Kornimate/medical-research-clean huggingface dataset:
esophageal cancer multimodal prehabilitation study

Conditions: Esophageal Cancer; Esophageal Neoplasms

Summary: the goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.

this research study is to test whether a novel, 4-week surgical multimodal prehabilitation protocol is feasible in at-risk older adult patients who have previously undergone neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal cancer. research study procedures include screening for eligibility, clinic visits, questionnaires, blood tests, and computed tomography (ct) scans. participation in this research study is expected to last 7 months. it is expected about 30 patients will participate in this study.

Eligibility criteria:
inclusion criteria: * 65 years of age and over * adult male or non-pregnant female volunteers * completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer * at least four weeks to esophageal cancer surgery * without skin conditions that preclude wearing sensors * able to speak english and consent exclusion criteria: * participants in any other interventional study that may bias results or limit study adherence during our study * dietary restrictions that prevent consumption of nutritional supplements * women who are pregnant, nursing, or at risk of becoming pregnant * profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.

Keywords: esophageal cancer esophageal neoplasms
closing the loop between glucose sensor and insulin pump-developing an algorithm

Conditions: Diabetes, Type I

Summary: an open interventional data collection study in order to build a database to close the loop between glucose sensor and insulin pump. background: the ultimate goal in diabetes treatment is to develop an autonomous insulin delivery system (artificial pancreas) capable of continuous glucose sensing, thereby mimicking the physiologic function of the islet beta cells and freeing the patient from the need for constant calculations of daily insulin and carbohydrates. several prototypes of closed-loop system have been developed in recent years, based on different types of control algorithms, to establish the connection between the sensor and the insulin pump. current research in the formulation of this type of subcutaneous closed-loop system still faces major challenges, therefore, there is a need for further study and evaluation. objectives: 1. to evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose levels by using continuous glucose sensor 2. to measure the insulin sensitivity as expressed by changes in blood glucose levels after s.c insulin infusion . 3. to evaluate real time sensor calibration algorithms based on the measured lag times 4. collecting clinical data in order to develop and evaluate mathematical models which will serve a base to simulators. 5. developing and accessing advanced learning and control algorithms as a step towards developing an artificial pancreas


Eligibility criteria:
inclusion criteria: 1. diabetes type 1 for at least one year. 2. ages \>10 years. 3. signed informed consent form. 4. willing to cooperate with all study requirements. exclusion criteria: 1. sensor allergy. 2. psychiatrist diseases. 3. other chronic diseases. 4. participation in another study that involves a medicine or a medical device.subjects have to finish participating in other studies at least 30 days before joining this study. each subject can participate in this study only once.

Keywords: type 1 diabetes artificial pancreas insulin pump
satin wp4 acute effect on appetite of pineapple juice with viscofiber and red ginseng

Conditions: Healthy

Summary: the objective of the study is to establish whether a pineapple juice with viscofiber and red ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the short-term.

a double-blind, randomised crossover design will be employed with an experimental (active) condition and a control condition at least one week apart. after having successfully completed screening procedures eligible participants will be invited for two separate test days, at least 7 days apart. on the two test days, the products will be provided in a randomized order as part of a fixed breakfast meal, and subjective appetite ratings will be measured every 30 min for the following 8 hours. satiety and satiation will be measured through administration of test meals in the laboratory supplied with controlled food intake under free-living conditions

Eligibility criteria:
inclusion criteria: * participants who have provided written informed consent * healthy men and women * ages between 18 and 55 years * bmi between 25.0-31.9 kg/m2 * regular breakfast eaters (eating breakfast ≥ 4 times a week) * regular menstrual periods (women only) exclusion criteria: * significant health problems as judged by the investigator * taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator * pregnant, planning to become pregnant within the next 4 weeks or breastfeeding (women only) * history of anaphylaxis to food * any known food allergies or food intolerance * smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes) * self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months * significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator * significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator * use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator * participants who work in appetite or feeding related areas * participants not able to comply with the study protocol * post-menopausal (women only)

Keywords: ad libitum energy intake appetite
the effect of adding dexamethasone to epidural bupivacaine for total knee replacement surgery

