Kornimate/medical-research-clean huggingface dataset:
second stop after pioglitazone priming in cml patients

Conditions: Chronic Myeloid Leukemia (CML)

Summary: single-center study, prospective, phase ii trial. the study objectives are : * to assess safety and pharmacokinetics of the combination of pio and tki in cml subjects who experience a loss of mmr following a first tki discontinuation. * to assess survival without loss of mmr over a 12 months period following a second tki discontinuation in subjects who achieve or maintain \< mr4.5 with the combination pio and tki administered for at least 6 months.


Eligibility criteria:
inclusion criteria: 1. cml in any phase. patient in mr4 2. loss of mmr following a first or subsequent tki discontinuation trial. 3. patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib 4. age \>18 years. 5. serum bilirubin \<1.5 x upper limit of normal values. 6. ast (sgot)/alt (sgpt) \<2.5x upper limit of normal values. 7. females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. women of child bearing potential must have a negative urine pregnancy test at the time of enrollment. acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence. 8. males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period. 9. signed informed consent. 10. be able and willing to comply with study visits and procedures exclusion criteria: 1. known loss of ccyr by marrow cytogenetic or blood fish for bcr-abl1. 2. loss of chr. 3. participation in another clinical trial with any investigative drug within 30 days prior to study enrolment. 4. prior allogeneic hematopoietic stem cell transplantation. 5. patient requiring anti-diabetic medications to manage hyperglycemia. 6. cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment. 7. hepatic insufficiency 8. history of bladder cancer. 9. diagnosed hematuria. 10. known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria) 11. known history of macular edema. 12. known history of abl1-domain mutation associated with resistance to the discontinued tki. 13. known allergy to pio. 14. pregnant or breastfeeding. 15. use of tzd within 28 days prior to enrollment. 16. significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug. 17. uncontrolled peripheral edema (2+ or more) of any etiology
characterizing ankle function during sloped locomotion for prosthesis development

Conditions: Traumatic Amputation of Lower Extremity

Summary: the proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. this data will be used to develop control parameters for a powered ankle-foot prosthesis. then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.


Eligibility criteria:
inclusion criteria: study 1: - between 18-60 years old. study 2 and 3: * between 18-60 years old. * at least 1 year post-amputation * no current problems with prosthesis or residual limb * at least a k3 level of ambulation study 4: - between 18-45 years old study 5: * between 18-45 years old * at least 1 year post-amputation * no current problems with prosthesis or residual limb * experience running with a passive prosthesis * at least a k4 level of ambulation exclusion criteria: studies 1-5 * cardiovascular, pulmonary, or neurological disease or disorder * musculoskeletal injury
the role of aldosterone in circulatory disorders within type 2 diabetes

Conditions: Endothelial Dysfunction; Insulin Resistance

Summary: the importance of aldosterone for endothelial function and insulin resistance observed within patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: * diagnosed diabetic \< 5 yrs. * bmi \< 32 kg/m2 * non-smoking * blood pressure \< 140/90 mmhg (treatment with maximum of two antihypertensive drugs) exclusion criteria: * insulin treatment * hypertension (\>140/90 mmhg) * sequelae to diabetes * smoking * known chronic diseases * pregnancy or birth within 3 month * alcohol misuse

Keywords: endothelial dysfunction insulin resistance type 2 diabetes mineralocorticoid blocker
internet-based cognitive behavioral therapy (cbt) for adolescents with anxiety disorders

Conditions: Anxiety Disorders

Summary: cognitive behavioral therapy (cbt) is a well-documented and effective method for the treatment of children and adolescents with anxiety disorders. lately there has been an increase in the development and use of internet-based cbt programs (icbt), as a means to reduce costs and enhance accessibility of psychological interventions. icbt has proven efficacious towards adults with anxiety disorders. research in the field of icbt with children and adolescents is still in its infancy though and to date, no program targeting anxiety disorders has been developed nor evaluated in denmark. the primary objective of this study is to investigate the efficacy of a newly developed internet-based treatment program for adolescents with anxiety disorders. the effect will be examined in a randomized controlled trial comparing icbt to a wait-list control condition.

