Kornimate/medical-research-clean huggingface dataset:
evaluation of the oscipulse rapid cycling compression device effects on venous blood flow

Conditions: Venous Thromboses; Venous Stasis

Summary: this study will evaluate the effects on venous blood flow of the investigational device, oscipulse system, which is an external intermittent limb compression device. the study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the oscipulse system, and use of two reference vascular compression devices. our hypothesis is that the oscipulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.

enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation sites. once the imaging valve is identified the baseline level of venous flow will be collected in 30 s video clips of 2d color doppler videos and spectral doppler. next, either the oscipulse device, or one of the two reference therapy devices, will be applied by study personnel according to the device's specific instructions. the subject will wear the device during the capture of 1 spectral doppler clip and three 30 s 2d color doppler ultrasound clips on both the left and right leg. next, the remaining two devices will be applied based on instructions, and vascular ultrasound clips captured for each. completion of this visit protocol will be the end of the study.

Eligibility criteria:
inclusion criteria: * adult age ≥40 years old * generally healthy. * no history of diagnosed vascular disease including: dvt, pe, vte, peripheral vascular disease, post-phlebitic syndrome, or chronic venous insufficiency. * mentally alert and understand english proficiently. * able to give informed consent. exclusion criteria: * skin breaks, abrasion, or irritation in the area of the limb in contact with the oscipulse device or reference therapies. * severe peripheral artery or venous disease.

Keywords: venous compression intermittent pneumatic compression
changes in gastrointestinal microbiota using vsl#3 in patients with ibs-d

Conditions: Irritable Bowel Syndrome

Summary: aim to compare changes in gut microbiota of ibs patients and healthy controls using next generation sequencing method like illumina sequencing based on 16s rdna profiling. the major objectives of the study are: to characterize type of bacterial species and compare diversity of the host's gut microbiota in 20 irritable bowel syndrome (ibs) patients with 16 healthy controls (hcs) using high through put culture-independent method like illumina sequencing. to study modulation of gut microbiota profile after treatment with probiotics (vsl #3) for 8 weeks. to study the improvement of symptoms after modulation of gut microbiota with probiotics (vsl #3) for more than 8 weeks.

introduction the role of the commensal flora in many disease states, including irritable bowel syndrome, inflammatory bowel disease, and even obesity, is now accepted and will undoubtedly lead to new therapeutic strategies. the recently nih-initiated human microbiome project will allow better understanding of the role of this complex intestinal community in human health and disease. on the clinical side, we are exploring the more common pathogenic bacterial strains in irritable bowel syndrome patients and use of probiotics in this functional gastrointestinal disease. we are taking support from genotypic institute, bangalore for illumina sequencing facility. asian institute of gastroenterology, the parent institution, is a 200 bed tertiary care referral hospital providing services to patients with gi diseases, with a daily attendance of 400 out-patients and 200 in-patients. the long term goals of the investigators, involving basic researchers and clinicians, include development of technological resources and applications of biotechnology for use in clinical trials to improve survival rates of patients with gi diseases. the major volume of the outpatient cases comprise of patients with irritable bowel syndrome. altered gi microbiota may contribute to ibs symptoms and studying dysbiosis in gut microbiota is an important to develop therapy for ibs.

Eligibility criteria:
inclusion criteria: * patients satisfying rome iii criteria exclusion criteria: * antimicrobial medication during last 2 months * probiotics medication during last 2 months * pregnant or lactating patients * previous major or complicated abdominal surgery * positive test for hiv, hbv or hcv
paediatric sjögren syndrome cohort study and repository (paedsscore)

Conditions: Sjogren's Syndrome Childhood-onset

Summary: sjögren syndrome (ss) in adults is characterised by inflammation of the exocrine glands, principally the salivary and lacrimal glands resulting in xerostomia (dry mouth) and xerophthalmia (dry eyes).it can also present with more extensive exocrinopathy as well as extra-glandular, systemic features. ss is defined as primary ss (pss) when it occurs in isolation, and as secondary ss, if associated with other autoimmune conditions. the incidence and prevalence rates of ss vary depending on the population. to date, there have been no studies reporting accurate incidence or prevalence of ss in childhood. childhood onset ss defined as disease diagnosed before 18 years of age is believed to be rare; however, it is likely it is under-recognised and therefore under-diagnosed. the overarching aim of this study is to identify epidemiological, clinical and laboratory characteristics of paediatric ss in a united kingdom (uk) multi-centre cohort of patients. using this data our goal is to develop universally accepted classification criteria that could be validated for use in a paediatric population. inclusion criterion for the study and repository is a diagnosis of ss made before 18 years by the referring physician. a data collection pack will be sent to authors willing to participate. information collected will include but not exclusive to: demographic, clinical and laboratory/histological data at diagnosis and subsequent follow-up appointments. biological samples including blood, tears, saliva, urine and glandular and extra-glandular (e.g. renal) tissue will be collected prospectively if available. outcome measures related to disease activity and damage, as well as patient reported outcomes will also be collected at set time points (every 6 months) and during flares. paedsscore will capture data on a significant cohort of children with ss providing a powerful resource to help improve our understanding of the pathogenesis and natural course of this disease. prospective data collection will allow a fuller analysis of poor prognostic features, impact of therapy and damage accrual, and variable outcome of childhood ss.


