Kornimate/medical-research-clean huggingface dataset:
analysis of plasma tumor dna in lung cancer patients

Conditions: Non Small Cell Lung Cancer Patients

Summary: the presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. egfr and alk) is associated with the clinical response to tyrosine kinase inhibitors (tkis) in patients with non-small cell lung cancers. therefore, the detection of altered genetic alterations is useful for predicting the treatment response for tkis in non-small cell lung cancer patients. however, good quality tumor tissues are available only in \<50% of patients with inoperable lung cancer for mutation analysis. in this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. in addition the investigators will analysis the resistant mechanism of tkis and chemotherapy with plasma tumor dna.


Eligibility criteria:
inclusion criteria: * have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer * have molecular evidence of genetic alterations in tumor sample (eg. egfr mutations, alk fusions) * patients must have given written informed consent exclusion criteria: * patients who refuse the blood samplings

Keywords: lung cancer, plasma dna, free dna, egfr, alk
safety and performance study of the edwards centera self-expanding transcatheter heart valve

Conditions: Aortic Valve Disease

Summary: the purpose of this study is to assess the safety and device success of the edwards centera transcatheter heart valve (thv) system in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

this is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in europe. patient participation will last for a minimum of 5 years. patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years

Eligibility criteria:
inclusion criteria: 1. high surgical risk: sts score ≥ 8,euroscore ≥ 15. 2. nyha ≥ ii. 3. heart team (including examining cardiac surgeon) agrees on eligibility including assessment that tavr is appropriate. 4. study patient is an adult of legal consent age. 5. study patient has provided written informed consent to comply with all of the study procedures and follow-up visits. exclusion criteria: 1. acute myocardial infarction ≤ 30 days before the intended treatment. 2. untreated clinically significant coronary artery disease requiring revascularization. 3. aortic valve is a congenital unicuspid or congenital bicuspid valve. 4. mixed aortic valve disease (with predominant aortic regurgitation).

Keywords: transcatheter aortic valve replacement aortic stenosis
comparison of the post-operative efficacy of arch bar with single plate and two plate fixation in mandibular parasymphsis fracture.

Conditions: Mandible Fracture

Summary: this clinical trial is designed to compare post-operative infection, symptoms of paresthesia, inferior border misalignment and operating time of one plate with arch bar against standard two miniplates in mandibular parasymphysis fracture in order to achieve the treatment which is beneficial for the patients. this study will contribute to literature for the betterment of patient. the objective of this study is to compare the post-operative efficacy of arch bar with single plate and two plate fixation in mandibular parasymphsis fracture.


Eligibility criteria:
inclusion criteria: * all patients with mandibular unilateral parasymphysis fracture exclusion criteria: 1. mandibular defect fractures. 2. grossly comminuted fractures. 3. medically compromised patient.(e.g uncontrolled metabolic disease * immunocompromised patient, patient receiving radiation and chemotherapy). 4. multiple fracture of mandible.
investigation of the effectiveness and efficiency of a structural clinical nutrition support

Conditions: Malnutrition

Summary: the purpose of this study is to investigate the effectiveness and efficiency of a structural clinical nutrition support by an interdisciplinary nutrition support team. to do this we examine nutritional management and its economic impact as well as the nutritional status of patients of university hospital tübingen before and after the implementation of a nutritional support team.

in german hospitals disease related malnutrition is a major problem. malnutrition is known to be associated with decreased quality of life, altered body composition as well as increased length of hospital stay. guidelines recommend the installation of nutrition support teams (nst) to combat this situation. however, the majority of german hospitals lacks a nst. in the present study, we want to examine the effectiveness and efficiency of a nutrition support team (nst) in an university hospital with 1500 beds. to do this we investigate the nutritional management, its economic impact and patient related data before and after nst-implementation. examinations include a structural analysis of the hospital with regard to nutritional procedures and a patient-based analysis. patients are recruited from three representative normal wards and two intensive care units. here we identify patients with risk for malnutrition with the help of nutritional screening tools (nrs 2002 \[nutritional risk screening\]; nutric \[nutritional risk in the critically ill\] score).this is performed within the first three days after admittance. the patients with risk for malnutrition (nrs 2002 of 3 or more than 3, nutric score of 4 or more than 4) are included for further investigations. these include anthropometric measurements , assessment of body composition, evaluation of nosocomial infection and decubitus rate, quality of life (sf-12 questionnaire), length of hospital stay, evaluation of mortality risk, organ function and severity of illness as well as economic factors. most examinations are repeated weekly depending from the length of stay in hospital. all this examinations and evaluations will be collected at two time points. before and after the implementation of a nutritional support team. that means we have two groups: group a- before nst-implementation (n=420) and group b - after nst-implementation (n=420). after the whole data collection we want to compare the results of the two groups.

