Kornimate/medical-research-clean huggingface dataset:
transcutaneous co2 monitoring at home for children with neuromuscular disease

Conditions: Sleep Disorder; Breathing-Related; Central Apnea; Neuromuscular Diseases; Obstructive Sleep Apnea

Summary: there is an unmet demand for the evaluation of nocturnal hypoventilation in children with nmd. an ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. if an ambulatory, at home, tcco2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.


Eligibility criteria:
inclusion criteria: * children with a confirmed diagnosis of nmd that meet criteria for evaluating sdb as per international recommendations * lives within the greater toronto area. exclusion criteria: * known diagnosis of nocturnal hypoventilation * current ventilatory support * physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).
coregistration of 18f-fdg-pet and mri in the staging of potentially resectable hilar cholangiocarcinoma: a pilot study

Conditions: Cholangiocarcinoma

Summary: to evaluate the feasibility and performance of coregistered 18f-fdg-pet/mri in the staging of potentially respectable hilar cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * hilar cholangiocarcinoma assessed by conventional imaging modalities (triphasic ct scan of the liver) and thought to be potentially resectable. exclusion criteria: * biliary drain inserted. * contraindication for mri. * pregnant or breast-feeding. * uncontrolled diabetes (over 9.7 mmol/l).

Keywords: potentially resectable hilar cholangiocarcinoma as per initial imaging studies. able to undergo pet/ct and mri with gadolinium
the effects of using augmented reality (ar) system to train foreign care workers.

Conditions: Oral Dryness and Saliva Altered; Oral Manifestations; Swallowing Disorder

Summary: the aim of this study was to evaluate the effect of augmented reality (ar) system training intervention of foreign care workers on the salivary biomarker and oral function of older people. this randomized controlled trial included experimental group: ar group (eg-a) video group (eg-b) and control group(cg), respectively. the eg-a will receive augmented reality (ar) system training intervention with ar tooth-cleaning skills session course add video-based oral hygiene education course . the eg-b receive video-based oral hygiene education course and the cg only receive only a leaflet.

a randomized experimental design was used. female foreign care workers whose aged 21 to 65 years and by cared older peoples whose aged 65 to 75 years were recruited through community-based site of long-term care service in kaohsiung city. each group was expected for 12 care workers and by cared older peoples who each group. g\*power (version 3.1.9.4) was used for power analysis. all foreign care workers whose participants will underwent questionnaire examination at baseline and at 1-month, 3-month, 6-month follow-ups. the information of foreign care workers regarding oral care cognition, attitude, self-efficacy, and oral care behavior intention will be collected by a self-report questionnaire before and after intervention. each by cared older peoples will be evaluation oral hygiene and function by oral hygienist, and will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up. older people by cared will assess plaque control record (pcr), tongue coating index (tci), repetitive saliva swallowing test (rsst), oral diadochokinetic (ddk), oral moisture degree (omd),masticatory efficiency (moe) and salivary biomarker at baseline (time 1), three months (time 2) and six months (time 3) follow-ups.

Eligibility criteria:
inclusion criteria: * 1. the indonesian caregivers who are employed in kaohsiung city are aged between 21 and 65 and have simple chinese communication skills. * 2. the elderly people being cared for is over 65 years old. exclusion criteria: * 1. elderly people who are unable to cooperate with instructions. * 2. elderly people with facial impairment.

Keywords: ar (augmented reality) oral care behavior saliva biomarker
the role of glass stage compared to wifi stage in predicting limb salvage

Conditions: Chronic Limb-Threatening Ischemia

Summary: compare between glass and wifi staging in predicting limb salvage in patients with chronic limb threatening ischemia ( clti) undergoing endovascular revascularization.

peripheral arterial disease (pad) is estimated to affect over 200 million people worldwide. these rates are expected to rise as increasing life expectancies continue to shift the population toward older age. at the most severe end of the disease spectrum, chronic limb-threatening ischemia (clti) affects 11% of patients with pad and is associated with high rates of limb loss and mortality as well as high costs of care.(1) the society for vascular surgery's wifi (wound, ischemia, foot infection) staging system was developed to classify threatened limbs using factors that affect amputation risk and clinical management in patients with chronic limb threatening ischemia . these include the extent of the wound, degree of ischemia, and severity of any foot infection. it has been validated as a predictor of limb salvage in peripheral artery disease.(2,3) the global vascular guidelines 'gvg "proposes a new global anatomic staging system (glass), which is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. but it has not been used for predicting limb salvage apart from use as a tool in deciding the mode of intervention for patients with chronic limb-threatening ischemia (clti).

