Kornimate/medical-research-clean huggingface dataset:
image guided and breathing adapted radiotherapy of early stage lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (sbrt), and thereby be able to design radiotherapy margins that takes into account the full motion span throughout an entire course of sbrt.

lung tumours move with respiration. this must be considered when designing margins for radiotherapy. this movement can be quantified by fluoroscopy or 4dct. it is possible to identify a tumour middle position for planning. this middle position will vary from day to day and the extent of this variation is not fully known. the aim of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (sbrt), and thereby be able to design margins for patients that take into account the full motion span throughout an entire course of sbrt patients: 15 consecutive patients with inoperable low stage lung cancer or solitary metastases to the lung (1-2) referred for sbrt - 45 gy/3 fractions. methods: a gold coil will be implanted into the lung tumour one week before the planning. at planning and all treatment days supplementary 4dct of thorax and two orthogonal fluoroscopy sessions will be performed. tumour motion in the superior-inferior, medio-lateral and cranio-caudal direction will be measured and variation in amplitude and baseline for the tumour motion will be reported. perspective: by examining the variation in tumour movement it will be possible design margins for sbrt, accounting for the full tumour motion span and minimizing the risk of geographical miss and thereby optimizing the chance for local tumour control.

Eligibility criteria:
inclusion criteria: * tumor \> 6 cm * no more than 2 tumours * histological proven non small celled lung cancer * signed informed consent exclusion criteria: * serious bleeding disorder * performance status 3-4 * tumour close to large vessels (judged by interventional radiologist)

Keywords: lung cancer stereotactic radiotherapy image guidance breathing adaption tumor motion implanted marker
use of mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in india and the uk

Conditions: Prediabetic State

Summary: primary prevention of diabetes is of paramount importance in both developed and in developing countries. several studies including the indian diabetes prevention programmes have shown that lifestyle modification in people with prediabetes can reduce the progression to diabetes by 58%. however, there are two main problems in applying diabetes prevention strategies to the population as a whole. (1) trial based interventions are unrealistic on a population level in any country. (2) the oral glucose tolerance test applied so far to identify those at high risk is a poorly reproducible and time consuming test both for the participant and for health care workers. hence more practical means of defining individuals who would benefit from lifestyle intervention are required. the current study proposes a prevention strategy that will employ a lifestyle modification programme delivered by text messaging in both india and the uk.subjects will be identified based on the hba1c measurement instead of the oral glucose tolerance test. the study will also assess the efficacy, acceptability and cost effectiveness of mobile phone based intervention both in india and the uk. messages will be based to deliver education, treatment targets, advice, support and motivation. subjects will be invited to participate and, once recruited, will be randomised to usual care or the sms intervention group. usual care will consist of a one-to-one 30 minute interview, conducted by the research team, delivering personalised diet and exercise advice. the intervention group will undergo the same initial interview and, in addition, will receive 3 times weekly text messaging with education, advice, support and motivation. these messages will be personalised to individual targets set at the initial interview. primary outcome:progression to diabetes secondary outcomes will be based on physical activity / cardiovascular risk factors/and quality of life. the study programme is compatible with major initiatives in both the uk and india for the prevention of diabetes and cardiovascular disease (cvd).


Eligibility criteria:
inclusion criteria: * men and women with no history of diabetes * persons with 2 or more risk factors including 1. age 35-55 years 2. positive family history of diabetes 3. body mass index ≥23kg/m2 4. waist circumference \>90cm for men and \>80cm for women 5. hypertension 6. sedentary habits * hba1c 6.0% - \<6.5% exclusion criteria: * known diabetes * any other illness * unwilling to participate

Keywords: lifestyle changes to prevent type 2 diabetes
hyperhydrosis treatment using botulinum toxin

Conditions: Hyperhidrosis

Summary: the purpose of this study is to describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. the same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.

the abobotulinumtoxina (abo) will be used in all patients. the abo will be prepared by adding 4 cc of normal saline to a 500-unit dysport© (ipsen ltd, berks, uk) vial preinjection patient pictures will be taken showing the technique used for each armpit. injection technique: 1. technique 1 the quadrant technique: 5 vertical lines and 5 horizontal lines will be draw on the hair bearing area of the armpit amounting to 25 injection points being more concentrated on the center. each injection consists of 5units of abobotulinum 2. technique 2 the six injection technique: will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units follow up will be done at 15 days for post injection pictures with iodine starch test a total of 15 male patients will be recruited. and the injection for each armpit in a given patient is randomized.

