Kornimate/medical-research-clean huggingface dataset:
genetic characterisation of high-grade paediatric osteosarcomas

Conditions: Paediatric Osteosarcomas

Summary: at present, the only recognised prognostic factor for primary high-grade osteosarcoma is the histological response to preoperative chemotherapy. our study was designed to identify new diagnostic markers that could eventually have a prognostic value and therapeutic consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while under treatment by the french society of paediatric oncology os 94 protocol. paired normal and biopsy samples were collected. in addition, surgical resection specimens, following preoperative chemotherapy, were obtained in many cases. after genomic dna extraction, an allelotyping analysis targeting microsatellites was planned. the studied dna regions contained mainly rb, p53, apc, p16, c-met, twist, c-kit, erbb2 and topoisomerases genes. the techniques used in this molecular analysis comprised mainly allelotyping study, quantitative real-time pcr, gene sequencing , immunohistochemistry. the first results showed the prognostic value of 7q31 region containing c-met and 5q21 containing apc (br j cancer, 2003, entz-werlé et al.), 7p21 containing twist (int j cancer, 2005, entz-werlé et al.) and 4q21 targeting c-kit gene (j clin oncol, 2005, entz-werlé et al.).


Eligibility criteria:
inclusion criteria: * patients under 20 years of age with primary osteosarcomas * under treatment by the french society of paediatric oncology os 94 protocol
to assess the efficacy of esomeprazole 20mg once daily in subjects who still had heartburn after receiving rabeprazole

Conditions: Gastroesophageal Reflux Disease; GERD; Reflux Esophagitis

Summary: administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.


Eligibility criteria:
inclusion criteria: * male of female aged 20 years or more * history of reflux esophagitis * ongoing (until date of visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.the subject must take rabeprazole at least 4 days a week in the past 7 days prior to visit 1. * persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to visit 1. exclusion criteria: * use of other ppis and/or h2ra during rabeprazole treatment * history or having other gastrointestinal diseases * history of upper gastrointestinal surgery * initiation of medications that can affect digestive functions within 4 weeks before study treatment * inability to complete questionnaires

Keywords: esomeprazole 20mg heartburn rabeprazole 10mg reflux esophagitis phase iv
a window of opportunity trial of mirdametinib plus vorinostat for nf1 associated, h3k27 trimethylation deficient malignant peripheral nerve sheath tumor [mpnst]

Conditions: Primary Malignant Peripheral Nerve Sheath Tumors

Summary: this is a single center phase 0 "window of opportunity" trial for the treatment of newly diagnosed, prc2 deficient, primary malignant peripheral nerve sheath tumors (mpnsts) with a short course of the combination of mirdametinib and vorinostat prior to the most appropriate standard of care treatment for their specific tumor (typically localized radiation followed by surgical resection). four to eight patients, 12 years of age or older and meeting the study's biomarker inclusion criteria, would be enrolled onto this trial. after voluntary written consent (assent with parent consent for minors) the patient undergoes mri and pet imaging of the tumor and a needle biopsy to collect tumor is performed. patients with histone h3k27 trimethylation deficient mpnst, as confirmed by immunohistochemistry, receive a single 28-day course of mirdametinib and vorinostat at standard oral dosing for each. at day 26, 27, or 28 the patient returns to clinic for a research visit repeating the baseline mri and pet imaging and the needle biopsy for tumor tissue. this ends direct study participation. the patient goes on to the most appropriate standard of care treatment for their mpnst. information about the subsequent standard of care treatment is collected for the purposes of this study.


Eligibility criteria:
inclusion criteria: * known neurofibromatosis type 1 (nf-1) syndrome based on current diagnostic criteria. * diagnosis of suspected mpnst by pet or mri imaging * confirmation of histone h3 lysine 27 trimethylation-negative mpsnt by immunohistochemistry * twelve years of age or older * complete blood count (cbc), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1 st dose of study drug. * must be able to swallow capsules. * females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib. males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat. * provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment. exclusion criteria: * pregnant or breastfeeding - females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to the 1 st dose of the study drugs. * significant cardiac disease * significant eye disease * radiation therapy or chemotherapy in the past year.
cancer diagnosis by multiparametric ultrasound of the prostate

Conditions: Prostate Cancer

Summary: in men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic strategy compared to a multi-parametric mri based diagnostic strategy lead to similar detection of clinically significant prostate cancer?

men who require prostate biopsy will be approached and consented to enter this study. participants will all undergo pre-biopsy mp-mri and mp-uss of the prostate. only men with positive scans will undergo prostate biopsy. the order in which lesions discovered on mp-mri or on mp-uss are sampled will be randomised. all biopsies will be taken via the transperineal route in a single procedure. comparison will be drawn between biopsy results of lesions detected by mp-uss with those lesions detected by mp-mri. consideration will be given as to whether a lesion detected by one imaging modality is the same abnormality as one detected by the other imaging modality, in the same patient. analysis will be carried out at both the level of the lesion and the whole prostate. men without suspicious lesions on either imaging modality will not proceed to biopsy.