Eligibility criteria:
inclusion criteria: * patient of university hospital tübingen * patient of one of the study-wards: gastroenterology, otolaryngology, visceral and transplantation surgery, internal intensive care unit, surgery intensive care unit * written informed consent of the patient/advisor * risk of malnutrition: nrs score of 3 or more than 3, nutric score of 4 or more than 4 exclusion criteria: * age under 18 years * withdrawn of written informed consent * length of hospital stay shorter than 2 days

Keywords: disease related malnutrition influence of nutrition support team length of hospital stay quality of life body composition health care costs
the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture

Conditions: Osteoporosis; Vertebral Fractures

Summary: the study is a parallel-group single blinded randomized controlled trial, examining the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture. the participants will randomly be assigned in a 1:1 ratio to the intervention group and the control group. the intervention will follow newly developed exercise recommendations for people with osteoporosis and vertebral fractures, which states the balance- and strength exercises should be performed at least twice a week. the intervention is a group exercise session circuit program lasting for 12 weeks. the participants will be tested at baseline, and followed up at 3 months and 6 months.


Eligibility criteria:
inclusion criteria: * women over 65 years, living at home, able to walk with or without walking aids * having osteoporosis verified by dxa scan (-2,5) * at least one vertebral fracture, verified by x-ray exclusion criteria: * health conditions that make it unsafe to exercise * not able to understand and speak norwegian adequately to participate in the intervention
randomized controlled trail for post laparoscopic pain

Conditions: Shoulder Pain

Summary: laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. however, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. the incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. in some cases, it has been reported to last more than 72 hours after surgery. the hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to c4. therefore, we should try to do is that if we could reduce carbon dioxide retention in the pelvic cavity. this clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.

all the patients will receive laparoscopic surgery using carbon dioxide (co2 ) gas as distension medium. at the end of the surgery, in the control group c, co2 was removed by passive exsufflation through the port site. in the intervention group a, at the end of the surgery, the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. we will leave the fluid in the abdominal cavity. then, patients will be placed in the trendelenburg position (30 degrees), and a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm h2o. the anesthesiologists held the fifth positive pressure inflation for approximately 5 seconds. during these maneuvers, the surgeon was instructed to ensure that the trocar sleeve valve was fully open to allow the co2 gas to escape. in the intervention group b, at the end of the surgery, the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. we will leave the fluid in the abdominal cavity. patients will be asked to fill out questionnaires up to 48 hours to determine the frequency and severity of their shoulder and upper abdominal pain. the scores will be assessed 12, 24, 48 hours after surgery using a visual analogue scale( vas) from 0 ( no pain) to 10 ( worst possible pain).

Eligibility criteria:
inclusion criteria: * patients receive benign gynaecological laparoscopic surgery. * american society of anesthesiologists (asa) physical status of patient: classification i-ii exclusion criteria: * the procedure will be required to conversion to laparotomy. * any cardio-vascular diseases.

Keywords: should and upper abdominal pain, post-laparoscopy
properties of glass ionomer cements associated with chlorhexidine or doxycycline

Conditions: Dental Caries

Summary: this study assessed the clinical performance of a resin-modified glass ionomer cement containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.

this study aimed to evaluate the in vivo microbiologic action of the best concentration of chlorhexidine and doxycycline associated with the resin-modified glass ionomer cement applied on remaining dentine after indirect pulp treatment.

