Kornimate/medical-research-clean huggingface dataset:
hematological anomalies in children with rasopathy

Conditions: RAS Mutation

Summary: during childhood, patients with rasopathies (noonan syndrome and related diseases) can harbor various hematological anomalies ranging from isolated monocytosis, myelemia, thrombocytopenia or splenomegaly to myeloproliferative disorders. these anomalies may spontaneously disappear or persist, sometimes leading to juvenile myelomonocytic leukemia. guidelines for initial screening and subsequent hematological follow-up have recently been published in france: peripheral blood analysis should be performed in all newly diagnosed patients and followed by biannual peripheral blood analysis in infants until the age of 2 years. in order to describe the characteristics of these abnormalities in terms of their incidence, age of occurrence, evolution and relation to genotype, we are conducting a longitudinal prospective study whose aim is to analyze peripheral blood cell counts and smears at diagnosis and one year later. in patients \<3 years of age recruited at certain centers, biobanking of mononuclear cells will be performed. these data could yield a new insight into hematological anomalies in patients with rasopathies and thereby help physicians to determine the appropriate rhythm for hematological follow-up according to genotype.


Eligibility criteria:
inclusion criteria: * age \< 16 years * patient newly diagnosed with genetically confirmed rasopathy : noonan syndrome, type 1 neurofibromatosis, noonan syndrome with multiple lentigines, cbl syndrome, costello syndrome, cardiofaciocutaneous syndrome or legius syndrome i.e. with a germline mutation of one of these genes: ptpn11, sos1, nras, raf1, braf, shoc2, mek1, mek2, cbl, nf1, spred1, kras, hras, nf1, shoc2, lztr1, sos2, rit1, rasa2, rras, ppp1cb, or a new gene of interest published during the recruitment period * no history of hematological malignancy * written informed consent obtained from the parents * health insurance exclusion criteria: * history of malignant hematological pathology

Keywords: rasopathie
signatures of immune reprogramming in anti-cd52 therapy of ms: markers for risk stratification and treatment response

Conditions: Multiple Sclerosis

Summary: alemtuzumab is a highly effective therapy in relapse remitting multiple sclerosis (rrms). the aim of this study is to elucidate the mechanism of action of the neuroprotective potential of alemtuzumab in rrms. therefore, the investigators will semi-annually analyse blood samples of rrms patients treated with alemtuzumab up to 36 months. using in vitro/ ex vivo assays the investigators aim to detect and characterize immune cells including their functional activity. furthermore, the study aims to combine this analysis with clinical data (mri, edss: expanded disability status scale, msfc: multiple sclerosis functional composite) to reveal the underlining mechanism of action of alemtuzumab to further improve its efficacy and safety for present and future patients.


Eligibility criteria:
inclusion criteria: * diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before prior to signing the informed consent form (icf) * age \> 18 years * written informed consent to study participation exclusion criteria: * medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, or to complete the study * any progressive form of ms * any condition that serves as a contraindication for alemtuzumab treatment * any disability acquired from trauma or another illness that could interfere with the evaluation of disability due to ms * major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage * significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis * inability to undergo mri with gadolinium administration
safety and efficacy of blue star max-5 lenses in myopia control

Conditions: Myopia, Progressive

Summary: the goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in chinese children aged 8-11 years with refractive error ranging from -0.50d to -6.00d. participants will wear spectacles and receive follow-up examinations every half year.


Eligibility criteria:
inclusion criteria: * aged 8 to 11 years; * under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 d in each eye and astigmatism of not more than 1.50 d and anisometropia of not more than 1.50 d; * best-corrected visual acuity of equal or better than 0.00 logmar (\>= 1.0 as snellen). * the intraocular pressure of 10 to 21mmhg. * volunteer to participate in this clinical trial with signature of the informed consent form. exclusion criteria: * history of eye injury or intraocular surgery; * clinically abnormal slit-lamp findings * abnormal fundus examination * ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function; * systemic diseases causing low immunity (such as diabetes, down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); * participation of the drug clinical trial within three month and the device clinical trial within one month; * only one eye meets the inclusion criteria; * unable to have regular follow-up * participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Keywords: concentric columnar microstructure myopia control
doripenem in the treatment of complicated intra-abdominal infections

