Kornimate/medical-research-clean huggingface dataset:
perioperative chemotherapy with bevacizumab for colorectal carcinomatosis french part of the main bev-ip study

Conditions: Colorectal Carcinomatosis

Summary: selected patients with peritoneal carcinomatosis (pc) from colorectal cancer (crc) benefit from cytoreductive surgery (crs) combined with intraperitoneal chemoperfusion (ipc). however, even after optimal cytoreduction, systemic and locoregional recurrence are common. perioperative chemotherapy with bevacizumab (bev) may improve the outcome of these patients. the bev-ip study is a phase ii, single-arm, open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous pc. this study evaluates whether perioperative chemotherapy including bev in combination with crs and oxaliplatin-based ipc results in acceptable morbidity and mortality (primary composite endpoint). secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.


Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis. * absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery. * resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy. * complete macroscopic cytoreduction at the time of surgery (cc-0/1) * good general health status (karnofsky index \> 70%) * expected life expectancy more than 6 months * no other malignancy than disease under study * serum creatinine \< 1.5 mg/dl or a calculated gfr ≥ 60 ml/min/1.73 m2 * serum total bilirubin \< 1.5 mg/dl * platelet count \> 100,000/ml * hemoglobin \> 9g/dl * neutrophil granulocytes \> 1,500/ml * international normalized ration (inr) 2 or \< 2 * absence of alcohol and/or drug abuse * no inclusion in other clinical trials interfering with the study protocol * no concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * absence of heart failure (nyha 2 or \> 2) or significant coronary artery disease * no pregnancy or breast feeding * adequate contraception in fertile patients exclusion criteria: * no written informed consent * tumour in the presence of obstruction * evidence of extra-abdominal disease or extensive liver metastasis * peritoneal cancer index \> 25 * active bacterial, viral or fungal infection * active gastro-duodenal ulcer * parenchymal liver disease (any stage cirrhosis) * uncontrolled diabetes mellitus * severe obstructive or restrictive respiratory insufficiency * psychiatric pathology capable of affecting comprehension and judgment faculty * known allergy to oxaliplatin.

Keywords: cytoreductive surgery, hipec, perioperative chemotherapy, peritoneal carcinomatosis, bevacizumab, colorectal surgery
resolution of neuro-muscular block in great obese patients: neostigmine vs sugammadex

Conditions: Resolution of Neuromuscular Blockade

Summary: it is a observational prospective study. the aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.


Eligibility criteria:
inclusion criteria: * great obese * videolaparoscopic surgery exclusion criteria: * age under 18 * no acceptation of informed consent * new york heart association \> 2
effects of 0.2% hyaluronic acid gel-impregnated dental flosses on clinical gingival parameters

Conditions: Gingivitis

Summary: this study aimed to evaluate the effects of 0.2% ha-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis.

gingivitis is a common inflammatory lesion caused by the build-up of oral biofilm and is an essential precursor to periodontitis. for its treatment, oral hygiene habits, such as dental flossing, must be improved, and adjunctive materials, such as hyaluronic acid, may be used to reduce plaque formation and gingival inflammation. this study aimed to assess the effects of 0.2% hyaluronic acid gel (gengigel®)-impregnated dental flosses on the clinical periodontal markers of patients with gingivitis. this clinical study adopted a split-mouth, randomized controlled trial design. after clinical data were assessed at baseline, and supragingival scaling and planing was performed, bilateral gingivitis regions were randomly allocated to either a test group (hyaluronic acid gel-impregnated floss) or a control group (regular floss) using a computer-generated randomization table. clinical parameters were recorded at 1, 2, and 4 weeks after treatment.

Eligibility criteria:
inclusion criteria: 1. ≥18-55 years of age 2. being systemically healthy 3. having gingivitis 4. not to have used any medication in the last three months 5. not smoking 6. right-handed 7. at least 20 natural teeth exclusion criteria: 1. patients with interdental caries 2. patients with orthodontic appliances 3. patients with removable (partial) prostheses 4. patients with oral and/or peri-oral pain 5. patients with significant oral lesions 6. patients with antibiotic use in the last 3 months, pregnancy and breastfeeding 7. patients who have undergone periodontal treatment within the last 6 months

Keywords: hyaluronic acid dental floss gingivitis oral hygiene
extension study evaluating long term safety and activity of agt-181 in children with mps i

Conditions: Mucopolysaccharidosis I

Summary: agt-181 is a fusion protein containing alpha-l-iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. this is a long term safety and tolerability study of agt-181 in patients with mps i who completed the previous 26-week study, agt-181-101. information on the biological activity of the investigational drug will also be collected.

agt-181-101e is a safety and tolerability study of agt-181 in patients with mps i who completed the previous 26-week study, agt-181-101. information on the biological activity of the investigational drug will be collected as well as longitudinal safety information.

