Kornimate/medical-research-clean huggingface dataset:
piloting a novel, mobile cognitive training tool for patients with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: to assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (moodify) versus an active control treatment (commercially available computer games).

the study will involve a randomized, controlled, double-blind trial to assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (moodify) versus an active control treatment (commercially available computer games). moodify is comprised of a novel continuous performance task (cpt) to improve cognitive slowing and lethargy often present in cases of major depressive disorder. this training method is based on an existing, validated cognitive training paradigm (tonic and phasic attention training, tapat1; wirb study no. 1126399). moodify will also employ two additional cognitive training modules previously validated in this and other clinical populations.

Eligibility criteria:
inclusion criteria: * participants must 18 to 85 years or older and not pregnant * participants must be fluent in english * participants must be able to engage with computerized cognitive tasks as required in order to participate in this study. * normal vision (or corrected to normal vision) * participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent. * participants must meet diagnostic criteria for mdd exclusion criteria: * participants report or present a hand tremor that prevents the use of a computer mouse or keyboard * participants unable to perform neuropsychological evaluations * participants cannot comprehend or follow instructions * participants not capable of giving informed consent * participants who appear to be intoxicated or under the influence of a controlled substance * participants with a history of significant medical diseases or multiple neurological events of the head * participants with serious or unstable medical illness (e.g. cardiovascular, hepatic, renal, endocrine, neurologic disease) * participants with a history or current diagnosis to specific diagnostic and statistical manual (dsm)-iv psychiatric illness such as (but not limited to): organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specific, bipolar disorder, substance dependence and substance abuse * participants with a history of seizure disorder
impact of child positioning on pain during a lumbar puncture

Conditions: Hematological Malignancies

Summary: this protocol is a pilot study on standard care. the main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children. it's a prospective, monocentric, randomized, open-label, cross-over study. inclusion period is one year, and number of inclusions forecasted is about 30. each patient will have one lp in a seated position and one in a lying position.

in pediatric oncology hematology, invasive procedures such lumbar punctures or myelograms are essential to diseases diagnosis and treatment. in hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization. two positions are possible to carry out lumbar puncture: seated or lying position. the main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress. this study is a prospective, monocentric, randomized, open-label, cross-over study. inclusion period is 1 year, 30 patients will be included from 2 to 18 years old. each patient will have 2 lp one in seated and one in lying position in a specific order determined by randomization. all data regarding pain and anxiety will be collected the day of lp. patients will be re contacted 48 hours and 15 days after lp procedure in order to evaluate complications such post-lumbar puncture syndrome or hematoma. the main analysis will be done on intent-to-treat-analysis basis and will compare pain intensity between the two groups.

Eligibility criteria:
inclusion criteria: * age between 2 and 18 years old * patients requiring at least 2 therapeutic lumbar punctures * patients able to receive analgesic procedure according to 20005 good practices recommendation * presence of one parent during lp procedure * child able to use assessment scales * lp realized with a 20 g needle * platelets \> 50000 * child with prior clinical examination * affiliated to a health care insurance regimen exclusion criteria: * seated or lying position impossible * lumbar puncture contraindication * patient or parent opposition to second lp realization in the required position * clotting trouble on lp day not allowing the lp procedure
cardiac dysfunction in critically ill covid-19 patients

Conditions: COVID-19; ARDS, Human; Cardiac Failure; Right Ventricular Dysfunction; Left Ventricular Dysfunction; Pulmonary Hypertension

Summary: we conducted an observation sub-study of the prospective randomized controlled trial "high dose inhaled nitric oxide in acute hypoxemic respiratory failure", in which we analysed the echocardiographic data collected both at baseline when patients where included and 3-5 days later for followup.

we conducted an observation sub-study of the prospective randomized controlled trial "high dose inhaled nitric oxide in acute hypoxemic respiratory failure" which was conducted in 2020/2021 during the covid-19 pandemic on patients with ards due to covid and requiring mechanical ventialtion. patients underwent echocardiography at baseline, and were then randomized either to control, or treatment with inhaled nitric oxide, starting at 80ppm and then 40ppm. followup echocardiography was performed 3-5 days later, and all echocardiographies were conducted by highly experienced sonographeres certified by the european association of cardiovascular imaging. analysis of these cardiac ultrasounds focused on the amount of patients showing signs of pulmonary hypertension, right ventricular failure and left ventricular failure. several parameters were used to estimate these, and we also aimed to evalute the utility of more novel measures such as rv and lv gls for this use in the icu.

