 months. one previous study suggested that ect treatment effects can be effectively sustained by group cbt (cognitive behavioral therapy, brakemeier et a. 2014). this previous implementation used a closed cbt-group set-up that implicated a longer waiting period for patients after finishing the acute ect and did not investigate whether patients who did not respond to ect could sufficiently profit from group cbt. in order to suit the complex needs of patients in a natural clinical setting, the present study aims to investigate the feasibility and effectiveness of a half-open continuous group cbt (named effective 2.0) as continuation treatment for all ect patients regardless of remission status after ect. this prospective study will recruit a total of 30 patients who concluded treatment with right-unilateral ultra-brief ect for depression. patients self-allocate to the group that is offered in addition to continuation treatment as usual (tau, e.g. pharmacological treatment, continuation ect, individual psychotherapy). ect completers who choose not to partake in the group for practical concerns or lack of interest and receive treatment as usual are recruited as a control group. the primary outcome measure is the change depression severity, measured with the montgomery-åsberg depression rating scale (madrs). secondary outcomes are quality of life assessed with the short-version of the who quality of life questionnaire (whoqol-bref) and emotion regulation as assessed with cognitive emotion regulation questionnaire (cerq). these measures will be assessed before, during, immediately after acute ect and six and 12 months into continuation therapy. it is hypothesized that a group cbt as add-on treatment to tau will lead to more favorable outcomes concerning depression severity, quality of life and emotion regulation.

Eligibility criteria:
inclusion criteria: * treated with ect for major depression exclusion criteria: * severe comorbid personality disorders * principal diagnosis other than depression
the radar study - wearable-based dysglycemia detection and warning in diabetes

Conditions: Diabetes Mellitus, Insulin-Dependent; Diabetes

Summary: the study radar aims at developing a wearable based dysglycemia detection and warning system for patients with diabetes mellitus using artificial intelligence.

prior research has investigated the general potential of data analytics and artificial intelligence to infer blood glucose levels from a variety of data sources. in this study patients with insulin-dependent diabetes mellitus will be wearing a continuous glucose meter (cgm) and a smartwatch for a maximum duration of 3 months in an outpatient setting. the gathered data will be used to develop a non-invasive and wearable based dysglycemia detection and warning system using artificial intelligence.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * age ≥ 18 years * diabetes mellitus treated with multiple daily insulin injections (mdi) or continuous subcutaneous insulin infusion (csii) exclusion criteria: * smartwatch cannot be attached around the wrist of the patient * known allergies to components of the garmin smartwatch or the dexcom g6 system * pregnancy, intention to become pregnant or breast feeding * cardiac arrhythmia (e.g. atrial flutter or fibrillation, av-reentry tachycardia, av-block \> grade 1) * pacemaker or icd (implantable cardioverter defibrillator) * treatment with antiarrhythmic drugs or beta-blockers * drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator

Keywords: smartwatch wearable physiological data prediction dysglycemia hyperglycemia hypoglycemia
evaluation of smectite effect as a food thickener on gastroesophageal reflux disease in neonates using combined esophageal multichannel intraluminal impedance

Conditions: Gastroesophageal Reflux in Neonates

Summary: study of diagnosis of gerd in neonates by mii-ph with trial of smectite for treatment

this is a prospective clinical trial conducted on 20 preterm neonates \< 37 weeks of gestation, admitted in nicu, maternity hospital, ain shams university. they were assessed for gastroesophageal reflux disease and investigated using ph-mii for detection of reflux episodes and they were given smecta 3gm/day for 7 days at least as a food thickener and then ph-mii repeated to assess the response

Eligibility criteria:
inclusion criteria: * • newborns free of any congenital anomalies or inborn errors of metabolism * infants had signs of reflux like: 1. typical or atypical crying and/or irritability 2. apparent life-threatening event 3. poor appetite; weight loss or poor growth (failure to thrive) 4. vomiting 5. bronchopulmonary dysplasia 6. wheezing, stridor 7. recurrent pneumonitis 8. sandifer syndrome (ie, posturing with opisthotonus or torticollis) exclusion criteria: * • newborns with git anomalies as trans-esophageal fistula, hiatus hernia and other git anomalies causing reflux. * patients with hirshsprung disease or delayed passage of meconium. * history of nec in the baby.
early physiotherapy in covid patients