within the context of a research and teaching clinic at the department of psychology and behavioral sciences, aarhus university, denmark, 70 adolescents aged 13-17 with a primary anxiety disorder as assessed by the adis c/p will be randomly allocated to either a 3 month wait-list control condition or a treatment condition. the treatment consists of an internet-based self-help program for adolescents with anxiety disorders called 'chilled out', based on material from the well-established manualised group-treatment cool kids program: adolescent version. it consists of 8 cbt-inspired modules of approximately 30 minutes each distributed over a 14-week period. the program is interactive using a combination of different media (text, audio, illustrations, cartoons, and videos) to deliver psychoeducation and cbt-inspired techniques, activities and exercises for adolescents to manage their anxiety. in addition, the adolescent will receive a limited amount of therapist support calls. participants (youth and parents) are assessed with semi-structured diagnostic interviews and self-report measures before treatment, after 14 weeks (post treatment) and 3 months after treatment (follow-up). participants are assessed at pre, post and 3-month follow up.

Eligibility criteria:
inclusion criteria: * a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, social phobia, specific phobia, obsessive compulsive disorder or panic disorder * age between 13 and 17 years * ability to read and write in danish * direct access to a home computer and internet exclusion criteria: * high degree of comorbid depression (csr above 5 as measured with adis-iv) * substance abuse * current self-harm or suicidal ideation * pervasive developmental disorder * learning disorder * intellectual disability * psychotic symptoms all participants are asked not to make changes to their medication status during the course of the trial
safety and efficacy study of ho/03/03 10-40 micro grams to treat hard to heal wounds

Conditions: Hard to Heal Wounds

Summary: this multicenter, prospective, open-label, outpatient study will assess the safety and efficacy of ho/03/03 10µg applied topically once daily for up to 24 weeks in up to 100 subjects with hard to heal documented chronic wounds of various etiologies (pressure ulcers, diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis and trauma wounds) of at least 4 weeks documentation.

all subjects with a wound size of up to 56.25 cm2 (inclusive) will be administered 1 vial of 10 ml ho/03/03 10μg per administration. for each increase in wound size of up to 56.25 cm2 an additional vial of ho/03/03 10 μg will be added up to a maximal wound size area of 225 cm2 (will be measured by healor central reviewer) utilizing 40µg (4 vials) per administration. 15 min post treatment wounds will be dressed according to standard of care.

Eligibility criteria:
inclusion criteria: * age 18 years old and above. * chronic wounds that have \< 30% change in area from screening * have single / multiple wounds; * have a hard-to-heal wound(s) of various etiologies exclusion criteria: * have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than diabetes mellitus type 1 or 2), hepatic or per the physician's discretion.

Keywords: pressure ulcers, diabetic ulcers, post operational wounds
trial of cladribine, cytarabine, mitoxantrone, filgrastim (clag-m) in relapsed acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Burkitts Leukemia/Lymphoma; Chronic Myelogenous Leukemia

Summary: clag-m is an active, well tolerated regimen in acute myelogenous leukemia. each of the agents is active in acute lymphoblastic leukemia (all) as well. the current trial will determine the efficacy of the regimen in patients with relapsed all.

patients will receive standard dose clag-m (cladribine, cytarabine, mitoxantrone, filgrastim). standard support care will be given. efficacy will be assessed through bone marrow examinations and blood tests.

Eligibility criteria:
inclusion criteria: * relapsed or refractory acute lymphoblastic leukemia, * burkitts leukemia/lymphoma, * lymphoid blastic cml, * lymphoblastic lymphoma.
effect of fluticasone furoate/vilanterol on eia in adolescents

Conditions: Asthma in Children

Summary: exercise induced asthma (eia) is common in adolescents. (fluticasone furoate (ff)/vilanterol (vi)) is a once daily inhaler with bronchodilator effect lasting 24 hours. our objective was to investigate the short and long-term effects of ff/vi on eia in adolescents. adolescent asthmatics were referred for evaluation of eia. patients with a positive exercise challenge test, were allocated to a single administration of salbutamol and 22 to ff/vi in a double blind, double dummy method to assess the short-term effect on eia. then they received ff/vi for 30-60 days and were reassessed by a repeat exercise test 24-hours after the last dose.

