Kornimate/medical-research-clean huggingface dataset:
an open-label extension trial to assess the safety of long-term treatment of rotigotine in early-stage parkinson's disease.

Conditions: Early-Stage Parkinson's Disease

Summary: the objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic parkinson's disease.

this is the open-label extension to the randomized, double-blind, placebo-controlled sp512 trial that assessed the efficacy and safety and tolerability of the rotigotine patch in subjects with early-stage idiopathic parkinson's disease.

Eligibility criteria:
inclusion criteria: * subjects who have completed six months of maintenance treatment in the sp512 double-blind trial exclusion criteria: * subjects who had an ongoing serious adverse event from sp512 double-blind trial that was assessed as related to study medication

Keywords: rotigotine
add-on effectiveness of ea or tens in early postpartum breast engorgement

Conditions: Breast Engorgement in Puerperium; Post Partum Depression

Summary: a total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in china medical university hospital, taichung, taiwan. the participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.

participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. on each visit, severity index (si) subject to the extent of erythema, tension and pain over breast will be assessed. questionnaires of breastfeeding self-efficacy scale (bses-sf) and of edinburgh postnatal depression scale (epds) will be performed. heart-rate variability was evaluated and recorded via a real-time handheld hrv device. oxycontin, cortisol, sodium and potassium levels in breastmilk will be tested . a telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * gestational age \> 37 wk * delivery of singleton, healthy newborn baby * within 7 days postpartum * within 24 hours from initial painful breast engorgement * difficulty on lactation due to plugged ducts, si index ≧ 5 (0-19) exclusion criteria: * fever\>37.5∘c * mastitis or breast abscess * signs of sepsis or other infection * perinatal mother and infant diseases (gestational hypertension、gestational diabetes mellitus、pre-eclampsia 、gestational thyroid diseases or intrauterine growth retardation) * psychological diseases * bleeding tendency * artificial valves * pacemaker * epilepsy * consciousness disturbance * skin infections * hepatitis b carrier * acquired immune deficiency syndrome * breast tumors * breast surgeries

Keywords: electrical acupuncture transcutaneous electrical nerve stimulation
combining language therapy with rtms in aphasia

Conditions: Aphasia

Summary: with the present rct, the investigators aimed at finding an optimal protocol for the neurorehabilitation of chronic post-stroke aphasia by combining two promising methods, ilat (intensive language action therapy) and 1-hz rtms to the right-hemispheric homologue of the anterior language area of broca (pars triangularis), thus taking advantage of recent research in speech and language sciences, neurorehabilitation and brain research.

new neuromodulation technologies, such as transcranial magnetic stimulation (tms), are promising tools for neurorehabilitation, aphasia therapy included. combined with behavioral techniques, intensive language-action therapy (ilat), tms could substantially amplify the beneficial effect of such behavioral therapy alone. in this randomized study of 17 subjects with post-stroke aphasia in the chronic stage will be studied the combined effect of ilat and 1-hz placebo-controlled navigated repetitive tms (rtms) to the right-hemispheric inferior frontal cortex (pars triangularis). participant will be randomized to groups a and b. participants in group a will receive a 2-week period of rtms during naming training where they name pictures every ten second displayed on the screen, followed by 2-weeks of rtms and naming combined with ilat. those in group b will receive the same behavioral therapy but tms is replaced by sham stimulation. language performance will be measured before, during and after the interventions for 3 months.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * presence of a single clinically documented stroke * chronic stage (at least 12 months post-stroke) * aphasia documented using the wab test * no recurring utterances or severe global (total) aphasia * residual ability to understand simple task instructions * availability of information about medication * right-handedness * native speakers of finnish. exclusion criteria: * severe global (total) aphasia (boston naming test less 3 points) * neglect, agnosia, severe vision impairment or hearing loss * severe attention or memory deficits * left-handedness * cardiac pacemaker or other stimulators * diagnosis of severe diabetes or severe depression * additional neurological diagnoses * other interventions, including speech therapy, in the same time period

Keywords: chronic aphasia rehabilitation randomized controlled trial (rct)
impact emotional intelligence program on opioid relapse