Conditions: Respiratory Insufficiency; Anxiety State

Summary: based on the hypothesis that early physiotherapy in patients hospitalized for covid-19 improves their functional capacity, perceived quality of life and decreases anxiety. our main objective is to analyze the differences between groups with respect to functional deterioration, need for oxygen therapy and anxiety when implementing an early physiotherapy program. we propose a randomized clinical trial with two arms and single-center, to be developed in hospitalization units and intermediate respiratory care units (ircu), with patients diagnosed with covid. the sample will consist of an experimental group of 66 admitted patients with covid-19 to whom an early physiotherapy program will be implemented from 48-72 hours after admission. the control group will be made up of another 66 admitted patients with covid-19 who will receive the treatment according to the usual procedure of the hospital center. sociodemographic and clinical variables will be collected, including: modified mmrc dyspnea scale, amount of oxygen therapy, mrc-ss, sit to stand test, hand grip, tinetti, hads anxiety and depression questionnaire, sf-12 quality of life questionnaire, clinical frailty scale (cfs) and frail scale. patients in both groups will be re-evaluated two months after hospital discharge with the above variables in addition to the pcfs post-covid patient functional status scale. a basic descriptive analysis and logistic regression will be performed to determine the effect of the intervention.


Eligibility criteria:
inclusion criteria: * all patients admitted to the hospitalization unit or intermediate respiratory care unit, diagnosed with covid-19 pneumonia, of legal age and who consent to participate in the study. pregnant patients or patients with dementia, terminal illnesses or those in which there are communication problems (language problems, comprehension ...) will not be included. exclusion criteria: * patients who are transferred to another acute hospital due to impossibility of completing the follow-up period, exitus during hospital admission and those who revoke consent.
clinical evaluation of two frequent replacement soft spherical contact lenses

Conditions: Myopia; Hyperopia

Summary: this was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

the aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age and has full legal capacity to volunteer. * has read and signed an information consent letter. * self-reports having a full eye examination in the previous two years. * anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week. * is willing and able to follow instructions and maintain the appointment schedule. * habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum. * has refractive astigmatism no higher than -0.75dc. * can be fit and achieve binocular distance vision of at least 20/30 snellen (or +0.20 logmar) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00ds) exclusion criteria: * is participating in any concurrent clinical or research study. * has any known active ocular disease and/or infection that contraindicates contact lens wear. * has a systemic condition that in the opinion of the investigator may affect a study outcome variable. * is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. * has known sensitivity to the diagnostic sodium fluorescein used in the study. * self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. * has undergone refractive error surgery or intraocular surgery.
rasch-analysis of clinical severity in fshd

Conditions: Facioscapulohumeral Muscular Dystrophy

Summary: the purpose of this study is to make a standardized and scalable rasch-built clinical severity scale to help in finding genetic and environmental modifiers of disease in facioscapulohumeral muscular dystrophy (fshd).


Eligibility criteria:
inclusion criteria: * genetic confirmation of fshd (either fshd-1 or fshd-2) exclusion criteria: * do not understand english * unable to provide informed consent

Keywords: fshd muscular dystrophy
the efficacy of amway uric acid lowering product on hyperuricemia

Conditions: Hyperuricemia

Summary: the goal of this three arms, randomized, double-blind controlled interventional study is to evaluate the efficacy of amway uric acid lowering product improving hyperuricemia in patients aged 18 and 65 years old. the main question it aims to answer is: - whether the serum uric acid level of patients with hyperuricemia could be significantly lowered after 3 months intervention with amway uric acid lowering product 180 eligible participants will be enrolled in one study site and randomized to three study groups (two product group and one placebo group), who will consume the assigned products for 3 months and be arranged to 3 site visits. all relevant clinical data will be captured and recorded into ctms (clinical trial management system) for statistical analysis and reporting. researchers will compare the three study groups to conclude how amway uric acid lowering product will improve hyperuricemia.


