Kornimate/medical-research-clean huggingface dataset:
pain and emotional expression in children with autism or mental retardation

Conditions: Autism; Mental Retardation

Summary: the purpose of this study is to describe facial, behavioral and physiologic (heart rate) reactivity of children with autism aged 3 to 6 years old, during a painful stimulation (venepuncture). children will be videotaped before, during and after a venepuncture. each recording will be rated with the facs (facial action coding system) and the nccpc (non communicating children's pain checklist).

children with autism will be matched with children with mental retardation and children without developmental disorder. matching will be established according the developmental age of children with autism.

Eligibility criteria:
inclusion criteria: group autism: * child aged 3 to 6 years old * diagnosis of autistic disorder established according a pluridisciplinary staff (icd-10 criteria, vineland scales, ados, etc.) * admitted to children's neuropediatrics or genetics department for a venepuncture control group mental retardation: * child aged 3 to 6 years old . * diagnosis of mental retardation established according a pluridisciplinary staff (icd-10 criteria, vineland scales, ados, etc.) * admitted to neuropediatric or genetic department for a venepuncture control group without developmental disorder : * child aged 18 months to 5 years old. * admitted to pediatrics department for a venepuncture

Keywords: autism mental retardation pain emotion sensory profile children
a phase i study of [177lu]lu-ff58 in patients with advanced solid tumors.

Conditions: Pancreatic Ductal Adenocarcinoma; Gastroesophageal Adenocarcinoma; Glioblastoma Multiforme

Summary: the purpose of the study is to test the safety and dosing of \[177lu\]lu-ff58, a radioligand therapy for patients with advanced or metastatic tumors that express proteins known as integrins: alpha-v beta-3 integrin (αvβ3) and alpha-v beta-5 integrin (αvβ5). the study will also further characterize the radioligand imaging agent \[68ga\]ga-ff58 including its ability to identify tumor lesions and its safety profile.

the study will be done in two parts. the first part is called "escalation" and the second part is called "expansion". in both parts of the study, patients will be screened with a \[68ga\]ga-ff58 positron emission tomography (pet)/computed tomography (ct) or pet/magnetic resonance imaging (mri) scan to assess eligibility for treatment with \[177lu\]lu-ff58. in the escalation part, different doses of \[177lu\]lu-ff58 will be tested to identify the recommended dose. the expansion part of the study will examine the safety and preliminary efficacy of \[177lu\]lu-ff58 at the recommended dose determined during the escalation part. the end of study will occur when at least 80% of the patients in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36 month long term follow- up period, or the study is terminated early in which case all patients would also be followed up for safety.

Eligibility criteria:
key inclusion criteria * age \>= 18 years old * patients with locally advanced unresectable or metastatic pdac, locally advanced unresectable or metastatic gea, or recurrent gbm * to be treated with \[177lu\]lu-ff58, patients must have at least one measurable lesion that shows \[68ga\]ga-ff58 uptake on pet/ct or pet/mri key exclusion criteria * absolute neutrophil count (anc) \< 1.5 x 109/l, hemoglobin \< 10 g/dl, or platelet count \< 100 x 109/l * prior external beam radiation therapy (ebrt) to \> 25% of the bone marrow * creatinine clearance \< 60 ml/min * unmanageable bladder outflow obstruction or urinary incontinence * non-gbm patients: presence of symptomatic central nervous system (cns) metastases, or cns metastases that require local cns-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within 1 week before \[177lu\]lu-ff58 administration other protocol-defined inclusion/exclusion criteria may apply

Keywords: pancreatic ductal adenocarcinoma pdac pancreatic cancer gastroesophageal adenocarcinoma gea gastric cancer gastric adenocarcinoma esophageal cancer esophageal adenocarcinoma glioblastoma multiforme gbm advanced solid tumors radioligand therapy rlt [177lu]lu-ff58 [68ga]ga-ff58 integrins alpha-v beta-3 integrin αvβ3 alpha-v beta-5 integrin αvβ5
intraoperative sonographically versus fluorescence-guided resection of contrast-enhancing gliomas and brain metastases