Conditions: Postoperative Pain

Summary: the purpose of this study was to evaluate the efficacy of dexamethasone when added to epidural bupivacaine on the duration of postoperative analgesia in patients underwent total knee replacement surgery.

fifty patients underwent total knee replacement were included in the study. the patients (11 male and 39 female) were classified into two equal groups:- the patients received 15 ml plain bupivacaine + 2 ml (bs), or 8 mg dexamethasone (bd). the total volume injected in both groups was 17 ml. postoperative records: 1. pain score (nrs) at base line, then every 4 hrs for 24 hrs. 2. frequency of rescue analgesia. 3. postoperative side effects like nausea, vomiting, and over sedation.

Eligibility criteria:
inclusion criteria: 1. patients scheduled for total knee replacement surgery. 2. asa physical status i,ii,iii. exclusion criteria 1. patients' refusal. 2. uncooperative patients / not able to understand pain assessment test. 3. patients with history of allergy to the used drugs. 4. significant liver disease. 5. pregnancy. 6. any contraindication for epidural anesthesia 7. failed technique.
an audit of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Conditions: Colorectal Cancer; Ovarian Cancer; Peritoneal Disease

Summary: peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. cytoreductive surgery (crs) and hyperthermic intraperitoneal chemotherapy (hipec) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. crs, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with hipec (for 90 min at a temperature of 42º c) and/or early postoperative intraperitoneal chemotherapy (epic) in order to eradicate all microscopic metastasis. crs with hipec is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the hipec phase, and even in the early postoperative period, with resultant significant morbidity and mortality. despite that most of the reported patients are in american society of anesthesiologist class i and ii, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. this study will see the challenges faced by the team regarding the pathophysiological alterations during the crs with hipec in the perioperative period.


Eligibility criteria:
inclusion criteria: 1. age between 18 to 70 years 2. asa class i to iii 3. colorectal and gynecological oncology cases posted for crs with hipc. exclusion criteria: 1. age less than 18 and more than 70 years 2. asa class iv and above
early characteristics of autism

Conditions: Autism; Autistic Disorder

Summary: this study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.

children with autism often suffer from social, educational, and functional problems. by understanding the social, linguistic, psychological, and physiological differences that distinguish between autistic children, developmentally delayed children, and children with typical development, researchers may be able to recognize autism early in life so that children with autism can be helped as early as possible and their long-term outcome can be improved. children in this study will be enrolled for 2 years. they will receive annual evaluations throughout the two-year period. they will undergo a magnetic resonance imaging (mri) scan and will complete various activities to determine brain functioning. in addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study. communication and social behavior scales, an early development interview, observations of parent/child interaction, and neuropsychological, cognitive, and adaptive behavioral measures will be used to assess participants.

Eligibility criteria:
inclusion criteria for autistic participants: * diagnosis of autism inclusion criteria for developmentally delayed participants: * exhibiting current delays in development inclusion criteria for participants with normal development: * exhibiting normal development inclusion criteria for all participants: * overall good health

Keywords: autism developmental delay disorders
contingency management for persons with severe mental illness

Conditions: Substance Abuse

Summary: contingency management is efficacious for treating cocaine abuse, but contingency management interventions have rarely been applied to patients with severe and persistent mental health problems. this pilot project will estimate effect sizes of contingency management for reducing cocaine use in patients receiving psychiatric care at a large community based mental health program. in total, 30 cocaine abusing patients will be randomized to one of two 8-week treatment conditions: standard care or standard care with contingency management. patients in both conditions will provide breath and urine samples for toxicology testing twice per week. in the contingency management condition, patients will receive the opportunity to win prizes for submitting cocaine negative urine samples. the investigators expect that patients receiving contingency management will evidence reductions in cocaine use and may show improvements in psychiatric symptoms and psychosocial functioning relative to patients in standard care. effect size estimates obtained from this study will be used to guide larger scale and longer duration evaluations of contingency management for dually diagnosed patients.


