Kornimate/medical-research-clean huggingface dataset:
quality of life and survival of patients with colorectal cancer 5 years after surgery - follow-up of the rct diqol

Conditions: Quality of Life; Colorectal Cancer; Colorectal Neoplasms; Survivorship

Summary: this observational follow-up study of the randomized trial (rct) diqol investigates long-term effects of an intervention with quality of life (qol) diagnosis and therapy on present qol, survival, and recurrence-free survival of colorectal cancer survivors more than 5 years after surgery. moreover, patients' experiences with aftercare for colorectal cancer during the covid-19 pandemic and their recollections of their illness and therapy are examined.

in a complex intervention a clinical pathway with quality of life (qol) diagnosis and tailored therapy had been developed for patients with colorectal cancer and its effectiveness was evaluated in a randomized trial (rct diqol, nct02321813, klinkhammer-schalke et al, 2020). in the rct diqol a total of 220 patients were randomised (1:1) into two groups: a care pathway, including qol-profiles consisting of 13 qol scales plus specific therapeutic recommendations forwarded to the patient's doctor (intervention) or standard postoperative care (control). qol was measured (eortc qlq-c30, qlq-cr29) in all patients after surgery and during aftercare (3, 6, 12, 18 months postoperatively). a need for qol therapy was defined as a score \<50 points on at least one qol scale. it was demonstrated that the proportion of patients with a need for qol therapy was significantly lower in intervention group patients at 12 months after surgery (primary endpoint). until now, it is unclear whether there are also long-term benefits of qol diagnosis and therapy. therefore, the aim of this observational, cross-sectional follow-up study of the rct diqol is to investigate long-term effects of the intervention on present qol (eortc qlq-c30, qlq-cr29), overall survival, and recurrence-free survival more than 5 years after surgery by comparing former intervention and control group patients. moreover, participants will be asked for their experiences during aftercare in relation of the covid-19 pandemic and for their recollection of their illness and therapy. data are collected via questionnaire.

Eligibility criteria:
inclusion criteria: * former participants of the rct diqol with a primary diagnosis of colorectal cancer between 01/2014 and 10/2015 who did not refuse to participate during the rct * informed consent exclusion criteria: - none -

Keywords: quality of life colorectal cancer complex intervention survivorship health services research
lipids and insulin sensitivity

Conditions: Obesity; Insulin Resistance

Summary: rationale: the investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity. objective: 1. the contribution of dietary vs endogenous fat sources to lipid overflow in the circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant subjects vs obese insulin sensitive controls. 2. the acute effect of meals with various fatty acid composition ((high saturated (sfa) vs polyunsaturated (pufa) vs monounsaturated (mufa)) on skeletal muscle lipid uptake and storage, fatty acid mediated gene expression and postprandial insulin sensitivity in obese insulin resistant subjects. study design: single-blind randomized cross-over trial study population: obese males (35-70 years) with or without insulin resistance intervention: 1. 1 test meal 2. 3 test meals with a different fatty acid composition main study parameters/endpoints: more insight whether dietary fat quality may modulate circulating lipids and skeletal muscle fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an increased insulin sensitivity.


Eligibility criteria:
inclusion criteria: * obese males aged between 35 and 70 years with insulin resistance. exclusion criteria: * history of type 2 diabetes. * liver or kidney failure. * diseases in which the live expectation is shorter then 5 years. * the use of experimental medication. * diseases/medication use that may have an influence on the glucose tolerance. * not to be able to understand the study information. * users of fatty acid supplements including fish oils etc. * users of high doses of antioxidant vitamins. * athletes. * people on a diet of people that are planning to lose weight.

Keywords: lipid metabolism
adaptive device for insulin pens for arthritic patients

Conditions: Diabetes Mellitus; Arthritis

Summary: approximately 34 subjects will be enrolled in an unblinded cross-over design. for one week, they will use the adaptive pen device and for the next week, they will use just the insulin (or other medication) pen. this will be repeated for another one week period each. at the end of each week, the subjects will fill out a questionnaire regarding their experiences and any suggestions for improvements for the design of the pen device.

this study is of an unblinded crossover design. each patient will be randomly assigned to initiate a one week observation period with either the pen alone or the pen with the device. the following week, the patient will switch to the other assignment. this will be repeated one more time for a total of two weeks with the device and two weeks without it. at the end of every week, the patients will be given a questionnaire to fill out. questions will include a measurement of their satisfaction with their insulin (or other medication) delivery system for that week. patients will be instructed to continue their usual dosage of medication as prescribed by their physician. if the patients have any problems with the device or feel uncomfortable with it, they are instructed to discontinue use of the device and continue using their pen as usual. the patients may keep the device at the end of the study. the questionnaires that the patients fill out will be the primary source documents.

