Kornimate/medical-research-clean huggingface dataset:
french version of the scales of fear of hypoglycaemia in children with type 1 diabetes and their parents

Conditions: Diabetes Type 1

Summary: type 1 diabetes usually appears brutally in children or young adults. while many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. it would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal. if there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (hfs, hypoglycemia fear survey is available in three versions: l'hfs-child (hfs-c) for children over 6 years old, hfs-parents of young children ( hfs-pyc) for parents of young children (under 8 years of age) and hfs-parents (hfs-p)) for parents of children over 8 years of age, on the other hand, there are no french and no french studies have evaluated the prevalence and impact of the fear of hypoglycemia in french patients with type 1 diabetes. it is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. having a tool in french and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) in order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia


Eligibility criteria:
inclusion criteria: * age between 2 and 18 years * type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody * insulin-treated type 2 diabetes by daily injections or insulin pump exclusion criteria: * trouble to read * trouble to understand * trouble to answer to the questionnaire * opposition.

Keywords: diabetes type 1 child ans teenager fear of hypoglycaemia
periodontal care and glycemic control in diabetes

Conditions: Diabetes Mellitus; Poor Glycemic Control; Peridontal Disease

Summary: diabetes is a prevalent and costly disease among users of va care. goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. improvements in periodontal status may also improve diabetes control.

background: diabetes is a prevalent and costly disease among users of va care. goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. improvements in periodontal status may also improve diabetes control. objectives: this project will determine the efficacy of a program of periodontal screening and therapy in improving the level of glycemic control in poorly controlled diabetics. methods: status: subject accrual is complete. data collection is ongoing.

Eligibility criteria:
inclusion criteria: patients must have diabetes mellitus, and hbalc \>9, \>8 teeth, and cpitn scores of 3 or 4 in, at least 2 sextants of the mouth, indicating moderate to high peridontal treatment need. exclusion criteria:
the influence of perioperative administration of dexmedetomidine on inflammation response and postoperative outcomes in patients undergoing hyperthermic intraperitoneal chemotherapy (hipec) cytoreductive surgery; double blind randomized controlled trial

Conditions: Colon Cancer

Summary: cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (hipec) has been reported to be an effective treatment approach for peritoneal cancer, however, the stress response to hipec is major neuroendocrine and cytokine response, which has been considered as the homeostatic defense mechanism. recently, dexmedetomidine has been suggested to exhibit anti-inflammatory properties. this study was designed to evaluate the effect of perioperative administration of dexmedetomidine on inflammation response and postoperative outcomes in patients undergoing hyperthermic intraperitoneal chemotherapy (hipec) cytoreductive surgery.


Eligibility criteria:
inclusion criteria: * patients between 20 and 70 years old * obtaining written informed consent from the patients who were undergoing hyperthermic intraperitoneal chemotherapy (hipec) cytoreductive surgery * weights under 90 kg and bmi under 32 exclusion criteria: * emergency operation * re-operations * combined surgery over 4 departments. * cardiac disease (unstable angina, congestive heart failure, valvular heart disease) * ventricular conduction abnormality * prior pacemaker insertion * uncontrolled hypertension (diastolic blood pressure \> 110mmhg) * bradycardia (hr \< 40 bpm) * cerebral vascular disease (cerebral hemorrhage, cerebral ischemia) * hepatic or renal failure * patients who take antiarrythmic agent * neurological or psychiatric illnesses * foreigner and patient who can not read the letter
effects of mother's voice and heartbeat sounds on preterm newborns

Conditions: Preterm Birth

Summary: the purpose of this rct is to learn more about how sounds that we experience in the womb can affect early development in premature infants. the investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. the investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.

the purpose of this rct is to learn more about how sounds that we experience in the womb can affect early development in premature infants. the investigators are specifically interested determining whether and what types of maternal auditory stimulation can influence physical growth, brain maturation, respiratory stability (including heart rate, respiratory rate and oxygen saturation levels) as well as early vocalization prior to 40 weeks gestation. the investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental outcomes in premature infants and will increase their potential to grow into healthy children.