Conditions: Emotional Intelligence; Opioid Use Disorder

Summary: addiction is the repeated and increased use of a substance, the deprivation of which gives rise to symptoms of distress and an irresistible urge to use the agent again and which leads also to physical and mental deterioration. the concept of emotional intelligent (ei) "the ability to perceive accurately, appraise and express emotion; the ability to access and generate feelings when they facilitate thought; the ability to understand emotion and emotional knowledge; and the ability to regulate emotions to promote emotional and intellectual growth". most drug addicts possess hidden defects in their social skills, and do not have good relations with their peers.

addiction is the repeated and increased use of a substance, the deprivation of which gives rise to symptoms of distress and an irresistible urge to use the agent again and which leads also to physical and mental deterioration. continued opioid misuse can result in syndromes of abuse and dependence and cause disturbances in mood, behavior, and cognition that can mimic other psychiatric disorders. opioid addiction affects the young and the old, the wealthy and the poor, and the professional and the unemployed. the concept of emotional intelligent (ei) "the ability to perceive accurately, appraise and express emotion; the ability to access and generate feelings when they facilitate thought; the ability to understand emotion and emotional knowledge; and the ability to regulate emotions to promote emotional and intellectual growth", the ability to manage and regulate emotions in an effective manner and ability to be sufficiently optimistic, positive and self- motivated in order to set and achieve goals. most drug addicts possess hidden defects in their social skills, and do not have good relations with their peers. the other possible causes of orienting toward drugs are defects in problem solving, stress-management, and prevention from dangerous and impulsive behaviors.

Eligibility criteria:
inclusion criteria: * in opioid groups: only opioid addiction * in healthy groups: no history of psychiatric illness or substance use exclusion criteria: * have medical conditions
same-session mr-only simulation and treatment with mri-guided adaptive palliative radiotherapy

Conditions: Malignancy; Metastasis; Hemoptysis; Gastrointestinal Bleeding; Pelvic Bleeding; Superior Vena Cava Syndrome; Mediastinal Disease

Summary: this proposed study is unique in that patients will not undergo computed tomography (ct) simulation at any point during their treatment course and will instead have same-session magnetic resonance (mr)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (art) workflow. in this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.


Eligibility criteria:
inclusion criteria: * diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative rt) * requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease. * at least 18 years of age. * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * pregnant. patients of childbearing potential must have a negative pregnancy test within 14 days of study entry. * medical contraindication to undergoing mr imaging.
19f thoracic radiotherapy for lung cancer

Conditions: Lung Cancer

Summary: the goal of this study is to determine the feasibility and efficiency of incorporating 19f mr functional lung imaging into the routine assessment of lung cancer patients prior to thoracic radiotherapy.

primary objective: determine feasibility by evaluating if: po1: patients diagnosed with lung cancer are able to successfully complete pre- and post-radiotherapy 19f mr imaging scans as scheduled. secondary objective: determine efficiency by evaluating if: so1: determine efficiency by evaluating if 19f mri data can be successfully analyzed and incorporated into the radiation planning system. so2: determine efficiency by evaluating if the incorporated 19f mri functional data can be successfully used to generate radiotherapy plan in a timely manner. so3: determine if pre- and post radiotherapy 19f mri scans can be readily compared to observe changes in pulmonary function. hypotheses investigators hypothesize that functional 19f mr imaging assessment is feasible in the lung cancer patient population and that the acquired images can be efficiently analyzed and integrated into radiotherapy planning.

Eligibility criteria:
inclusion criteria: * subject has histologic or cytologic confirmation of lung cancer (nsclc or small cell) and has been recommended thoracic radiotherapy as part of standard of care management. * ability to undergo mr imaging, tolerate breath hold procedures and follow direction during the imaging process * karnofsky performance status ≥60, with expected survival of ≥6 months * at least 18 years of age * patient is not pregnant * patient can be reliably reached for post-mri follow up ae check. * patient able to sign a study specific informed consent form. exclusion criteria: * any condition including, metallic implants or cardiac pacemakers that makes the candidate ineligible for mr imaging. (mri research screening form will be completed prior to each mri scan). * malignant pleural effusion or pericardial effusion

Keywords: thoracic radiation therapy lung function
natural killer(nk) cell therapy for acute myeloid leukemia

Conditions: AML, Adult

Summary: this is an open-label, phase i study of qn-023a (allogeneic car-nk cells targeting cd33) in relapsed/refractory acute myeloid leukemia (aml). the clinical study is to evaluate the safety, tolerability and preliminary efficacy of qn-023a in patients with relapsed/refractory aml,where a "3+3" enrollment schema will be utilized at dose escalation stage. up to 18 patients will be enrolled.