Eligibility criteria:
inclusion criteria: * currently using a pen to administer medication at least once a week * currently are having some difficulty (self reported) using their pens because of dexterity issues exclusion criteria: * woman of child-bearing age who are known to be pregnant * people who are unable or unwilling to sign the informed consent document * patients who do not understand the proper use of the device after sufficient instruction * anyone in the principal investigator's judgment who cannot properly use the device

Keywords: diabetes mellitus arthritis
radiofrequency energy delivery for gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: this study is to evaluate the safety and efficacy of radiofrequency energy procedure for gastro-esophageal reflux disease (gerd) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. symptom assessment was performed at baseline and 3, 6, 12 months after treatment.

gastroesophageal reflux disease (gerd) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. uncontrolled gerd can significantly impact quality of life. the use of proton pump inhibitors (ppi) remains the mainstay therapy. however, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term ppi use. anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. but the current research on radiofrequency treatment of the data is limited in china. therefore, the investigators conduct this multi-center clinical trial.

Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosis of gerd established by either * 24-h oesophageal ph monitoring (performed off medications) showing an abnormal oae (ph \< 4 at least 4% of time) and/or * an upper gastrointestinal (gi) endoscopy showing oesophagitis grade a or b in los angeles (la) classification * presence of typical symptoms of gerd (heartburn and ⁄or regurgitation with at least three episodes of typical symptoms per week in the absence of ppi therapy), * adequate symptom relief obtained with ppis,but needing maintenance with at least standard dose. exclusion criteria: * presence of barrett's oesophagus \>3 cm and ⁄or with dysplasia and ⁄or previously treated, * presence of hiatus hernia \>3 cm, * presence of oesophagitis grade c or d in la classification, * presence of oesophageal stricture or achalasia, * history of oesophageal or gastric surgery, * presence of gastric or oesophageal varices, * impossibility to stop an anticoagulant therapy or severe coagulopathy, * any contraindication to general anaesthesia.

Keywords: heartburn regurgitation
computer-based training on cognitive dysphagia in stroke survivors

Conditions: Dysphagia

Summary: this is a multicenter randomized controlled study. the study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland china as the participants (study subjects). the study duration for each participant was 15 days. the subjects were randomly divided into an experimental group and a control group. during the treatment, all patients received routine rehabilitation treatment. in addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

computer-assisted cognitive training is a rehabilitation method that uses computer technology and psychological principles to promote the recovery of cognitive function.this is a multicenter randomized controlled study. the study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland china as the participants (study subjects). the study duration for each participant was 15 days. the subjects were randomly divided into an experimental group and a control group. during the treatment, all patients received routine rehabilitation treatment. in addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * meeting the diagnostic criteria for traumatic brain injury. * montreal cognitive assessment score \ 18 (adjusted by 1 point if the educational level is high school graduation or above). * confirmed swallowing disorder through fiberoptic endoscopic examination of swallowing. * duration of illness greater than three months. * patients or their family members are aware of and consent to participate in the study. exclusion criteria: * presence of other intracranial lesions, such as stroke. * cognitive impairment caused by other diseases. * mental abnormalities. * inability to complete treatment and assessments due to other impairments. * concurrent severe injuries.
work of breathing and kangaroo mother care

Conditions: Premature Infant; Work of Breathing; Oxygen Saturation

Summary: to compare work of breathing and oxygen saturation before, during, and after kangaroo mother care in preterm very low birth weight (vlbw) infants stable on non-invasive respiratory support.


Eligibility criteria:
inclusion criteria: * very low birth weight infants (those less than 1500g at birth) * respiratory insufficiency * \>4d pma * stable and receiving non-invasive respiratory support for ≥12 hours (nc, hfnc or cpap) * requiring ≤40% supplemental fio2 exclusion criteria: * infants with skeletal, neuromuscular or abdominal surgical disorders that may affect the accuracy of work of breathing measurements * infants who do not meet criteria to participate in kangaroo mother care
a study of jnj-64042056 in participants with preclinical alzheimer's disease

Conditions: Preclinical Alzheimer's Disease

Summary: the purpose of this study is to assess the effect of jnj-64042056 on cognitive decline, as measured by preclinical alzheimer's disease cognitive composite 5 (pacc-5) compared with placebo.