Conditions: Bacterial Infections and Mycoses; Appendicitis; Cholecystitis; Pancreatitis; Peritonitis

Summary: the purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.

doripenem is an antibiotic medication not yet approved by the us fda. this is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. doripenem or comparator is administered. the primary endpoint is the clinical response measured at late follow-up visit. the patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

Eligibility criteria:
inclusion criteria: * has a requirement for surgical intervention within 24 hours of study entry * requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections exclusion criteria: * female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control * any rapidly-progressing disease or immediately life-threatening illness

Keywords: complicated intra-abdominal infections appendicitis cholecystitis peritonitis
pharmacokinetic study of diazoxide choline in hypertriglyeridemic subjects

Conditions: Hypertriglyceridmia

Summary: once a day oral administration with dccr is the optimal dosing regimen

population the population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dl and ≤ 1500 mg/dl at the screening visit. number of subjects a total of 10 subjects will be enrolled in the study at 1 site in the usa.

Eligibility criteria:
inclusion criteria: basic requirements 1. healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing 2. body mass index (bmi) between 22 and 35 kg/m2 specific laboratory test results 3. fasting triglyceride ≥ 150 mg/dl and ≤ 1500 mg/dl 4. fasting glucose ≤ 110 mg/dl 5. hba1c ≤ 6.0 % exclusion criteria: medications: recent, current, anticipated 1. thyroid hormones or preparations within 1 month prior to screening visit (except in subjects on stable dose of replacement therapy for at least 1 month) 2. thiazide diuretics within 2 weeks prior to screening visit history of allergic reaction or significant intolerance to: 3. diazoxide 4. thiazides 5. sulfonamides lifestyle changes 6. subjects intending to change exercise habits, and/or quit smoking specific diagnoses, medical conditions and history 7. known type i or iii hyperlipidemia 8. known type 1 dm 9. known type 2 dm 10. any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the investigator specific laboratory test results 11. any relevant biochemical abnormality interfering with the assessments of the investigational drug

Keywords: dccr diazoxide chonline controlled-release tablet = dccr hypertriglyceridemia triglycerides pharmacokinetics
study of people's profile living in france who could be interested in the use of a nanohydroxyapatite toothpaste

Conditions: Dental Caries; Hydroxyapatite

Summary: nano-hydroxyapatite is an interesting candidate to be a substitute for fluor in toothpastes or a complement to fluorides in order to prevent caries. the objective of this transversal descriptive study is to evaluate the profiles of people living in france who could be interested in using a nano-hydroxyapatite based toothpaste. participants in this transversal descriptive study have been chosen by a self-administered method. before answering 16 questions, the participants were asked to watch a short video describing the main concepts to know about fluoridated toothpastes and nano-hydoxyapatite toothpastes. pros and cons of each one them were mentioned. in order to compare the answers, pivot tables have been produced.


Eligibility criteria:
inclusion criteria: * internet acces * interested in the use of a nanohydroxyapatite toothpaste exclusion criteria: * age \< 18 years * peoples who no lives in france

Keywords: cariostatic agents toothpaste
pre-eclampsia prediction by doppler screening of uterine arteries and angiogenic factors in second trimester of pregnancy