Eligibility criteria:
inclusion criteria: - patients with clti who will undergo endovascular revascularization at our department: • rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene) exclusion criteria: * rutherford stage 1,2,3 aortoiliac level of occlusion unsalvageable limb patients with contraindications to contrast media non atherosclerotic lschemia as • acute ischemia * post traumatic ischemia * chronic ischemia caused by connective tissue diseases or vasculitis
effects of lifeskills workshop on bp in hypertensive employees

Conditions: Hypertension

Summary: a number of psychosocial risk factors have been strongly related to a range of health problems (chief among them cvd). clinical research has shown that behavioral interventions have enormous promise to ameliorate the psychosocial distress, the health-damaging effects and the costs associated with these risk factors. however, few such programs have been implemented in a large-scale way. corporations are increasingly interested in providing such services for their employees, but they have encountered difficulties in knowing which programs are most effective. until these programs are developed as products that can be tested and shown to produce consistent benefits, dissemination of these beneficial programs will be hindered. taken together, these findings make a strong case that the development of a standardized, protocol-driven behavioral intervention package that can be delivered in a wide range of corporate settings presents a remarkable commercial opportunity. the overall goal of this sbir fast-track-funded project is to gain empirical evidence in a rct that documents the effectiveness of the williams lifeskills workshop (a protocol driven 6-session workshop) in reducing bp, psychosocial risk factors, and promoting positive health outcomes in a cost effective manner in a corporate setting. this empirical support, tested in a setting independent of the program developers and by an experienced research team, will then be used to help market the product in the corporate wellness marketplace. it is hypothesized that participants (employees in an urban medical center) in the lifeskills intervention will experience greater reductions in blood pressure and improvements in measures of psychosocial well-being than those receiving usual medical care and given educational materials on reducing bp.


Eligibility criteria:
inclusion criteria: * adults age 18-75 * employees of columbia university medical center * bp \>= 140/90 on 2 occasions (average of 3 readings each time) exclusion criteria: * pregnancy * end-stage renal disease * bp \> 165/110 (average over 3 readings)

Keywords: hypertension stress reduction
randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with nk cells in high-risk aml

Conditions: Acute Myeloid Leukemia

Summary: the trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation

randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia

Eligibility criteria:
inclusion criteria: * newly diagnosed aml other than acute promyelocytic leukemia (apl) according to who criteria * in aml defined by cytogenetic aberrations the proportion of blasts may be \<20% * age ≥60 years * clinical performance corresponding to ecog score 0-2 * high-risk karyotype * \<5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy * maximal two preceding chemotherapy cycles * potentially available haploidentical family donor (child/ sibling), willing and fit for nk cell donation exclusion criteria: * aml with favorable or intermediate risk cytogenetic features * persistent aplasia following preceding chemotherapy * relapsed or refractory aml * known pre-existing autoimmune diseases * any severe concomitant condition which makes it undesirable for the patient to participate in the study * any condition which could jeorpadize compliance of the protocol * participation in another clinical trial during or within 4 weeks before study entry

Keywords: aml high-risk aml acute myeloid leukemia nk cells haploidentical natural killer cells immunotherapy
additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation

Conditions: Persistent or Long-standing Persistent Atrial Fibrillation

Summary: additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial ﬁbrillation can reduce atrial ﬁbrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.

the intervention in the lala-land-af trial is the additional laai in patients with catheter ablation for persistent af and will be performed once as index ablation as outlined above. with exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for af as stated by the european society of cardiology (esc) 11,18 and an expert consensus statement on catheter and surgical ablation1. patients may be treated with a specific antiarrhythmic drug (aad) for a maximum of 3 months following the index ablation. no repeat ablation for af should be performed within the first 3 months. thereafter, repeat ablations are permitted for recurrent af irrespective of group allocation. ablation strategy at repeat ablation includes pv re-isolation if required in both groups and re-isolation of the laa in the intervention group. in the control group, laai may only be performed in case all pv were isolated.

