Kornimate/medical-research-clean huggingface dataset:
lung hexert: helium, xenon mri for nsclc patients

Conditions: NSCLC

Summary: the university of sheffield is one of the leading centres in the world for basic and translational research with inhaled gas mri, which provides lung images with unprecedented spatial and temporal resolution. our previous work demonstrated that inhaled gas mri can provide significant clinical information for lung cancer radiotherapy planning and post-treatment evaluation. building upon this unique experience, a multidisciplinary team will conduct an inhaled gas and proton lung mri study that will address two of the major clinical problems faced by lung cancer patients treated with radiotherapy. 1. normal lung tissue is often damaged by the curative radiation dose. the investigators hypothesise that regional ventilation-perfusion lung function imaging with inhaled gas and proton mri before and after treatment will help to lower the risk of radiation-induced lung injury and help to detect such damage at an early stage. 2. identification of the extent of cancerous tissue is error-prone when planning treatment from ct images alone. the investigators hypothesise that advanced proton mri techniques will improve the identification of tumour volume, which is critical to successfully targeting the radiation dose. to achieve these goals, image acquisition and image processing methods will be tested with a study of 20 patients. results from this study will make an important contribution to improving the treatment of lung disease which is one of the key research priorities of the nhs.


Eligibility criteria:
inclusion criteria: * patients with an mdt diagnosis of nsclc based on findings of positive histology, positive pet scan or growth on serial ct scan requiring ct planning for radiotherapy treatment * patients aged over 18 * patients able to undergo mri scanning. exclusion criteria: * patients with co-morbid conditions that exclude radiotherapy treatment * patients who are pregnant or women with child bearing potential * patients unable to give informed consent * patients who do not understand english sufficiently to read the patient information sheet, provide informed consent or converse with research staff without interpreters.
sirolimus for massive polycystic liver

Conditions: Polycystic Kidney Diseases

Summary: the purpose of this study is to evaluate the effectiveness and safety of sirolimus in reducing liver volume in autosomal dominant polycystic kidney disease.

autosomal dominant polycystic kidney disease (adpkd) is one of the most common causes of end stage renal disease (esrd), affecting an estimated 0.2% of population. of adpkd patients, 58% in 15-24 year, 85% in 25-34 year, and 94% in 35-46 year olds suffer from polycystic liver in addition to polycystic kidneys. several anti-proliferative drugs have been used in clinical trials to stop cyst growth both in liver and kidneys. among them, octreotide and sirolimus have been shown to be one of the most promising drugs to reduce cyst volume. sirolimus already has been used as one of the most potential oral immunosuppressants. moreover, the serum trough level is quite easy to measure. sirolimus is the mtor inhibitor that has been proven to be effective in reducing cyst growth both in animal models. however, its efficacy and safety is not well proven in previous studies. this is a open-label, prospective study to evaluate the effectiveness and safety of sirolimus to reduce cyst growth in adpkd patients with massive polycystic liver.

Eligibility criteria:
inclusion criteria: * age 18 - 65 * patients diagnosed as adpkd based upon the unified criteria for ultrasonographic diagnosis of adpkd * polycystic liver with total liver volume \> 2500 ml or symptomatic polycystic liver * estimated glomerular filtration rate (idms-traceable mdrd equation) \>= 30 ml/min/1.73m2 exclusion criteria: * concomitant systemic renal parenchymal or urinary tract disease (random urine albumin-to-creatinine ratio \> 500 mg/g) * wbc \< 4,000/ul, platelet \< 100,000/ul, or hemoglobin \< 10.0 g/dl * diabetes mellitus, cancer, or psychiatric disorder * increased liver enzymes (2-fold above normal value) * hypercholesterolemia (fasting cholesterol \> 200mg/dl) or hypertriglyceridemia (\>150 mg/dl) not controlled by lipid lowering therapy * infection with hepatitis b, c, hiv * any condition that could prevent full comprehension of the purpose and risks of the study * pregnant or lactating women or fertile women without effective contraception * history of intervention, such as cyst aspiration or embolization in past 1 year

Keywords: total liver volume liver cyst
study of low-dose naltrexone in chronic migraine with fibromyalgia

Conditions: Chronic Migraine; Fibromyalgia; New Daily Persistent Headache

Summary: this research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. a few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.