Eligibility criteria:
inclusion criteria: * age 18 years or older * meet dsm-iv criteria for cocaine abuse or dependence * english speaking * pass a brief quiz regarding study procedures to ensure understanding of the informed consent process. exclusion criteria: * dementia * in recovery from pathological gambling
busulfan, melphalan and etoposide as conditioning for autologous transplantation for non-hodgkin's lymphoma (nhl)

Conditions: Non-Hodgkin's Lymphoma

Summary: the investigators developed a protocol utilizing once-daily intravenous busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (hdt) in the patients with high risk or relapsed non-hodgkin's lymphoma (nhl).

treatment: busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Eligibility criteria:
inclusion criteria 1. histologically confirmed aggressive nhl 2. mantle cell lymphoma 3. salvage chemotherapy sensitive relapse/refractory nhl 4. performance status: eastern cooperative oncology group (ecog) 0-2. 5. age; 18-65 6. adequate renal function: serum creatinine ≤ 1.5mg/dl 7. adequate liver functions: transaminase (ast/alt) \< 3 x upper normal value \& bilirubin \< 2 x upper normal value exclusion criteria 1. low grade nhl 2. any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 3. other serious illness or medical conditions * unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry * history of significant neurological or psychiatric disorders * active uncontrolled infection (viral, bacterial or fungal infection) 4. pregnant or lactating women, women of childbearing potential not employing adequate contraception 5. hiv (+) 6. patients who have hepatitis b virus (hbv) (+) are eligible. however, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for hbv carrier to prevent hbv reactivation during whole treatment period

Keywords: transplantation conditioning
double-masked trial of nova22007 (ciclosporin 0.1%) versus vehicle in patients with moderate to severe dry eye syndrome

Conditions: Moderate to Severe Dry Eye Syndrome

Summary: a phase iii, multicenter, randomized, controlled, double-masked trial of nova22007 (ciclosporin 0.1%) ophthalmic cationic emulsion versus vehicle in patients with moderate to severe dry eye syndrome


Eligibility criteria:
inclusion criteria: * males or females 18 years of age or greater. * at baseline, moderate to severe dry eye condition persisting despite conventional management. exclusion criteria: * presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results. * any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, stevens-johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc. * any other ocular diseases requiring topical ocular treatment during the study period. * patient who has participated in a clinical trial with a new active substance during the past month before study entry. * participation in another clinical study at the same time as the present study.

Keywords: moderate severe dry eye ciclosporin cyclosporine
biochemical and physiological response to stressogenic stimuli

Conditions: Post Traumatic Stress Disorder

Summary: post-traumatic stress disorder (ptsd) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. a psychiatric diagnosis of ptsd is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. discernable patterns of stress-related measures may constitute a physiological and biochemical phenotype characteristic of ptsd, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans. the current study is aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with ptsd. physiological and biochemical data will be collected from participants with and without ptsd using wearable sensors and adhesive biosensor patches. the data will be collected in two conditions: in a neutral, quiet situation, and during and following exposure to controlled stressogenic stimuli.


Eligibility criteria:
inclusion criteria: * ptsd diagnosis (excluding controls) * proper ability to give informed consent exclusion criteria: * active oncological/cardiovascular condition * dialysis patients * active psychotic or suicidal symptoms * severe dissociative symptoms * a traumatic brain injury (tbi) diagnosis * pregnancy
biomarker for hyaline fibromatosis syndrome (biohfs)

Conditions: Hyalinosis; Hyaline Membrane Disease; Juvenile Hyaline Fibromatosis; Fibromatosis Hyalinica Multiplex Juvenilis; Skin and Connective Tissue Diseases

Summary: development of a new ms-based biomarker for the early and sensitive diagnosis of hyaline fibromatosis syndrome from the blood

