Kornimate/medical-research-clean huggingface dataset:
a multimodal intervention program for children with attention deficits (child vireal support program)

Conditions: Attention Deficit; Attention Deficit Disorder With Hyperactivity

Summary: the main aim of this study is the development and implementation of a multimodal intervention program consisting of parent training and child training which utilizes the potentials of immersive virtual reality technology (ivr) in order to test its effectiveness for children with attention deficits.

attention deficits are commonly observed in children and attention deficit hyperactivity disorder (adhd) is one of the most commonly diagnosed childhood neurodevelopmental disorders. it is evidently known that attention deficits affect children's school, social and family life making it essential for them and their parents to receive specialized supportive services. behavioral parent training (bpt) and cognitive-behavioral treatment (cbt) are considered evidence-based interventions for children with adhd. in fact, they have positive effects on the management of children's behaviors, organization, reduction of parental stress and enhancement of parental self-efficacy. in addition to these traditional evidence-based interventions, immersive virtual reality (ivr) technology has been applied lately as part of intervention programs for children with attention deficits / adhd diagnosis specifically for cognitive training. in line with the above, investigators have designed and developed a multimodal intervention program named child vireal support program. this program is comprised of parent training and child training and utilizes the potentials of ivr technology. in order to assess the efficacy of child vireal support program, the investigators will conduct a randomized controlled trial, which consists of a pre-training phase, a training phase, a post-training phase and a follow-up.

Eligibility criteria:
inclusion criteria: * participants 9-12 years old and their parents * adhd diagnosis (by the approved body of ministry of health) * greek speaking participants (child and parents) * full scale iq \> 80 (wisc-v) for child * naïve drug treatment for adhd * participants able to comply with all testing and study requirements exclusion criteria: * treatment with psychostimulants or other psychotropic drugs * children who received intervention based on cbt or parents who attended other behavior parent training programs * history of comorbid neurological disorders, seizure disorder, autism spectrum disorders, psychosis, or severe dysregulation disorders that may interfere with study participation or use of virtual reality equipment * participants presenting a hearing or vision impairment that does not allow the tasks to be performed with the use virtual reality equipment * intellectual disability or wisc-v full scale iq \< 78 (1.5 standard deviations (sd) below mean) * non-greek speaking child or parent * parents or children who refuse to give written consent for their participation in the study

Keywords: immersive virtual reality (ivr) multimodal intervention behavioral parent training cognitive-behavioral treatment neurodevelopmental dysfunctions cognitive training
intratumoral holmium microspheres brachytherapy for patients with pancreatic cancer

Conditions: Pancreas Cancer

Summary: this is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.


Eligibility criteria:
inclusion criteria: 1. female or male aged 18 years and over. 2. diagnosis of primary (borderline) resectable pancreatic cancer by dutch pancreatic cancer group (dpcg) guidelines: i. 1o-90o contact between tumor and the superior mesenteric artery, celiac axis or common hepatic artery. or; ii. 90o-270o contact between tumor and superior mesenteric vein or portal vein, without occlusion. iii. the discussion on resectability has to be made in consensus at multidisciplinary meetings/discussions and may overrule the above criteria (i, ii). 3. patient is deemed eligible for surgical resection of the pancreatic cancer, however, during open surgery a more advanced disease than initially anticipated is found and resection is no longer feasible. 4. life expectancy of 12 weeks or longer. 5. world health organisation (who) performance status 0-1. 6. one or more measurable lesions of at least 10 mm in the longest diameter by spiral ct or mri according to the response evaluation criteria in solid tumours (recist) 1.1 criteria. 7. negative pregnancy test for women of childbearing potential. exclusion criteria: 1. radiation therapy within the last 4 weeks before the start of study therapy. 2. calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract 3. any unresolved toxicity greater than national cancer institute (nci), common terminology criteria for adverse events (ctcae version 4.0) grade 2 from previous anti-cancer therapy. 4. leukocytes \< 4.0 109/l and/or platelet count \< 100 109/l. 5. significant cardiac event (e.g. myocardial infarction, superior vena cava (svc) syndrome, new york heart association (nyha) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia. 6. patient is deemed ineligible for implantation of 166ho by an expert panel (surgeon, nuclear medicine physician and researcher) due to tumour anatomy or nearby structures. 7. pregnancy or breast feeding (women of child-bearing potential). 8. patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression. 9. patients who are declared incompetent.