Eligibility criteria:
inclusion criteria: 1. all recruited patients should be diagnosed with sjogren's syndrome alone or in association with other autoimmune conditions (rheumatic or not) based on their rheumatologist opinion or have clinical and serological/imaging features which in the opinion of their clinician raise the suspicion of sjogren's syndrome. 2. patients with symptoms onset /imaging, serological and glandular biopsy abnormalities suggestive of ss (suspected ss) or ss diagnosis made by expert clinicians prior to age 18 3. patients/ carers who can provide informed consent and agree to provide access to the results of their routine care investigations for research purposes irrespective of being able provide blood or saliva samples. 4. patients of 6 years or age or above exclusion criteria: 1. inability to provide informed consent or have informed consent provided on their behalf.
evaluation of on-couch cbct image quality

Conditions: Head and Neck Cancer; Thoracic Cancer; Abdominal Cancer; Pelvic Cancer

Summary: this is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch cbct imaging technology (hypersight) in patients receiving radiation treatment for cancer on a c-arm linear accelerator (truebeam).


Eligibility criteria:
inclusion criteria: * patient age is ≥ 18 years old. * patient has a diagnosis of primary or metastatic cancer, including but not limited to tumors arising from or involving the head/neck, lungs, liver, pancreas, prostate, urinary bladder, rectum, cervix or uterus. * a previous (standard-of-care) decision was made to treat the patient with radiation therapy using a varian truebeam treatment system. * a previous (standard-of-care) decision was made to treat the patient with a radiation dose of at least 20 gy in at least 5 fractions, one fraction per day on consecutive days, monday to friday. * patient is willing and able to provide informed consent to participate in the study. exclusion criteria: * patient is pregnant or has plans for pregnancy during the period of treatment. * patient is part of a vulnerable population (per iso 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response").
a phase iii clinical study to evaluate the efficacy and safety of gzr18 injection in subjects with type 2 diabetes mellitus and poor blood glucose control by diet and exercise

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: the main purpose of this study is to investigate the efficacy and safety of gzr18 injection in chinese subjects with type 2 diabetes mellitus and poor blood glucose control by diet and exercise


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 (as of the date of signing the informed consent form (icf)), male or female. 2. t2dm is diagnosed for at least 8 weeks according to the diagnostic criteria of diabetes mellitus issued by the world health organization (who) in 1999 and the supplementary diagnostic criteria of who in 2011 (hba1c diagnosis is recommended). 3. no birth plan from the signing of icf to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and baseline. 4. fully understand the purpose, nature, methods, and possible adverse drug reactions (adrs) of the study, be able to communicate well with the investigator, can understand and comply with the requirements specified in this study, can maintain a regular diet and exercise lifestyle during the study, and voluntarily sign the icf to enter the study. - exclusion criteria: 1. poor compliance during the run-in period as assessed by the investigator. 2. known or suspected to be allergic to glp-1r agonists or their excipients, or have contraindications to their use. （3)systolic blood pressure (sbp) ≥ 160 mmhg or diastolic blood pressure (dbp) ≥ 100 mmhg at screening or before randomization (concomitant antihypertensive drugs are allowed). （4）have the following cardiovascular and cerebrovascular diseases within 6 months before screening: decompensated cardiac insufficiency (new york heart association nyha class iii or iv), angina unstable or myocardial infarction, history of heart valve replacement surgery, coronary artery bypass grafting or other invasive cardiovascular surgery including percutaneous coronary intervention, ischemic or hemorrhagic stroke (excluding lacunar infarction), or transient ischemic attack. （5）history or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (men) 2a or 2b before screening. （6）history of malignant tumors before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) or the presence of underlying malignancy at screening. （7）participated in any drug clinical study (received non-placebo medication during the study) within a period of time before randomization (90 days or 5 half-lives of the previous imp, whichever is longer), or plan to participate in another clinical study before completing all scheduled assessments in this clinical study. （8）subjects with any other factors that may affect the efficacy or safety evaluation of this study as judged by the investigator.-

