Kornimate/medical-research-clean huggingface dataset:
real life pediatric obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive; Children

Summary: objectives: primary: to analyze the cognitive alterations in children with obstructive sleep apnea osa in different age groups and changes at 12 months after treatment with a protocol based on usual clinical practice. design: observational, longitudinal, prospective, and multicenter study.

study population: children aged 3 to 12 years consecutively referred to the sleep units due to clinical suspicion of osa. sample size: to evaluate the relationship between cognitive measures and polysomnographic variables and differences before-after treatment, a sample size of 1200 children is calculated. methodology: the followiong will be obtained in all children included in the study: personal medical history, spanish version of pediatric sleep questionnaire (psq), physical and otorhinolaryngological examination, neurocognitive assessment by customary neurocognitive and behavioral tests routinely used in spain (cumanin neuropsychological tests, enfen neuropsychological tests, and spanish version of the ecbi (eyberg child behavior inventory)), sleep study by polysomnography (psg) or respiratory polygraphy (pr) and blood test. the diagnosis and treatment of osas will be established according to the criteria of the spanish consensus document of osas in children. depending on the treatment, three groups will be obtained: group 1: children with osas and adenotonsillar hypertrophy we will perform surgical treatment. group 2: children with osas and without adenotonsillar hypertrophy will be evaluated other treatments (sleep hygiene-diet and physical activity guidance, medical, orthodontic, continuous positive pressure on the airway (cpap) treatment, group 3: regular follow up but no treatment for children referred for suspicion of osas and that in psg or rp the diagnosis of osas is not established. in all three groups, at 12 months, we will repeat all assessments as delineated for the initial visit

Eligibility criteria:
inclusion criteria: * children aged 3 to 12 years consecutively referred to the sleep units due to clinical suspicion of osa. exclusion criteria: * a significant medical and/or psychiatric comorbidity that may require urgent treatment (respiratory failure, heart failure, cardiac malformations, tumors, psychiatric type disorders that may require specific treatment...) * craniofacial malformations, deposit diseases and/or malformation syndromes (including down's syndrome) * already diagnosed neurocognitive type disorders (e.g.: autism, cerebral palsy, etc.) * attention deficit hyperactivity disorders previously diagnosed according to dsm-iv criteria * girls ≤ 12 with menarche at the time of starting the study * children that refuse to take part in the study (do not sign the informed consent

Keywords: sleep apnea children neurocognitive
nasal high flow therapy for the treatment of respiratory insufficiencies during sleep

Conditions: Sleep Disordered Breathing; Congestive Heart Failure

Summary: respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities. the purpose of this study is to assess the possibility that a nasal high flow therapy device may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing reduction in blood oxygen. heart failure patients will be screened at a heart failure clinic, and will be asked to undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies during sleep. this sleep study may be completed in the sleep laboratory (attended polysomnography, psg) or in-home (in-home polygraphy, pg). if they are diagnosed with respiratory insufficiencies, they will be asked to attend further overnight studies to see if treatment with nasal high flow therapy can be used to stabilize breathing.


Eligibility criteria:
inclusion criteria: * men and women aged ≥ 18 years * heart failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months * left ventricular systolic dysfunction (lvef ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). all echocardiography must be within a maximum of 1 year of the screening visit. * new york heart association class ii or iii after optimization of medical therapy * stable clinical status on stable optimal medical therapy for ≥ 1 month before entry exclusion criteria: * unstable angina * myocardial infarction within the last 12 months * cardiac surgery within the previous 6 months * pregnancy * unwilling or unable to provide informed consent * uncontrolled arrhythmias * severe valvular heart disease * current/prior use of mechanical ventilation (including cpap). at the investigator's discretion.
open versus laparoscopic ablation of liver malignancies

Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma; Liver Metastases

Summary: the purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.

liver malignancies is a major cause of cancer-related mortality and the incidence is increasing. patients with liver malignancies are often left with limited surgical treatment options due to extensive tumor burden or comorbidities. ablation is a less invasive treatment for these patients that can be performed percutaneously, by laparoscopy or open surgery. ablation during open surgery has a high potential of complications. laparoscopic ablation presumably has a lower complication rate than during open surgery, yet still offers some of the same advantages needed for tumors in locations not favorable for percutaneous ablation. this study aims to compare laparoscopic ablation with ablation during open surgery to investigate a treatment option with a supposed lower complication rate and equally treatment effectiveness after one month.

Eligibility criteria:
inclusion criteria: * one or more tumors not amenable to percutaneous ablation, age ≥ 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment. exclusion criteria: * ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak danish.

