Kornimate/medical-research-clean huggingface dataset:
left atrial appendage closure with the lambre

Conditions: Atrial Fibrillation; Left Atrial Appendage Closure; Stroke

Summary: the study was to retrospectively analyse the efficacy and safety of laa closure using the lambre in our center from april 2014 to november 2015.

the study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (laa) closure using the lambre (lifetech scientific co., ltd., shenzhen, china) in our center from april 2014 to november 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (tee) examination. the average followup was 2-years.

Eligibility criteria:
inclusion criteria: 1. patient is ≥18 years of age; 2. chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular af; 3. chads2-vas score 2 or higher; 4. patient can understand the trial purpose, voluntarily join this clinical trial with informed consent; 5. patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process. exclusion criteria: • a. clinical exclusion criteria 1. presence of rheumatic, degenerative or congenital valvular heart diseases, 2. the diameter of left atrial ≥65 mm; 3. laa size \ 30 mm 4. left atrium has been removed; 5. heart transplantation patients; 6. symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%); 7. acute myocardial infarction or unstable angina; 8. decompensated heart failure (new york heart association functional class iii-iv); 9. recent myocardial infarction (\< 3 months); 10. patients with an atrial septal defect or received an atrial septal occluder. the patient has an ablation procedure planned within 30 days of potential lambre occluder implant 11. the patient has a planned cardioversion 30 days post implant of the lambre occluder 12. patient who after artificial mechanical heart valve replacement operation; 13. uncontrolled heart rate ≥ 110 beats / min17) history stroke or tia within 30 days; 14. presence of complex aortic plaque(4mm) in ascending aorta; 15. cardiac tumors or other malignancy with estimated life expectancy u less than 2 years; 16. have thrombocytopenia (platelet 《105 / μl) or anemia（hb\<10g/dl）; 17. women who is pregnancy or plan to pregnancy during the trial period; 18. presence of active sepsis or endocarditis; 19. patient participated in the other trials; 20. the investigators expect the patient not be able to complete the trial according to requirements. b. esophageal ultrasonic exclusion criteria 1. lvef≤30%; 2. presence of left atrial appendage thrombus; 3. high risk pfo patients(presence of atrial septal aneurysm); 4. have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2); 5. have obvious and unexplained pericardial effusion(≥4 cm2). 6. presence of complex aortic plague(≥4 mm) in ascending aorta.

Keywords: atrial fibrillation left atrial appendage closure lambre device stroke
french study in icu patients treated with tigecycline

Conditions: Bacterial Infections

Summary: this study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (icu) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned. data will be collected only from subjects providing informed consent.

healthcare visit. extension rationale: in order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of basic results due 26-may-2011 for protocol 3074a1-4448 (b1811030), nct00799591. our proposed submission date is 14-sept-2011. pfizer acquired wyeth on october 16, 2009. with regard to this study, our reconciliation of data identified some discrepancies in data listed in the project database (managed by the cro) and the safety database (managed by pfizer). we are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. we are requesting this extension to complete that work so that the data can be treated as final and the csr can be completed.

Eligibility criteria:
inclusion criteria: * adult men and women (18 years). * subjects hospitalized in a medical or surgical intensive care unit (icu) (on the day of enrolment in the study). * subjects treated with tigecycline (first, second or third line), said treatment freely chosen by the participating physician, prior to enrollment in the study. exclusion criteria: * subjects participating in another biomedical research study. * patient (or legal representative) who has not dated or signed informed consent document.

Keywords: registre montravers
anal sphincter prosthesis in treating patients who are undergoing surgery for anal or rectal cancer

Conditions: Anal Cancer; Colorectal Cancer; Perioperative/Postoperative Complications

Summary: rationale: an anal sphincter prosthesis may replace the need for a permanent colostomy and may improve the quality of life of patients who are undergoing surgery for anal or rectal cancer. purpose: clinical trial to study the effectiveness of an anal sphincter prosthesis in treating patients who have anal or rectal cancer and are undergoing surgery to remove the anus and rectum.

objectives: * determine the risk of complications and feasibility of total anorectal reconstruction using the acticon neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer. * determine continence, bowel function, and quality of life of patients treated with this surgery. outline: patients undergo abdominoperineal resection (apr) with perineal colostomy and diverting loop ileostomy. at least 3 months after apr, patients undergo placement of the acticon neosphincter prosthesis. at least 6 weeks after prosthesis placement, the prosthesis is activated. when the patient demonstrates the ability to operate the prosthesis, the ileostomy is reversed. quality of life is assessed at 6 and 12 months and then annually thereafter. patients are followed at 6 and 12 months and then annually thereafter.