hyaline fibromatosis syndrome (hfs) is rare autosomal recessive disease characterized by the deposition of amorphous hyaline material in skin and visceral organs. it represents a disease spectrum with infantile systemic hyalinosis (ish) being the severe form and juvenile hyaline fibromatosis (jhf) being the mild form. dermatologic manifestations include thickened skin, perianal nodules, and facial papules, gingival hyperplasia, large subcutaneous tumors on the scalp, hyperpigmented plaques over the metacarpophalangeal joints and malleoli, and joint contractures. ish shows a severe visceral involvement, recurrent infections, and early death. the lesions appear as pearly papules or fleshy nodules. the severity is variable. some individuals present in infancy and have additional visceral or systemic involvement, which can lead to early death. these patients may show intractable diarrhea and increased susceptibility to infection. other patients have later onset of a milder disorder affecting only the face and digits. additional features include gingival hypertrophy, progressive joint contractures resulting in severe limitation of mobility, osteopenia, and osteoporosis. histologic analysis of skin lesions shows proliferation of spindle-shaped cells forming strands in a homogeneous and hyaline eosinophilic extracellular material in the dermis. new methods, like mass-spectrometry give a good chance to characterize specific metabolic alterations in the blood of affected patients that allow diagnosing in the future the disease earlier, with a higher sensitivity and specificity. therefore it is the goal of the study to identify and validate a new biochemical marker from the blood of the affected patients helping to benefit other patients by an early diagnose and thereby with an earlier treatment.

Eligibility criteria:
inclusion criteria: * informed consent will be obtained from the parents before any study related procedures. * patients of both gender older than 2 months * the patient has a diagnosis of hyaline fibromatosis syndrome or a high-grade suspicion for hyaline fibromatosis syndrome high-grade suspicion present, if one or more inclusion criteria are valid: * positive family anamnesis for hyaline fibromatosis syndrome * coarse facies * subcutaneous nodule * gingival fibromatosis * skeletal muscle atrophy * progressive flexion contractures exclusion criteria: * no informed consent from the parents before any study related procedures. * patients of both gender younger than 2 months * no diagnosis of hyaline fibromatosis syndrome or no valid criteria for profound suspicion of hyaline fibromatosis syndrome

Keywords: hyaline fibromatosis syndrome biomarker
relationships between quality of ageing and age-related degenerated disease (compalimage)

Conditions: Age-related Degenerated Disease

Summary: this project aims to assess the impact of chronic micro-inflammation on age-related loss of muscle (sarcopenia) and bone (osteopenia). the hypothesis is that chronic micro-inflammation and oxidative stress, which prevalence increases during ageing, may participate in the pathogenesis of both sarcopenia and osteopenia.

in order to explore the effect of a moderate chronic inflammation on skeletal muscle function and protein metabolism and on bone status, two groups of 16 subjects each will be selected according to their inflammatory status ie non-inflamed versus micro-inflamed. the volunteers will be sampled twice at week 0 and week 6 in order to quantify plasma concentration of c reactive protein (crp) using the ultra sensitive assay. the subjects exhibiting crp lower than 1 mg/l twice will be included in the non-inflamed group and the subjects exhibiting crp higher than 3 and lower than 15 mg/l will be included in the micro-inflamed group. during the two weeks before the metabolic studies dietary intakes, dexa, muscle function, vo2 max and biomarkers of bone remodelling will be assessed. volunteers will then be submitted to a diet controlled for its protein content, for 4 days (1 g protein/kg/day and 30 kcal/kg/day) before metabolic investigations. one day before, urine will be collected for metabolomics. on the day of metabolic investigations, after an overnight fast, blood samples will be collected for albumin, fibrinogen, inflammatory cytokine and adipokine determination. then, the subjects will be perfused with l-\[1-13c\] leucine for 8 hours (post absorptive sate then post prandial satte) during which expired gas and blood samples will be taken, as well as 2 muscle biopsies. isotopic enrichments in expired gas, in plasma cetoiscaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins.

Eligibility criteria:
inclusion criteria: * male * body mass index 21 bmi 30 kg/m2 * affiliated to national health insurance * subject giving his written informed consent * subject considered as normal after clinical examination and medical questionnaire. exclusion criteria: * positive serologies to hiv or hcv, determined on blood samples * previous medical and/or surgery judged by the investigator as incompatible with this study * chronic pathologies : diabetes, cardiovascular diseases, cancer, chronic inflammation diseases, renal, pulmonary impairments reported xylocaïne allergy * osteoporosis * prostate hypertrophy * glaucoma * heavy consumer of alcohol * practising intensive physical exercise * being under someone's supervision * refusal to be registered on the national volunteers data file * dietary habits unreliable to controlled food intake * being in exclusion on the national volunteers data file

Keywords: ageing inflammation muscle protein synthesis osteopenia sarcopenia