Kornimate/medical-research-clean huggingface dataset:
dose-deescalated 3-fraction stereotactic body radiotherapy for centrally located lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (sbrt) regimen to 45 gray (gy) in 3 fractions for centrally located thoracic tumors.

the purpose of this trial is to test a deescalated 3-fraction sbrt regimen to 45 gy in 3 fractions for centrally located thoracic tumors in a phase ii trial. this will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "no fly zone" for both primary non-small cell lung cancer (nsclc) and for lung metastases of any histology. this registration describes the design and eligibility criteria for the 36 nsclc subjects the investigators plan to enroll. local control, cancer-specific survival, and overall survival results from the nsclc patients will be compared to both 3- and 5-fraction historical controls, specifically rtog 0236 and 0813 results. the outcomes of the metastatic patients will also be reported. there will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.

Eligibility criteria:
inclusion criteria: 1. lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on rtog and md anderson cancer center definitions 33,34). multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. these concurrent tumors other than study target lesion can be treated as per soc and does not necessarily have to meet the above size limit. the pi will review and prospectively approve any lesions abutting these organs. 2. ecog performance status of 0-2 3. age \> 18 4. patients must sign a study-specific consent form. exclusion criteria: 1. prior history of radiotherapy near target lesion resulting in overlapping treatment fields. previously irradiated will be defined as oar structures receiving the following doses (in \<3gy per fraction): * spinal cord previously irradiated to \> 40 gy * brachial plexus previously irradiated to \> 50 gy * small intestine, large intestine, or stomach previously irradiated to \> 45gy * brainstem previously irradiated to \> 50 gy * lung previously irradiated with prior v20gy \> 35% 2. active systemic, pulmonary, or pericardial infection 3. interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung 4. pregnant or lactating 5. any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
the efficacy and safety of hlx208 in advanced anaplastic thyroid cancer (atc) with braf v600 mutation

Conditions: Anaplastic Thyroid Cancer; ATC

Summary: the purpose of this study was to assess efficacy, safety and pk in anaplastic thyroid cancer (atc) given hlx208 (braf v600e inhibitor).


Eligibility criteria:
inclusion criteria: 1. age\>=18y; 2. good organ function; 3. expected survival time ≥ 3 months; 4. advanced braf v600 atc that have been diagnosed histologically; 5. at least one measurable lesion as per recist v1.1; 6. ecog score 0-1. exclusion criteria: 1. pregnant or lactating women; 2. previous treatment with braf inhibitors or mek inhibitors; 3. a history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin; 4. severe active infections requiring systemic anti-infective therapy.
treatment of low-flow venous malformations with electrosclerotherapy. prospective observational study

Conditions: Vascular Malformations

Summary: venous malformations (mvs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. histologically they are characterized by large, venous-like vascular spaces. scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. currently, bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.


Eligibility criteria:
inclusion criteria: * diagnosis of low-flow venous malformations eligible for electrosclerotherapy * non-indication for embolizing treatment * previous treatments are not an exclusion factor, provided that at least 30 days have elapsed. exclusion criteria: * previous treatment for \< 30 days * pregnancy and lactation status * patients of childbearing age without contraceptive use * presence of metal synthetic media * copd with fio2 \< 30 mmhg * impaired renal function with egfr\<30 ml/min/1.73mq * patients with bleomycin intolerance or previous episodes of toxicity bleomycin-related * patients who have already received a cumulative dose of bleomycin ≥100 mg * patients who have undergone prior thoracic radiotherapy * patients with a history of seizures and epilepsy

Keywords: electrosclerotherapy
a silver lining in the vad sky

Conditions: LVAD (Left Ventricular Assist Device) Driveline Infection

Summary: the investigators propose to conduct a prospective randomized trail (rct) of a driveline management protocol. the study will be initiated at ucsf from january 1st 2022 to december 31st 2022 as a pilot to be extended to other sites with the ultimate goal to develop a multi-center rct. the driveline dressing protocol studied will include a silver-based dressing barrier as well as a dressing change protocol and material designed to reduce the risk of driveline dressing induced dermatitis and allergies. assessment will include dli rates, dli speciation, dermatitis rate, comfort, ease of use, compliance and cost