Keywords: glp-1ra
effect & safety of inhaled isoflurane vs iv midazolam for sedation in mechanically ventilated children 3-17 years old

Conditions: Sedation

Summary: this is a study to compare safety and efficacy of inhaled isoflurane delivered by the anaconda-s (anaesthetic conserving device (acd)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.

this is a phase iii, multi-centre, prospective, randomized, active-controlled, assessor-blind study. primary endpoint: percentage of time of adequately maintained sedation, in absence of rescue sedation, within the comfort-b interval (light, moderate, or deep sedation) prescribed at randomization, monitored every 2 hours for an expected minimum of 12 hours (up to 48 hours).

Eligibility criteria:
inclusion criteria: * patients at least 3 years to 17 (less than 18) years at the time of randomization, admitted to an icu/with planned icu admission. * expected mechanical (invasive) ventilation and sedation for at least 12 hours. * informed consent obtained from the patient, patient's legal guardian(s) exclusion criteria: * ongoing seizures requiring acute treatment. * continuous sedation for more than 72 hours at time of randomization. * less than 24 hours post cardiopulmonary resuscitation. * uncompensated circulatory shock. * known or suspected genetic susceptibility to malignant hyperthermia. * patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion. * patient with tidal volume below 30 ml or above 800 ml. * inability to perform reliable comfort-b assessment in the opinion of the investigator * patients with intracranial pressure (icp) monitoring or with suspected increase in icp * patients with treatment-induced whole-body hypothermia. * patients with pheochromocytoma. * patients with prolonged qt interval or with significant risk for prolonged qt interval. * patient not expected to survive next 48 hours or not committed to full medical care.

Keywords: sedation isoflurane mechanically ventilation pediatric midazolam
research on the brain mechanism of tavns in regulating pd motor symptoms

Conditions: Parkinson Disease

Summary: this study is a double blind comparative study exploring the neural underpinnings of tavns modulating pd motor deficits. we hypothesize that tavns might improve pd motor deficits by regulating the balance between excitation and inhibition in the primary motor cortex.

patients in the experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (tavns, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham tavns with the electrodes were fixed at the left earlobe . assessments of motor symptoms and cortical activity (using functional near-infrared spectroscopy and transcranial magnetic stimulation) were performed two times: at baseline, one day post intervention.

Eligibility criteria:
inclusion criteria: * (1) had a diagnosis of idiopathic pd according to the movement disorder society clinical diagnostic criteria for pd and on-medication hoehn and yahr (h\&y) stage ≤2, * (2) had stable pharmacotherapy for pd at least one month prior to the study, * (3) were aged between 40 and 80, * (4) signed written informed consent, * (5) can cooperate with the testing and tavns treatment. exclusion criteria: * (1) with cognitive impairment, according to montreal cognitive assessment (moca) \< 24; * (2) with severe tremor or levodopa-induced dyskinesia; * (3) with current intake of anticholinergics or any drugs that could induce cerebral functional change; * (4) with tavns contraindications; * (5) received vns treatment during the past six month; * (6) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.

Keywords: parkinson's disease motor symptoms tavns neural mechanism
long term follow up to evaluate dtx301 in adults with late-onset otc deficiency

Conditions: Ornithine Transcarbamylase (OTC) Deficiency

Summary: determine the long-term safety of dtx301 following a single intravenous (iv) dose in adults with late-onset ornithine transcarbamylase (otc) deficiency.

study 301otc02 is a long-term follow-up study to evaluate the safety and efficacy of adeno-associated virus (aav) serotype 8 (aav8)-mediated gene transfer of human otc in adults with late-onset otc deficiency. only subjects who complete study 301otc01 (nct02991144) are eligible to participate in study 301otc02.

Eligibility criteria:
inclusion criteria: 1. completed the week 52 visit in study 301otc01. 2. willing and able to provide written informed consent. 3. willing, able, and committed to comply with scheduled study site visits, study procedures, and requirements. exclusion criteria: 1. planned or current participation in another interventional clinical study that may confound the efficacy or safety evaluation of dtx301 during the duration of this study. 2. any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or would impede the study.