Conditions: Gliomas, Malignant; Metastases to Brain

Summary: objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid

fluorescence with 5-aminolevulinic acid, fluorescein and intraoperative magnetic resonance imaging (mri) are the most common modalities used to intraoperatively rate extent of brain tumor resection. intraoperative sonography is another promising method of intraoperative visualization. it's advantages include possibility of real-time estimation of tumor remnants without disturbing of surgical workflow, opportunity to discover residual tumor under normal brain tissue and chipper cost. at this time there are no published results of randomized control trials comparing ultrasound and fluorescence-guided brain tumor resection. objective of this study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as 5-aminolevulinic acid fluorescence-guided surgery. participants of the study will be randomly operated using intraoperative ultrasound or fluorescence with 5-aminolevulinic acid. extent of resection will be assessed in postoperative mri by blinded radiologists

Eligibility criteria:
inclusion criteria: * single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas) * one or several brain metastases * newly diagnosed * karnofsky performance status 60-100% * age 18-79 years * performed magnetic resonance imaging with contrast enhancement exclusion criteria: * tumor spreading to corpus callosum or brainstem * previously performed brain radiotherapy * planned supratotal tumor resection until neurophysiologically revealed eloquent areas * known hypersensibility to 5-aminolevulinic or to porphyrin * hepatic or renal insufficiency * porphyria * pregnancy * breast feeding

Keywords: contrast-enhancing glioma brain metastasis sonography ultrasound fluorescence 5-aminolevulinic acid 5-ala
the effects of active surveillance protocol on long term quality of life in patients with mild pericoronitis

Conditions: Pericoronitis

Summary: the complications that could occur during or after the extraction of the mandibular third molar teeth with pericoronitis affect patient's life quality considerably. various scales are used to reveal how much the life quality of patients is affected this treatment. the aim of this study is to identify the long term life quality of patients through the ohip-14 tr scale without removing the mandibular third molar teeth with mild pericoronitis.

increasing the lenght stay in the mouth at a maximum rate and following the patient up after the necessary treatment and information procedures are completed. as a result of clinical and radiographical examinations fifty-five voluntary patients whose average age was 24 and who have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild pericoronitis were included in the study.after the patients in the study filled out the form including their contact and demographic data and dental symptomsand completed ohip-14 tr scale which last about 5 minutes, their curretage and operculectomy treatments were done under local anesthesia. the patients were invited for reexamination on seventh day after the treatment. also, an active patient follow up about life quality was performed by phone at 1,3,6 month after the treatment using the self -assessment question form and the ohip-14 tr scale.

Eligibility criteria:
inclusion criteria: * having the first episode of mild pericoronitis, having a good periodontal health, having an age between 18 and 25 years * having a diagnosis of pericoronitis of a vertically erupted or semi erupted lower third molar, having no systemic discomfort and being in the asa i and asaii exclusion criteria: * having no lower third molar with a vertical position * having a systemic discomfort * having moderate to severe pericoronitis * having a history antibiotics or nsaiid

Keywords: quality of life pericoronitis third molar
clinical effectiveness of various professionally applied fluoride prophylaxes in groups at high risk

Conditions: White Spot Lesion; Caries

Summary: the study is to compare the prophylactic and therapeutic clinical effectiveness of two fluoride varnishes in children at high caries risk. it was hypothesized, the use of fluor protector s (i) fluoride varnish in children with deciduous teeth at high risk of caries (p) reduces caries and the activity/remineralisation of carious enamel spots (transformation of white spot lesion into d (decay)) (o), similarly to what occurs after the use of duraphat varnish (c).

the study is to compare the prophylactic and therapeutic clinical effectiveness of two fluoride varnishes in children at high caries risk. it was hypothesized, the use of fluor protector s (i) fluoride varnish in children with deciduous teeth at high risk of caries (p) reduces caries and the activity/remineralisation of carious enamel spots (transformation of white spot lesion into d (decay)) (o), similarly to what occurs after the use of duraphat varnish (c). the question set bases on a caries assessment by risk management system basing on the occurrence of major caries causative agents (biological and medical), and also of the protective/preventive ones. questions related to the social and economical status will be left out because of the difficulty of getting them answered honestly. teeth will be scored according to international caries detection system ii classification, and oral hygiene according to the greene and vermillion simplified oral hygiene index (ohi-s) (1964). children and their parents/guardians will receive hygienic, dietary and prophylactic guidelines.