this prospective research clinical trial will be conducted in a single academic medical center. the enrollment period will be between january 1st, 2022 and december 31st, 2023. the initial follow-up period will be closed on december 31st 2023 with a continuation of the follow-up until december 31st 2024. patients will be selected from current lvad patients followed by our medical center clinic and from patients implanted with lvad at our center during the study enrollment timeframe. patients will be randomly assigned to the control protocol and the silver protocol. both protocols will be taught to the patients and nursing staff by the vad coordinators. the comparative evaluation will be done through adverse event collection, driveline culture results, patient survey and dl photos at specific intervals. interventions a new driveline dressing kit will be trialed on patients randomized to the intervention arm of the study. both arms will have a regular dressing kit and a sensitive dressing kit. the trial arm kits include: 1. for standard dressing: a silverlon antimicrobial patch, chg swabs for cleaning, an occlusive dressing with window, and driveline anchors. the driveline dressing change frequency will be weekly. 2. for sensitive skin dressing: a silverlon antimicrobial patch, providone/iodine swabs for cleaning, an occlusive dressing with window, and sensitive driveline anchors. the driveline dressing change frequency will be weekly. the control arm kits include: 1. for standard dressing: no antimicrobial barrier, chg swabs for cleaning, an occlusive dressing with window, and driveline anchors. the driveline dressing change frequency will be every 96 hours. 2. for sensitive skin dressing: no antimicrobial barrier, providone/iodine swabs for cleaning, an occlusive dressing with window, and driveline anchors. the driveline dressing change frequency will be every 96hr.

Eligibility criteria:
inclusion criteria: * \>18 years of age * implanted with lvad as dt or btt at the academic medical center with implantation scheduled between january 1st, 2022 and december 31st, 2022 exclusion criteria: * a history of dli * a history of sternal wound infection * implantation secondary to vad exchange for device infection
pivotal study of the lvis (low profile visualized intraluminal support)

Conditions: Intracranial Aneurysms

Summary: the purpose of this study is to evaluate the safety and efficacy of the low profile visualized intraluminal support(lvis™ and lvis™ jr.)devices from microvention, inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.


Eligibility criteria:
inclusion criteria: * subject age between 18 and 75 years * subject with an unruptured or ruptured(\>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio \<2)intracranial saccular aneurysm (\<20mm maximum diameter in any plane) exclusion criteria: * subject with significant extra or intracranial stenosis of the parent artery (\>50%) proximal to the target aneurysm. * subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke * subject with contraindications to the use of antiplatelet agents * subject who is unable to complete the required follow-up

Keywords: intracranial, saccular, aneurysms, stenting, coiling
mobile transcranial magnetic stimulation

Conditions: Depression

Summary: for this study 5 patients will be treated with transcranial magnetic stimulation in their residence (home, nursing home).

an investigation of the feasibility of rtms treatments outside a clinical-medical context (e.g. in a residential facility and/or at the patient's home) is to be carried out (5 patients in total). before the actual start of the study, the test subjects are informed in detail about the experimental setup and the methods used, as well as about contraindications and possible side effects. following the information session, the test subjects sign a declaration of consent and complete questionnaires with relevant information (demographic data, health data to rule out serious illnesses and diagnostic questionnaires). on this day, a tms test with a few test pulses is also planned in order to familiarize the test subjects with the tms and to evaluate their tolerance. the stimulation intensity (so-called motor threshold) is also determined as part of this. in the following week, the tms treatment is carried out on 5 consecutive days with a further visit. following the preparations, a protocol modified from the stanford accelerated intelligent neuromodulation therapy (saint) protocol is carried out. for this purpose, the test subjects are treated in 5 sessions per day on 5 consecutive days (25 stimulations in total). an itbs protocol (3 bursts at 50 hz in 2 seconds, 8 second pause) with 1800 pulses should be used every hour, which means that the duration of a stimulation is approximately 10 minutes and a total of 9,000 pulses could be applied per day. the individual sessions are monitored by a medbo regensburg employee on site. there should be a break of 50 minutes between each hourly stimulation. after the treatment, a follow-up should take place after 4 weeks with questionnaires and a short verbal evaluation. each subject can voluntarily terminate participation in the study at any time without giving reasons and without negative consequences (except for the lack of treatment). if the participant's compliance is severely impaired, the study may be terminated by the investigator.