Eligibility criteria:
inclusion criteria: * born between 24-36 weeks ga. exclusion criteria: * chromosomal or congenital anomalies; congenital infections; \> grade ii ivh; * maternal use of tobacco, alcohol, or illicit drugs; * significant abuse or malnutrition during pregnancy, * failed abr. * no exclusions based on gender or ethnicity.

Keywords: neonatal care, preterm, maternal sounds, auditory stimulation
newborns of obese mothers

Conditions: Obesity

Summary: this was a prospective bi-centric study, exposed-unexposed. in an effort to better understand the potential independent effect of maternal obesity on fetal growth, investigators designed a prospective study, comparing fetal growth between normal weight (18.5 ≤ bmi \< 25 kg/m2) or obese pregnant women (bmi ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was screened and treated throughout pregnancy.

the study population concerned obese pregnant women (bmi ≥ 30 kg / m² before pregnancy) and their newborn and normal weight pregnant women (18.5 ≤imc \ 40 years, multiple pregnancy, first consultation after 18 wg, pregestational diabetes, obesity due to genetic disorder or secondary to intracranial tumor or radiotherapy, bariatric surgery, chronic diseases other than the obesity, inability to converse in french language. the matching criteria for controls were: age ± 5 years, primigravida or multigravida, duration of gestation ± 4 weeks. the main objective of this project was to assess the independent effect of maternal obesity: * on the weight and adipose tissue of newborn * on the function of adipose tissue (production of leptin and adiponectin) * on fetal growth factors (c-peptide, igf-1) * on carbohydrate metabolism of the newborn. two maternities were involved in the study: pitié salpêtrière and armand trousseau, in paris, france. this research was conducted over a 3 years period. the duration of participation of each woman corresponded to the duration of pregnancy care and duration of care for the newborn immediately after birth, usually the length of stay in the maternity. the only differences compared to the usual care included: * additional oral glucose tolerance test at 32 weeks of gestation; * determination of fasting blood glucose during late pregnancy * maternal blood samples on arrival at the delivery room * drawing blood from the umbilical cord after section; * skinfold measurement of the newborn within 72 hours of life.

Eligibility criteria:
inclusion criteria: 1. - bmi ≥30 kg / m² or between 18.50 and 24.99 kg / m². 2. - pregnant woman coming to the centre before 18 weeks of gestation. 3. - age ≥ 18 and ≤ 40 years 4. - single pregnancy 5. - no constitutional or progressive disease other than obesity: inflammatory disease, epilepsy, pathology psychiatric, tumor... 6. - informed written consent. exclusion criteria: 1. - pregnant woman coming to the center after 18 weeks of gestation, bmi \<18.5 kg / m² or between 25 and 29.99 kg / m². 2. - age \ 40 years 3. - multiple pregnancy 4. - presence of a constitutional disease or progressive disease other than obesity. 5. - patients who underwent obesity surgery type "bypass" or gastroplasty 6. - obesity secondary to genetic disorder, intracranial lesions or pituitary radiotherapy 7. - not stabilized endocrine pathology. 8. - pregestational diabetes 9. - no affiliation to a social security scheme

Keywords: diabetes, obesity, skinfold, newborn
folate supplementation in schizophrenia

Conditions: Schizophrenia

Summary: this study aims to examine factors potentially contributing to differences in blood folate, homocysteine or b12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.

this study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the sans global assessment subscales, with the exception of the attention global assessment subscale. the specific aims of this study are: * to examine factors potentially contributing to differences in blood folate, homocysteine or b12 levels between patients at baseline, including dietary intake and cigarette smoking. * to test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. we will also control for dietary intake cigarettes smoking, gender, and age. * to examine the efficacy of folate supplementation for reducing negative symptoms

Eligibility criteria:
inclusion criteria: 1. schizophrenia, any subtype 2. ages 18-68 3. male or female 4. a score at least a 3 (moderate or greater severity) on at least one of the sans global assessment subscales, with the exception of the attention global assessment subscale 5. stable antipsychotic dose for \> 6 weeks 6. capable of providing informed consent exclusion criteria: 1. unstable medical illness 2. substance abuse 3. megaloblastic anemia 4. non-english speaking

Keywords: schizophrenia negative symptoms folate
the teaspoon study - telefitting spinal cord stimulation for pain

Conditions: Spinal Cord Injuries; Chronic Pain

Summary: spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. this study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). each participant will try out all types of available stimulation but be blinded to the type. over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.