Conditions: Pregnancy; Pre Eclampsia

Summary: background: pre-eclampsia complicates about 2% of pregnancies. it accounts for at least 50 000 maternal deaths per year worldwide and is the second most common cause of maternal death in the developing world. also, pre-eclampsia is the commonest cause of iatrogenic prematurity, it frequently coexists with intrauterine growth restriction (iugr) and placental abruption, other important causes of adverse prenatal outcome. there have been many studies investigating whether the disease can be prevented. in order to achieve this, one needs to be able to identify firstly those women that are at highest risk of the disease. early studies showed that impedance to flow in the uterine arteries decreases with gestation in normal pregnancies, while in pregnancies with established pre-eclampsia or iugr the impedance is increased. these observations led to a number of screening studies in the second trimester, which assessed if it is possible to predict those pregnancies destined to have complications of impaired placentation. these studies showed that women with increased impedance to uterine artery blood flow have an increased risk of developing pre-eclampsia, and detection can be further increased by using angiogenic factors (that are involved in the pathogenesis of pre- eclampsia and could be useful for early prediction of the disease: vegf, pigf, pp13, sflt1) in combination with uterine arteries doppler study in the second trimester. methods: in this study we would like to add uterine arteries doppler to the early routine detailed ultrasound examination (14-16 weeks), in 3000 women in jerusalem. in addition we would like to check angiogenic factors from the serum blood taken for the routine triple test in these women (16-18 weeks).pregnancy outcome would be collected after labour from the medical centers participating in this research.


Eligibility criteria:
inclusion criteria: * pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination, in jerusalem, israel exclusion criteria: * none

Keywords: pre eclampsia doppler uterine arteries angiogenic factors
estramustine, etoposide and paclitaxel treatment for hormonally responsive adenocarcinoma of the prostate

Conditions: Prostate Cancer

Summary: hormonal therapy is the standard treatment for prostate cancer which has spread to other areas of the body. despite the high initial response rates to hormonal therapy, the vast majority of men will develop cancer which is no longer responsive to hormone deprivation. the average time for hormonal therapy to be effective is about 18 months. chemotherapy combinations which can treat the disease when it no longer responds to hormonal therapy have been developed, but these treatments are not curative. one of these combinations is estramustine, etoposide and paclitaxel. in men with far advanced disease, 60% will have a decrease in their psa (prostate specific antigen) or shrinkage of tumors after treatment with this chemotherapy. despite this, these men have all developed further disease progression requiring additional treatment. one possible way to make chemotherapy more effective is to give it when the number of tumor cells is smallest, and the number of cells to be killed is at a low level. one situation in which this is true is when a man has responded to hormonal therapy any tumors are at their smallest size. this study will test whether the addition of chemotherapy at that time will prolong the time until the cancer becomes unresponsive to hormonal therapy.


Eligibility criteria:
all patients must have a histologic diagnosis of adenocarcinoma of the prostate with evidence of metastases on bone or ct scan. patients with regional metastases to pelvic lymph nodes (d1 disease) as their only site of metastases will be excluded from this study. patients on androgen suppression therapy at the time of registration must have received less than seven months of therapy (excluding any neoadjuvant hormonal therapy) and must have a decreasing or stable psa level. patients may not be undergoing concurrent chemotherapy, biologic therapy, or radiation therapy. prior to radiation therapy must have completed more than 4 weeks prior to registration. patients may not have received prior cytotoxic chemotherapy. patients may not have evidence of brain metastases or untreated spinal cord compression.
postoperative radiotherapy according to molecular analysis of surgical margins of oral and oropharyngeal scc

Conditions: Oral Cancer; Oropharynx Cancer

Summary: there is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. loco-regional control rates range between 80-85% at five years. surgical margins molecular analysis for microsatellite instability (msi) marker could help to select the high-risk patients who should receive postoperative radiotherapy. we expect to include 120 patients in five years and have 60 informative tumors for msi marker. patients with positive molecular margins will receive postoperative radiotherapy (50 gy). patients with negative molecular margins will not receive radiotherapy.


Eligibility criteria:
inclusion criteria: * oral and oropharynx (exclusion vallecula) squamous cell carcinoma * t1 or t2 * unique, untreated tumor * n0 or nodes \<3cm * complete pathological resection * no perineural spread, vascular emboli \<5 * pn0 or \<=2n+r- * signed inform consent exclusion criteria: * vallecula carcinoma

Keywords: oral and oropharynx carcinoma surgery postoperative radiotherapy molecular analysis microsatellite instability
the effects of long-term consumption of full-fat dairy products on satiety, body weight and glycemic control

Conditions: Overweight or Obesity; Body Weight

Summary: the proposed study looks at the effect of long-term diet modification with or without full-fat dairy products or restrictive eating on body weight, body composition and cardiometabolic markers in healthy overweight/obese men and women.

a total of 93 males and females will participate in the study at the university of toronto. at the beginning and after 12 weeks, body weight, composition will be measured through bodpod scans. resting metabolic rate and thermogenesis will be measured by indirect calorimetry. also, fecal samples will be collected for gut microbiome profiling along with blood for glucose, insulin, hormones, triacylglycerol, hba1c, short-chain fatty acid, red blood cells and fgf21. urine samples will be collected throughout the study. a followup session at 16 weeks will reassess previous measures.