Eligibility criteria:
inclusion criteria: consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis will be included in this study exclusion criteria: * patient that has received a botulinum injection in the past year patient that had a liposuction in the armpit or laser for the hair patients with preexisting neuromuscular conditions (myasthenia gravis, eaton lambert syndrome) patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics) patients with sensitivity to botulinum toxin or human albumin

Keywords: botulinum toxim abobotulinum hyperhydrosis injection
magnesium sulfate in pregnancy and postpartum

Conditions: Severe Pre-eclampsia With Postnatal Complication

Summary: there are huge doubts as to how long to keep postpartum magnesium sulfate. studies demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take into account the use of magnesium sulphate before delivery. termination of pregnancy is the best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know the minimum effective dose.the investigators believe that if the patient has received less than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for 6 hours is as effective as keeping it for 24 hours.

the definitive treatment known for pre-eclampsia is the interruption of pregnancy. while the definitive treatment is the pregnancy interruption, management includes other measures that have proven effective, including the administration of antihypertensive drugs for severe hypertension and that the use of anticonvulsant such as the magnesium sulfate. there are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe / serious disorder. unfortunately these studies used the drug before birth and continue after birth. therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure. that is, if the cure or definitive treatment of pre-eclampsia is the interruption, did not seem necessary to justify the administration of anticonvulsant drugs after birth. obvious post delivery management sulfate arises from the large number of postpartum eclampsia reported in many studies. it is unknown if the administration of magnesium sulfate for a minimum period not yet determined before birth and delivery requires even keep the drug after discontinuation. for all these reasons the investigators propose the following: a randomized trial where all those patients who received magnesium sulfate for less that 8 hours before birth will be randomized to two groups of study: 1- continue magnesium sulfate for 24 hours and 2-continue magnesium sulfate for 6 hours postpartum.

Eligibility criteria:
inclusion criteria: severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth. exclusion criteria: * complications such as: hellp syndrome, renal failure, eclampsia, retinal detachment, cerebral edema, pulmonary edema, hypertensive encephalopathy.
clinical implication of atrial fibrillation detection using wearable device in patients with cryptogenic stroke

Conditions: Atrial Fibrillation; Ischemic Stroke; Transient Ischemic Attack

Summary: it is known that atrial fibrillation after stroke significantly increases the risk of stroke or systemic embolism. accordingly, efforts have been made to detect hidden atrial fibrillation and apply treatment using anticoagulants instead of antiplatelet agents. the conventional method used to screen for atrial fibrillation in stroke patients who did not have atrial fibrillation at first admission is 24-hour holter monitoring. this study will compare the detection rate of atrial fibrillation with discontinuous ecg monitoring three times a day and 72 hours of single-lead ecg patch monitoring compared with the conventional holter test.


Eligibility criteria:
inclusion criteria: * newly diagnosed brain infarction * no history and diagnosis of atrial fibrillation at the time of admission * rejected implantable loop recorder * informed consent exclusion criteria: * cannot use kardiamobile system alone or with the help of others

Keywords: atrial fibrillation ischemic stroke transient ischemic attack
post market clinical follow-up study protocol for profemur® gladiator cemented femoral stems

Conditions: Joint Disease

Summary: microport orthopedics (mpo) is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of its total hip arthroplasty (tha) european union (eu) . these types of studies are required by regulatory authorities for all tha devices that do not have clinical evidence available at the time of gaining approval to market in the eu. this study has been designed in accordance with meddev 2.12/2 rev 2.

total hip arthroplasty (tha) has been performed since the early 1920s and is generally considered to be one of the most successful orthopaedic surgeries performed. the 8th annual report from the national joint registry of england and wales reported 95.3% component survivorship at 7 years for over 300,000 tha implantations. microport orthopedics, inc. (mpo) currently markets several tha components throughout the world, including the european union (eu). as part of the process for gaining approval to market in the eu, mpo is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of these tha components. the objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Eligibility criteria:
inclusion criteria: * has undergone primary tha for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia; * inflammatory degenerative joint disease such as rheumatoid arthritis; or * correction of functional deformity * subject is implanted with the specified combination of components * subject is willing and able to complete required study visits or assessments exclusion criteria: * subjects implanted with a metal-on-metal articulation * subjects implanted with non-mpo or non-wright medical technology components (femoral heads, acetabular shells, acetabular liners) in the enrolled tha * subjects skeletally immature (less than 21 years of age) at time of primary tha surgery * subjects currently enrolled in another clinical study which could affect the endpoints of this protocol * subjects unwilling to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated or have pending incarceration