Keywords: gene therapy otc deficiency urea cycle disorder
incorporating voice activated communication aids into everyday communication

Conditions: Dysarthria

Summary: dysarthria is a speech disorder resulting in speech that is slow, slurred and difficult to understand, limiting a person's opportunities to study, work, and develop relationships. people with dysarthria often use communication aids to help them to communicate creating spoken messages using a keyboard, touchscreen or joystick. communication aids can increase independence but are often too slow to keep pace with normal conversation. developments in speech recognition technology have led to apps which can learn to recognise a set of words or sounds spoken by the individual with dysarthria, and connect these with a clear spoken output. the investigator's previous research provides some evidence that these voice input communication apps may be faster than traditional communication aids. this study aims to find out who can benefit from this technology, and what support they will need to use it successfully. this information can be used by professionals involved in providing communication aids, and will help the investigators to plan further research into their effectiveness. this research has two phases: 1. 20-30 individuals with dysarthria will be asked to use a voice input communication app for 6 months. the investigator's will collect information on whether vocatempo improves their communication, and helps participants to reach their goals. 2. focus groups will be held with professionals involved in providing and supporting people with communication aids, to understand factors affecting their ability to provide the support identified as needed in part 1 of the research. the investigators have a panel of communication aid users, who are advising and contributing throughout the study, for example, helping the investigators to identify informal support networks to recruit participants from. the investigators will let people know about the findings through support groups used by people with dysarthria, publications read by people involved in providing communication aids, and academic papers and conferences.


Eligibility criteria:
inclusion criteria: * over 18 years of age * moderately or severely dysarthric (identified using the frenchay dysarthria assessment * minimum of 2 distinct vocalisations over which they have voluntary control * able to give informed consent and take part in interviews with appropriate communication support (scores level 1-3 on consent support tool) * communicates predominantly in english exclusion criteria: * they have significant cognitive impairment and are unable to give informed consent on their own behalf or actively take part in interviews (tested using the consent support tool, scoring at level 4), or are unable to use a communication aid. * they have no controlled vocalisations. * they have dysarthria as a result of a progressive condition
study of durvalumab plus tremelimumab as first-line treatment in chinese patients with unresectable hepatocellular carinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of druvalumab plus tremelimumab as first-line treatment in chinese patients with unresectable hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * confirmed hcc based on histopathological findings from tumor tissue or radiologically findings * no prior systemic therapy for hcc * barcelona clinic liver cancer (bclc) stage b (not eligible for locoregional therapy) or stage c * child-pugh score class a or b * ecog performance status (ps) of 0-2 at enrollment (child-pugh score class a and ecog ps of 0-1 will be enrolled in cohort 1 and child-pugh score class b or ecog ps of 2 will be enrolled in cohort 2) * at least 1 measurable lesion per recsit 1.1 guidelines exclusion criteria: * hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy * clinically meaningful ascites * main portal vein tumor thrombosis * active or prior documented gi bleeding (eg, esophageal varices or ulcer bleeding) within 6 months * hbv and hvc co-infection, or hbv and hep d co-infection
8-week pilot study of relaxation for weight loss in adults with chronic kidney disease

Conditions: Obesity

Summary: obesity plays a causal role for kidney disease incidence and progression. moderate weight loss reduces the high metabolic demands on the kidney and decreases proteinuria in both diabetic and non-diabetic nephropathies. however, maintaining behavioral changes for weight loss is very challenging, and common chronic kidney disease (ckd) co-morbidities such as decreased exercise capacity only compound this difficulty. moreover, no weight loss medications have been adequately tested in adults with ckd and most are contraindicated in this population. mindful meditation or "mindfulness" in addition to other relaxation techniques may help adults lose weight by interrupting learned behavior, curbing compulsive eating, and reducing stress and appetite. although mindful meditation and other relaxation techniques have gained the attention of the mainstream media for obesity treatment, scientific data on its efficacy remain limited. due to the short duration of this study, substantial weight loss in any participant is not expected. instead, the primary purpose of this study is to examine the feasibility of a randomized controlled trial of mindful meditation relaxation techniques combined with standard care compared to standard care alone for the treatment of obesity among veterans with ckd.


Eligibility criteria:
inclusion criteria: * receive medical care at the hines va ckd clinics. * presence of chronic kidney disease defined as an estimated glomerular filtration rate \< 60 ml/min/1.73 m2 bsa or a spot urine albumin/creatinine ratio ≥ 30 mg/g * bmi ≥ 35 kg/m2 or a waist circumference ≥ 102 (40 inches) and ≥ 88 cm (35 inches) in men and women, respectively. exclusion criteria: * inability to give informed consent * inability to come to va for two group sessions * inability to listen to an mp3 player using headphones

Keywords: obesity meditation chronic kidney disease