exercise induced asthma (eia) is common in adolescents. relvar® (fluticasone furoate (ff)/vilanterol (vi)) is a once daily inhaler with bronchodilator effect lasting 24 hours. our objective was to investigate the short and long-term effects of ff/vi on eia in adolescents. ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation of eia. 44 patients had a positive exercise challenge test (ect), 22 (22/44) were allocated to a single administration of salbutamol (400 µg) and 22 to ff/vi (92/22 µg) in a double blind, double dummy method to assess the short-term effect on eia. then they received ff/vi for 30-60 days and were reassessed by a repeat ect 24-hours after the last dose.

Eligibility criteria:
inclusion criteria: * adolescent asthmatics aged 12-18 years * symptoms of shortness of breath on exercise and asthmatics before entry to military service * referral for evaluation of exercise challenge test exclusion criteria: * baseline fev1\<65% before exercise test * acute illness * history of intolerance to beta agonists * use of the following medications prior to the study was restricted: inhaled corticosteroids or montelukast (2 weeks), systemic steroids (2 months) and bronchodilators (24 hours)
efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia

Conditions: Sleep Initiation and Maintenance Disorders; Insomnia

Summary: the aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.


Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for at least one month preceding the study visit. * disturbance of sleep maintenance: * based on patient' s information: * patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks, * patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month, * patient must report impact on daytime functioning associated with sleep maintenance insomnia inclusion will be based on the nocturnal polysomnography (npsg) recordings performed at the sleep laboratory during the two screening nights. exclusion criteria: * females who are lactating or who are pregnant, or of childbearing potential not using an acceptable form of contraception * patients presenting with acute or chronic pain resulting in insomnia * patients with current psychiatric disturbances * body mass index \> 32 * evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety * clinically significant and abnormal electrocardiogram (ecg) (including qtc b \> 500ms), * a positive test for hepatitis b (hepatitis b surface \[hbs\] antigens) or c (hepatitis c virus \[hcv\] antibodies) * positive qualitative urine drug screen at screening * consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day * use of any over-the-counter or prescription sleep medication, or of any substance with psychotropic effects or properties known to affect sleep/wake, within one week or five half-lives (whichever is longer), prior to screening * night shift workers, and individuals who nap 3 or more times per week over the preceding month * based on medical history and/or npsg: * primary hypersomnia * narcolepsy * breathing-related sleep disorder (apnea-hypopnea index \> 10/hour of sleep) * circadian rhythm sleep disorder * parasomnia (e.g. somnambulism)

Keywords: primary insomnia sleep maintenance insomnia awakening
rhomboid intercostal block versus retrolaminar block for postoperative analgesia after thoracoscopic sympathectomy

Conditions: Post Operative Pain

Summary: background: although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. both rhomboid intercostal block (rib) and retrolaminar block (rlb) are recent techniques used for pain control after such procedures objectives: to compare the effectiveness of rib and rlb in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes. patients and methods: this prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group a; general anesthesia with intraoperative ipsilateral ultrasound-guided rib, whereas in group b; general anesthesia with intraoperative ipsilateral ultrasound-guided rlb.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ≤ ii * age from 18 to 60 years * body mass index (bmi) \< 35 kg/m² exclusion criteria: * american society of anesthesiologists (asa) physical status \> ii * age \ 60 years * body mass index (bmi) ≥ 35 * local infection at the puncture site * altered mental status * pregnant women * allergy to study drugs * chronic pain * coagulation abnormalities or on anticoagulants * severe hepatic or kidney disease

Keywords: rhomboid intercostal block retrolaminar block regional analgesia
a post-marketing study to monitor the safety of a mf59-adjuvanted influenza vaccine administered in korean subjects aged 65 years or older

Conditions: Influenza

Summary: this study will evaluate the safety of an influenza (flu) vaccine in korean men and women aged 65 years and older.