Eligibility criteria:
inclusion criteria: * an active deep carious lesion at the internal half of the dentine thickness of a primary molar that had not been previously restored and that involved the occlusal or occlusoproximal surface; * the absence of signs of irreversible damage to the pulp * the absence of radiolucencies at the interradicular or periapical region or thickening of the periodontal spaces, absence of internal and external root resorption, absence of calcification of the pulp tissue * children presenting no systemic disease or those not using medications. exclusion criteria: * presence of signs of irreversible damage to the pulp * children presenting systemic disease or those using medications.

Keywords: glass ionomer cement indirect pulp therapy
community health workers and diabetes education

Conditions: Diabetes

Summary: the aim of this study is to evaluate the effect of a diabetes education program delivered to chw in improving the metabolic control of patients with type 2 dm. the study is a randomized controlled trial conducted in a primary care unit. eight chw, providing care for 118 patients, are randomized in two groups to receive a one-month diabetes education program (intervention group, patients n= 62) or an education course in other health issues (control group, patients n= 56).

background: in brazil, community health workers (chw) are members of the community hired by the government to provide education and care for patients for a broad range of health issues, including diabetes mellitus (dm). however, few chw are trained for diabetes education and little is known about the effectiveness of their interventions. the aim of this study is to evaluate the effect of a diabetes education program delivered to chw in improving the metabolic control of patients with type 2 dm. materials and methods: the study is a randomized controlled trial conducted in a primary care unit. eight chw, providing care for 118 patients, are randomized in two groups to receive a one-month diabetes education program (intervention group, patients n= 62) or an education course in other health issues (control group, patients n= 56). each chw is responsible for transmitting the acquired knowledge to patients from their respective working areas. the primary outcome is change in hba1c three months after intervention.

Eligibility criteria:
inclusion criteria: * adult patients with diabetes mellitus who live in the community of the health care unit and who agree to participate the study. exclusion criteria: * none.

Keywords: diabetes education community health workers diabetes control
efficacy and safety of extract of gelidium elegans

Conditions: Obesity

Summary: extract of gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in vitro and in vivo. it has also anti-obesity effect by inhibiting weight gain and decreasing body fat. in a preliminary study of obese adults aged 20 years or older, the extracts of gelidium elegans showed a tendency to decrease in body fat and visceral fat, and to increase lean body mass. based on these results, we tried to confirm the effect of body weight and body fat reduction of gelidium elegans extract in overweight and obese people.


Eligibility criteria:
inclusion criteria: * 1. between the ages of 19 and 50 * 2. bmi is at or greater than 23 and less than 30 kg/m\^2 exclusion criteria: * 1. uncontrolled hypertension * 2. uncontrolled diabetes * 3. current serious cerebrovascular and cardiovascular disease
remediation for mild cognitive deficits after cancer

Conditions: Cognitive Remediation; Breast Cancer

Summary: cancer survival rates have improved significantly over the past decades and patients now experience a number of side effects including cancer-related cognitive impairment (crci): problems with memory, executive function, attention, and difficulties performing two tasks at the same time. the frequency of crci in cancer patients is estimated to be between 10 to 40%, and more than 50% of patients describe difficulties in their daily life. these cognitive difficulties negatively impact the patient's quality of life as well as that of their family, and can also have negative consequences for their social and professional reintegration once cancer treatment is finished. despite an increasing number of studies on crci, a standard of care for patients with crci after breast cancer is yet to be established. in the absence of clear directives, and in an attempt to respond to the increasing demand to provide care for breast cancer patients with crci, physical medicine and rehabilitation units in france have started providing day-hospital multidisciplinary interventions. the objective of this project is to use the single case experimental design method to investigate the efficacy of two such rehabilitation programs: a group-based program and a one-on-one program.


Eligibility criteria:
inclusion criteria: * treated in the past for breast cancer with chemotherapy, surgery, and / or radiotherapy, * admitted as a day patient at the henry gabrielle hospital or the pontchaillou chu hospital during the study, * given free, informed consent in writing after being informed orally and in writing of the how the study will proceed. exclusion criteria: * presence of another active cancer, * ongoing chemotherapy and/or radiotherapy treatment, * active progression of breast cancer, * history of neurological or psychiatric conditions, * major disturbances in comprehension that prevent them giving free, informed consent, * pregnant, parturient or breastfeeding women, * person under a legal protection measure such as guardianship or curatorship, * people not affiliated to a social security scheme (french social security) or beneficiaries of a similar scheme.