Eligibility criteria:
inclusion criteria: * age ≥18. * positive pcr for covid-19. * admission to the icu. * endotracheal intubation and mechanical ventilation. * severe hypoxemia, defined by pao2/fio2 \< 300 mmhg. * inclusion in the trial "high dose inhaled nitric oxide in acute hypoxemic respiratory failure" exclusion criteria: * endotracheal intubation for \>72h before inclusion. * do not resuscitate order or other limitation of care. * known pregnancy. * cases where the treating physician opposes inclusion due to safety concerns or considerations that renders inclusion unfeasible. * not having had echocardiography performed during the trial period (exclusion criteria for this sub-study).
functional organ preservation surgery

Conditions: Organ Preservation

Summary: this is a prospective randomized controlled trial comparing functional organ preservation surgery (fops) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. this study has a hypothesis that the fops is an effective treatment strategy to preserve the organ function without compromising oncologic safety and survival.

this prospective study compare the following items between two groups: * functional outcomes: laryngeal, pharyngeal, and quality of life * oncological outcomes: survivals, locoregional controls * combined imaging and molecular biomarkers with follow-up data the functional organ preservation surgery (fops) is defined as a surgery preserving the laryngeal or pharyngeal function regardless of open or transoral route. the fops may include: * radical tonsillectomy or other oropharyngeal resection * partial laryngectomy or pharyngectomy * transoral laser microresection * transoral robotic surgery (tors) * reconstructive surgery may be combined with primary resection * neck dissection may be indicated in some patients * postoperative radiotherapy or chemoradiotherapy may be indicated in some patients according to their pathologic reports. the standard concurrent chemoradiotherapy (crt) is generally used but radiotherapy (rt) alone may be indicated for some patients under tumor-board discussion. the salvage surgery may be indicated for patients with residual or recurrent diseases after crt or rt.

Eligibility criteria:
inclusion criteria: * patients with squamous cell carcinomas arising in the oropharynx, larynx, or hypopharynx * resectable tumors without distant metastases * age range: 18-80 years * pretreatment karnofsky performance scale \> or 70% * operable patients * no significant loss of pretreatment larynx and pharyngeal functions exclusion criteria: * patients with a present or previous history of other cancers except benign tumors, premalignant lesions, carcinoma-in-situ (at some organ sites), well-differentiated thyroid carcinoma and low-grade salivary gland cancers (from tumor-board decision whether the tumors significantly affect the survival outcomes) * other organ-site cancers * low-performance status or non-operable patients * non-resectable or distant-metastatic tumors * extensive primary or neck nodal diseases * significant pretreament loss of laryngeal or pharyngeal functions * ct1n0 glottic carcinomas

Keywords: laryngeal and pharyngeal preservation, survivals
mannitol dose response study in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. past studies have shown bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. the study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis (sweat test/genotype) * 7 years or older * fev1 between 40% and 90% of predicted for height, age and gender. * able to perform acceptable-quality spirometry * clinically stable in the week up to study entry * no additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted) exclusion criteria * currently active asthma * subjects colonized with burkholderia cepacia or mrsa * considered "terminally ill" or listed for transplantation * requiring home oxygen or assisted ventilation * concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale) * significant episode of haemoptysis (\>60 mls) in the previous 12 months * heart attack or stroke in last 3 months * known aortic or cerebral aneurysm * subjects who are breast feeding or pregnant. * at risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study * subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry. * known intolerance to mannitol or unable to take any form of bronchodilator medications. * uncontrolled hypertension, systolic bp \> 200 or diastolic bp\> than 100 * concurrent use of beta blocker medication * concurrent use of hypertonic saline canada: * concurrent use of other pharmacological mucolytic agents other than pulmozyme argentina: * concurrent use of other pharmacological mucolytic agents including pulmozyme
cerament™|g - bone healing and re-infection prophylaxis

Conditions: Osteomyelitis

Summary: the surgical management of long bone infections is often challenging. adequate surgical debridement decreases the bacterial load, removes dead tissues, and gives a chance for the host immune system and antibiotics to arrest infection. adequate debridement may leave a large bony defect. an appropriate management of the dead space is essential to arrest the disease, and for maintenance of the bone's integrity. the current strategy includes the use of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the dead space. the cement are usually removed after 2 to 4 weeks and replaced with a cancellous graft harvested from the hip of the patient. cerament™\| g is a ce-marked resorbable ceramic bone graft substitute composed by calcium sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system and to promote bone healing. the antibiotic gentamicin is included in the ceramic to prevent colonization of gentamicin-sensible microorganisms in order to protect bone healing. the aim of this study is to investigate the device absorption and bone in-growth of cerament™\| g in a surgically revised bone infection. in addition, bone healing and infection non-recurrence will be evaluated during 12 months of follow-up. the investigators expect a treatment success of \>90 % and that a similar bone healing will be obtained as with a standard two-stage surgical procedure. in addition, the investigators believe that the use of cerament™\| g will be of advantage for the patient as bone healing will be achieved with a one-stage surgical procedure (in combination with antibiotic therapy), instead of a two-stage procedure, thus decreasing potential surgery-related complications.