Keywords: intratumoral therapy holmium microspheres
clinical performance of afgen1

Conditions: Atrial Fibrillation; Afib; ECG

Summary: afgen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ecg is needed to identify episodes of afib. the purpose of this study is to establish the clinical performance of afgen1 on human participants.

the primary purpose of this study is to demonstrate the ecg signal acquired by the afgen1 device is of adequate quality and is suitable to support its intended use for the detection of afib. this will be evaluated by comparing the ecg data acquired by afgen1 to that acquired by an fda cleared 12-lead ecg device. the study will also seek to demonstrate that there is no degradation in the quality of the ecg signal it acquires over the maximum 7-day wear period that it can be prescribed for use. the secondary purpose of this study is to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ansi aami ec12-1 .

Eligibility criteria:
inclusion criteria: 1. 18+ willing to sign the consent form exclusion criteria: 1. implanted pacemakers 2. implanted cardioverter defibrillators 3. implanted cardiac resynchronization devices 4. potential life-threatening arrythmias 5. physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study 6. open wounds, abraded or irritated skin at the application site 7. planned to undergo a mri during the course of the study duration 8. known or suspected to be pregnant 9. student or employee of trivirum

Keywords: ecg signal quality
evaluation of a hysteroscopic morcellator in hysteroscopic treatment of submucosal fibroids

Conditions: Evaluate Both Technics on Procedure Duration; Characteristics and Perioperative Complications

Summary: hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. limit of this technic is duration of procedure which is correlated to operative complications. so, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. a new technic of hysteroscopic surgery is available which is quicker than conventional technic. this technic is poorly evaluated. aim of this study is to evaluate both technics on procedure duration.

material and methods we propose a monocentric-randomised study. inclusion criteria are women over 18 years requiring hysteroscopic surgery for fibroma. after informed consent, patients will be randomised in two groups: hysteroscopic surgery with morcellation technic and conventional hysteroscopy technic with resection. the main objective is duration of procedure. secondary objectives are characteristics and perioperative complications (distension media quantity, cervical injury, uterine perforation), immediate et long term postoperative data's (postoperative pain and synechia). we hypothesis hysteroscopic with morcellation reduces duration of procedure of 50%. the estimated size of population number is 30 per group and 60 for the study. expected results we expected a significant decrease of procedure duration with hysteroscopic morcellation. this data will be interesting according peroperative complications are correlated to procedure duration and allow hysteroscopic surgery to patients with large or several fibromas.

Eligibility criteria:
inclusion criteria:- patient who is at least 18 years. * patient under effective contraception. * patient who underwent ultrasound confirming the presence of at least one or both uterine fibroids with a diameter less than 6 cm for the largest fibroid. * patient who underwent diagnostic hysteroscopy confirming the presence of one or two uterine fibroids classified as type 0, 1 or 2 according to figo classification (10). * patient with an indication of intrauterine fibroid resection (bleeding disorders fetilité) by hysteroscopy. * patient who agreed to participate in the study and who signed informed consent. exclusion criteria: * early removal linked to patient's wish
the norwegian cerebral venous thrombosis study

Conditions: Cerebral Vein Thrombosis; Cerebral Venous Sinus Thrombosis

Summary: the nocvt study will investigate cvt (2014-2023) in a large norwegian population (\> 3 millions) using several approaches combining existing health registries, clinical databases and new prospectively collected clinical data to explore epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cvt.

a retrospective hospital-based chart review will be conducted at 13 different hospitals covering all four health regions and more than 3 million inhabitants in norway. these 13 hospitals are akershus university hospital, haukeland university hospital. oslo university hospital (ullevål), sørlandet hospital kristiansand, drammen hospital, st.olavs hospital, nordlandsykehuset bodø, university hospital of north norway, innlandet hospital lillehammer, tønsberg hospital, telemark hospital (skien), molde hospital and stavanger university hospital. a search will be made in the clinical database for patients with the relevant diagnosis of cvt in the period between january 1, 2014, and december 31, 2023. data from hospital charts will be linked with data from statistics norway (ssb), fd-trygd, and norwegian prescription database (norpd). using this combination of clinical data and health registries will make it possible to describe risk factors, clinical and radiological presentation, treatment and short-term outcome in a large norwegian cvt cohort. further, data from hospitals will be linked with data from ssb, fd-trygd, norpd, norwegian patient registry (npr) and cause of death registry (dår) up to five years after cvt. using this methodology will make it possible to investigate overall long-term prognosis and outcomes in terms of mortality, health care utilisation, medication use and working situation up to five years after cvt in a large norwegian cohort. lastly, a prospective follow-up study will include patients that have been diagnosed with cvt at the nocvt hospitals during 2019-2023. by combining the collected data from the retrospective hospital chart review with the new follow-up interviews and self-reported questionnaires it will be possible to describe quality of life, vocational outcomes, psychological distress, depression, insomnia and disease-related disability in cvt.