Eligibility criteria:
inclusion criteria: * 22 years of age or older * scheduled to undergo spinal cord stimulation * english speaker * baseline pain rating (nrs/vas) \>=6 exclusion criteria: * scheduled for permanent implantation only without trial * presence of pacemakers or other neurostimulators * pregnant * inability to read or use smart phone * individuals who are unable to consent * employees or students of pi * prisoners
conduct disorder in prison: search for prospective and retrospective recurring and contextual elements

Conditions: Mental Disorders

Summary: the prediction of dangerousness remains a delicate subject, relevant in current psychiatry. scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. the french high authority of health (has) recommends to identify and prevent risk situations of violence and to develop research at this level. some authors have worked on criminal career and became interested in risk factors for aberrant driving behaviors but also in environmental or clinical elements accompanying these phases. to our knowledge, no specific study about contextual elements before misconduct and which could lead to aberrant driving behaviors among individuals diagnosed with antisocial personality disorder has been described to date the investigators propose to follow individuals diagnosed with antisocial personality disorder in prison during 6 months in order to list their conduct disorders and contextual elements upstream of these misconducts. the investigators will also study the effect of contextual factors related to judicial steps on the appearance of aberrant driving behaviors.

this study aims at identifying elements that can provoke frustration and lead to aberrant driving behaviors. the question is whether there are triggers that occur more frequently for the same subject. if so, these specific contextual elements could be detected in order to prevent violent acts.

Eligibility criteria:
inclusion criteria: * male * over 18 * detention sentence in prison in rochefort between march and august 2015 * positive psychopathy score at pcl-r (psychopathy checklist-revised) test: score greater than or equal to 30 exclusion criteria: * chronic psychosis * bipolar disorder * women * minors, * negative score at the pcl-r * subject under protection measure (curator or guardian) * refusal to participate
vitd and barrier function in ibd

Conditions: Crohn's Disease

Summary: increased intestinal permeability is detectable in clinically active crohn's disease, in stable crohn's disease and is predictive of clinical relapse. maintenance of the epithelial barrier integrity is therefore essential for intestinal homeostasis. vitamin d may have a critical role in improving barrier function.


Eligibility criteria:
inclusion criteria: * all patients must fulfill the clinical criteria for diagnosis of cd as defined by lennard-jones et al. (1976) * all patients must be in clinical remission for at least 1 month at study entry as defined by a crohn's disease activity index (cdai) of \<150 * 18-65 years * patients on stable drug therapies for at least 1 month pre-enrolment * sufficient english language ability to carry out the study requirements exclusion criteria: * symptomatic cd at study entry including cdai \>150 * pregnancy * previous extensive small bowel resection (less than 200 cm of viable small bowel or a loss of 50% or more of the small intestine) * presence of an ileostomy or colostomy * known hypersensitivity to vitamin d * hypercalcaemia (corrected serum calcium \> 2.66 mmol/l) * those currently using supplemental vitamin d \>800 iu/d * diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, renal failure, pseudohyperparathyroidism, malignancy, active, lymphoma, short bowel syndrome * antibiotic use in the 4 weeks prior to enrolment * current use of bisphosphonates * renal impairment, diabetes mellitus * patients participating in a concurrent rct * alcohol dependency

Keywords: crohn's disease vitamin d intestinal permeability tara raftery
a study to assess the effectiveness and safety of treatment with vedolizumab in adult participants with ulcerative colitis (uc) or crohn's disease (cd) in real life

Conditions: Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Summary: the purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

this is a prospective, non-interventional and pharmaco-epidemiological study of participants with ibd. the study will provide the real-life data of treatment effectiveness and safety of vedolizumab in adult participants with uc or cd. the study will enroll approximately 300 participants. all participants will be enrolled in one observational group: vedolizumab data will be collected and observed for 24 months in the participants who will be freely chosen by physicians to prescribe vedolizumab at the end of consultation in the recruitment period. this multi-center trial will be conducted in france. the overall time to participate in this study is 36 months, including participant's recruitment period of 12 months and treatment period of 24 months. participants will make a minimum of 4 follow-up visits to the clinic in treatment period at month 6, 12, 18, and 24.