Keywords: neuropsychology psychological distress quality of life rehabilitation
a study of capecitabine (xeloda) in combination chemotherapy versus surgery alone in participants with gastric cancer

Conditions: Gastric Cancer

Summary: this study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. participants will be randomized to either the chemotherapy arm or the observation arm. capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m\^2) twice daily (bid) on days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (iv) infusion, 130 mg/m\^2 every 3 weeks for 8 cycles. the anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.


Eligibility criteria:
inclusion criteria: * adult participants greater than or equal to (\>=) 18 years of age * gastric adenocarcinoma, stage ii, iiia or iiib * potentially curative resection of tumor within 6 weeks prior to randomization * previously untreated with chemotherapy or radiotherapy exclusion criteria: * serious concomitant medical illnesses that would limit life expectancy to less than (\<) 5 years * sexually active males and females (of childbearing potential) unwilling to practice contraception during the study * any evidence of metastatic disease (including presence of tumor cells in the ascites)
effect of nutritional intervention based on prediction model on adult umbilical cord blood transplantation patients

Conditions: Nutrition Disorders

Summary: based on the nutritional factor prediction model, the individualized nutritional management of patients with umbilical cord blood transplantation (ucbt) was carried out to observe the impact on the survival efficacy of patients.

the data of 80 ucbt patients were analyzed retrospectively, and the influence of nutritional parameters on the clinical outcome of ucbt patients was first confirmed, the skinfold thickness ≥20.5 mm and peripheral blood alb \< 33.6 g/l at 30 days after transplantation were the independent influencing factors of os and dfs. in order to further verify the accuracy of the survival prediction model, the center intends to base on the model and aim at the nutritional parameters of patients 30 days after transplantation, a single-arm, single-center, phase ii, prospective intervention trial was conducted to explore individualized nutrition management in ucbt patients.

Eligibility criteria:
inclusion criteria: * age 18-65 years old, conscious, with language communication skills; * ucbt patients to be performed; * major organs without serious dysfunction; * the participants agreed to participate in the study and signed the informed consent form. exclusion criteria: * age \ 65 years old or with cognitive impairment can not complete this survey; * failure or recurrence of transplantation; * combined with severe other organ system diseases (such as severe cardiac insufficiency, autoimmune disease, active infection, severe trauma) ; * patients who have difficulty collecting data to complete the nutritional intervention; * patients who asked to withdraw from the study.

Keywords: umbilical cord blood transplantation nutrition intervention
prospective analysis of the treatment of progressive familial intrahepatic cholestasis (treatfic)

Conditions: Progressive Familial Intrahepatic Cholestasis

Summary: the project has the following general aims: 1. natural course and prognosis: to prospectively follow the natural course and prognosis of the different types of pfic, to broaden the understanding of the different very rare diseases and to allow predictions about the course of disease in different types of pfic. 2. efficacy: to define the course of disease in fic patients and identify associations with different treatments (symptomatic treatments, interruption of the enterohepatic circulation by surgical or medical means and other therapies such as corrector/potentiator or exon skipping therapy. the course of disease will be characterized by biochemical, clinical and surgical parameters, including liver transplantation. 3. safety: to define the complications associated with the different treatments (symptomatic treatments, interruption of the enterohepatic circulation by surgical or medical means and other therapies such as corrector/potentiator or exon skipping therapy, liver transplantation). follow up will be as long as possible. 4. (surrogate) biomarker response: biochemical parameters will be longitudinally collected and associated with changes in treatments / course of disease. 5. genotype-phenotype relationships: if patient numbers permit, to establish genotype-phenotype relationships for (non)responsiveness towards different treatments in patients with genetic mutations causing the different forms of fic disease.


Eligibility criteria:
inclusion criteria: - genetically confirmed cases of a pfic type disease: fic1 deficiency, bsep deficiency, mdr3 deficiency, tjp2 deficiency, fxr deficiency, slc51a deficiency, usp53 deficiency, kif12 deficiency, zfye19 deficiency, myo5b deficiency, sema7a deficiency, vps33b deficiency, pskh1 deficiency. exclusion criteria: - cases with suspected pfic type disease, but without genetic testing data available.

Keywords: pfic asbt ibat biliary diversion liver transplantation