Eligibility criteria:
inclusion criteria: * participants aged between 18 and 65 years old (mostly above 35 years old), including male and female and the ratio of male to female is not limited; * patients with hyperuricemia: meet the diagnostic criteria set out in the "chinese guidelines for diagnosis and treatment of hyperuricemia and gout (2019)", and fasting blood uric acid level exceeds 420 μmol/l twice on different days. further classification using the janssens gout diagnostic scale included asymptomatic hyperuricemia (that is, never had a gout attack) and patients with a history of gout, with a ratio of about 1:1; * participants agree not to take any drugs, supplements, or performance enhancers during the study, or they will be eliminated * participants understand the test procedure, read, and sign an appropriate informed consent form indicating their willingness to participate. exclusion criteria: * secondary gout caused by kidney disease, blood disease, drug use, tumor radiotherapy and chemotherapy; * subjects who are using drugs during gout attacks; * malignant diseases: patients with severe lung, cardiovascular, blood and hematopoietic system, central nervous system or other system diseases, as well as tumor patients; * severe obesity (bmi\>32kg/m2); * abnormal liver and kidney function: abnormal level of alanine aminotransferase or aspartate aminotransferase; serum creatinine was higher than the upper limit of the normal range; * allergic to the test drug or weak or allergic; * pregnant or lactating women or those who have pregnancy plans; sex hormone replacement therapy and oral contraception in the past 3 months; * subjects who have participated in other research projects within three months; * subjects that other researchers considered should be excluded.

Keywords: uric acid amway
xeltis peripheral artery disease (xpad) bypass conduit early feasibility study

Conditions: Peripheral Artery Occlusive Disease

Summary: a prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the xpad conduit in patients with peripheral arterial occlusive disease (paod), scheduled to undergo elective above-knee femoral popliteal bypass surgery.


Eligibility criteria:
inclusion criteria: 1. subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery 2. patient has rutherford grade 3, 4, or 5 occlusive vascular disease and tasc c or d lesions. rutherford grade 5 may be included with a wound, ischemia and foot infection (wifi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch 3. at least 18 years of age at screening 4. suitable anatomy (assessed by a pre-procedural contrasted ct scan or previous angiogram assessed up to 90 days prior to baseline) 5. patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent 6. patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography 7. life expectancy of at least 24 months exclusion criteria: 1. subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. 2. presence or history of bypass in the diseased limb 3. subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts 4. stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (modified rankin scale 3 or above) 5. history of acute arterial occlusion requiring an emergent intervention 6. severe chronic renal insufficiency (serum creatinine \>2.5 mg/dl) or undergoing hemodialysis 7. previous renal transplant 8. uncontrolled arterial hypertension (bp \>200 mmhg) at 2 successive readings 9. uncontrolled or poorly controlled diabetes 10. abnormal blood values that could influence patient recovery and or/ graft hemostasis 11. reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, international normalized ratio (inr) \>1.5 or prothrombin time (pt) \>18 seconds 12. any active local or systemic infection 13. known heparin-induced thrombocytopenia 14. known active bleeding disorder and/or any coagulopathy or thromboembolic disease 15. allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically 16. previous enrolment in this study 17. subject is participating in another study 18. pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives 19. any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit intra-operative exclusion criteria: 1. unsuitable anatomy to implant the xpad conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)
reducing perioperative s. aureus transmission via or pathtrac

Conditions: S. Aureus Transmission; Surgical Site Infection

Summary: healthcare-associated infections (hais) occur frequently and are associated with patient harm. it is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. eskape bacteria (enterococcus, s. aureus, klebsiella, acinetobacter, pseudomonas, and enterobacter spp.) are particularly pathogenic. isolation of these pathogens from intraoperative reservoirs has been associated with postoperative infection development (i.e. surgical site infections). this project involves implementation of a software platform and bacterial collection system (or pathtrac) that leverages the epidemiology of intraoperative bacterial transmission to guide dynamic, prospective improvements in perioperative infection control measures. we will assess the effectiveness of or pathtrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.

our objective was to analyze the impact of surveillance feedback optimization of a multifaceted, perioperative infection control program on s. aureus transmission and ssis. a multifaceted infection control program was implemented over 8 months (november 2018 to june 2019). a prospective cohort impact study was then conducted over 8 months (july 2019 to march 2020) to compare the incidence of within-case s. aureus transmission (primary outcome) and surgical site infection (secondary outcome) before (4.5 months) and after (3.5 months) implementation of surveillance feedback.