Eligibility criteria:
inclusion criteria: * a diagnosis of cvt 2014-2023 from the 13 participating primary hospitals exclusion criteria: * none
a study of hs-10529 in kras g12d patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: hs-10529 is an oral, highly selective, small molecular inhibitor of kras g12d. this study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of hs-10529 in kras g12d patients with advanced solid tumors.

this is a phase 1, first-in-human, study of hs-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of hs-10529 in kras g12d patients with advanced solid tumors and evaluate the preliminary efficacy of hs-10529.

Eligibility criteria:
inclusion criteria: * at least age of 18 years at screening. * patients of advanced solid tumor，who have progressed on or intolerant to standard therapy. * with measurable lesion according to recist 1.1. * agree to provide fresh or archival tumor tissue. * eastern cooperative oncology group (ecog) performance status of 0\~1. exclusion criteria: * previous or current treatment with kras g12d inhibitors. * uncontrolled pleural, ascites or pericardial effusion. * known and untreated, or active central nervous system metastases. * history of other primary malignant tumors. * serious, uncontrolled, or active comorbidities. * refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.

Keywords: advanced solid tumors kras g12d
effects of a ketogenic diet on psychological outcomes

Conditions: Overweight; Mood; Appetitive Behavior

Summary: the aim of the study is to investigate how glycemia and ketonemia variations during three different diet protocols: a ketogenic diet without any restriction on calories intake (kd), a calorie-restricted ketogenic-mediterranean diet (kemephy) and a calorie-restricted mediterranean diet (md) affect appetite, executive functions and mood in overweight young women.

fifty overweight young women with a body mass index (bmi) greater than 25 will be randomly assigned to a ten days of ketogenic diet (kd), calorie-restricted ketogenic-mediterranean diet (kemephy) or mediterranean diet (md). all subjects will begin the prescribed diet at the beginning of their follicular phase. body composition, fasting blood glucose and β-hydroxybutyrate (bhb), visual analogue scale (vas) to test appetite as well as psychological tests (one mood test and two cognitive tasks) will be obtained 5 days before the beginning and on the last day of the diet-period.

Eligibility criteria:
inclusion criteria: * female sex age between 20 and 35 years, * 25\ 39.9 kg/m2 exclusion criteria: * smokers, * subjects under diet-treatment, * subjects treated for diseases such as diabetes, * cardiovascular diseases, * depression, * subjects doing sport more than 2 hours per week.

Keywords: ketogenic diet mediterranean diet ketones glycaemia executive functions
assessing an eeg biomarker of response to tms for major depression

Conditions: Depression

Summary: veterans with treatment resistant depression (trd) have the opportunity to receive transcranial magnetic stimulation (tms) treatment via the va's national tms clinical pilot program. while some see improvement with their depression, others do not. therefore, it may be beneficial to be able to predict with biomarkers what participants may see improvement with their treatment. electroencephalography (eeg) is a means to identify such biomarkers. four hundred veterans with trd will be enrolled in this trial to determine whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (tms) can be prospectively replicated in a large ecologically valid sample. participants will have a total of eeg scans at baseline, every 5th treatment session, and at the end of treatment for a total of 7 eeg scans.

the goals of this study are to: (1) test a potential predictive resting eeg biomarker of antidepressant response (differential patters of gamma oscillations) in a large sample of veterans with trd receiving tms (n=400); (2) assess whether a second putative biomarker (early changes in theta cordance during treatment) predict eventual response to tms, as well as, leverage this large sample to identify other potential biomarkers (such as markers of early versus late response to tms, markers of response to other tms parameters (e.g., 5 hz, 1 hz or theta burst tms), and markers of change with treatment that may speak to mechanism); and (3) create an infrastructure to rapidly identify and test additional eeg-based biomarkers of treatment response in patients with depression and other psychiatric conditions.