Eligibility criteria:
inclusion criteria: * generally healthy children aged 3-5 years * high risk of caries * parent/legal guardian consent for participation in research study exclusion criteria: * chronic diseases or medication in medical history * planned change of residence within a year * aged \ 5 years

Keywords: white spot lesion caries
semen parameters and covid-19 in infertile men

Conditions: Sperm Count, Low; Hormone Disturbance; Covid19

Summary: coronavirus disease-19 (covid-19) is a global pandemics which affects many organs and systems with a range of morbidities and high mortality rates. there are a number of studies revealed that covid-19 may affect the testes and male genital tract which may in turn disrupt the gonadal functions.the current study aimed to evaluate the effect of covid-19 on semen parameters and sex-related hormone levels.

in this current study, the investigators aimed to elucidate the alteration in semen parameters of the infertile male patients who had been infected with sars-cov-2, through the comparison of the spermiogram results which were reported before and after the diagnosis of covid-19. the investigators also aimed to evaluate the impact of covid-19 on the sex-related hormone levels as follicle-stimulating hormone (fsh), luteinizing hormone (lh), and testosterone (t). the current study is conducted in ankara city hospital, the highest capacity tertiary health care center of the capital town of turkey. the study included 21 patients who applied to ankara city hospital, andrology clinic for male infertility up to 05 october, 2020 and have had the semen analyses reported before and after the clinically confirmed diagnosis of covid-19 through reverse transcriptase pcr. besides the semen analyses, 8 of these 21 patients have also the had the reported levels of t, fsh and lh which were also analyzed.

Eligibility criteria:
inclusion criteria: reproductive age infertile men clinically confirmed (with reverse transcriptase polymerase chain reaction-rt pcr) covid-19 history semen analyses performed before and after the diagnosis of covid-19 (must be applicable for all patients) sex-related hormone levels including fsh, lh, and t which were reported before and after the diagnosis of covid-19 (was applicable for some of the patients) exclusion criteria: azoospermia semen analyses performed only before or after the diagnosis of covid-19 semen analysis performed in another hospital rt-pcr results which were reported in another hospital chronical renal disease chronical liver failure patient age lower than 18 years old

Keywords: covid-19 male infertility semen parameters sex-related hormone levels
evaluation of the effect of psycho-oncological intervention on well-being of patients with advanced prostate cancer on lhrh analogs and their partners. a randomized controlled pilot study.

Conditions: Prostate Cancer

Summary: the purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (lhrh) analogs in the treatment of prostate cancer and their partners.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of prostate cancer on biopsy * locally advanced or metastasised prostate cancer in need of hormonal treatment. * on lhrh analogue treatment for a minimum of 5 months (at inclusion) * having a female partner * patients and their partner are able to fill out questionnaires, attend group sessions and give consent exclusion criteria: * serious psychiatric difficulties * life expectancy \< 12 months
effects of wbv associated with imt on inflammatory markers, body composition, muscle strength and thickness

Conditions: Frail Elderly Syndrome

Summary: aging generates immune, muscular and functional changes. in the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. this study aims to evaluate the effects of a whole body vibration training associated with the training of inspiratory muscles on the inflammatory, muscular and body composition outcomes in pre-frail elderly women.


Eligibility criteria:
inclusion criteria: * elderly individuals able to walk without assistance * good understanding to carry out the proposed tests, evaluated through the mini mental state examination (mmse). exclusion criteria: * contraindication or difficulty to perform evaluation procedures * users of medications that interfere with the cardiovascular and / or muscular system * smokers * neuromuscular or degenerative diseases * pulmonary comorbidities * heart diseases * labyrinthitis.