Keywords: laparoscopic ablation open ablation complications ablation response quality of life randomized multicenter
mobile interpretation bias modification clinical trial

Conditions: Anxiety Sensitivity; Suicidal Ideation

Summary: the mobile-interpretation bias modification clinical trial aims to examine the efficacy of a brief mobile phone delivered interpretation bias modification to reduce anxiety sensitivity cognitive concerns and suicidal ideation in national guard personnel. the investigators propose a randomized controlled trial testing the efficacy, acceptability, and usability of m-ibm with a sample of 114 national guardsmen with current suicidal ideation and elevated anxiety sensitivity cognitive concerns. participants will complete assessments, receive assistance on installing m- ibm on their phone, complete an m-ibm intervention session, and complete post-intervention assessments. baseline measures of psychopathology, and usability/acceptability of m-ibm will be obtained during the initial session. in addition, 1-month, and 3-month follow-ups would be scheduled to examine changes in psychopathology. the investigators hypothesize that those randomized to m-ibm will experience reductions in anxiety sensitivity cognitive concerns, suicidal ideation. in addition participants will find m-ibm acceptable and easy to use.


Eligibility criteria:
inclusion criteria: * elevated ascc (\>2) and include only guard members who also have current si (\> 0) . * ownership of a smartphone exclusion criteria: * those determined by military or study personnel to be actively psychotic, manic, or imminently suicidal and in need of emergency services
sarcopenia and risk of fall in osteoporotic postmenopausal women

Conditions: Sarcopenia; Falls Patient; Osteoporosis, Postmenopausal

Summary: the main scope of the present pilot study is to evaluate the possible association between the status of sarcopenia and the risk of fall in osteoporotic postmenopausal women. forty osteoporotic postmenopausal women, previously (pre-recruitment) classified by dxa in 20 sarcopenic and 20 non-sarcopenic subjects, will be recruited. the investigators will collect data on: 1) bone (vitamin d) and muscle (myokines) metabolisms through blood sampling; 2) risk of fall by the oak device produced by khymeia; 3) thigh muscle quality through mr.

a grave change associated with human ageing is progressive decline in skeletal muscle mass, a downward spiral that may lead to decreased strength and functionality. the term 'sarcopenia' (greek 'sarx' or flesh + 'penia' or loss) has been proposed to describe this age-related decrease of muscle mass. sarcopenia represents an impaired state of health with increased risk of falls and fractures, impaired ability to perform activities of daily living, and loss of independence. the imaging technologies used to detect loss of skeletal muscle mass in sarcopenia include: dual x-ray absorptiometry (dxa), magnetic resonance imaging (mr), computed tomography, peripheral quantitative computed tomography, and ultrasound. the main scope of the present pilot study is to evaluate the possible association between the status of sarcopenia and the risk of fall in osteoporotic postmenopausal women. forty osteoporotic postmenopausal women, previously (pre-recruitment) classified by dxa in 20 sarcopenic and 20 non-sarcopenic subjects, will be recruited. data will be collected on: 1) bone (vitamin d) and muscle (myokines) metabolisms through blood sampling; 2) risk of fall by the oak device produced by khymeia; 3) thigh muscle quality through mr. a secondary outcome is to evaluate the differences in bone and muscle metabolism, risk of fall, and muscle quality between sarcopenic and non-sarcopenic subjects.

Eligibility criteria:
inclusion criteria: * female. * aged over 60 yo. * classified as osteoporotic with t-score = or \< -2,5 evaluated by dxa. * autonomous walking. * signed informed consent. exclusion criteria: * male. * aged under 60 yo. * psychiatric disorders. * neurological pathologies. * endocrine disorders. * active cigarettes smoke. * recent bone fractures (6 months) * surgical treatments for orthopedic pathologies (6 months). * pacemaker carrier. * use of drugs influencing bone metabolism or limiting physical function.

Keywords: sarcopenia risk of fall osteoporosis muscle dxa mr muscle metabolism
evaluation of fm220 in patients with peripheral arterial disease (pad)

Conditions: Peripheral Arterial Disease; Intermittent Claudication

Summary: the purpose of this study is to determine whether 12 weeks of daily home use of the fm220 in the most affected leg of patients with pad and claudication, will improve peak walking time (pwt) at three months as compared with a non-treated control group.


