Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study comparing fibrocaps and tachosil in hepatic surgery

Conditions: Surgical Bleeding

Summary: the primary objective of the study is to demonstrate the non-inferiority or superiority of fibrocaps plus gelatin sponge compared to tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.


Eligibility criteria:
inclusion criteria (pre-surgery): 1. subject has signed an independent ethics committee (iec)-approved informed consent document 2. subject is undergoing hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines 3. subject age is \>18 years at time of consent 4. if female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding 5. if subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits inclusion criteria (during surgery): 6. presence of mild to moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical 7. absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety 8. approximate tbs surface area of ≤ 100 cm\^2 exclusion criteria: 1. subject has known hypersensitivity to fibrocaps or any of its components 2. subject has known allergy to porcine gelatin 3. subject has known hypersensitivity to tachosil or any of the excipients included in tachosil 4. subject is unwilling to receive blood products 5. subject is having hepatic surgery due to emergency-traumatic event 6. subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections 7. subject has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator, or baseline abnormalities of international normalized ratio (inr) \> 2.5 or activated partial thromboplastin time (aptt) \> 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin) 8. subject has a platelet count \< 100 x10\^9 plt/l during screening 9. subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures 10. subject is currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery or is planning participation in another clinical trial within 6 weeks after surgery
18f-2-fluoro-2-deoxy-d-glucose in positron emission tomography computed tomography

Conditions: Solitary Pulmonary Nodule; Oncology; 18F-2-fluoro-2-deoxy-D-glucose; Adverse Event

Summary: the study objectives are as follows: * to determine the safety of trial 18f-2-fluoro-2-deoxy-d-glucose, produced by a new manufacturer, by surveillance for adverse events in patients having positron emission tomography computed tomography scans in a comprehensive program for indications including, but not limited to, oncology, neurology, cardiac and infectious/inflammatory processes. * to determine the efficacy of 18f-2-fluoro-2-deoxy-d-glucose positron emission tomography in differentiating benign from malignant solitary pulmonary nodules and calculate sensitivity, specificity, and accuracy using pathologic confirmation as the gold standard when available, or greater than 6 month follow up stability on computed tomography scan when not. the purpose of performing this clinical trial is to provide local access of 18f-2-fluoro-2-deoxy-d-glucose to the patients of newfoundland and labrador. this product has been offered to patients over the last three years by transporting from facilities outside of the province. there have been significant delays in access and in fact, times where 18f-2-fluoro-2-deoxy-d-glucose has not been available through this process. this has caused delays and limitations of treatments for patients who rely on positron emission tomography computed tomography scans for diagnosis.


Eligibility criteria:
inclusion criteria: * known or suspected disease for which 18f-2-fluoro-2-deoxy-d-glucose positron emission tomography computed tomography is appropriate for the investigation of. this includes, but is not limited to: known or suspected cancer, neurological disorders (dementia or epilepsy), cardiac conditions (inflammation or myocardial viability), known or suspected presence of infection/inflammation process patients must satisfy all the following: * able to provide written informed consent, or consent obtained from appropriate guardian * able to tolerate the physical and logistic requirements of completing a positron emission tomography computed tomography scan exclusion criteria: * pregnant women: if there is any possibility of pregnancy, a blood beta human chorionic gonadotropin level will be obtained as per eastern health policy. * patients unwilling or unable to stop breast feeding for 12 hours * patients who are too medically unstable to tolerate the uptake period or lie flat for the duration of the scan * patients who exceed the safe weight limit of the positron emission tomography computed tomography scanner bed (500 lbs.) or who cannot fit through the bore (70 cm diameter) * patients unwilling to proceed with scan (i.e. claustrophobia) prior to injection * if patients inability to follow staff direction causes a safety hazard prior to injection

Keywords: 18f-2-fluoro-2-deoxy-d-glucose adverse event solitary pulmonary nodule oncology
using motivational interviewing to reduce parental risk-related behaviors for early childhood caries

Conditions: Caries,Dental; Caries

Summary: the study's aim was to investigate if a motivational interviewing intervention (mi) improved oral self-care behaviors of aian caregivers of infants and determine if the mi intervention promoted positive changes in caregivers' ecc risk-related behaviors.