Eligibility criteria:
inclusion criteria: * leading diagnosis of a depressive episode according to icd-10 in the context of a uni- or bipolar disorder * moderate depression according to the hamilton depression rating scale * adult persons aged 18-80 of all genders * place of residence in germany and understanding of the german language sufficient to understand the information * written declaration of consent exclusion criteria: * fulfillment of the contraindications for tms (electrical implants or metallic objects in the body such as pacemakers or insulin pumps, skin diseases on the head) * the presence of a serious neurological disease (e.g. cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformation, severe head injuries in the medical history) * participation in another study during the treatment * pregnancy and breastfeeding period
impact of video-enhanced consent on informed decision-making for parents of extremely preterm infants eligible for the vides study

Conditions: Understanding of Consent in Clinical Research; Implementation of Video-Consent in Clinical Research

Summary: this pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. the investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the vides study, which investigates the effectiveness of vitamin d supplementation in extremely preterm infants (the vides study is separately registered as nct05459298).


Eligibility criteria:
inclusion criteria: * parents/legal guardians of extremely preterm infants (\<28 weeks gestational age or \<1000 g birth weight) admitted to the neonatal intensive care unit at children's memorial hermann hospital that qualify for the vides study (vides study is separately registered as nct05459298) exclusion criteria: * parents/legal guardians deaf or blind * parents/legal guardians unable to consent for the vides study
study of fty720 in patients with uveitis

Conditions: Acute Noninfectious Posterior, Intermediate, or Pan Uveitis

Summary: this study will assess the safety, tolerability, and efficacy of fty720 in patients with acute, noninfectious intermediate, posterior and pan uveitis


Eligibility criteria:
inclusion criteria: * acute noninfectious posterior, intermediate, or pan uveitis * vitreous haze score of 1+ or more in the study eye at screening and baseline visits exclusion criteria: * vaso-occlusive vasculitis involving the retinal macula * behçet's uveitis * patients requiring corticosteroid or another systemic immunosuppressive medication for any other disease (e.g., asthma or some other autoimmune disease) that would contraindicate tapering (topical steroids permitted) * other protocol defined inclusions and/or exclusions may apply.

Keywords: uveitis, fingolimod, phase ii, visual acuity, vitreous haze, oct
children and parents with adhd and related disorders

Conditions: General Population; TDAH; Children Aged 5 to 18 Years

Summary: almost all rating scales for attention-deficit/hyperactivity disorder (adhd) are not validated in france. this clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. this study is conceived to collect data in the general population of children aged from 4 to 18 years in public schools in the city of nice. children are pseudo-randomly selected from classes of randomly selected schools in the city of nice (france). teachers fill out questionnaires using a dedicated secured website, and ask parents to fill out a similar set of questionnaires regarding their child's behaviour at home. since adhd has a strong genetic components, parents are also asked to fill out questionnaires regarding their own behaviour at adulthood and in childhood retrospectively. additionally, known factors related to adhd and other disorders as well as other putative factors are tested in the epidemiologic study.


Eligibility criteria:
inclusion criteria: * child known for the teacher for at least three months so that his evaluation reflect most faithfully possible the usual behavior of the child, * child having the frenchman for mother tongue to avoid the consequences on him behavior of a linguistic obstacle, * authorization to use the data signed by at least one of the parents of the child and by the very child when he is old at least of six years. * parents speaking and reading the frenchman. exclusion criteria: * child known to follow a specific treatment of a disorder(confusion)attentional with / without hyperactivity-impulsiveness (eg. ritaline ò, ritaline ò lp, arranged ò lp, strattera ò) whatever is its duration. indeed, a selection on this criterion would introduce a way major which(who) would return the less reliable results(profits) of the study. * child presenting a known neurological or psychiatric disorder, or a deficit intellectual because the attentional disorders(confusions), the psychomotor excitement and the impulsiveness can be symptoms inherent to the other pathologies neurological and\\or psychiatric.
mindfulness for older adults with cognitive concerns

Conditions: Mild Cognitive Impairment

Summary: the current study will examine the effects of a brief mindfulness based intervention (bmbi) on mood, memory and attention in comparison to a wait-list control (wlc) group. participants for the study will be 90 adults aged 50 years and above who have presented at a memory clinic within slam nhs trust with subjective cognitive concerns and/or those who have received a diagnosis of mild cognitive impairment (mci) from their memory clinic.