Eligibility criteria:
inclusion criteria(main): 1. patients aged 40 or more. 2. peripheral arterial disease as determined by resting abi\<0.90. 3. reduction in post exercise ankle brachial index (abi) of \> 20% in the symptomatic limb. 4. stable claudication for the past three months 5. baseline pwt between 1 and 10 minutes 6. if the patient is under claudication drug therapy (eg. cilostazol and pentoxifvlline) the use and dose of these drugs has been stable for the last 60 days. 7. if the patient is receiving of statin and antiplatelet therapy, the use and dose of these drugs has been stable for the last 60 days. exclusion criteria: 1. any active pathological heart, muscular, neurological, orthopedic, cognitive or pulmonary disease which might interfere with patient compliance or ability to walk on a treadmill in the opinion of the investigator. 2. non compressible arteries as defined by abi\>1.1 3. clinical evidence of acute or subacute superficial or deep venous thrombosis confirmed by continuous-wave doppler in the affected extremity. 4. deep venous insufficiency on clinical grounds or by lab measurements. 5. prior below-knee surgical revascularization procedure within the last 6 months. 6. significant likelihood of lower extremity arterial revascularization procedure within the next 6 months. 7. ulcer, cellulitis, skin conditions, or superficial thrombophlebitis in regions covered by the compression device preventing use of the device. 8. acute pulmonary embolism. 9. osteomyelitis of the lower extremity. 10. gangrene of the lower extremity. 11. acute limb ischemia. 12. clinical scenarios in which increased venous or lymphatic return is undesirable. 13. painful calf conditions which would exclude use of the pump. 14. peripheral neuropathy that, in the opinion of the investigator, would prevent patient from accurately assessing claudication symptoms or identifying cutaneous comfort of the device vein ligation. 15. pulmonary edema. 16. significant aorto-iliac disease as demonstrated by physical examination or objective testing. absence of aorto-iliac disease must be documented by segmental testing performed within 90 days of study enrollment. 17. critical leg ischemia with evidence of rest pain, ischemic ulceration, gangrene. 18. participation in any clinical trial within the past 30 days. 19. morbid obesity, defined by bmi\>40, weight greater than 300 lbs or leg circumference greater than 19.7 inches. 20. pregnancy.

Keywords: peak walking time absolute claudication distance claudication onset time initial claudication distance intermittent compression
hepatitis c lab testing comparison study

Conditions: Hepatitis C

Summary: hepatitis c (hcv) hcv antibody assays are the standard of care test used to screen for hcv, but confirmation of acute infection is relegated in the current us guidelines to polymerase chain reaction (pcr) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. hcv core antigen is a new, research use only immunoassay intended for use on the abbott alinity i system, an fda-cleared instrument for clinical chemistry and immunoassay testing. the aim of the study is to evaluate the 48-hour stability of hcv core antigen in fresh serum and plasma specimens collected from individuals with a detectable hcv viral load (hcl vl), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories.

this study seeks to test the stability of a novel method of hepatitis-c testing called hcv core antigen testing. this will be accomplished by prospectively consenting patients who have had a recent, positive standard of care hcv viral load test, and drawing additional blood to conduct hcv core antigen testing within the infectious period. viral load amount of the core antigen test will be recorded at baseline and subsequent timepoints. stability is defined as \<10% change from baseline and will be recorded at various timepoints up to 144 hours post-draw. stability will also be tested at room temperature vs. refrigerated storage and on the gel vs. off the gel processing techniques. this information is necessary to ensure hcv core antigen is sufficiently stable following specimen collection to enable robust, accurate, and precise measurement using the hcv core antigen assay.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * had detectable hcv vl in a standard of care hepatitis c rna quantitative test * initial hepatitis c vl testing took place at any healthpartners lab * able to undergo a study blood draw within 3 weeks of initial hepatitis c vl testing * ability to sign e-consent prior to presenting for a study lab draw exclusion criteria: * age \<18 years * on the healthpartners research opt-out list * hcv vl not detectable at follow-up lab draw (screen fail)
vasoreactivity testing with intravenous sildenafil in patients with precapillary pulmonary hypertension

Conditions: Pulmonary Hypertension Associated With Connective Tissue Disease

Summary: sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary hypertension it is approved for treatment. the trial seeks to find out, whether the acute response to this treatment (= vasoreactivity testing) given intravenously is effective and allows prediction of therapy success during a following oral treatment.


Eligibility criteria:
inclusion criteria: * precapillary pulmonary hypertension associated with connective tissue disease * resting mean pressure in the pulmonary artery of \> 24 mmhg * resting mean pulmonary capillary wedge pressure (pcwp) of \< 16 mmhg * age 18 to 80 years * women of childbearing potential must have a negative pregnancy test (ß-hcg in urine) and must use effective methods of contraception * women must not be breastfeeding * ability to understand and sign the informed consent, correctly signed informed consent exclusion criteria: * pretreatment with sildenafil * contraindications for sildenafil treatment: * known intolerance to sildenafil, * optic neuropathy (naion), * known hereditary retina disease, * need of nitrate therapy * advanced liver cirrhosis - child c * severely reduced renal function with gfr \< 30 ml/min/1,73 m² * stroke or myocardial infarction within the last 6 months