Eligibility criteria:
subject inclusion criteria: * histologically proven cancer of distal rectum or anus * not candidates for sphincter preservation * \> or = 18 years of age * an acceptable risk for surgery and general anesthesia * sufficient dexterity and mental capacity to operate the device * willing and able to give valid informed consent subject exclusion criteria: * patients with recurrent anorectal cancer * patients with metastatic anorectal cancer * patients at high risk for local recurrence * patients with active pelvic sepsis * patients currently enrolled in another study involving an investigational product

Keywords: perioperative/postoperative complications stage ii anal cancer stage i anal cancer stage iii anal cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer
health service intervention for the improvement of access and adherence to colorectal cancer screening

Conditions: Colorectal Carcinoma

Summary: this phase i study investigates how well a health service program called witness cares services works in increasing access and adherence to colorectal cancer screening in patients who have not undergone a colorectal screening in the past year. providing patients with navigational and screening services via witness cares services may improve access to and adherence levels of colorectal screening.

primary objectives: i. test the feasibility of witness cares (wc) services to achieve colorectal carcinoma (crc) screening for non-adherent medicaid clients. ii. develop an algorithm for predicting crc screening outcomes following intervention services. outline: patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). patients desiring a stool test receive navigator assistance by facilitating fecal tests. after completion of study, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * participants who are non-adherent to crc screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years) * medicaid or medicaid/medicare subscribers * uninsured patients may be included from mercy comprehensive care center (mccc), but will only be eligible for services to obtain fecal immunochemical tests (fit) through the new york state (nys) cancer services program exclusion criteria: * any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for crc will be excluded * participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for crc screening * participants symptomatic for crc will be excluded from the study
smart phone delivered cognitive behavioral therapy for adults with psoriasis and co-morbid depression symptoms

Conditions: Psoriasis; Depressive Symptoms

Summary: a single arm, pilot study in which all eligible participants will be enrolled in an 8-week coach-guided smartphone delivered cbt program. the full duration of the program, with follow-up interview, will be 9 weeks.

1. to demonstrate the feasibility and acceptability of coach-guided, smartphone-delivered cbt for depression among adults with psoriasis 2. to demonstrate the preliminary efficacy of coach-guided, smartphone-delivered cbt on the symptoms of depression and psoriasis primary endpoints * percentage of participants who engage with at least 6/8 (75%) modules * median client satisfaction questionnaire-8 score at week 8 * change from baseline in phq-9 at week 8 secondary endpoints * rate of participant dropout * app acceptability to participants, as measured by the umars * change from baseline in skindex-16 at week 8 * change from baseline in psi at week 8 * change from baseline in aai at week 8 * frequency \& severity of related adverse events * the patient perspective on the feasibility and acceptability (qualitative) analysis plan investigators will assess the feasibility of smartphone-based cbt by reporting the proportion of participants who engaged with at least 75% of the treatment modules and assess patient acceptability with descriptive statistics summarizing the client satisfaction questionnaire scores. paired t-tests will be used to examine the differences in the pre- and post- treatment phq-9 scores, in all patients who complete the baseline study visit. additionally, secondary outcomes (dropout rates, patient feedback from the mobile application rating scale, skindex-16, psoriasis symptom inventory, appearance anxiety inventory) will be reported descriptively. post-treatment interviews will be transcribed, edited for clarity, coded to identify themes and summarized.