Eligibility criteria:
inclusion criteria: * 2 years of age or older (and less than 18) * must have been previously enrolled in study agt-181-101 * written consent and assent as required * female patients must not be pregnant, willing to utilize appropriate birth control methods and undergo pregnancy testing during the study exclusion criteria: * refusal to complete all assessments * pregnant or lactating * received investigational drug within 1 year prior to study enrollment * medical condition or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance * clinically significant spinal cord compression or evidence of cervical instability (i.e. expected to require intervention during study participation) * has developed clinically relevant hypersensitivity/anaphylactoid reactions to agt-181

Keywords: mps i; hurler syndrome
effects of pioglitazone on platelet function

Conditions: Diabetes; Platelet Function; Healthy

Summary: the purpose of this study is to determine how pioglitazone and aspirin affect platelets in the blood of diabetic and non-diabetic subjects. platelets are small cells in the blood that help with blood clotting. pioglitazone is a drug that is used to lower blood sugar and fats by helping the body to use insulin correctly. pioglitazone is presently used to treat diabetes but has not been approved for non-diabetics. this study will determine whether pioglitazone reduces the activity of platelets in people who are or are not also taking aspirin.

blood samples will be taken at time 0 to measure platelet aggregation. 30mg pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. after 6-9 days, subjects will ingest 81mg of aspirin. another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.

Eligibility criteria:
inclusion criteria: * subjects must be over 21 years of age and provide written informed consent. * normal subjects must have a bmi \<30 and must not have known cardiovascular disease, diabetes mellitus (dm), hyperlipidemia, or hypertension. diabetic subjects must have previously diagnosed dm. exclusion criteria: * subjects will be excluded if they have hypersensitivity to aspirin or pioglitazone, or if they are receiving warfarin or heparin therapy, are pregnant, or have congestive heart failure or hepatic function impairment. * subjects must not have taken aspirin or other drugs inhibiting platelet function such as plavix or non-steroidal anti-inflammatory drugs for 7 days. * subjects will be excluded if they have a history of renal failure, severe liver disease, myeloproliferative disease or other conditions that impair platelet function.

Keywords: pioglitazone thiazolidinediones platelet function platelet aggregation diabetic aspirin.
a trial of two mask systems in preventing sars cov-2 in healthcare workers (hcw)

Conditions: SARS CoV-2 Infection; Influenza -Like Illness

Summary: a cluster randomized trial will be conducted to evaluate the difference between an acteev™ system (acteev™ n95 masks yqd8008 during shifts+ acteev™ fabric masks in community) and a standard system (standard n95 masks during shifts+ fabric masks in community) in preventing severe acute respiratory syndrome coronavirus 2 (sars cov-2)in healthcare workers(hcws).

this is a maximum 10-week (8-week intervention+2-week follow up) two-armed controlled study to investigate efficacy of acteev™ system (acteev™ n95 masks yqd8008 during shifts+ acteev™ fabric masks in community) compared with standard system (standard n95 masks during shifts+ fabric masks in community) in hcws working in high-risk hospital wards (icu, emergency), against the prevention of sars cov-2 infection. prospective hcws will be identified for the study by the study investigator/study team and be invited for participation in the study. all study procedures will begin only after obtaining written informed consent from the subjects. subjects will be randomized in one of the two arms mentioned below after meeting all the study eligibility criteria: arm 1:acteev™ system (acteev™ n95 masks yqd8008 during shifts+ acteev™ fabric masks in community) arm 2: standard system (standard n95 masks during shifts+ fabric masks in community).

