Kornimate/medical-research-clean huggingface dataset:
spanish validation of tool questionnaire to assess patients´perception about antipsychotic treatment

Conditions: Schizophrenia; Bipolar Disorder

Summary: non-interventional, prospective study to validate spanish version of tool questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment


Eligibility criteria:
inclusion criteria: * schizophrenia and bipolar disorder (dsm-iv criteria) * stabilized out-patients * treated with the same oral antipsychotic at least in the last month exclusion criteria: * participation in another clinical trial within 6 months prior to enrolment into this study * administration of a depot antipsychotic medication

Keywords: schizophrenia bipolar disorder antipsychotic treatment patients´preferences
intervention to reduce fear of hypoglycemia and optimize type 1 diabetes outcomes

Conditions: Type1diabetes; Fear of Hypoglycemia

Summary: the overall objective and primary aim of this limited competition: small grant program (r03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of blood glucose awareness training, which has been adapted for, but never evaluated in adolescents with type 1 diabetes (t1d) and their parents.


Eligibility criteria:
inclusion criteria: * adolescents aged 10-17 years and their parent(s) or legal guardian; * t1d duration \>1 year; * insulin pump use \>6 months; * agreement of both parent and adolescent to participate in intervention sessions; * elevated scores on the parent hypoglycemia fear survey - behavior subscale. exclusion criteria: * developmental disability or reading disorder that prevents understanding of the intervention materials; and * non-english speaking adolescents and parents.
single incision laparoscopic colorectal surgery

Conditions: Laparoscopic Colorectal Surgery

Summary: single incision laparoscopic surgery (sils) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

the patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. the operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. it is worthy of clinical application.

Eligibility criteria:
inclusion criteria: * 18 years \< age \< 80 years * tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) * pathological colorectal carcinoma * clinically diagnosed ct1-4an0-2 m0 lesions according to the 7th edition of ajcc cancer staging manual * tumor size of 5 cm or less * ecog score is 0-1 * asa score is ⅰ-ⅲ * informed consent exclusion criteria: * body mass index (bmi) \>30 kg/m2 * the lower border of the tumor is located distal to the peritoneal reflection * pregnant woman or lactating woman * severe mental disease * previous abdominal surgery（except appendectomy and cholecystotomy） * emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer * requirement of simultaneous surgery for other disease

Keywords: sils colorectal cancer
correlation between the pulmonary function parameters and the circulatory parameters (psv, edv, ri) of retrobulbar blood vessels (cra, pca, and oa) in 48 t2dm patients did not combinate with dr

Conditions: Diabetes Mellitus, Type 2

Summary: objective: the main target of this study was to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients with type 2 diabetes (t2dm) without diabetic retinopathy (dr). method: t2dm patients without dr were choose to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels. the primary endpoints were the pulmonary function parameters; the secondary endpoints were the hba1c, fpg, 2hpg, wc, and bmi. the tertiary endpoints were the blood-fat; in addition, the retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler imaging (cdi).

pulmonary function parameters (vc%, fvc%, fev1%, pef%, mvv%, tlc%, fev1/fvc%, dlco%, and dlco/va%); the retrobulbar circulation (psv, edv, ri);retrobulbar blood vessels (cra, pca, and oa);blood-fat(tc, hdl-c, ldl-c, and tg). pulmonary function was measured by spirometer which was provided by jaska corporation in japan, model number: hi-101; the cdi recordings were taken using a powervision ssa-380a (toshiba, japan) using a 7-mhz transducer.

Eligibility criteria:
inclusion criteria: 1. the patients were diagnosed with t2dm according to the guidelines of the american diabetes association; 2. no smoking history, pulmonary disease nor pulmonary infection within a fortnight; 3. did not have hepatopathy, nephropathy, and gastrointestinal disease; and 4. likely to have good compliance and able to visit our hospital for periodic assessments. exclusion criteria: 1. t1dm, gestation and lactation; 2. renal inadequacy, a serum creatinine \>132 µmol/l (male), or a serum creatinine \>123 µmol/l (female); 3. hypohepatia, the liver enzyme was two times higher than normal; 4. intensive care with insulin treatment; 5. the patients combinated with dr and hypertension (antihypertensive drugs were used); 6. patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or introacular surgery; 7. new york heart association class iii or iv heart failure, a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months; 8) cholesterol-lowering drugs can not control the blood-fat (tc \> 250 mg/dl, hdl-c \ 170 mg/dl, tg \> 200 mg/dl) adequately; and 9) use of systemically injected glucocorticoids within 3 months prior to our study.
myocardial strain analysis in anaesthetized coronary artery disease patients during hyperoxia and normoxaemia