participants will be randomly assigned to either the bmbi group or the wlc group. those assigned to the bmbi group will complete a number of cognitive assessments and questionnaires at time 1. they will then receive a 45 minute mindfulness intervention. following this, they will be asked to practice mindfulness for 30 minutes per day for 7 days a week in their own homes. after 7 days, participants in the bmbi group will be invited to complete a paired set of cognitive assessments and questionnaires (time 2). participants in the wlc group will complete the same number of cognitive assessments and questionnaires as the bmbi group at time 1. however, they will not receive the 45 minute mindfulness intervention nor will they be asked to practice it at home for 7 days. after 7 days, participants in the wlc group will be invited to complete a paired set of cognitive assessments and questionnaires (time 2). after completion of the measures at time 2, the wlc participants will then receive the 45 minute mindfulness intervention. all assessments, questionnaires and the intervention will be carried out either in a slam memory clinic or at participants own homes depending on level of mobility.

Eligibility criteria:
inclusion criteria:people aged 50 years and older with subjective memory concerns (smc) and/or those who meet criteria for amnestic mild cognitive impairment (mci) who have been seen by one of the three slam memory services (i.e. croydon memory service; southwark and lambeth memory service; and lewisham memory service) in the past three months. participants must be able to give informed consent to participate. - exclusion criteria: diagnosis of dementia or multi-domain mild cognitive impairment, intellectual disability, current substance misuse, a current diagnosis of epilepsy or another neurodegenerative disorder (such as parkinson's), a history of brain injury or stroke, a severe and enduring mental health disorder (e.g. severe depression or anxiety, personality disorder, schizophrenia, schizoaffective disorder, bipolar affective disorder), active suicidal ideation, severe sensory impairment that would significantly impair a person's ability to engage in the intervention. -

Keywords: brief mindfulness
ethanol in the prevention of central venous catheter infections

Conditions: Catheter Related Infection

Summary: in recent years, several new methods for treatment of catheter-related bloodstream infections (crbsi) such as antibiotic or antiseptic lock-therapy have been developed with variable success \[1-10\]. long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. however, they are not free of complications such as bacteremia. the need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique. ethanol lock-therapy was demonstrate her utility in this cases. but no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term cvcs. objectives: to investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term cvc related infections in a heart post-surgical intensive care unit (hpsicu). methods: an academic, prospective, randomized and controlled clinical trial is proposed. patients at hpsicu who have a cvc more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). in the follow-up period, we will register all necessary data to evaluate the end-points of study (cbrsi rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).


Eligibility criteria:
inclusion criteria: * older than 18 years old * signed informed consent * central venous catheter more than 48 hours placed exclusion criteria: * pregnancy * denial informed consent form * ethanol intolerance * liver cirrhosis

Keywords: infection catheter bacteriaemia ethanol
rhodiola rosea for mental and physical fatigue

Conditions: Fatigue

Summary: the primary objective of this trial is to assess whether rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.


Eligibility criteria:
inclusion criteria: * fourth year nursing students enrolled in nurs 495 (nursing practice) * participating in permanent overnight (between 11 pm and 7 am) or rotating shift work * otherwise healthy * consent to participate in the study exclusion criteria: * nurses aged 18 years or younger * breastfeeding or pregnant women, as confirmed by a blood test * female participants with child bearing potential not practicing a form of birth control throughout the trial * presence of a primary medical condition associated with fatigue (e.g. cardiac, gastrointestinal, respiratory, renal, rheumatologic, or oncologic disease) * presence of schizophrenia, bipolar disorder, dementia, eating disorders, insomnia or substance abuse * presence of diabetes * concurrent utilization of hypoglycaemic or agents for raising or lowering blood pressure * known allergy or hypersensitivity to rhodiola rosea or sedum family extracts or pollen * know allergy to microcrystalline cellulose or silicone dioxide * concurrent utilization of stimulant drug such as methylphenidate (ritalin), amphetamine (dexedrine, adderall), methamphetamine (desoxyn) and pemoline (cylert) * concurrent utilization of other rhodiola or ginseng products (both fall in the same therapeutic category known as an "adaptogen") * any significant medical condition * any neurological or mental health condition * taking medication that has central nervous system effects * aged 55 years or older * low blood pressure or history of significant dizziness

Keywords: fatigue adaptogen rhodiola rosea