Eligibility criteria:
inclusion criteria: - healthy mothers/caregivers of infants exclusion criteria: * subjects with recent antibiotic use (within 3 months) * subjects on any medication that is immunosuppressive * subjects who self-report they have xerostomia due to medication use

Keywords: early childhood caries motivational interviewing
combination of olmesartan effect on myocardial viability of patients with dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: the study proceeds with prospective, randomized, open and controlled clinical trials. the subject of the investigator's study was the first patient diagnosed with dilated cardiomyopathy. subjects who agreed to participate in the study and were determined to meet the selection / exclusion criteria were randomly assigned to each group, and the experimental group was treated with 20 mg of olmesartan and 5 mg of rosuvastatin for 6 months, and the control group is treated with 40 mg of valsartan and 5 mg of rosuvastatin.

myocardial viability plays an important role in improving the function of the heart. to date, the most reproducible and objective method has been established as a method or tool for assessing myocardial viability. olmesartan is known to have the strongest inhibitory ability of angiotensin receptors compared with other angiotensin receptor binding inhibitors. research has been reported that statin drugs may help improve vascular endothelial function, and several researchers have suggested that these mechanisms may affect the improvement of myocardial survival. in addition, studies have shown that angiotensin receptor binding inhibitors and statins may improve left ventricular function in patients with left ventricular function. however, since the studies did not assess myocardial survival, the mechanisms could not be clearly identified. the purpose of this study is to investigate the effect of olmesartan on myocardial survival in patients with dilated cardiomyopathy who have left ventricular dysfunction.

Eligibility criteria:
inclusion criteria: * dilated cardiomyopathy exclusion criteria: * contraindication to angiotensin receptor blocker * cardiogenic shock * sensitive to rosuvastatin * liver cirrhosis more than child class b
tdcs and physical therapy in stroke

Conditions: Cerebrovascular Accident

Summary: the purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tdcs) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. research in healthy subjects has shown that when tdcs is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. the tdcs procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. this study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tdcs stimulation or placebo. only the person performing the procedure will know which one participants are receiving. only by comparing the tdcs procedure to a sham (placebo) procedure can we understand if the tdcs actually improves motor function. we hypothesize that tdcs will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.


Eligibility criteria:
inclusion criteria: * first time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed) * demonstrates adequate balance while wearing a hand restraint on the unaffected arm * ability to stand from a sitting position and ability to stand with or without upper extremity support * stroke onset at least 6 months prior to study enrollment exclusion criteria: * significant pre-stroke disability * any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing * excessive pain in any joint of the paretic extremity * a terminal medical diagnosis consistent with survival of less than 1 year * advanced liver, kidney, cardiac, or pulmonary disease * coexistent major neurological or psychiatric disease (including epilepsy) * a history of significant alcohol or drug abuse in the prior 3 years * use of neuropsychotropic drugs - such as antidepressants * patients may not be actively enrolled in a separate intervention study targeting stroke recovery * patients may not have already received constraint-induced movement therapy and/or tdcs treatment for stroke

Keywords: apoplexy cerebral stroke cerebrovascular accident, acute cerebrovascular apoplexy cerebrovascular stroke cva (cerebrovascular accident) stroke stroke, acute vascular accident, brain
impact of bariatric surgery in patients with morbid obesity

Conditions: Obesity, Morbid; Anal Incontinence; Image, Body

Summary: the main objective is to compare the prevalence of anal incontinence (ai) before and after bariatric surgery in obese patients. inclusion: patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following french national recommendations). primary objective: after inclusion, all patients will fill in a specific self-questionnaire evaluating ai (pfdi-20 score) before surgery and at 6 months after surgery. investigators will evaluate the prevalence of anal incontinence before and at 6months after surgery using this pfdi- 20 score. in those patients with preoperative anal incontinence (only in patients with 3 positive answers to question n°9,10, and 11 of pfdi-20 score self-questionnaire), a pelvic mri will be performed before and at 6 months after surgery. consequently, no further imaging exam will be performed in patients without preoperative anal incontinence (less than 3 positive answers to question n°9,10, and 11), secondary objectives: * to evaluate the ai severity variation before and at 6 months after bariatric surgery regarding the percentage of postoperative weight loss. * to compare the quality of life (pfiq-7 score) related to ai day before and at 6 months after bariatric surgery.