Eligibility criteria:
inclusion criteria: * elevated brain tau pathology defined as braak 3 region of interest standardized uptake value ratio (roi suvr) greater than (\>) 1.1 on a screening tau pet scan, reviewed centrally by a qualified reader * clinical dementia rating (cdr) global score of 0 at screening and baseline * mini mental state examination (mmse) greater than or equal to (\>=) 27 (with educational adjustment) * able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening * a participant must be of non-childbearing potential exclusion criteria: * history consistent with or known autosomal dominant ad (mutation identified in the family and/or participant) * fulfills diagnostic criteria for alzheimer's dementia or non-alzheimer's dementia, including, but not limited to frontotemporal dementia (ftd), diffuse lewy body dementia (dlbd), vascular dementia (vad), alcoholic dementia, parkinson's dementia, korsakov, creutzfeldt-jakob or other prion diseases, posterior cortical atrophy * diagnosis of mild cognitive impairment (mci) * vitamin b12 or folate levels below the central laboratory lower limit of normal, unless in the opinion of the investigator it does not require treatment * history of or current neurological disease other than preclinical ad that may make interpretation of possible new neurological signs or symptoms difficult
trajectories of psychopathology in response to net

Conditions: Posttraumatic Stress Disorder (PTSD)

Summary: narrative exposure therapy (net) has been proven to be effective in the treatment of posttraumatic stress disorder (ptsd) and trauma-related depression in more than a dozen controlled clinical trials. symptom reduction was greatest during long-term follow-ups after the completion of the therapy. in the current study, we will investigate the progression of ptsd symptoms and emotional stress before, during and after therapy. after a semi-structured interview all participants will be asked to report in monthly telephone interviews their core symptoms. structured interviews after 6 and 12 months are used to validate the outcome. a convenience sample of individuals with a ptsd will be offered participation in the study.

participants will be recruited through the center of excellence for psychotraumatology, university of konstanz, with focus on refugees. all of them (approx. 100) will receive a structured interview and a detailed diagnosis. the interview includes questions about sociodemography, traumatic events, ptsd and depression symptomatology. individuals with a ptsd diagnosis (up to 30) will be offered a narrative exposure therapy (net). irrespective of treatment and diagnosis, respondents are asked to participate in monthly telephone interviews assessing trauma-related and emotional distress and changes in life. interviews assessing ptsd, depression symptoms and emotional distress will be conducted 6 and 12 months after the initial interview. in addition, participants receiving net will rate their ptsd symptoms and functionality prior to each therapy session.

Eligibility criteria:
inclusion criteria: * for treatment group: ptsd diagnosis (dsm-iv or v) * for non-treatment group: none exclusion criteria: * acute psychosis * cerebro-organic disease * acute drug or alcohol intoxication * already receiving another psychotherapy * anti-epileptic drugs at baseline

Keywords: course posttraumatic stress disorder narrative exposure therapy
3d-hd optic systems influence surgical performance

Conditions: Operative Time; Fatigue; Surgery--Complications

Summary: randomized controlled trial in which two different laparoscopic systems: standard 2d and olympus visera elite ii 3d will be compared in terms of laparoscopic skills, length of surgery, intraoperative complications and surgeon's fatigue in a group of senior surgeons and senior residents will be measured when performing laparoscopic roux-en-y gastric bypass.

the introduction of minimally invasive surgery has faced the surgeon with some difficulties that were not present in traditional open surgery. the foremost disadvantage of laparoscopy is the loss of depth perception in 2-dimensional (2d) vision while having to operate in a 3-dimensional (3d) space. minimally invasive surgery has become the standard approach for most of the abdominal surgical procedures. it is associated with less surgical trauma, faster recovery, shorter hospital stay and better cosmetic results. these advantages have led laparoscopic skills to become a basic competence for general surgery programs. advanced laparoscopic surgery involves a long learning curve, including demanding minimally invasive skills such as intracorporeal suturing and knot tying. video quality is critical for an accurate training. this is especially important for advanced laparoscopic skills training, where high-definition cameras are needed. hd imaging has been shown to provide subjectively improved image for visualization and to improve surgical task performance. some authors have investigated the effect of laparoscopic 3-dimensional view, and have demonstrated an improvement in speed, efficiency, optics and handling as well as surgeon's subjective assessment. moreover, 3d systems have been demonstrated to provide better optical visualization that allows simpler presentation of anatomical structures, which can decrease intraoperative errors and postoperative morbidity secondary to visual distortions and may reduce postoperative fatigue of the surgeon. the hypothesis of the study is that the length of surgery is reduced with the use of 3d laparoscopic systems compared with 2d laparoscopic systems, the reduction on the length of surgery will be higher on the training surgeons compared with the senior surgeons, and that the use of 3d laparoscopic systems reduces the postoperative fatigue of the surgeons. in this study a group of full-trained surgeons and of 4th and 5th year general surgery residents performing laparoscopic roux-en-y gastric bypass will be randomized into the use of 2d standard laparoscopic optics or 3d laparoscopic optics.