Eligibility criteria:
inclusion criteria: 1. persistent or long-standing persistent af (i.e. continuous af that was/is sustained \>7 days or \>12 months, respectively) 2. age ≥18 and ≤80 years 3. indication for af ablation as per current guidelines exclusion criteria: 1. missing informed consent 2. laa diameter \>25mm 10mm distant from circumflex artery assessed by tee 3. paroxysmal atrial ﬁbrillation 4. long-standing persistent atrial ﬁbrillation with a continuous af duration of \>4 years 5. previous pulmonary vein isolation or maze surgery 6. previous led atrial appendage closure or surgical excision 7. left atrial diameter \>60 mm at baseline 8. left atrial thrombus at baseline
amcenestrant (sar439859) plus palbociclib as first line therapy for patients with er (+) her2(-) advanced breast cancer

Conditions: Breast Cancer

Summary: primary objective: to determine whether amcenestrant (sar439859) in combination with palbociclib improves progression free survival (pfs) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (er+), human epidermal growth factor receptor 2 negative (her2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. secondary objective: * to compare the overall survival in both treatment arms. * to evaluate the objective response rate in both treatment arms. * to evaluate the duration of response in both treatment arms. * to evaluate the clinical benefit rate in both treatment arms. * to evaluate progression-free survival on next line of therapy. * to evaluate the pharmacokinetics of amcenestrant, and palbociclib. * to evaluate health-related quality of life in both treatment arms. * to evaluate the time to first chemotherapy in both treatment arms. * to evaluate safety in both treatment arms.

study duration per participant was approximately 59 months, which includes a 33- month treatment period.

Eligibility criteria:
inclusion criteria : * adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment. * confirmed diagnosis of er+/her2- breast cancer. * no prior systemic treatment for loco-regional recurrent or metastatic disease. * measurable disease evaluable per response evaluation criterion in solid tumors (recist) v.1.1 or non-measurable bone-only disease. * eastern cooperative oncology group (ecog) performance status 0-2. * participants should be willing to provide tumor tissue. * capable of giving informed consent. exclusion criteria: * known active brain metastases. * prior neo (adjuvant) treatment with any selective estrogen receptor degrader (serd). * inadequate organ and marrow function. * disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy. * pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods. * male participants who disagree to follow contraception. * participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term. * participants with significant concomitant illness. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
postprandial effect of chinese tea flavor liquor on selected cvd risk factors

Conditions: Alcohols; Cardiovascular Diseases

Summary: background: human studies of chinese liquor are sparse. we hypothesis that chinese tea flavor liquor may be beneficial to cvd risk factors postprandially. design: three-way crossover design with one week wash time.16 young men were included to consume 60ml chinese tea flavor liquor(45% alcohol content), chinese meijiao liquor 45% alcohol content) or water control.blood samples were collected fasted, 0.5,1,2,4 hours postprandially. tested serum indices: lipids, glucose, insulin, hs-crp, uric acid, liver function parameters.


Eligibility criteria:
inclusion criteria: * no cvd history or liver disease, healthy young men exclusion criteria: * smokers

Keywords: chinese tea flavor liquor postprandial uric acid high-sensitive c-reactive protein
sensetoknow autism screening device validation study

Conditions: Autism; Autism Spectrum Disorder

Summary: this is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the sensetoknow app for the detection of autism spectrum disorder in children 16-36 months of age.

this is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the sensetoknow app for the classification of autism spectrum disorder when administered by parents in a sample of patients 16-36 months of age. the trial design is a non-interventional cross-sectional study comparing the sensetoknow app classification of autism spectrum disorder ("autism") versus non-autism with the patient's diagnostic status based on expert clinical diagnosis in a population of pediatric patients.