Eligibility criteria:
inclusion criteria: * • adults aged 18 years of age and older * dermatologist confirmed diagnosis of psoriasis * current depression symptoms, defined as a phq-9 score of 5 or greater * current psoriasis symptoms, defined as a scaled score of "mild" on any of the skindex-16 subscales * participants must be proficient in english and have access to an android or ios smartphone exclusion criteria: * previous participation in cbt for depression * current participation in any type of psychotherapy * those on psychotropic medications must be taking a stable dose for 2 months prior to enrollment and be willing to remain at a stable dose during the 8-week study * current elevated suicide risk (see section 5.3 for details) * individuals who are incarcerated or compulsory detained * any uncontrolled or poorly controlled chronic medical condition that may interfere with an individual's ability to participate in the clinical trial
extracorporeal shockwave therapy vs mesotherapy in the treatment of myofascial pain syndrome: a case-control study

Conditions: Myofascial Pain Syndrome; Trigger Point Pain, Myofascial

Summary: myofascial pain syndrome (mps) is a disorder of the musculoskeletal system manifested by referred pain associated with functional limitation, muscle contractures, and possible neuralgic manifestations; this condition is characterized by the presence of "trigger points". the goal of this case-control study was to compare the effects and benefits of treatment with eswt vs mesotherapy in myofascial pain syndrome. the main question it aims to answer is: what is the best rehabilitation project-program between eswt and mesotherapy for patients with myofascial syndrome? a case-control study was conducted at the u.o.c. of "recovery and functional rehabilitation" a.o.u.p. "p. giaccone" of palermo from february 2022 to dicember2023. patients were randomized into 2 groups: in group "a", no. 5 sessions of focal eswt were given weekly; in group "b", no. 5 sessions of mesotherapy with administration of thiocolchicoside fl 4mg/2ml and mepivacaine fl 10mg/1ml were given weekly. patients in group "a" and group "b" were evaluated at baseline (t0), after 5 sessions (t1) and one month after the end of treatment (t2). researchers will compare patients treated with eswt and patients performing mesotherapy to see if there are real differences in terms of pain reduction and improved quality of life.


Eligibility criteria:
inclusion criteria: * age 35-65 years * diagnosis of myofascial syndrome * nrs at t0 ≥ 4 * written informed consent exclusion criteria: * pregnant patients * patients with malignancies already diagnosed or in the process of diagnostic definition * coagulation disorders and/or therapy with anticoagulants * skin lesions and/or local infections * contraindications and/or allergies to the active ingredients of mesotherapy.

Keywords: muscle contracture eswt mesotherapy myofascial syndrome trigger point
reducing sedentary time in bariatric: the take a stand for health study

Conditions: Obesity, Morbid; Bariatric Surgery

Summary: this research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in post-bariatric patients. to this aim, we will conduct a crossover trial and a randomized controlled trial. the crossover trial aims to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition. the 4-month parallel-group randomized controlled trials aim to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light- (or very light-) intensity physical activity in these patients. a multitude of gold-standard techniques will be applied to evaluate the effects of the intervention on several outcomes, including sedentary time (primary outcome), physical activity levels, clinical parameters specific to each condition, cardiometabolic risk factors, immune function, and health-related quality of life.


Eligibility criteria:
inclusion criteria: women aged 20 to 50 years with bmi ≥ 35 kg / m2 and associated comorbidities, or bmi ≥ 40 kg / m2 who are about to undergo roux-en-y gastric bypass surgery at the metabolic and bariatric surgery unit of the faculty of medicine. - exclusion criteria: exclusion criteria will involve sedentary time (sitting / reclining) \<8 hours per day; anemia; hypothyroidism; current malignancy or history of cancer within the past 5 years; cardiovascular disease; neurological disorders; any physical disabilities that could hamper physical testing; and being physically active (i.e., participation in ≥ 150 minutes per week of moderate-to-vigorous physical activity in bouts of ≥ 10 minutes, or ≥ 75 minutes per week of vigorous-intensity physical activity). -
gastrointestinal decompression in stroke

Conditions: Stroke; Stomach Acidity; Pulmonary Infection; Gastrointestinal Decompression

Summary: acute severe ischemic stroke is a life-threatening subtype of stroke. due to stress ulcer and gastric reflux in acute stage, patients with severe ischemic stroke are always complicated with stomach bleeding and pulmonary infections, resulting in poor prognosis and even death. reducing stomach acidity and avoiding gastric reflux play a pivotal role on controlling serious complications after austere ischemic attack. gastrointestinal decompression is an cheap, safe, effective and acknowledgemented strategy for treating stomach bleeding and preventing gastric reflux in clinical settings. early gastrointestinal decompression seems to be an available method to reduce stomach acidity and avoid gastric reflux after severe ischemic stroke. therefore, we aimed to evaluate the safety and efficacy of early gastrointestinal decompression in patients with acute severe ischemic stroke.