Eligibility criteria:
inclusion criteria: * adult patients requiring anesthesia and intravenous catheter placement. exclusion criteria: * pediatric patients, without requirement of anesthesia and/or intravenous catheter placement.

Keywords: transmission surgical site infection s. aureus
clinical implications of hmgb1 in patients treated with chemotherapy or hematopoietic stem cell transplantation

Conditions: Acute Graft-versus-host Disease

Summary: acute graft-versus-host disease(agvdh) after allogeneic hematopoietic stem cell transplantation is one of the meaningful issues in aspect of patient's recovery and survival. in recent years, the understanding of the pathology of gvhd is much important to prevent or treat agvhd. additionally, (oral) mucositis is one of the problems in patients with high dose chemotherapy, and mucositis by high-dose chemotherapy is related to hmgb-1 as proinflamtory cytokines. hmgb1 is a nuclear protein acts as a transcription factor, but, if it was released to the outside of cells by damaged cell or necrotic tissues, it works as cytokines for promoter of inflammation and cancers. at this point, there are no reported articles about correlation of hmgb1 and agvhd in human. recently, we have seen excessive secretion of serum hmgb1 in mouse model, then base on this results, we will check correlation of hmgb1 and agvhd/ oral mucositis in human.

1. materials 1) inclusion criteria 1. over 18-year-old 2. patients with myeloablative conditioning regimen 3. autologous transplant 4. patients with confirmation of acute gvhd as over grade ii 5. patients with salvage chemotherapy 2) exclusion criteria 1. old age ( over 60-year-old) 2. patients with reduced intensity stem cell transplantation 2. method 1) check the serum level of hmgb1, tnf-a, il-1b, il-6, th1, th2, th17, foxp3 on 7-day before transplant day(d-7), transplant day(d0), 7-day after transplant(d+7), d+14, d+21. 2) check the immunohistochemistry level of tissue in diagnosed agvhd ( performed sigmoidoscopy and random biopsy of gut is routine process in our center) 3) check the oral mucositis grades (using who grading system, nci -ctc ver.3 scoring system) 3. analysis 1) student t-test , chi-square test 2) survival analysis

Eligibility criteria:
1. inclusion criteria: 1. over 18-year-old 2. patients with myeloablative conditioning regimen 3. autologous transplant 4. patients with confirmation of acute gvhd as over grade ii 5. patients with salvage chemotherapy 2. exclusion criteria: 1. very old age ( over 75-year-old) 2. patients with reduced intensity stem cell transplantation

Keywords: hmgb1 protein graft versus host disease immunosuppressive agents oral mucositis
compare the pharmacokinetics and safety of ckd-391 with co-administration of d086 and d337

Conditions: Hyperlipidemias

Summary: compare the pharmacokinetic characteristics and safety between ckd-391 tablet and d337, d337 combination


Eligibility criteria:
inclusion criteria: 1. between 19 aged and 45 aged in healthy male adult 2. over 50 kg, bmi between 18.0-29.0 kg/m2 3. subjects in good health as determined by physical exams and medical examinations. no congenital or chronic diseases and no abnormal signs determined by medical examinations. 4. not abnormal or not clinically significant lab values. 5. subjects who signed informed consent form with good understandings after explanations by investigators. exclusion criteria: 1. no history or presence of clinically significant diseases. 2. subjects showing adverse reaction to investigational product 3. genetic problems in galactose intolerance, lapp lactose deficiency, or glucose-galactose malabsorption. 4. history of myopathy 5. subjects with abnormal lab values at least one below 1) ast or alt\>2 fold of upper normal limit 2) total bilirubin\>2 fold of upper normal limit 3) ck\>2 fold of upper normal limit 4) estimated glomerular filtration rate\<60ml/min/1.73m2 6. drink over 21 units/week (1 unit= 10g=12.5ml of pure alcohol) or unable to stop drinking during clinical trials 7. smoke over 10 cigarettes per day or unable to stop smoking 8. subjects who previously participated in other clinical trials within 90 days 9. subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days 10. subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days. 11. taking medications which induce or block medication metabolism 12. history of drug abuse 13. subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days. 14. disagree to contraception 15. subjects who are in any conditions impossible participating in the clinical trials