Eligibility criteria:
inclusion criteria: * health care workers and allied health care staff working in covid wards, covid icu, non covid icu (this will include all specialty icus in the hospital), casualty/emergency, operation theatre and pathology lab of the hospital * health care workers and allied health care staff involved in performing high risk procedures like suctioning, intubation, nebulized medications, chest physiotherapy, other aerosol generating procedures and handling pathology samples * negative covid 19 rt-pcr test within last 3 days of screening * covid 19 vaccinated or non-vaccinated exclusion criteria: * unable or refused to consent * current respiratory illness, rhinitis and/or allergy * currently participating in any other clinical trial * beard or facial hair

Keywords: clinical respiratory illness (cri)
impact of pediatrician intervention on the smoking habits of parents of sick children

Conditions: Tobacco Consumption; Bronchiolitis

Summary: reducing tobacco consumption is a major public health objective, with the prevalence of active smoking estimated in 2017 at 26.9% of the french population aged 18 to 25. the negative impact of passive smoking on children's health and development has been demonstrated by numerous studies, especially with regard to respiratory pathologies. parental smoking is also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of 1.72 if at least one of the two parents is a smoker). it has been shown that intervention with parents can reduce the number of children exposed to passive parental smoking by about 5%.

reducing tobacco consumption is a major public health objective, with the prevalence of active smoking estimated in 2017 at 26.9% of the french population aged 18 to 25. the negative impact of passive smoking on children's health and development has been demonstrated by numerous studies, especially with regard to respiratory pathologies. parental smoking is also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of 1.72 if at least one of the two parents is a smoker). it has been shown that intervention with parents can reduce the number of children exposed to passive parental smoking by about 5%. the paediatrician's role is therefore to try to make parents aware of the consequences of tobacco consumption on their children's health and to encourage them to stop smoking. minimal advice (simple, clear, written and oral information on the actors and means of helping to stop smoking) is the first step in triggering an attempt to stop smoking. the paediatrician seems to be a particularly influential actor since he intervenes at a time when parents are trying to improve their child's health. the minimum advice would have an effectiveness of 2-5% on smoking cessation in general. there is no data on the impact of this minimum advice when given by paediatricians. there are also no data on the current prevalence of smoking in france among parents of children with various chronic diseases, such as cystic fibrosis or diabetes. it is also necessary to describe the smoking habits of parents, as children's exposure and its impact on their health depends in particular on where their parents smoke.

Eligibility criteria:
inclusion criteria: * parents of legal age, of children being followed for cystic fibrosis or type 1 diabetes or being hospitalized for the first time for bronchiolitis. * having given their non-opposition to participate in the research * covered by a social security scheme exclusion criteria: * refusal to participate * parent already in the process of quitting smoking * adult person under guardianship/curators or safeguard of justice

Keywords: tobacco consumption
evaluation of vaccination coverage and determinants of success of the covid-19 vaccination program among populations in very precarious situations

Conditions: COVID-19

Summary: the main objective of the study is to assess the level of vaccination coverage (vc) against covid-19 among migrants, homeless and travelling community, according to their living conditions and housing. the secondary objectives are : * to compare the estimated level of vaccination coverage in the different sites and strata (emergency shelters/hotels, camps, workers' hostels, on the street) with the estimated level in the general population of the same territory obtained from the french health insurance data (sivac). * identify the obstacles and leverage of vaccination (i.e. mobile team) according to living conditions and habitat (socio-demographic factors, personal health history, vaccine adherence, local health policies, etc.).


Eligibility criteria:
inclusion criteria: * adult (18 years and older) * people considered as homeless (homeless, living in a camp or squat) or * living in adapted housing (migrant workers' hostel) or * housed in residences of the national system or * housed in a social residence such as a 115 hotel or a social housing centre * freely and voluntarily consenting to participate exclusion criteria: * refusal to participate in the study (non-consent). * language barrier with no in-person or telephone translation available. * impossibility to give free and informed consent (comprehension barrier, cognitive and/or psychiatric and/or addictive disorders, external pressure from family and friends, persons under guardianship, etc.).

Keywords: vaccination coverage migrants homeless travelling community
dna methylation biomarkers for cervical cancer screening

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer

Summary: the purpose of this prospective study is to evaluate whether dna methylation can be applied in cervical cancer screening.