this study is proposed to all obese patients evaluated for potential bariatric surgery during a multidisciplinary evaluation for about 1 year following current french national recommendations. demographics are collected from medical records (age, sex, weight, height, diabetes, sleep apnea syndrome, hypertension, lipid disorders, distal neuropathy, depression, number of pregnancies, history of vaginal delivery, traumatic delivery, caesarean section, hysterectomy, urinary incontinence surgery, proctologic surgery, presence of rectal prolapse (operated or not), cholecystectomy, digestive resection, menopause, history of urinary or fecal or gaseous leakage, current treatments, tobacco consumption, diet. data are collected by self-questionnaire to all included patient during the preoperative consultation (about 6 weeks before bariatric surgery) and during the 6-months postoperative clinical visit scheduled during the regular follow-up.

Eligibility criteria:
inclusion criteria: * bmi\>40 kg/m2 * bmi\> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome) exclusion criteria: * anal incontinence due to chronic diarrhea * transit constipation * peripheral neuropathy (diabetes ...) * patient opposition * any previous bariatric surgical procedure * any pelvic surgical procedure performed during the study period (between preoperative and postoperative period at 6 months)
early copd for china pulmonary health study stage ii

Conditions: Obstructive Pulmonary Disease

Summary: discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease

this project is aimed to investigate and explore the heterogeneity during the progression of chronic obstructive pulmonary disease (copd) in the early stage, utilizing the large-scale population cohort databases (including "china pulmonary health study", "the cohort study for chronic obstructive pulmonary disease in china" and "acute exacerbation of copd patient registry in china" ), biological sample libraries(including blood, sputum, expiratory air, bronchoalveolar lavage fluid(balf), and lung tissue from copd patients with different stages and phenotypes), and multi-omics sequencing (including scrna-seq, metabolomics, proteomics, and metagenome). we propose to establish a new standard for copd stages and subtypes. by analyzing and mining the multi-omics data, it is expected to illustrate the association between clinical phenotype and molecular, cellular and tissue heterogeneities, thus reveal biomarkers related to the progression, clinical phenotypes, and prognosis of early-stage copd disease.in addition, we will construct different types and stages of copd animal models for further mechanism studies, such as the different pathogenic factors, innate and adaptive immunity, and the airway microbial ecosystem, so that we can discovered more potential therapeutic target for early-stage copd. this project can bring a new insight and scientific evidence for copd treatment.

Eligibility criteria:
inclusion criteria: * younger than 50 years * smoking more than 10 pack-years * early airflow limitation(post-bronchodilator fev1/fvc\< lower limit of normal) exclusion criteria: * cancer * other respiratory diseases * mental illness
efficacy and safety of tislelizumab (bgb-a317) as neo-adjuvant treatment in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: this study will evaluate the safety, and tolerability of neo-adjuvant treatment with tislelizumab in participants with early-stage (stage ii-iii) microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. ecog performance status of 0 or 1. 2. pathologically (histologically) confirmed diagnosis of potentially resectable stage ii or stage iii colon/rectal cancer (crc) with msi-h confirmed by sponsor designated central laboratory or known msi-h status by local laboratory. participants should be eligible for an r0 resection with curative intent. 3. evaluable or measurable disease as assessed by the investigator per recist v1.1. 4. adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose. exclusion criteria: 1. any prior therapy for current crc, including chemotherapy or radiotherapy or immunotherapy. 2. any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose. 3. active autoimmune diseases or history of autoimmune diseases that may relapse. note: other protocol defined inclusion/exclusion criteria may apply.
the national danish schizophrenia project

Conditions: Schizophrenia

Summary: a prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of icd-10, f-2 type. patients were treated with: 1) 'supportive psychodynamic psychotherapy as a supplement to treatment as usual', 2) an 'integrated, assertive, psychosocial and educational treatment programme', and 3) 'treatment as usual'.