Eligibility criteria:
key inclusion criteria: * provision of signed and dated informed consent form (icf) * ≥18 years old * diagnosis of r/r aml * subjects with cd33 positive leukemia cells * eastern cooperative oncology group (ecog) performance status ≤1 * adequate organ function as defined in the protocol * donor specific antibody (dsa) to qn-023a: mfi \<= 2000 key exclusion criteria: * allergic to drug used in this study * accept other anti-tumor drug within certain time of day 0 (first qn-023a dose infusion), time window and drug defined in the protocol. * received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy * acute promyelocytic leukemia (apl) * active central nervous system leukemia. * uncontrolled, active clinically significant infection * clinically significant cardiovascular disease as defined in the protocol * known hiv infection, active hepatitis b (hbv) or hepatitis c (hcv) infection * history of central nervous system (cns) disease such as stroke, epilepsy. * females are pregnant or lactating * investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
bidirectional oxygenation valve in the management of pulmonary complications of covid-19

Conditions: COVID-19

Summary: the objective of this study is to determine the safety, feasibility and efficacy of a bidirectional oxygenation positive end expiratory pressure (peep) mouthpiece in coronavirus disease 2019 (covid-19) patients requiring supplemental oxygen by non-rebreather mask.

severe cases of covid-19 often mimic the typical course of adult respiratory distress syndrome (ards) and its predictable sequelae. these patients often require intubation and ventilator support in order to sustain adequate oxygenation. once a covid-19 patient is intubated, positive end expiratory pressure (peep) is a mainstay of treatment and is used in order to improve lung function, treat underlying atelectasis, improve oxygenation, and improve survival. in fact, early clinical data as well as reports from front line physicians treating covid-19 suggest that peep has been the most effective treatment modality. in many cases, peep has resulted in improved oxygenation and improved survival. peep decreases the propensity for the alveoli to collapse by increasing the air pressure in the lungs. this residual pressure in the lungs at the end of exhalation decreases shunting and allows for more complete gas exchange and improved oxygenation. in patients, peep is one of the safest ways to increase partial pressure of oxygen (pao2) and is used on almost all modern ventilator settings. the go2 peep mouthpiece is a simple, comfortable, and straightforward mouthpiece with a bidirectional valve that effectively delivers peep with every breath. early application of the go2 peep mouthpiece in non-intubated covid-19 patients may improve outcomes and save lives. furthermore, this device may allow for less strain on limited resources, especially ventilators. this peep mouthpiece could be employed under an oxygen non-rebreather mask to improve oxygenation and avoid intubation.

Eligibility criteria:
inclusion criteria: * covid-19 positive * oxygen saturation \<92% * able to provide informed consent * receiving oxygen by non-rebreather mask * not currently requiring intubation exclusion criteria: * unable or unwilling to provide informed consent * cognitive impairment * rapidly decompensating status requiring urgent or emergent higher level of care

Keywords: bidirectional oxygenation pulmonary compromise supplemental oxygen
comparison with observational methods and performance assessment from real-life experience of closed-loop insulin delivery systems

Conditions: Diabetes Mellitus, Type 1

Summary: this study aims to compare glycemic control obtained under closed loop depending on the system : smartguard (medtronic 780) versus control iq (tandem) in patients with diabetes type 1.

since 2021, several closed-loop insulin delivery systems have been reimbursed in france for patients living with type 1 diabetes. the "real-life" efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials. to date, there are no clinical trial comparing closed-loop systems. there are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology. given the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the centre hospitalier sud-francilien since 2021 (\> 400), we propose a single-center analysis to compare real-life performance of smartguard (medtronic 780) versus control iq (tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score

Eligibility criteria:
inclusion criteria: * patient \> 16 years * patient with diabetes type 1. * patient treated with a control-iq or smartguard closed-loop insulin delivery system between 01/2021 and 05/2022. * follow-up patient in centre hospitalier sud francilien exclusion criteria: * women who had pregnancy within 12 months of system initiation. * patient who have been treated with both systems within 12 months. * patient or parental authority objecting the use of data

Keywords: diabetes type 1 closed loop insulin delivery system continuous glucose monitoring sensor-augmented pump
efficacy study of acetazolamide versus diazepam in continuous spike and wave/landau-kleffner syndrome

Conditions: Landau-Kleffner Syndrome; Status Epilepticus, Electrographic

Summary: the purpose of this study is to compare the effectiveness of the medications acetazolamide and diazepam in the treatment of continuous spike wave in sleep (csws) and landau-kleffner syndrome (lks).