Keywords: aging whole body vibration respiratory muscle training
proton beam therapy for chondrosarcoma

Conditions: Chondrosarcoma

Summary: the goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. the safety of this treatment will also be studied.

patients who have skull base chondrosarcoma require complicated treatment because of its challenging location and nearness to critical structures within the brain. pathology will be confirmed prior to discussion of the study. if you are found to be eligible to take part in this study, you will receive proton beam therapy, no sooner than 2 weeks after the last surgery to remove tumor. you will receive proton beam therapy once a day for about 35 treatments (7 weeks). treatment will be given for 5 days in a row each week (except for saturdays, sundays, and holidays) at the proton center in houston. the whole process should take up to 1 hour each day. if your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy. after the proton beam, and possibly photon beam, therapy, you will be asked to come in for study follow-up visits every year, until the study is completed. at these visits, you will have magnetic resonance imaging (mri) scans, blood draws (less than 1 teaspoon) to monitor your pituitary function, and neuropsychological testing. for the neuropsychological testing, you will be interviewed and tested by a neuropsychologist to evaluate your memory, fluency (the ability to talk and form words) complex thinking ability, planning ability, and coordination. these tests could last from 1-2 hours. you will also have eye exams performed by an ophthalmologist from md anderson and hearing exams. it is anticipated that it will take about 5 years to complete this study. this is an investigational study. the proton beam center and its treatment are approved by the fda for patient use. a total of up to 15 patients will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed grade 1-3 chondrosarcoma of the skull base 2. contrast enhanced postop mri or ct if there is clinical contraindication for mri of the skull base obtained with 90 days of study registration at m. d. anderson 3. the patient has been assessed by mdacc skull base surgeons to have undergone maximal surgical debulking of disease 4. karnofsky performance status greater than or equal to 60 5. signed informed consent exclusion criteria: 1. previous irradiation of the skull base 2. documented evidence of disseminated metastatic disease

Keywords: skull base chondrosarcoma proton beam therapy chondrosarcoma cns
safety and efficacy of the naviaid™ g-eye system during colonoscopy

Conditions: Colorectal Cancer; Polyp; Adenoma

Summary: to evaluate the safety of using the naviaid™ g-eye system during colonoscopy

colonoscopy is the gold-standard method for crc screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. it is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. the naviaid™ g-eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range. the g-eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. the naviaid™ g-eye may be used for performing controlled withdrawal and endoscope stabilization. a major attribute of the naviaid™ g-eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal. this is a single-center, non randomized open-label study intended to evaluate the serious adverse events prevalence when using the naviaid™ g-eye system during colonoscopy.

Eligibility criteria:
inclusion criteria: * the patient is undergoing colonoscopy for screening, for surveillance of previous colon polyp(s) or for diagnostic evaluation. * the patient is 40-75 years old; * the patient must understand and provide written informed consent for the procedure. exclusion criteria: * subjects with inflammatory bowel disease; * subjects with a personal history of polyposis syndrome; * subjects with suspected colonic stricture potentially precluding complete colonoscopy; * subjects with active diverticulitis or toxic megacolon; * subjects with a history of radiation therapy to abdomen or pelvis; * pregnant or lactating female subjects; * subjects who are currently enrolled in another clinical investigation. * subjects with routine oral or parenteral use of anticoagulants * subjects with recent (within the last 3 mounts) coronary ischemia or cva (stroke) * any patient condition deemed too risky for the study by the investigator

Keywords: colorectal cancer polyp adenoma detection rate colonoscopy naviaid™ g-eye procedure naviaid™ g-eye system g-eye procedure g-eye system
evaluate the efficiency impact of conducting active temperature management during cardiac cryoablation procedures

Conditions: Atrial Fibrillation

Summary: left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. delivery of radiofrequency (rf) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula.esophageal mucosal lesions are the likely precursor to aef, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%. active esophageal cooling during rf ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device. the aim of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.

this study is a prospective, pilot study using the attune medical ensoetm esophageal heat transfer device to actively warm the esophagus during cryoablation procedures. this design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance. once patient consent is obtained, the subject will undergo preparation and anesthesia procedures following standard practice. once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the ifu. the device will remain in place until the ablation procedure is completed and will be removed before extubation. left atrial cryoablation using the standard approach will be performed with the ensoetm set at a temperature of 42 degrees c. all patients will be followed up in total for 6 weeks (long term fu visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.

Eligibility criteria:
inclusion criteria: * adult patients (age over 18 years). * undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation. * patients must be able to understand and critically review the informed consent form. * subjects must understand and agree to study requirements and sign a written informed consent. exclusion criteria: * patients who are unable to provide informed consent. * significant co-morbidities that preclude standard ablation procedure. * patients with \<40 kg of body mass. * patients with relevant esophageal pathology (e.g. esophageal cancer).