Eligibility criteria:
inclusion criteria: * women with age ≥20 and sexual experience * agree to sign icf exclusion criteria: * women had received hysterectomy * women had destructive therapy for cervical lesions in 6 months, for examples: conization, laser or cryotherapy, chemotherapy, and radiation therapy * women are at pregnancy or had baby delivery in 6 weeks

Keywords: dna methylation cervical cancer
leap motion controller for pain during venipuncture in pediatrics

Conditions: Procedural Pain; Venipuncture

Summary: venipuncture is the most frequent invasive procedure in hospitals and clinics. in the pediatric population this is very often associated with fear, anxiety, distress and enhanced perception of pain. local anesthetic creams (like emla) are used to reduce pain and distress but they need 30-60 minutes of waiting between the application and the puncture, which is too much time for most of everyday life clinical contests. many distraction techniques have been studied, both active (ie video games, virtual reality) and passive (ie listening to music, visual stimulation). active production of music is one of the most complex activities for our central nervous system. it requires a precise timing of a lot of well-coordinated actions, like recognition and conservation of a rhythmic structure, precise execution of quick and complex fine movements, and with an important involvement of intense emotional experience. it stimulates bilaterally primary and secondary auditory cerebral areas, but also motor and premotor areas, language areas and their contralateral, cognitive areas. at the same time, it activates reward and gratification circuits with stimulation of the limbic system and endorphin release and also neurovegetative system. music is probably the most immediate and spontaneous communication tool that can also act at subcortical level without the person being aware of what they are receiving and transmitting. music activates the dopaminergic mesolimbic system, which regulates memory, attention, executive functions, motivation and also mood and pleasure through the nucleus accumbens. it also produces measurable cardiovascular and endocrine responses indicated by reduced serum cortisol levels and inhibition of cardiovascular stress reactions. the leap motion controller is an infrared device that digitalizes the movements of the hand above it in real-time: this is connected with a software that converts this signal into a musical tone specifically set. the melody is created very easily just by moving the hand above it. with this device, children will be able to produce music without anything interposing between them and the sound production. this will allow the patient to focus only on the melodies, without technical difficulties that could derive for instance from a visual interface or an instrument you have to hold.


Eligibility criteria:
inclusion criteria: * children aged 8-17 years undergoing venipuncture exclusion criteria: * patients with cognitive impairment * patients who do not understand the italian language or with parents who are unable to provide a written informed consent in italian language * patients medicated with local anaesthetic cream

Keywords: procedural pain venipuncture children, distraction
d-dimer in patients with atrial fibrillation receiving anticoagulation therapy

Conditions: Atrial Fibrillation; Strokes Thrombotic

Summary: this is a sigle-center, prospective study to evaluate the role of d-dimer testing in patients with atrial fibrillation receiving dabigatran or warfarin anticoagulation therapy.

patients with atrial fibrillation receiving dabigatran or warfarin anticoagulation therapy was screened and signed to two group: dabigatran group and warfarin group. d-dimer test was analyzed before and 3 months after anticoagulation starting specificly. patients were followed-up for at least 12 months,and clinical outcomes, including thrombotic events major bleeding events and all-cause deaths were recorded during follow-up period.

Eligibility criteria:
inclusion criteria: * non-valvular atrial fibrillation * receiving oral anticoagulation therapy and have good compliance exclusion criteria: * life expectancy less than 1 year * thrombosis or major bleeding history within 3 months * refusal to participate
non-interventional study on effectiveness of elxaban tab. in patients with non-valvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is prospective cohort study which was performed in multicenter (general hospital) in korea. inclusion criteria is patients with atrial fibrillation taking elxaban (generic drug of apixaban) who visit hospital. the purpose is to analyze bleeding (major bleeding, minor bleeding), stroke, systemic embolism, death, other clinical events (acute myocardial infarction, pulmonary embolism, transient ischemic attack, hospitalization), drug adherence, questionnaire of life quality (afeqt), cognitive function (kdsq) according to the use of elxaban.


Eligibility criteria:
inclusion criteria: 1. patients with atrial fibrillation taking elxaban (patients with age more than 19) 2. patients who agree with study inclusion exclusion criteria: 1. patients who do not agree with study inclusion 2. patients with age less than 19 3. pregnancy, breastfeeding

Keywords: elxaban