Eligibility criteria:
inclusion criteria: * subjects will be adults of all genders ages 18 and older. * patients with a diagnosis of cm (with or without ndph) by ihc-3 criteria, diagnosed by a certified headache specialist. * subjects who received a new prescription for ldn * fibromyalgia-diagnosed according to fibromyalgia rapid screening tool * subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months. * subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice. * subjects willing to fill out pre and post intervention surveys * subjects willing to comply with planned follow up phone calls and visits. exclusion criteria: * not planning on follow up care with clinician. * patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.
insulin tolerance test study in patients with type 1 diabetes

Conditions: Type 1 Diabetes; Hypoglycemia

Summary: the primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with type 1 diabetes


Eligibility criteria:
inclusion criteria: * inclusion criteria: diagnosis of diabetes =\> 4yrs, on insulin =\> 4yrs, hba1c\<= 10%, at least one episode of severe hypoglycemia in past 12 months, fasting c-peptide \<0.7 ng/ml exclusion criteria: * hypoglycemia unawareness, dka within 3 months prior to randomization, reduced renal function, anxiety and depression
binge eating anxiety and mood

Conditions: Binge-Eating Disorder; Binge Eating; Anxiety Disorders; Mood Disorders

Summary: binge eating disorder (bed) is the most common eating disorder, and currently, the best behavioral treatments only work for 40-60% of adults. bed often co-occurs with mood and anxiety disorders, and both are associated with neurocognitive deficits related to executive function (ef). these ef deficits contribute to worsening bed symptoms and make it difficult for these adults to adhere to treatment recommendations. the proposed study aims to develop an ef training enhanced behavioral treatment for bed and compare its effectiveness to the standard cognitive behavioral therapy for patients with bed and a co-occurring mood or anxiety disorder.

a randomized controlled trial (rct) will evaluate an ef training enhanced cognitive behavioral therapy (cbt) for bed (ef-bed+cbt) compared to standard cbt in patients with bed and a comorbid mood/anxiety disorder to assess the feasibility, acceptability, and preliminary efficacy of ef-bed+cbt in reducing binge eating, impairment, and comorbid depression/anxiety symptoms. adult participants with bed and comorbid mood/anxiety disorder will be randomized to a four month remote treatment of either ef-bed+cbt or cbt alone. participants will be assessed at baseline, following treatment (month 4) and 2-month follow-up (month 6).

Eligibility criteria:
inclusion criteria: * age 18-65 * ability to read english at a 6th grade level * clinical or subclinical bed and at least one comorbid mood or anxiety disorder exclusion criteria: * known cognitive disability (e.g., brain injury with loss of consciousness \>30 min, intellectual disability) * psychosis * psychiatric condition that could interfere with program participation (e.g., substance abuse, suicide attempt within previous 6 months, active purging, active suicidality) * currently pregnant, lactating or plan to be in the timespan of program follow-up * change in psychotropic medication or other medication that could have impact on weight, binge eating or anxiety/mood symptoms during the previous 3 months * participating in an organized program for overeating
surgical scar treatment with the pulsed dye laser in combination with a co2 laser

Conditions: Scars

Summary: prospective, randomized, split lesion treatment with 4 study arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post moh's surgery.

prospective, randomized, split lesion treatment with 4 study arms: 1) treatment with pulsed dye laser (pdl) only, 2) treatment with co2 laser only, 3) pdl and co2 laser combined treatment, and 4) split scar combined lasers with an additional single co2 laser treatment immediately post-surgery vs. no treatment.

Eligibility criteria:
inclusion criteria: * comprehension of, and willingness to sign, the informed consent form. * have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm. * be a healthy male or female of at least 18 years old. * fitzpatrick skin type i-v. * willingness to follow the treatment and follow-up schedule and the post-treatment care instructions. * non pregnant and/or breast feeding, if applicable. * willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months. * agree to follow and undergo all study-related procedures. * use of daily use of sunblock spf 30 or higher for duration of the study. exclusion criteria: 1. pregnant and/or breastfeeding. 2. fitzpatrick skin type vi. 3. prior treatment for the surgical scar to be treated in this study. 4. having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treated area, unless treatment is conducted following a prophylactic regimen. 5. use of isotretinoin or other systemic retinoids within the past 6 months. 6. use of topical retinoids or therapeutic topicals in the treatment area in past 2 months. 7. use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges. 8. suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions. 9. history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. 10. having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study. 11. excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study. 12. participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment. 13. as per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
chongqing intracerebral hemorrhage study