Keywords: osteoarthritis avascular necrosis ankylosis protrusio acetabuli rheumatoid arthritis correction of functional deformity revision procedures
prehabilitation via a mobile application in oesophago-gastric cancer

Conditions: Oesophageal Cancer; Gastric Cancer; Prehabilitation; mHealth Application

Summary: the overall aim of this study is to assess the feasibility of a mhealth prehabilitation programme delivered via a mobile app for people with oesophago-gastric cancer by evaluating its user satisfaction and acceptance. the research question asks what is the feasibility of a mhealth prehabilitation programme delivered via a mobile app for patients with oesophago-gastric cancer? the primary aim of this single centred feasibility randomised controlled trial (rct) is to explore the recruitment, adherence, and compliance of taking part in a mhealth prehabilitation programme delivered for 6 weeks via a mobile app prior to oesophago-gastric surgery. this study will develop a prehabilitation programme to investigate the feasibility and impact of delivering prehabilitation via a mobile app to patients with a diagnosis of oesophago-gastric cancer before surgery.

the study will test a six-week mhealth prehabilitation programme delivered via a modified mobile application called the asensei app. asensei is a commercial company who have already successfully developed a digital platform known as the asensei app that delivers tailored training with individualised programmes and automated responsive feedback for the fitness industry via mobile applications. in summary, participants recruited to the study will require three visits to the hospital for measures to be taken. outcome measurements will be taken at baseline (t0), prior to surgery (t1) and 30 days post surgery (t2). outcome measures relating to feasibility, physical and nutritional functioning as well as quality of life will be collected at the above specified three time points (t0,1,2). there will also be weekly phone calls and one to one discussion after the six weeks of prehabilitation to explore how useful people have found the app and how easy and engaging it was to navigate. this study will gain valuable insight into the role mhealth applications could offer in preventing functional decline, improving quality of life and preventing secondary complications in patients with a diagnosis of cancer prior to surgery.

Eligibility criteria:
participants will need to fulfil the following eligibility criteria: inclusion criteria: * diagnosis of oesophago-gastric cancer awaiting surgery, * 18 years of age or over, * medically stable to participate in a prehabilitation programme with exercise intervention, english speaking, * access to an iphone * able to provide informed consent. exclusion criteria: * medically unstable, * diagnosis of metastatic cancer, * contraindications for physical activity, * presence of a pacemaker or other internal medical device, * uncontrolled blood pressure and or heart arrhythmias.
the cognitive variability in nf1 and tsc monozygotic twins

Conditions: Neurofibromatosis Type I; Tuberous Sclerosis Complex

Summary: both neurofibromatosis type 1 (nf1) and tuberous sclerosis complex (tsc) are highly heterogeneous diseases. cognitive features seem to vary widely even between family members carrying the same mutation. this phenotypic variability is not well understood, but is generally assumed to be caused by modifier genes which regulate the affected pathways. however, recent studies brought forward an alternative explanation for the phenotypic variability. post-mortem studies showed that second hit mutations causing loss of the second ('healthy') allele are more widespread than previously believed. these loss of heterozygosity (loh) mutations cause bi-allelic loss of the disease-linked gene and are known to cause the gross of somatic features in both diseases (like neurofibromas and hamartomas). hence, it could be the stochastic occurrence of second-hit mutations in the brain are the cause of the variable cognitive phenotypes. to investigate to what extent these loh mutations in the brain contribute to the phenotype and to what extent this variation is due to genetic modifiers factors is unknown. the investigators therefore propose to elucidate this variability by comparing the correlation of cognitive features of monozygotic twins with nf1 or tsc to healthy twins in the population. if modifier genes are the cause of the variability of cognitive features in nf1 and tsc the investigators expect that the variability in cognitive tests in monozygotic twins is the same as monozygotic twins in the healthy population. however, if the variability is caused by the occurrence of loh mutations, the investigators expect to have a lower correlation in our monozygotic patients compared to the healthy twins.


Eligibility criteria:
inclusion criteria: * the participant is part of a monozygotic twin pair (which is genetically confirmed); * nf1 or tsc patients with a genetically confirmed diagnosis; * oral and written informed consent by participant in case ≥ 18 years of age. * oral and written informed consent by both caregivers and assent by participant in case of minor participants. exclusion criteria: * a potential subject of whom the twin sibling is not willing or able to participate in this study, will be excluded from participation in this study. * symptomatic brain pathology.