Eligibility criteria:
inclusion criteria: * eses and clinical csws/lks defined by all of the following: * swi ≥50% during first hour of sleep * bilateral synchrony of discharges during sleep * clinical evidence of behavior and/or academic regression * daytime swi ≤20% exclusion criteria: * previous treatment with benzodiazepine or acetazolamide for electrical status epilepticus in sleep (eses) * current treatment with carbamazepine, phenytoin, oxcarbazepine, phenobarbital, vigabatrin or lamotrigine * antiepileptic medication changes over the month prior to enrollment * epileptic encephalopathy other than csws/lks * prior serious adverse reaction to benzodiazepines or acetazolamide * sulfa allergy * progressive underlying neurologic condition * frequent seizures that would prevent the patient from maintaining a stable dose of medications * female patient that has begun menses or is pregnant

Keywords: continuous spike wave in sleep landau-kleffner syndrome acetazolamide diazepam
follow-up at 6 years of a cohort of children born very prematurely

Conditions: Premature Birth

Summary: utilization of nitric oxide (no) therapy has been related to a trend towards short term improvement in very premature infants. a two year follow-up of children treated soon after birth with no in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. this study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.

utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age. a two year follow-up in children treated soon after birth with no in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. no long term evaluation on respiratory outcome has yet been done. this study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely, some of them having had nitric oxide as a rescue treatment for respiratory distress syndrome.

Eligibility criteria:
inclusion criteria: * all infants included at birth in a randomized controlled trial using early nitric oxide therapy exclusion criteria: * parental refusal

Keywords: follow-up premature infants nitric oxide respiratory function testing neurodevelopmental outcomes
alcohol and women : screening in general

Conditions: Alcoholism

Summary: the alcohol consumption of adults has been decreasing in france since the sixties. when focusing on the particular case of women, this trend goes on the opposite direction. in addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (aud) in general medicine.

to improve the screening of women with aud in general médicine, from their perceptions and experiences, and to create a screening tool to general practitioners. the chosen method is a qualtitative study through semi-structured interview with women with aud. a qualitative assessment of these individual interviews could show various topics.

Eligibility criteria:
inclusion criteria: - over 18 years old alcoholic women, with one or several addiction, from all social class. exclusion criteria: - not being able to answer the questionnaire

Keywords: women reporting alcohol abuse and/or dependence women recruted during hospitalisation and/or consultation alcohol
effectiveness of kinesio taping in patients with congenital muscular torticollis

Conditions: Torticollis Congenital

Summary: the aim is to investigate the effectiveness of kinesiotaping application in addition to congenital muscular torticollis exercise on neck joint range of motion, tilt degree and muscle function test. research group: in addition to the regular exercise program, patients diagnosed with congenital muscular torticollis will be given kinesio taping for torticollis. kinesio taping will be applied for 4 weeks, 5 days on and 2 days off. control group: patients diagnosed with congenital muscular torticollis will continue their regular exercise program. no intervention will be applied. patients will be evaluated with neck joint range of motion, tilt degree and muscle function test before and 3 months after treatment.


Eligibility criteria:
inclusion criteria: * being followed up with a diagnosis of congenital muscular torticollis * the family's willingness to participate in the study exclusion criteria: * presence of cardiopulmonary disease and musculoskeletal deformity that will prevent exercise * having an open wound in the area where kinesio taping will be applied or being allergic to tape application
diagnostic imaging aid for management of cervical lesions

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasias; Digital Colposcopy; Precancerous Cervical Lesions

Summary: a handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. the handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. the investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. the investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.


Eligibility criteria:
inclusion criteria: * women who are at least 18 years old * women who are not pregnant as confirmed by a urine test * women who are not breastfeeding * women who understand the study procedures and can provide written informed consent exclusion criteria: * women who do not meet the inclusion criteria * women who have had a hysterectomy