Eligibility criteria:
inclusion criteria: 1. suffering from active disease of uc or cd according to the investigator's judgment. 2. in failure or intolerant to a previous biologic treatment, or with contra-indication to anti-tnfalpha after failure of conventional treatments, regardless of the line of treatment. 3. meeting the same criteria as those described at the pre-screening. 4. prescription of vedolizumab during consultation. 5. able to be followed a priori over a period of 24 months. exclusion criteria: 1. with exclusion criteria for vedolizumab and any contra-indication to vedolizumab: hypersensitivity to the active substance or to any of its excipients, active severe infections, such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (pml). 2. participation in an interventional study (but not in another non-interventional study). 3. unclassified colitis. 4. stomy.

Keywords: drug therapy
gene therapy in treating patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: phase i trial to study the effectiveness of gene therapy in treating patients with ovarian cancer that has not responded to previous treatment. inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer cells more sensitive to treatment.

objectives: i. determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and paclitaxel-resistant ovarian epithelial cancer. ii. determine the qualitative and quantitative toxic effects of this regimen in these patients. iii. document the observed anti-tumor activity of this regimen in these patients. iv. evaluate the biological endpoints (e.g., induction of apoptosis, p53 expression) of this regimen in these patients. outline: this is a dose escalation study. patients undergo laparoscopy for p53 assessment and catheter placement. patients receive daily intraperitoneal injections of adenovirus p53 (ad-p53) for 5 days every 3 weeks. treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients each are treated at each dose level of ad-p53. the maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic ovarian epithelial cancer that is platinum- and paclitaxel resistant as defined by: disease progression while on first-line regimen containing both a platinum drug and paclitaxel or tumor progression within 6 months of completion of platinum-based therapy (either as first- or second-line) or paclitaxel-based therapy (either as first- or second-line) * refractory or recurrent ovarian epithelial cancer as defined by: lesions of any diameter * nonmeasurable disease (with ca-125 at least 35) * ascites and/or pleural effusions allowed * no borderline or low malignant potential tumors patient characteristics: * age: 18 and over * performance status: zubrod 0-2 * life expectancy: at least 12 weeks * wbc at least 3,000/mm3 * granulocyte count at least 1,500/mm3 * platelet count at least 100,000/mm3 * bilirubin no greater than 1.5 mg/dl pt/ptt normal * creatinine no greater than 1.4 mg/dl * no active, unresolved upper respiratory infections * not hiv positive * at least 5 years since prior malignancy, except nonmelanomatous skin cancer * willing and able to undergo placement of tenckhoff catheter in the peritoneal cavity for sampling of ascites or peritoneal fluid * no concurrent serious medical illness * no untreated gastrointestinal obstruction * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: * may have failed an unlimited number of prior chemotherapy regimens * at least 30 days since prior chemotherapy * no prior radiotherapy to the pelvis or abdomen * eligible for laparoscopy

Keywords: stage iv ovarian epithelial cancer recurrent ovarian epithelial cancer
phase iii trial of adjuvant chemo-radiotherapy after d2 surgery of gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to explore the efficacy of adjuvant radiotherapy for d2 resected gastric cancer

the radiotherapy dose of 45gy in 25 fractions as adjuvant treatment after d2 surgery for gastric cancer

Eligibility criteria:
inclusion criteria: 1. aged 18-75； 2. had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction； 3. ecog 0-1； 4. subjects has to voluntarily join the study and sign the informed consent form for the study; 5. d2 and r0 resection; 6. locally advanced (uicc stage, t4, n2, n3) gastric cancer after surgery; 7. more than 15 lymph nodes; 8. adequate organ function as defined below: hematologic anc ≥ 2\*109/l, platelets ≥ 100\*109/l, ast and alt ≤ 2.5×uln, tbil ≤ 1.5×uln. exclusion criteria: 1. previous radiotherapy or chemotherapy； 2. inadequate organ function; 3. pregnant or lactating women or women of childbearing potential.

Keywords: gastric cancer radiotherapy postoperative