Conditions: Coronary Artery Disease; Anesthesia

Summary: the purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.

up to 106 patients with coronary artery disease undergoing elective coronary artery bypass graft (cabg) surgery will be recruited to undergo this single visit study. in the timeframe shortly after the induction of anaesthesia and prior to the start of surgery, myocardial strain as a marker of cardiac function will be measured by transesophageal echocardiography (tee). echocardiography measurements will be acquired at two different oxygen states for each patient. the fraction of inspired oxygen (fio2) will be adjusted to reach a normoxaemic state (fio2=0.3) and a hyperoxic state (fio2=0.8). patients will be randomized to which oxygen level is investigated first. thereafter, the study intervention is completed and anaesthesia and surgery will be performed as planned by the treating team. echocardiography images will be analyzed in a blinded manner for cardiac function and systolic and diastolic strain parameters. the results will help anaesthesiologists to better weigh risks and benefits when selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia as a risk factor for myocardial injury.

Eligibility criteria:
inclusion criteria: * elective cabg surgery (with or without other cardiac surgery) * ability to give and sign informed consent * age \>18 years. exclusion criteria: * absolute contraindication for tee * emergency surgery, including but not limited to patients with instable cad: st- and non-st-elevation myocardial infarction (stemi, nstemi) and instable angina (instable ap) * atrial fibrillation or significant arrhythmia * pacemaker, crt, left bundle branch block * severe-grade valvular disease * pericardial disease * previous cardiac or thoracic aortic surgery * previous chest radiation therapy or cardiotoxic or bleomycin chemotherapy * severe pulmonary hypertension, cor-pulmonale, or right ventricular dysfunction, i.e., where high fio2 might reduce pulmonary vascular resistance and right ventricular afterload * patients where study explanation and informed consent cannot been performed/obtained at the latest on the day before scheduled surgery * females of child-bearing potential

Keywords: coronary artery disease transesophageal echocardiography (tee) hyperoxia strain myocardial deformation anaesthesia cabg normoxaemia
promoting recovery outcomes through precise early locomotor interventions in persons with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (bwstt) affects walking ability following a traumatic spinal cord injury. specifically, the study will look at whether starting bwstt, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, while we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy. the study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. the additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.


Eligibility criteria:
inclusion criteria: * history of acute and traumatic sci with ais classification of b, c, or d between the neurological levels of c5 and t12 * between the ages of 16-74 * weight bearing as tolerated in bilateral lower extremities * able to tolerate a harness * ability to provide informed consent. for minors, consent of parents or primary caregivers/guardians and assent of the minor * able to provide informed consent within 60 days of injury onset * able to participate in all study related activities, including 1-year follow up exclusion criteria: * orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing * a weight over 250lbs and if so a bmi greater than 30, or deemed clinically inappropriate due to body habitus * moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition * presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program. * other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation * pregnancy, as confirmed by blood draw
nutritional oleic acid modulation of adipose cholesterol metabolism in patients living with obesity

Conditions: Obesity; Visceral Adipose Tissue; White Adipose Tissue Inflammation; Subcutaneous Adipose Tissue

Summary: disruption of white adipose tissue (wat) homeostasis during obesity is central to the development of associated cardiometabolic complications. dietary supplementation with oleic acid in obese patients can limit these complications. experimental data, obtained in preclinical models, suggest that the beneficial effects of oleic acid may protect the tab by increasing cholesterol esterification. the namico study aims to test this hypothesis using tab biopsies collected from obese patients undergoing bariatric surgery who had previously undergone dietary enrichment with either a conventional oil or an oil rich in oleic acid.