Conditions: Intracerebral Hemorrhage; Stroke; Hematoma

Summary: the chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor qi li from chongqing medical university. professor peng xie will be the senior consultant for the study. the chongqing intracerebral hemorrhage study will focus on the epidemiology, natural history, pathogenesis, laboratory, radiological aspects, clinical outcomes and the effects of treatment in patients with intracerebral hemorrhage. the clinical, laboratory, imaging, genetic and outcome data of patients diagnosed with acute intracerebral hemorrhage will be prospectively collected. the prognosis of patients with intracerebral hemorrhage will be assessed by using several outcome measure scales at different time points.

the chongqing intracerebral hemorrhage study will try to address several key issues in ich. the baseline clinical data including demographic, disease severity scores, prior drug history and relevant medical history, premorbid mrs scores will be prospectively recorded. the admission and follow-up imaging data of all registered patients will be saved as dicom format for future use and review. the functional outcomes will be assessed and recorded by experienced neurologists.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * informed consent to participate in the study * patients diagnosed with ct-confirmed spontaneous intracerebral hemorrhage (ich) * patients are willing to participate in the follow up assessment exclusion criteria: * did not agree to participate in the study * secondary ich to hemorrhagic infarction or tumor bleeding etc. * traumatic ich

Keywords: intracerebral hemrrohage stroke china hematoma ct predictor prognosis outcome
mgr001 / advair diskus local equivalence study in asthma

Conditions: Asthma

Summary: the purpose of this study is to determine whether mgr001 is equivalent to advair diskus when administered by inhalation in adult asthma patients


Eligibility criteria:
key inclusion criteria include: * male or female subjects aged ≥18 years. females may be of either childbearing or non-childbearing potential * physician diagnosed history of asthma for at least 12 weeks prior to screening * pre-bronchodilator fev1 60-85% at screening and other specified visits * post-bronchodilator reversibility \>/=12% * non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years * subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required * body mass index between 18-40 kg/m2 inclusive key exclusion criteria include: * presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities * respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, churg-strauss disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis * history of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s) * in patient hospitalization (not including er visits) for an asthma exacerbation within the past year or during the run in period * an asthma exacerbation requiring change in asthma therapy or oral/iv corticosteroids in the 3 months prior to screening * history of seasonally unstable asthma where the season will coincide with the subject's participation in the study * use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc * suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy * clinically significant abnormalities in the screening ecg * evidence of alcohol or drug abuse or dependency within 6 months prior to screening

Keywords: asthma fluticasone salmeterol crc749 diskus advair fev1 mgr001
effect of stuttering remediation exercises on cortical auditory evoked potentials

Conditions: Developmental Stuttering; Evoked Potentials Auditory

Summary: studying how the cortical auditory evoked potentials differ in children who stutter from who do not stutter and how these potentials change with therapy

measuring amplitude and latency of p1, n1, p2 n2 between a group with developmental stuttering and a control group with no stuttering at baseline. recording the potentials through passive listening to a 60db stimulus and active speaking, describing pictures and rapid naming. assigning the group with stuttering to remediation exercises using fluency shaping program for 2 to 4 months then remeasuring amplitude and latency of the previously mentioned potentials.

Eligibility criteria:
inclusion criteria: * patients with developmental stuttering * normal hearing and vision. * adequate language for age. exclusion criteria: * known history of epileptic fits. * intellectual disability and other neurological deficits. * cluttering
pessary satisfaction criteria for urogenital prolapse

Conditions: Genital Prolapse; Pessary; Satisfaction

Summary: genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. the use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate. the main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.

this is a prospective observational cohort conducted at the universitary hospital of caen over a total period of 5 years. patients with a symptomatic genital prolapse will all be offered the installation of a pessary. if they agree to participate in the study, they will be asked to respond to validated questionnaires: symptom questionnaires (pfdi-20, iciq-sf, usp), a sexuality questionnaire (pisq-12), a quality of life questionnaire (pfiq-7, bis) and satisfaction (pgi-i), several times: before the installation of the pessary, at one month, at 6 months, then annually over 5 years