Keywords: von recklinghausen's disease bourneville's disease cognitive variability loss of heterozygosity
fibrotic interstitial lung disease and nocturnal oxygen

Conditions: Idiopathic Pulmonary Fibrosis; Obstructive Sleep Apnea; Sleep Disturbance; Sleep Hypoventilation

Summary: home sleep studies - which allow the measurement of breathing while the person sleeps - will be performed on patients with fibrotic interstitial lung disease attending two of the uk's largest respiratory medicine services.the study will investigate at how symptoms, and breathing and exercise tests differ between these two groups after 12 months of study.

the interstitial lung diseases are a group of diseases in which patients develop uncontrolled scarring (called fibrosis) within the lung. this causes failure of the lung and patients become progressively more breathless over time. the commonest of these diseases is idiopathic pulmonary fibrosis and this is a devastating condition with a survival of 3-5 years. many people with fibrotic interstitial lung diseases have disrupted sleep as well as low oxygen levels at night or obstructive sleep apnoea (osa - pauses in breathing at night time due to obstruction of the upper airway). patients with low oxygen levels at night have a worse quality of life, with fatigue during the day and survive for less long. 102 patients from specialist clinics at guy's and st thomas' and the royal brompton and harefield nhs foundation trusts will be recruited. this research is funded by a grant from the british lung foundation. the investigators aim to compare patients with and without low oxygen levels at night by observing how their disease and quality of life changes over a year. patients will be asked to complete a two-night home sleep study which will involve wearing a probe over the finger connected to a sensor on the wrist. patients will also be provided with a home spirometer to measure their breathing at home daily during the study. lung function testing (which is part of normal clinical practice), a six-minute walk test and quality of life questionnaires will be performed at the beginning of the study. these investigations will be repeated at six and twelve months and this will tell us how night time oxygen levels affect the progression of the disease, quality of life, exercise tolerance, hospitalisation frequency and survival of these patients.

Eligibility criteria:
inclusion criteria: * mdt diagnosis of fibrotic interstitial lung disease including but not limited to idiopathic pulmonary fibrosis (ipf), non-specific interstitial pneumonitis (nsip), chronic hypersensitivity pneumonitis (chp), fibrotic organising pneumonia and unclassifiable fibrotic lung disease. * competent to provide written consent in english exclusion criteria: * presence of an underlying connective tissue disease * daytime/resting hypoxaemia with po2 \<8.0 * other indication for oxygen therapy * 3% odi \>15 events/hour studied or established on cpap * predominant emphysema on ct * inability to provide informed consent or complete health-related quality of life questionnaires in english * current participation in a research project which might alter lung function or sleep study results
predictive and prognostic biomarkers in patients with mycosis fungoides and sézary syndrome.

Conditions: Mycosis Fungoides; Sezary Syndrome

Summary: a translational study for identification of prognostic and treatment-predictive biomarkers in mycosis fungoides and sézary syndrome.


Eligibility criteria:
inclusion criteria: * age 18-100 years * histologically confirmed (according to the world health organization (who)/eortc classification) mf/ss stages i-iv * who performance status 0 -3 * absence of psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study. * written informed consent according to international conference on harmonization (ich)/(good clinical practice (gcp), and swedish regulations * no minimum or maximum required routine laboratory data exclusion criteria: not applicable. no exclusion criteria are specified.

Keywords: skin lymphoma mycosis fungoides sezary syndrome translational research biomarkers treatment prediction lymphoma microenvironment skin neoplasms treatment
essential fatty acids during complementary feeding

Conditions: Obesity; Growth; Metabolic Syndrome; Cardiovascular Disease

Summary: the objective of this intervention study is to examine the effect of n-3 lcpufa on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.


Eligibility criteria:
inclusion criteria: * singleton infants, 9 mo +/- 2 wk, born \>= 37 wk of gestation * birth weight \>=2500g, a 5-min apgar score \>= 7, birth weight \>= 5th percentile for gestational age exclusion criteria: * chronic diseases expected to influence growth and dietary intake * use of medicine expected to influence growth and dietary intake * fish oil supplementation

Keywords: n-3 lcpufa fish oil essential fatty acids infant growth obesity intestinal microbiota