Eligibility criteria:
inclusion criteria: 1. duke health pediatric patient at enrollment 2. 16-\<37 months of age at enrollment 3. parent/legal guardian speaks english or spanish 4. parent/legal guardian understands and voluntarily provides informed consent exclusion criteria: 1. severe motor impairment that precludes study measure completion 2. known genetic disorders 3. severe hearing or visual impairment as determined on physical examination according to parent report 4. acute illnesses likely to prevent successful or valid data collection 5. uncontrolled epilepsy or seizure disorder 6. history or presence of a clinically significant medical disease, or a mental state that could confound the study or be detrimental to the subject as determined by the investigator 7. acute exacerbations of chronic illnesses likely to prevent successful or valid data collection 8. receiving therapies that affect vision 9. parent/legal guardian and/or investigator believes that the child will be unable/unwilling to sit in the parent's lap to watch the app videos 10. parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment 11. participants who are otherwise judged as unable to comply with the protocol by the investigator 12. any other factor that the investigator feels would make the study measures invalid

Keywords: diagnosis digital device
comparative efficacy of fixed-dose combination sofosbuvir + ledipasvir, 8 vs. 12 weeks in chronic hepatitis c genotype 6

Conditions: PT-NANBH

Summary: the primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of sof/led for treatment-naïve, non-cirrhotic, hcv genotype 6 2. 12-week treatment of sof/led for all other hcv-6 populations

the secondary objective of this study is to describe safety, persistency, and tolerability of sof/led in patients with hcv-6.

Eligibility criteria:
inclusion criteria: 1. male or female, age ≥18 years 2. hcv genotype 6 or indeterminate and later assessed at screening and confirmed as genotype 6 3. selected to start on treatment by their treating providers 4. willing and able to provide informed consent 5. able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments 6. females of childbearing potential must have a negative serum pregnancy test at screening and a negative pregnancy test on baseline 7. male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 8. lactating females must agree to discontinue nursing before the study drug is administered exclusion criteria: 1. previous recipient of a liver transplant 2. co-infection with human immunodeficiency virus (hiv) or hepatitis b (hbv)

Keywords: hepatitis c, genotype 6
effect of catheter-based radiofrequency ablation therapy in patient with therapy-resistant hypertension and sleep apnea syndrome

Conditions: Therapy-resistant Hypertension and Sleep Apnea

Summary: the aim of this prospective single-center study is to evaluate sympathetic nervous system directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome (defined by a complaint of excessive daytime sleepiness, an epworth sleepiness score\>8\[10\], and an apnea/hypopnea index (ahi\>15/h) before and after catheter-based radiofrequency ablation of renal nerve. if the selected patients are treated with cpap, this therapy should be stable during the whole study time. primary and secondary end-point will be measured before and 1, 3, 6 and 12 months after renal sympathetic denervation.


Eligibility criteria:
inclusion criteria: we plan to include male or female subjects, age 18-80 with a diagnosis of medium-severe sleep apnea syndrome (defined by symptoms, a complaint of excessive daytime sleepiness, an epworth sleepiness score \>8, and an apnea / hypopnea index \>15/h) and a resistant hypertension (systolic blood pressure \>140 mmhg or \>130 mmhg in patients with type ii diabetes or chronic kidney disease, under treatment with three antihypertensive drugs including a diuretic). if the selected patients are treated with cpap, this therapy should be stable during the whole study time. every patient will be asked for a written informed consent. exclusion criteria: - heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure). * long acting nitrates, or pde-5-hemmer * alcohol or drug abuse, * malignancy (unless healed or remission \> 5 years) * disease with systemic inflammation (e.g. rheumatoid arthritis, m. crohn) * pulmonary hypertension (pap\>50 mmhg) * pregnancy * anatomical contraindication to renal denervation * know allergy to contrast * participation in another study within the last month