the study is a prospective, comparative, longitudinal study with an intervention period of a minimum of two years and a registration of data at baseline and 1, 2 and 5 years after inclusion. three sub-cohorts with different treatment modalities were designed: treatment1: 119 patients were, in addition to tau, offered spp, i.e. a scheduled manualised supportive individual psychotherapy (1 session of 45 min. per week, for a period of 1-3 years) and/or group psychotherapy (1 session of 60 min. per week for a period of 1-3 years). anti-psychotic medication was given in doses based on individual needs; treatment 2: 139 patients were offered it, i.e. a scheduled, two-year long programme consisting of assertive community treatment, psycho-educational multi-family treatment (a.m. mcfarlane, consisting of 4-6 families including the patients, meeting 1½ hour every second week for 1½ year), social skills training (concerning medication, self-management, coping with symptoms, conversational skills, problem and conflict solving skills), and antipsychotic medication (low dose strategy). this project, opus, has been described in detail elsewhere

Eligibility criteria:
inclusion criteria: consecutively referred patients, age 16-35 years, who suffered from a first-episode psychosis of the schizophrenic spectrum disorder (icd-10, df 20-29). - exclusion criteria: * patients suffering from mental retardation or other organic brain damage, and patients who were not proficient enough in danish due to their foreign origins.
evaluation of perioperative lung ultrasound scores in laparoscopic pediatric surgeries

Conditions: Postoperative Pulmonary Atelectasis

Summary: laparoscopic surgeries require carbon-dioxide into the abdomen which may occasionally lead to atelectasis. the extent of this atelectasis is not well documented in peri-operative period although it has been extensively researched in critical care set up. in this study, it is aimed to observe the ultrasonographic condition of lungs in laparoscopic pediatric surgeries. the hypothesis was the lung ultrasound scores would worsen in those surgeries by the end of the operation. aged between 1-18 years pediatric patients who are scheduled for laparoscopic surgeries will be included in the study to observe the changes in the lung visuals throughout the operation. for that, after safe endotracheal intubation first ultrasonography will be performed for the first (t1) time, and the second ultrasonography will be performed once the surgery is finished and before extubation (t2). lastly, the third evaluation will be performed after 30 minutes in post anesthesia care unit (t3). lung ultrasound score (lus) is calculated as follows: both hemi-thoraxes are divided into 6 different zones, and depending on the number of b-lines, which happens due to aeration loss in lung tissue, every zone is scored. if there is no b-line, it is zero points. if the b-lines in the visual lower than 4, the area is scored as 1 point. the areas with b-lines more than 3 is scored as 2 points. furthermore, if there is any disruption on the pleural face, then the area is scored as 3 points. accordingly, the worst case scenario refers 36 points, meaning the less the points the better the lung aeration. primary outcome is defined as t2 lus which will show the actual condition of at the end of the surgery. for that, t1 scores and t2 scores will be compared. the secondary outcomes include t3 lus, (t3-t1)lus, intraoperative hemodynamics, length of stay in post anesthesia care unite, postoperative aldrete scores for discharging to ward, and intraoperative ventilation variables.


Eligibility criteria:
inclusion criteria: * laparoscopic pediatric surgeries * aged between 1-18 years exclusion criteria: * patients with constitutional lung diseases * patients with heart failure * patients with pulmonary hypertension

Keywords: pediatric anesthesia atelectasis
to assess the safety and efficacy of the 4 channel nmes compensatory medical device in swallowing, multicenter study

Conditions: Dysphagia

Summary: this study is a confirmation study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. the purpose of this study is to validate the 4ch nmes device.

* design: prospective study * inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study * intervention: applied electrical stimulation by a "synchronized electrical stimulation device(sesd)" * main outcome measures: videofluoroscopic parameters, eq-5d (euroqol-5d) questionnaire, ii. m. d anderson dysphagia inventory

Eligibility criteria:
inclusion criteria: * patient who do not belong to the criteria excluded for subjects aged 19 years or older * patient who is confirmed to be dysphagia by videofluoroscopy * patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury * those voluntarily agreeing to the clinical trial exclusion criteria: * patient who refuse inspection, do not agree * simple "commend obey", first step is impossible * when instructions can not be executed due to dementia, psychiatric disorders, etc. * dysphagia occurs due to respiratory failure, neck surgery, etc., * pregnant women and lactating women

Keywords: stroke cervical spinal cord injury