Eligibility criteria:
inclusion criteria: 1. a potential need for prostate biopsy indicated by raised psa or other clinical parameter, the final decision over which will be taken after imaging. 2. psa \</=20ng/ml measured within 6 months of screening visit 3. an understanding of the english language sufficient to understand written and verbal information about the trial and consent process 4. estimated life expectancy of 5 years or more 5. signed informed consent exclusion criteria: 1. any contraindication to the ultrasound contrast agent including right to left shunt, pulmonary hypertension, uncontrolled hypertension and adult respiratory distress syndrome. also patients with a recent acute coronary syndrome or unstable ischaemic heart disease. 2. any form of hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit 3. irreversible coagulopathy predisposing to bleeding 4. inability to undergo transrectal ultrasonography 5. prostate volume, measured at the time of mp-uss if previously unknown, of \>60cc. 6. previous radiation therapy to the prostate 7. previous hifu, cryosurgery, thermal therapy, irreversible electroporation, photodynamic, photothermal therapy, microwave or injectable toxin therapy to the prostate. 8. transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality within 6 months of screening visit 9. nodal or metastatic prostate cancer on any form of imaging at any time-point 10. not fit for general anaesthetic 11. any other condition the investigator considers would make the patient unsuitable
dk nano-culotte stenting for coronary bifurcation lesion

Conditions: Coronary Artery Disease

Summary: true coronary bifurcation lesions are still great of interest due to their complex anatomy, uncertainty of optimal stenting strategy and increased adverse cardiovascular outcomes. provisional stenting is recommended in patients with non-complex coronary lesions while 2-stent strategies should be considered in complex coronary bifurcation lesions. however, optimal 2-stent strategy is still controversial. double kissing (dk) crush stenting is the prominent technique in true bifurcation lesion, especially in patients with left main coronary artery disease. dk mini-culotte stenting, increasing use in clinical practice, has become popular over dk crush stenting. it was demonstrated in a bench test that stent malapposition was lower in the dk mini-culotte stenting compared to the dk crush technique. thus, dk mini-culotte stenting may be preferred over dk crush stenting in complex true coronary bifurcation lesion. on the other hand, it was demonstrated in previous studies, less than minimal protrusion (generally called as nano protrusion) had better clinical outcomes. kawasaki et al was first demonstrated the minimal (nano) protrusion of culotte stenting technique. then, toth et al revealed a novel modified culotte stenting technique named single string culotte. there was no major adverse cardiac events (mace) in patients underwent single string stenting technique with a median follow-up period of 6±4 months. unsurprisingly there was no mace occurred in patients who underwent szabo 2-stent technique. in the light of foregoing data, the least possible amount of protrusion is known to have the best results. in addition to this, double kissing balloon dilatation with culotte stenting technique seems to have better results than other stenting techniques. in our study, we aimed to evaluate the angiographic and clinical results of a novel dk nano-culotte stenting in coronary bifurcation lesion.


Eligibility criteria:
inclusion criteria: * patients with de novo true bifurcation lesion (medina classification 1,1,1 or 0,1,1 or 1,0,1) * the main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm exclusion criteria: * patients presenting with st segment elevation myocardial infarction, cardiogenic shock and killip class iii-iv heart failure * patients with a history of coronary artery bypass grafting surgery * patients with a chronic total occlusion in the bifurcation area * lesions with severe calcification that needs additional intervention such as atherectomy * patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up * patients with hematological disorders, malignancy, end stage renal (gfr\<30 ml/min) and hepatic failure * patients with active bleeding * pregnant women * patients with life-expectancy \< 1 year * patients treated with small open cell stent platforms

Keywords: coronary bifurcation lesion dk nano-culotte stenting
open-label rollover study of pbi 4050 in subjects with alström syndrome

Conditions: Alström Syndrome

Summary: phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and tolerability of pbi-4050 in subjects with alström syndrome who have completed a preceding prometic-sponsored alström syndrome study with pbi-4050.

this is a phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and tolerability of pbi-4050 in subjects with alström syndrome who have completed the end-of-treatment (eot) visit in a preceding prometic-sponsored alström syndrome study with pbi-4050. this study will also evaluate the efficacy and pharmacological effects of pbi 4050 in this multi faceted disorder. approximately 20 to 30 subjects will be enrolled to receive 800 mg pbi-4050 once daily for 96 weeks or until product licensing or study termination by the sponsor, whichever occurs first.

Eligibility criteria:
inclusion criteria: * subject completed a preceding prometic-sponsored alström syndrome study with pbi-4050. * subject has signed informed consent * subject has a documented diagnosis of alström syndrome * subject receiving antidiabetic medications is able and willing to self-monitor blood glucose levels * subject must be willing to forego other forms of experimental drug treatment during the study. * female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use adequate birth control from screening throughout the study and for 30 days after the last investigational medicinal product (imp) administration * if a male subject has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last imp administration. exclusion criteria: * subject discontinued pbi-4050 for safety reasons from any preceding prometic-sponsored alström syndrome study with pbi-4050 * subject has had a documented episode of severe hypoglycaemia within 12 months before screening and investigator judges that the subject is unable to adequately monitor their glucose levels. * subject has uncontrolled hypertension with bp \> 170/100 mmhg as determined at screening. * woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study as determined at screening * subject has any condition that, in the investigator's opinion, is likely to interfere with study conduct and compliance * subject has a history of an allergic reaction to pbi-4050 or any of its excipients.
evaluation of home-based sensor system to detect health decompensation in elderly patients with history of chf or copd

Conditions: COPD; Chronic Obstructive Pulmonary Disease; COPD Exacerbation; CHF; Congestive Heart Failure

Summary: sensorum health (sensorum) is conducting a pilot study to determine if sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.