Eligibility criteria:
inclusion criteria: * the research protocol will be proposed to all patients with a symptomatic genital prolapse, over 18 years of age, who speak french and who agree to participate in this study * prolapse defined according to the international classification pop-q-. exclusion criteria: * minors under 18 years of age * pregnant or lactating women * women not speaking french (the good understanding of french is necessary to answer questionnaires and for informed information) * women unable to understand due to cognitive impairment or degenerative disease (dementia/ alzheimer's disease)

Keywords: quality of life efficiency
hcv reinfection after daa therapy in pwid in belgium

Conditions: Hepatitis C Virus Infection, Response to Therapy of; Drug Use

Summary: the primary aim of this study is to calculate the incidence of hcv reinfection after successful daa treatment among people who have recently injected drugs. the secondary aim is to identify factors associated with reinfection in this population. individuals with active injecting drug abuse with a chronic hcv infection who have achieved end of treatment response (etr; defined as non-detectable hcv rna at end of treatment) to any interferon-free daa combination will be included in this multicenter interventional study.

this protocol is an adapted version of the protocol 'hepatitis c reinfection after successful directly acting antiviral treatment: a north-atlantic multicenter interventional study'. the investigators will plan this study so that the data are similar to this protocol and results can be compared within this alliance of hepatologists with special interest in care for substance users. study schedule: data collection will be performed according to the study schedule shown in table 1. following assessment for svr12, participants will be followed for 2 years at 6 months' intervals at the discretion of each study site.

Eligibility criteria:
inclusion criteria: * informed consent * age 18 years or older * injecting drug use within 6 months before start of treatment * achieved an etr following at least eight weeks of daa treatment * completed daa treatment no more than 6 months prior to inclusion * blood sample drawn within 6 months pre-treatment stored at -70° c exclusion criteria: * patients not fulfilling the inclusion criteria.
cholinesterase activity and delirium during critical illness study

Conditions: Delirium; Cognitive Impairment

Summary: delirium is a syndrome of acute brain dysfunction involving attention and cognition that affects up to half of older hospitalized patients and 50%-75% of critically ill icu patients, such that millions of patients worldwide experience this acute threat to their health and well being every year. one-third to half of critical illness survivors struggle with a dementia-like disorder similar in severity to moderate-to-severe traumatic brain injury or alzheimer's disease, and the only proven risk factor that is potentially modifiable is delirium in the icu. despite the frequency and impact of delirium in the icu, little is known regarding the biological mechanisms that lead to this form of organ dysfunction during critical illness. a widely held hypothesis proposes that inflammation is regulated by the cholinergic system, and that this interaction plays a pivotal role whether delirium developments in the setting of acute illness. acetylcholinesterase (ache) and butyrylcholinesterase (buche) are enzymes that hydrolyze the neurotransmitter acetylcholine. changes in the activity of these enzymes, which can be measured in whole blood, reflect altered regulation of circulating acetylcholine. ache and buche activities have promise as both predictors of delirium (when found to be low at admission) and biomarkers of delirium (when low during serial measurement). neither of these biomarkers, however, have been studied in the icu setting where delirium risk is the highest. the current investigation, therefore will be the first to determine the validity of circulating ache and buche activities as biomarkers of delirium during critical illness and subsequent cognitive impairment after discharge. this study will measure whole blood ache and butyrylcholinesterase buche activities within the framework of the icu delirium and cognitive impairment study group's ongoing clinical trials in critically ill patients.


Eligibility criteria:
inclusion criteria: * english-speaking adults (\>18 years of age) treated for acute respiratory failure (with mechanical ventilation or non-invasive positive pressure ventilation \[nippv\]) and/or shock (with vasopressors) in a medical and/or surgical icu at vanderbilt university medical center enrolled in an icu delirium and cognitive impairment study group's clinical trials. exclusion criteria for the parent studies are summarized below. no additional exclusion criteria are required for this investigation. exclusion criteria: * expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening) * active substance abuse, psychotic disorder, or homelessness without a secondary contact person (which would make long-term follow-up difficult) * blindness or deafness (which would prevent assessment of the study's outcomes) * inability to obtain informed consent