Keywords: vasoreactivity testing sildenafil precapillary pulmonary hypertension connective tissue disease mean pressure in the pulmonary artery 25 mmhg or more mean pulmonary capillary wedge pressure below 16 mmhg
transcranial magnetic stimulation (tms) for motor symptoms in psychiatric disorders

Conditions: Psychomotor Retardation; Psychomotor Slowing; Schizophrenia and Related Disorders; Major Depressive Disorder

Summary: psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. it refers to slowing of fine motor skills, motor planning and gross motor behavior. in major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. this randomized, sham-controlled, prospective trial will test, whether 15 sessions of repetitive transcranial magnetic stimulation (rtms) may ameliorate psychomotor slowing in schizophrenia or major depression.

psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. it refers to slowing of fine motor skills, motor planning and gross motor behavior. in major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. this randomized, sham-controlled, prospective trial will test, whether 15 sessions of rtms in 3 weeks may ameliorate psychomotor slowing in schizophrenia or major depression. eligible participants will be randomized to one of four arms:

Eligibility criteria:
inclusion criteria: * suffering from major depressive disorder or schizophrenia spectrum disorder according to dsm-5 criteria * right handedness * normal or corrected-to-normal vision and hearing exclusion criteria: * epilepsy * history of severe head trauma * current abuse of drugs or alcohol; past addiction to drugs or alcohol * pregnancy * incompatibility to cerebral mri
acupuncture as the therapeutic modalities of acute toxicity in the radiotherapy of head and neck tumors

Conditions: Malignant Tumor of Soft Tissue of Head, Face and Neck

Summary: the aim of the study is to evaluate the benefit of the acupuncture as healing modalities in the therapy of acute toxicity of radiotherapy.

the study will enroll 100 patients in current radiotherapy of the head and neck cancer with acute radiotoxic symptoms at least of g1. the patients will be randomized (by ticket) in two regimens 1:1. regimen a (control regimen): standard support treatment of adverse events of the radiotherapy. regimen b (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture. due to the disease and patients differences, treatment will be individualized. used acupuncture points will be documented. the patients difficulties will be observed and their medication and will be recorded in the patient diary. possible skin toxicities wil be documented by the photography. before the randomization, all subjects will sign the voluntary informed consent. after the achievement of 50 enrolled subjects in any regimen, the enrollment will continue only to the other regimen. head and neck cancer therapy will include only curative and adjuvant radiotherapy.

Eligibility criteria:
inclusion criteria: * curative and adjuvant radiotherapy for head and neck tumors; * ps 1-2; * patient collaboration in evaluation of the toxicity diary. exclusion criteria: * palliative radiotherapy in the head and neck tumor; * ps 3; * non-compliance of the patient.
allogeneic stem cell transplantation for patients with severe aplastic anemia

Conditions: Anemia, Aplastic

Summary: for patients with severe aplastic anemia (saa) who have failed to respond to immunosuppressive therapy and lack an hla identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of cytoxan, reduced total body irradiation (tbi) and campath ih. the principle measures of safety and efficacy will be : 1. patient survival probability at 100 days, 1 year and 2 years. 2. incidence of graft versus host disease (gvhd), as well as incidence of acute gvhd and chronic gvhd within 6 months and 2 years. 3. engraftment at 6 months, 1 year and 2 years

the objective of this trial is to make an initial assessment for this new treatment regimen and to show it is equal or superior to the current standard practice. with this initial assessment be hope to gain information suggesting further study of this regimen or discontinuation of this regimen before exposing large numbers of patients to this new treatment option. we also will gain experience with this new regimen giving insights as to possible modifications in dosing and monitoring and selection of patients for future treatment in case of positive results. for this initial study we plan to enroll up to 24 patients.

Eligibility criteria:
inclusion criteria: * diagnosis of saa based on bone marrow aspirate and biopsy results. failure to respond to immunosuppressive therapy and/or lack of an hla identical family member. * a 10/10 or 9/10 hla matched unrelated donor or a 9/10 matched related donor available after high resolution typing. exclusion criteria: * patients with aplastic anemia and active infection must be treated to maximally resolve this problem before beginning the conditioning regimen. * hiv seropositive patients * patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome. * patient greater than 60 years of age. * women who are pregnant or nursing. * patients with active hepatitis * patients with severe cardiac dysfunction defined as shortening fraction \<25%. * patients with severe renal dysfunction defined as creatinine clearance \<40ml/mim/1.73m2. * patient with severe pulmonary dysfunction with fev1, fvc and dlco 40% of predicted or 3 sd below normal.

Keywords: severe aplastic anemia (saa) transplant for severe aplastic anemia (saa)