Eligibility criteria:
inclusion criteria: * aged 65 years or older * able to consent * documented history of diagnosis of chronic obstructive pulmonary disease (copd) and/or congestive heart failure (chf) * currently admitted to jsumc for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ed visits) in the past 12 months exclusion criteria: * significant cardiac valvular disease * end-stage renal disease (esrd) * end-stage chf * end-stage copd
a study to examine mpi spect imaging with bms068645 and adenosine compared to coronary angiography

Conditions: Heart Disease; Ischemic Heart Disease

Summary: the purpose of the study is to determine whether bms068645 is as effective as adenosine spect at detecting blockages in heart arteries, and to determine if it will have fewer side effects


Eligibility criteria:
inclusion criteria: * referral for pharmacologic stress spect mpi * have suspected ischemic heart disease exclusion criteria: * acute myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment * severe asthma or copd
to assess the level of adherence of subjects receiving saizen® via easypod™ in slovakia

Conditions: Growth Disorders

Summary: this is a slovakian, multicentre, observational study to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents/ subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™. secondary objective: * to identify adherence subject profiling * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to asses the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to the summary of product characteristics (smpc) * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in an interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
home based program physical training in congenital heart disease

Conditions: Congenital Heart Disease; Functional Capacity; Body Composition; Quality of Life

Summary: previous studies indicate that a substantial proportion of the congenital heart disease patients has unhealthy lifestyle behaviors, such as smoking, lack of physical activity, and inadequate dietary patterns, leading to the development of metabolic disorders such as overweight/obesity, metabolic syndrome, and chronic diseases such as cardiovascular disease. another highly prevalent risk factor in these patients is sedentary behavior; these patients are not encouraged to engage in sports and exercise during childhood due to their cardiac condition, leading to a progressive decrease in physical capacity. studies have shown that congenital heart disease patients are not active enough and that a substantial amount of patients is overweight.this study is a randomized controlled trial that investigates the effects of the home based program physical training, in the exercise capacity, quality of life and body composition.

the objective of the study was to verify the effect of home physical training on improving physical capacity, body composition, quality of life, metabolic markers in patients with congenital heart disease.

Eligibility criteria:
inclusion criteria: * repaired congenital heart disease of all complexities * age ≥ 18 years * new york heart association (nyha) class i or ii * able and willing to participate in a 12-week cardiac rehabilitation program exclusion criteria: * inability to give informed consent * inability to participate in an exercise training program * severe musculoskeletal disorders. * patient heart failure * patients who perform regular physical activities. * patients with univentricular physiology, * patients severe asthma, * patients with a pacemaker. * patients with atrial fibrillation; * exercise-induced arrhythmia and/or ischemia * cyanosis at rest * severe intellectual disability
a clinical study to assess the gingivitis and plaque effects of various dentifrices

Conditions: Gingivitis

Summary: the primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. the secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be in general good health as determined by the investigator based on a review of the health history/update for participation in the trial; * have at least 16 gradable teeth; * have mild to moderate gingivitis with at least 20 bleeding sites; * agree to return for scheduled visits and follow the study procedures; * agree to refrain from use of any non-study oral hygiene products for the duration of the study; * agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; * agree to refrain from any oral hygiene the morning of your visit * agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing. exclusion criteria: * having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the baseline visit; * have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; * having had a dental prophylaxis within 2 weeks of plaque sampling visits; * removable oral appliances; * fixed facial or lingual orthodontic appliances; * self-reported pregnancy or lactation; * any diseases or condition that might interfere with the safe participation in the study; and * inability to undergo study procedures.
transcranial magnetic treatment (tms) in unipolar depression

Conditions: Unipolar Depression

Summary: repetitive transcranial magnetic stimulation (rtms) can improve mood and decrease sadness in patients with depression. in this study, the investigators seek to increase their understanding about how rtms improves depression, and to determine which form of rtms is most effective for depression, when used in combination with antidepressant medication.

patients will be assigned for 4 treatment arms, receiving either left high frequency plus right low frequency, or left high frequency plus right sham, or left sham, plus right low frequency, or left sham plus right sham treatment. all subjects will receive treatments for 10 days and will be followed for another 4 weeks.

Eligibility criteria:
inclusion criteria: * major depression * no physical health problems exclusion criteria: * history of epilepsy * metal in the head/neck or skull * pacemaker * pregnancy

Keywords: repetitive transcranial magnetic stimulation tms