Eligibility criteria:
inclusion criteria: 1. males and females aged 65 years and above on the day of enrollment, who were eligible for seasonal influenza vaccination. 2. in the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedures. exclusion criteria: 1. history of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein. 2. receipt of another (inactivated) vaccine within 2 weeks, or receipt of a live vaccine within 4 weeks prior to study day 1, or planning to receive some other vaccination before the final study visit (about day 29 after vaccination). 3. any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.
artificial intelligence to evaluate postoperative pain based on facial expression

Conditions: Artificial Intelligence; Facial Expression; Analgesia; Pain, Postoperative

Summary: patients' subjective complaints about pain intensity are difficult to objectively evaluate, and may lead to inadequate pain management, especially in patients with communication difficulties.

analgesia nociception index (ani 0-100) and patient-reported numeric rating scale (nrs 0-10) were trained on a convolutional neural network (cnn) model by linking the patients' facial expression with the score. by applying the predicted pain score by the ai model to evaluate pain, it is intended to measure the intensity of pain in an automatic, fast, and objective way for appropriate pain management.

Eligibility criteria:
inclusion criteria: * patients aged 19-75 years who were scheduled for elective laparoscopic abdominal surgery under general anesthesia * american society of anesthesiology (asa) class i-ii exclusion criteria: * patients who have difficulty in communicating and reporting pain * underlying diseases: liver, kidney, brain * patients with bmi greater than 30 and less than 18.5 * alcohol or drug dependent patients * patients with severe or acute respiratory failure * opioid, nsaid allergy * patients who are scheduled to be admitted to the intensive care unit after surgery * patients who undergo cooperative surgery
a study to determine the feasibility of online recruitment of people using an anti-obesity medication for weight loss

Conditions: Obesity

Summary: this observational study is designed to determine the feasibility of recruitment from a digital research community of people using an anti-obesity medication for weight loss to understand willingness to consent to survey research and at home self-blood testing. this study will engage an active community of people using anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of participants to engage in a digital study, provide consent, and complete various study-related tasks, including a self-collected capillary blood sample for assay testing and health related surveys.


Eligibility criteria:
inclusion criteria: * adults 18 - 80 years of age. * living in the united states. * consented from the inspire online platform patient community for cosmos-digital. * self-reported current use of, and intention to continue for at least 30 days, one of the following medications for the indications of weight management/obesity: * semaglutide (wegovy) * tirzepatide (zepbound) exclusion criteria: * currently receiving treatment in another investigational device or drug study, or participation in a current clinical trial. * self-reported sensitivity/allergy to any of the components of the self-draw collection device including stainless steel or elements commonly found in stainless steel. * self-reported fear of blood. * self-reported circulatory conditions causing difficulty in drawing capillary blood. * known history of bleeding diathesis or any coagulation disorder. * history of skin disorders, abnormal skin integrity or atypical skin health within the areas to be tested in the upper arm.
safety and efficacy of subretinal implants for partial restoration of vision in blind patients

Conditions: Retinitis Pigmentosa; Retinal Degeneration

Summary: patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight. subretinal implant "on" results in significant visual acuity improvement, when compared to "off" condition.


Eligibility criteria:
inclusion criteria: * hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones. * pseudophakia * angiography shows retinal vessels adequately perfused, despite pathological rp condition. * age between 18 and 78 years. * blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation. * ability to read normal print in earlier life, optically corrected without magnifying glass. * willing and able to give written informed consent in accordance to en iso 14155 (section 6.7) and local legislation prior to participation in the study. able to perform the study during the full time period of one year for module-2. exclusion criteria: * period of appropriate visual functions approx. 12 years / lifetime. * optical coherence tomography (oct) shows significant retina edema \&/or scar tissue within target region for implant. * retina detected as too thin to expect required rest-functionality of inner retina as shown via optical coherence tomography (oct). * lack of inner-retinal function, as determined by electrically evoked phosphenes (eep). * heavy clumped pigmentation at posterior pole * any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment). * amblyopia reported earlier in life on eye to be implanted * systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases). * neurological and/or psychiatric diseases (e.g. m. parkinson, epilepsy, depression). * hyperthyroidism or hypersensitivity to iodine * women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study. * participation in another interventional clinical trial within the past 30 days.

Keywords: retina implant, subretinal legal blindness genetic diseases, inborn eye diseases retinitis pigmentosa retinitis retinal degeneration eye diseases, hereditary retinal diseases