Eligibility criteria:
inclusion criteria: * veterans participating in the va tms pilot program age 18 years or older * able to provide written informed consent to participate in the eeg portion of this study and to allow linking such data to data collected as part of the tms pilot program * diagnosis of mdd based on dsm-5 criteria and be currently depressed despite prior treatment with at least one adequate antidepressant treatment * receiving stable doses of psychiatric medications (no dose changes for \>4 weeks prior to study entry), in stable psychotherapy, or receiving no psychiatric medications and/or psychotherapy exclusion criteria: * history of seizure disorder * known structural or neurologic abnormalities present or close to the treatment site that would increase risk of seizure * history of brain surgery * history of recent traumatic brain injury (within 6 months) or any history of moderate to severe traumatic brain injury * clinical evidence of severe or uncontrolled alcohol or substance use disorders within three months * active withdrawal from alcohol or other substances of abuse * implanted metal device in the head that would increase the risk of tms * metal in the head that would increase the risk of tms * current psychosis

Keywords: depression transcranial magnetic stimulation electroencephalography biomarkers
orofacial pain in woodwind and cello musicians in german orchestras

Conditions: Orofacial Pain; Sleep Problems

Summary: professional musicians in german professional orchestras represent a population group that has received little attention so far, despite being exposed to a variety of work-related factors that may pose potential health risks to the orofacial system. these factors include environmental noise, irregular working hours, tight schedules, and high demands for quality and discipline, all of which can lead to stress, sleep disturbances, and physical impairments. this prospective, non-interventional survey study aims to assess the health challenges faced by woodwind players (oboe, flute, clarinet, bassoon). it will explore the relationship between the type of instrument played, orofacial pain, sleep problems, and oral health-related quality of life (ohrqol). woodwind players, due to their playing techniques, may be more susceptible to orofacial complaints, which could negatively impact their quality of life. a control group of cellists, whose playing techniques put less strain on the orofacial system, will be used for comparison. participation will be via an online questionnaire targeting musicians who have been employed in a german professional orchestra for at least 12 months.


Eligibility criteria:
inclusion criteria: * musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello * at least 12 months of employment or freelance work in the past 5 years with a german professional orchestra exclusion criteria: * consent not given

Keywords: musicals orchestra orofacial pain quality of life stress sleep disorders
a multiple-dose study to evaluate the pharmacokinetics and safety of voriconazole in immunocompromised adolescents

Conditions: Pharmacokinetics

Summary: this study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. this will help establish voriconazole dosing recommendations for adolescents.


Eligibility criteria:
inclusion criteria: * subjects who are expected to develop neutropenia following chemotherapy. * subjects who require treatment for the prevention of systemic fungal infection. exclusion criteria: * subjects with a history of severe intolerance of azole antifungal agents. * subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.

Keywords: pharmacokinetics and safety data of voriconazole in immunocompromised adolescents
the effect of complex decongestıve therapy on oxıdatıve stress and antıoxıdants

Conditions: What Are the Effects of Lymphedema Treatment

Summary: it is aimed to determine the changes of complex decongestive therapy applications on oxidative stress parameters and antioxidants in patients with lymphedema after breast cancer treatment.

lymphedema, which is the most common late complication of patients undergoing cancer treatment, affects the physical, social and psychological lives of the individual and decreases the quality of life as it causes motor dysfunctions, cosmetic deformations and psychological disorders. the addition of radiotherapy to surgical intervention increases the risk of lymphedema by 36%. when free radicals increase in intensity, they cause structural defects in lipids, proteins and nucleic acids, and as a result, they are a cause and risk factor for chronic diseases such as cancer, neurodegenerative diseases and cardiovascular diseases. cancer cells produce high levels of reactive oxygen species (ros) due to their fast metabolism and impaired cellular signaling mechanisms. high levels of ros are generally harmful to cells and the redox state of cancer cells is different from normal cells. therefore, cancer cells maintain ros levels at a moderately high tumorigenic level, above the low cytostatic level, but below levels that may be cytotoxic. the oxidative stress state in a cancer cell is different from the oxidative stress state in a normal cell. it is also well known that increased oxidative stress and inflammation are associated with cancer risk. the number of studies investigating the effect of complex decongestive therapy, which is stated to be the most effective treatment method in the treatment of lymphedema, the most common complication after breast cancer treatment, on oxidative stress and antioxidant levels is quite limited. in this study, it was aimed to reveal the changes of complex decongestive therapy applications on oxidative stress parameters and antioxidants in participants with lymphedema after breast cancer treatment.

Eligibility criteria:
inclusion criteria: * development of lymphedema after breast cancer treatment * clinical stage of lymphedema stage-2 or stage-3 diagnosis exclusion criteria: * receiving treatment for lymphedema in the last three months * those diagnosed with severe heart failure and/or arrhythmia * persistent infection in the affected extremities * ongoing chemotherapy treatment * diagnosed with liver disease

Keywords: breast cancer lymphedema oxidative stress