Eligibility criteria:
inclusion criteria: * morbid obesity (bmi \> 30) * laparoscopic gastric bypass candidates exclusion criteria: * non-obese patients. * candidates to other surgical procedures than laparoscopic gastric bypass

Keywords: 3d optic systems fatigue length of surgery 3d laparoscopy intraoperative complications bariatric and metabolic surgery
virtual reality used during tooth extraction and extirpation treatment

Conditions: Anxiety and Fear; Tooth Disease

Summary: this study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.

aims and objectives: virtual reality glasses can be used as a distraction method in dental practices for children. this study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years. design: a randomized controlled experimental study design will use. methods: the sample of the study consisted of 120 seven to ten-year-old children, including 60 in the experimental group and 60 in the control group, who will receive tooth extraction and extirpation treatment in the pediatric dental clinic of an oral and dental health center. data collection tools included a child and family information form, the children's fear scale, and the child anxiety scale-state. during the procedure, the children in the experimental group will watch a video that they chose through virtual reality glasses. no intervention will apply to the control group. data will analyz using the chi-square test, t-test, shapiro-wilk, mean, and percentage distributions.

Eligibility criteria:
inclusion criteria: * children who will between the ages of 7-10, * children who have tooth extraction * children who have extirpation treatment * have no cognitive development problems, exclusion criteria: * children who will not want to participate in the study, * leave the research during the study, * have an audio-visual disorder that could prevent the use of virtual glasses.

Keywords: tooth extraction extirpation child anxiety fear nursing virtual reality
comparing the efficacy between lignocaine given via madgic atomizer and lignocaine pump spray

Conditions: Sore Throat; Cough; Hoarseness; Hemodynamic Instability

Summary: comparing the efficacy between lignocaine given via madgic atomizer and lignocaine pump spray pre endotracheal intubation in adult undergoing general anesthesia.

comparing the efficacy of lignocaine given via 2 device (lignocaine spray and madgic atomizer) on hemodinamic parameters postintubations and severity grading of post operative sore throat, cough and hoarseness of voice.

Eligibility criteria:
inclusion criteria: * adult with the age of 18 to 65 years old * gender of both male and female * planned for elective surgery scheduled at general operation theatre that require elective intubation for general anesthesia * american society anaesthesiologist (asa) preoperative physical status assessment of 1 and 2 * airway assessment malampati scoring 1and 2. exclusion criteria: * pregnancy * known allergy or hypersensitivity to lignocaine * pre existing sore throat or hoarseness of voice identified during preoperative assessment. * the use of airway device other than endotracheal tube (ett) such laryngeal mask airway/supraglottic device' * oral and neck surgery

Keywords: lignocaine madgic atomizer airway anesthesia
comparison of ropivacaine-poloxamer 407 hydrogel and tap block for postoperative pain management in laparoscopic/robotic gastrectomy

Conditions: Gastric Cancer

Summary: this study aims to determine whether ropivacaine-poloxamer 407 hydrogel provides non-inferior pain control compared to tap block for patients undergoing minimally invasive gastrectomy. the results will guide postoperative pain management practices and enhance recovery protocols for gastric cancer surgery.


Eligibility criteria:
inclusion criteria: 1. patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery. 2. patients who have undergone a complete surgical resection (r0 resection). 3. patients with an asa (american society of anesthesiologists) score of 3 or below. 4. patients aged 20 years or older. 5. patients who have undergone laparoscopic or robotic gastrectomy exclusion criteria: 1. patients under 19 years of age. 2. presence of ascites or peritoneal metastasis. 3. patients who have undergone preoperative chemotherapy or radiotherapy. 4. diagnosis of malignancies other than gastric cancer. 5. uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing. 6. history of allergy or adverse reactions to ropivacaine or other local anesthetics. 7. pregnant women. 8. patients with preoperative chronic pain conditions, including crps. 9. patients with long-term preoperative use of opioid analgesics. 10. patients with psychiatric disorders deemed likely to interfere with study participation. 11. patients with severe liver disease, renal disease, or arrhythmia.