Eligibility criteria:
inclusion criteria: * age 18-80 years * severe ais, including nihss score\>20 in dominant hemisphere infarction, or nihss score\>15 in non-dominant hemisphere infarction, or nihss consciousness score \>1; · massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (ct) or mri * onset-to-needle time within 24 hours * prestroke modified ranking scales (mrs)≤1 * sign the informed consent. exclusion criteria: * recent respiratory infection and/or gastrointestinal bleeding * austere diseases such as tumors and dyscrasia * intention to undergo emergency thrombectomy * pregnant women or nursing mother * contraindication for gastric tubes * participating in other clinical trials within previous 3 months.
the effect of oxytocin on the consolidation of trauma-associated memories

Conditions: Intrusive Memories; PTSD

Summary: the purpose of the study is to examine whether oxytocin and certain polygenic risk scores affect the development of intrusive memories, a cardinal symptom of ptsd.


Eligibility criteria:
inclusion criteria: * healthy female volunteers * german on a native level exclusion criteria: * former or present disorder according to the diagnostic and statistical manual of mental disorders 5 (dsm-5) * any physical illnesses * any medication intake (except oral contraceptive) * history of traumatic experience, e.g. history of sexual abuse or rape * pregnancy or lactation period * follicular phase of menstrual cycle for all women not using oral contraceptives
the preventive effect of 2-years use of hydroxyapatite containing toothpastes in children.

Conditions: Caries

Summary: the aim of this rct was to verify the caries preventive efficacy of toothpastes containing biomimetic hydroxyapatite (h.a.) complex in children compared to traditional fluoridated toothpastes. in total 610 children of two age groups (4-5 years and 6-7 years at baseline) were enrolled. four toothpastes, two containing fluoride-substituted hydroxyapatite (h.a.f.) (1000 and 1450 ppm f-) and magnesium-, strontium-, carbonate-substituted hydroxyapatite, in a chitosan matrix and two traditional fluoridated toothpastes (1000 and 1450 ppm f-) without other active components were administered randomly to two groups with younger children (gyoung) and to two groups with older children those containing1450 ppm f (gold) during 24 months. a standardized questionnaire was administered to parents/caregivers to gain information regarding caries risk factors. caries evaluation was performed at school using icdas, scoring lesions as initial (up to score 2), moderate (scores 3-4) and severe (scores 5-6).


Eligibility criteria:
inclusion criteria: * written declaration of informed consent signed by parents/guardians; * age between 4-5 years and 6-7 years; good general health, as assessed by the examiners; * agreement of not to use any oral hygiene products except for the toothpastes provided for the duration of the study. exclusion criteria: * ongoing oral or dental treatment except for emergency treatment; * known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx; * allergy to one of the components of the test products or the standard toothpaste; * participation in another clinical trial either currently or within the last 30 days; * antibiotic therapy within the past 3 months.

Keywords: toothpaste, hydroxyapatite, fluoride, dental caries, rct, children
renablate-ii feasibility study of catheter based renal denervation to treat resistant hypertension - 157

Conditions: Hypertension, Renal

Summary: this is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.


Eligibility criteria:
inclusion criteria: 1. subject has a systolic blood pressure ≥ 140 mmhg based on an average of 3 office blood pressure readings measured according to the bp guidelines. 2. subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months. 3. subject is \> 18 and \< 85 years of age. 4. subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study. key exclusion criteria: 1. a secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h abpm at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, adult polycystic kidney disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, cushing's syndrome, conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment. 2. subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s). 3. subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter. 4. subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery. 5. subject has an estimated glomerular filtration rate (egfr) of \< 45ml/min/1.73m2, using the mdrd formula. 6. subject has type 1 diabetes mellitus. 7. subject has history of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques. 8. subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.

Keywords: renal sympathetic denervation
feedback on perioperative temperature management and patient outcomes: three-arm trial to compare feedback

Conditions: Surgical Site Infections; Hypothermia

Summary: the investigators aim to assess the impact of benchmarked and ranked feedback on anesthesiologists' perioperative temperature management and subsequent patient outcomes.


Eligibility criteria:
inclusion criteria: * staff anesthesiologists at the ottawa hospital exclusion criteria: * none

Keywords: feedback temperature management anesthesia