Eligibility criteria:
inclusion criteria: * • individual who has given informed consent. * female adult aged between 18 and 60 years (included). * patient with obesity at inclusion, meeting the has criteria for bariatric surgery eligibility: bmi ≥ 35 kg/m² associated with a comorbidity or bmi \> 40 kg/m². * european origin: for this pilot study, we need to reduce variability factors and focus the research on women of european descent only (having both parents identified by the patient as of european origin). * effective contraception if sexually active, or abstinence, or menopause (criterion required for bariatric surgery). * presenting at inclusion with at least two clinical criteria of insulin resistance according to the definition of the international diabetes federation (idf): * dysglycemia (fasting glucose ≥ 100 mg/dl, glucose intolerance, or type 2 diabetes). * hypertension (≥ 130/85 mm hg). * low hdl-cholesterol (\< 50 mg/dl). * elevated triglycerides (≥ 150 mg/dl). * affiliated with a social security system or a beneficiary of such a system. * bariatric surgery performed at nantes university hospital (chu de nantes). exclusion criteria: * • modification of diabetes treatment within the past month. * ongoing or planned insulin therapy before bariatric surgery. * modification of lipid-lowering treatment within the past three months. * systemic corticosteroid therapy. * antiviral therapy (hiv). * dietary supplementation affecting lipid metabolism, including proactive margarine, danacol, polyunsaturated fatty acid supplementation, or any other substance identified by the investigator. * exocrine pancreatic insufficiency. * pregnancy or breastfeeding. * history of organ transplantation. * individual deprived of liberty or under legal protection (guardianship or trusteeship). * any clinical condition in which the investigator considers that inclusion in the study may harm the patient's health or compromise the proper conduct of the study. * participation in other clinical trials, except for non-interventional studies and research on surgical techniques or postoperative strategies. * type i, monogenic or secondary diabetes.

Keywords: obesity visceral adipose tissue adipocyte dysfunction oleic acid cholesterol esterification
comparison of a live herpes zoster vaccine and a recombinant vaccine in 50-59 and 70-85 year olds

Conditions: Shingles; Herpes Zoster

Summary: this study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. one vaccine is live (zostavax, licensed by fda) and the other, herpes zoster subunit (hz/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. the vaccines are being compared to assess their ability to stimulated protection against shingles. the study will provide an opportunity to determine the safety profile of each vaccine in a single trial. the study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.

160 people from the denver area will participate. duration is up to 5 years with 10-12 visits in that period. subjects are randomized into one of 4 arms to receive either zostavax or hz/su. in this single blind study all subjects receive 2 injections: one at the first visit (day 0) and the second at day 60. hz/su subjects will receive vaccine at both visits; zostavax subjects will receive vaccine at the first visit and a placebo at the day 60 visit. blood is collected from all subjects at most visits. some subjects spit into a tube for saliva collection. a urine sample is collected prior to vaccination if subject is a woman of childbearing potential. subjects are asked to complete a diary to record any reactions in the 30 days after each injection. the day 90 visit is the last one until the annual visits for blood draws begin at day 365. some subjects are also seen at year 2 and year 4; all subjects are seen at year 5 for blood draw.

Eligibility criteria:
inclusion criteria: * history of varicella or residence int he us for 30 years * for arms c and d - prior live zoster vaccine at least 5 years previously * for arms a and b - age 50-59 or 70-85 * for arms c and d - age 70-85 * for women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine exclusion criteria: * history of herpes zoster * for arms a and b - prior live zoster vaccine * immune compromising illness or therapies or chronic illness * allergy to previous herpes zoster vaccine * other investigational drugs or vaccines within the past 6 months before the study and until last visit * blood products for 3 months prior to or planned during the study * concomitant non-topical antiviral therapy within 3 days prior to and 7 days after vaccination. * vaccines within 2 weeks (inactive vaccine) or 4 weeks (live vaccine) prior to the study until 30 days after any dose of either vaccine. * pregnancy or breast-feeding * current drug addiction or alcoholism.

Keywords: shingles vaccine immune response zoster vaccine
patient anxiety during radiological examination

Conditions: Anxiety

Summary: this clinical trial design evaluates whether hand massage reduces anxiety levels in cancer patients as they undergo radiological examination to evaluate tumor response. anxiety levels will be investigated before massage, after massage, and following the completion of the radiological exam. the visual analog scale (vas), a validated anxiety assessment tool, will be used to measure anxiety.


Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥ 18 years * scheduled to undergo radiologic imaging evaluation of a tumor exclusion criteria: * known hand injury within 30 days prior to study participation * known pregnancy * mental disability as determined by the treating physician * actively receiving radiation therapy * actively receiving chemotherapy
repeated transcranial magnetic stimulation in the elderly with cognitive impairment

Conditions: Dementia; Cognitive Impairment, Mild

Summary: introduction and purpose: in recent years, non-pharmacological treatment methods for dementia patients have been gradually explored. among these, transcranial magnetic stimulation (tms) has been proposed as a non-invasive treatment option. however, the optimal frequency and stimulation site for repetitive transcranial magnetic stimulation have not been definitively determined. methods: this study is a randomized controlled trial. we randomly assigned 30 patients with mild cognitive impairment or dementia to the high-frequency transcranial magnetic stimulation group (40 hz rtms) or the moderately high-frequency transcranial magnetic stimulation group (10 hz rtms). stimulation was applied to the bilateral dorsolateral prefrontal cortex (dlpfc). each patient received a course of treatment for 10 consecutive working days. the high-frequency group received pulses at 40 hz with an intensity of 40% of the maximum intensity for 2 seconds followed by a 58-second rest period, per set. the moderately high-frequency group received pulses at 10 hz with an intensity of 90% of the maximum intensity for 4 seconds followed by a 56-second rest period, per set. each day, patients received 30 sets of stimulation (15 times on the left side and 15 times on the right side), totaling 2400 pulses. cognitive assessments were conducted on patients before and after the treatment course. quantitative analysis will be performed using the statistical package for the social sciences statistical software. the kolmogorov-smirnov test will be used to check if the data follows a normal distribution. the chi-squared test will compare differences in baseline categorical variables between the groups, while independent t-tests or the mann-whitney u test will compare baseline differences in continuous variables to assess the effectiveness of random assignment. analysis of variance (anova) and post-hoc comparisons will be used to compare intergroup and intragroup differences. the significance level is set at α = 0.05.


Eligibility criteria:
inclusion criteria: 1. age 60 and above. 2. have received at least 2 years of education. 3. diagnosed with dementia or mild cognitive impairment (mci). 4. clinical dementia rating (cdr) score of ≥0.5. exclusion criteria: 1. mental illness. 2. alcohol or substance addiction. 3. history of heart rhythm disorders. 4. history of epilepsy. 5. history of brain injury. 6. underwent neurosurgery.

Keywords: high-frequency transcranial magnetic stimulation cognitive impairment dementia
middle-ear implant with met v transducer (aka met v system)

Conditions: Mixed Conductive and Sensorineural Hearing Loss, Bilateral

Summary: the purpose and objective of this study is to evaluate the safety and efficacy of the met v system for the treatment of individuals with mixed hearing loss.

the met v system is an investigational, fully-implantable middle ear hearing prosthesis. a mixed hearing loss has both a sensorineural component and a conductive component that results when sound being delivered to an impaired cochlea is attenuated by a disordered outer or middle ear.

Eligibility criteria:
inclusion criteria: * adult men or women, 18 years of age or older * moderate to severe mixed hearing loss, as a result of a combination of sensorineural hearing loss and chronic ear disease, prior failed tympanoplasties, severe otosclerosis, radical mastoidectomy, or congenital abnormality as evidenced by the following in the ear to be implanted: * bone conduction thresholds are measurable at 0.5,1,2,3 and 4 khz * bone conduction thresholds are 20 db or poorer at greater than 2 khz * air conduction thresholds are 35 db or poorer at 0.5,1,2,3 and 4 khz * air-bone gap in ear to be implanted is greater than 15 db at three or more frequencies from 0.5 - 4 khz * word recognition appropriate for sensorineural component of loss * non-fluctuating and stable hearing status a. as defined as by no significant change or progression in the bone conduction thresholds \>15db at two consecutive octaves for at least 12 months. * english speaking (fluent) * realistic expectations for the device * willingness to sign the informed consent and participate in the study exclusion criteria: * vestibular disorder, including meniere's syndrome * recurring otitis media over the past year (\>2/year) * non-organic hearing loss * retrocochlear hearing loss * central auditory nervous system disorder * medical contraindications to surgery or use of the device * women who are pregnant or at risk of becoming pregnant * developmentally delayed or manifesting organic brain dysfunction * persons with physical or geographic limitations that may render them incapable of completing scheduled study visits