Eligibility criteria:
inclusion criteria: * bmi: ≥ 27 and ≤ 34.9 kg/m2 * fasting serum glucose: ≤ 7 mmol/l * low ≤1 serving of dairy consumption * waist circumference \>88cm (women) and \>102cm (men) * willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. * willing to maintain current dietary supplement use throughout the trial. on test days, participant agrees not to take any dietary supplements until dismissal from the study. failure to comply will result in a rescheduled test visit. * willing to abstain from alcohol consumption for 24 h prior to all test visits. * willing to avoid vigorous physical activity for 24 h prior to all test visits. * understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator exclusion criteria: * fasting blood glucose \> 7 mmol/l * triglycerides ≥ 2.3 mmol/l * smoking tobacco products and marijuana * thyroid problems * previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease. * presence of gastrointestinal disorder or surgeries within the past year. * consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement. * known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months. * irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal * unwillingness or inability to comply with the experimental procedures * known intolerance, sensitivity or allergy to dairy products * consumption of protein powders/protein supplements * extreme dietary habits * uncontrolled hypertension as defined by the average blood pressure measured at screening. * weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity * excessive alcohol intake * restrained eaters
a feasibility study of the impact on blood pressure control of supplementing community pharmacist services with structured information on blood pressure and its treatment

Conditions: Hypertension

Summary: hypertension is a major health problem, however its control is unsatisfactory. one of the reasons for such a high prevalence of this disease includes poor patient compliance to treatment. approximately 30 % of newly diagnosed hypertensive patients stop taking their blood pressure medication by six months and 50% by 12 months. the uk government is keen to encourage community pharmacists to play an active role in participation of services that can improve patient adherence to their medications. the new medicines service (nms) and targeted medicines use reviews (mur) are established services which fund community pharmacists to review and explain medicine use to patients, with hypertension a common condition for which advice is given within these schemes. within these schemes, advice is verbal and unstructured, with no specific written information provided on drugs or the disease being treated. this study aims to determine whether structured information provided to participants verbally and in writing by community pharmacists about blood pressure and current medicine(s) within nms and targeted murs will be retained and will be associated with improved hypertension control. participants will be recruited from people eligible for nms and murs and attending community pharmacies.


Eligibility criteria:
inclusion criteria: 1)18 or over 2) male or female 3) have been started on any blood pressure medication exclusion criteria: 1)patients with english language problems
a comparison between a pyrocarbon and a cocr shoulder resurfacing implant

Conditions: Osteoarthritis of the Shoulder

Summary: the purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. the study will compare results between an implant made of cobalt-chrome(cocr) and an implant made in pyrocarbon.


Eligibility criteria:
inclusion criteria: * primary or secondary osteoarthritis of the shoulder * age 40-75 years * patient capable of giving informed consent * patient agrees to comply with the study plan exclusion criteria: * destruction of the proximal humerus * insufficient bone stock * deficient rotator cuff or earlier failed surgery of the rotator cuff * large muscle defects or insufficient blood supply in the affected arm * neuromuscular disorders * infection, untreated malignancy or transmittable disease preventing the patient from fulfilling the study * patient unwilling to comply with study regulations * patient with earlier allergic reaction to pyrocarbon * patient with known metastatic disease * patient who has been treated with more than 10 mg corticosteroids (e.g. prednisone) daily within 3 months from surgery. * patient participating in other clinical study * patient in need of glenoid replacement

Keywords: shoulder arthroplasty pyrocarbon randomized controlled trial shoulder resurfacing