Eligibility criteria:
inclusion criteria: * patients with a long bone infection in femur, tibia, humerus or radius * candidate for one stage procedure * patients above the age of 18 * written informed consent obtained before any study-related activities * patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program exclusion criteria: * clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation * hypersensitivity to aminoglycoside antibiotics * myasthenia gravis * severe renal impairment * pre existing calcium metabolism disorder. * women who are pregnant or breastfeeding (a pregnancy test will be done in women of childbearing potential) * history of hypersensitivity to the investigational device or any of its ingredients

Keywords: osteomyelitis bone substitute ceramic gentamicin
anatomical and functional outcome of psg vs bmg for urethral substitution in long segment anterior urethral strictures

Conditions: Anterior Urethral Stricture, Male

Summary: this study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

since previous studies were: * retrospective and very few were prospective randomized studies * some studies were done on lichen sclerosis cases that have an adverse effect on the psg outcome. * the follow-up duration was longer for psg patients. * stricture length was usually longer for psg cases. this study aims to compare the psg and bmg for substitution of long anterior urethral strictures using one-sided dorsal perineal approach. the investigators hypothesize that: ❶ conducting a well-designed prospective, randomized study can help identify which technique is better than the other. ❷ using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.

Eligibility criteria:
inclusion criteria: * the study will include patients with long segment anterior urethral stricture (\>2 cm). exclusion criteria: * urethro-cutaneous fistula, urethral abscess or diverticulum. * a scarred and unsalvageable urethral plate or scarred perineum. * lichen sclerosis (balanitis xerotica obliterans). * unhealthy/unavailable buccal mucosa.

Keywords: urethral stricture urethroplasty bmg psg penile skin
focal laser ablation of low to intermediate prostate cancer tumors

Conditions: Prostate Cancer; Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Localized Prostate Carcinoma

Summary: the primary purpose of this study is to evaluate the feasibility and safety of mri-guided focal laser ablation (laser-induced interstitial thermal therapy, litt) to treat low-risk native prostate cancer.

the study is being done to evaluate the safety and effectiveness of magnetic resonance imaging (mri)-guided focal laser therapy with the visualase thermal therapy system to treat low-risk prostate cancer tumors. unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.

Eligibility criteria:
inclusion criteria * male, 45 years of age or older. * diagnosis of prostate adenocarcinoma. * clinical stage t1c or t2a. * gleason score of 7 (3+4 or 4+3) or intermediate risk gleason 6 * psa less than or equal to 20 ng/ml * three or fewer biopsy locations with prostate cancer which correlate with mri findings. * no lesion \> or = 2cm * one, two, or three tumor suspicious regions identified on multiparametric mri * no definite radiographic indication of extra-capsular extension. * estimated survival of 5 years or greater, as determined by treating physician. * tolerance for anesthesia/sedation. * ability to give informed consent. exclusion criteria * presence of any condition (e.g., metal implant, shrapnel) not compatible with mri. * history of other primary non-skin malignancy within previous three years.
titration of continuous positive airway pressure could predict success of oral appliance to treat sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: background: the oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (cpap). it is not well established yet in the literature, which patients with mild to moderate osa will present a good response to treatment with oral appliances. objective: to determine a value of cpap pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea. patients and methods: two groups of 30 male patients (25-65 years, body mass index \< 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (ahi) between 5 and 15 events per hour of sleep and the second one with an ahi between 15 and 30 events per hour of sleep. each patient will undergo three polysomnographic recordings (baseline, cpap titration, after two months of treatment with oral appliance). subjective (sleep disorders questionnaire, the epworth sleepiness scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (sf-36), mood (poms), and anthropometric measurements (neck circumference and craniofacial characteristic). good response to treatment with the aio will be considered as a 50% reduction in the baseline ahi index or ahi after treatment less than 5 events per hour of sleep.


Eligibility criteria:
inclusion criteria: * male subjects aged between 25 and 65 years old * epworth sleepiness scale \> 9 * apnea-hypopnea index between 5 and 30 exclusion criteria: * presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders. * presence of anatomical obstructive upper airway, tonsil grade iii e iv, septal deviation and grade iii that may affect the outcome of cpap * loss of posterior dental support to undermine the retention of oral appliance * active of periodontal disease, compared dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite * protrusive displacement lass then five millimeters * limited mouth opening * alcoholism * use of sleep-inducing medications * habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle * intolerance to cpap * obesity grade ii (moderate) or iii (severe)

Keywords: oral appliance continuous positive airway pressure obstructive sleep apnea syndrome snore
physiological assessments during non operative treatment on the chest wall deformities

Conditions: Pectus Excavatum; Pectus Carinatum

Summary: the physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. these functional benefits outweigh the aesthetic benefits associated with anatomical improvement. the functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated. assessment of effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods. anatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by mri, and 2) of the heart by echocardiography. noninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (vo2max). subjective assessment of functional gain between the initial and final balance sheet, based on eva scales, valued by patients, parents and doctors.


Eligibility criteria:
inclusion criteria: * patient with pectus excavatum or pectus carinatum who does not require surgery * patient with sufficient displacement of the chest wall during an initial test carried out during the first consultation :for pectus carinatum correction must be obtained with a pressure lower than 9 psi (pound per square inch). for pectus excavatum less than 250 mbar depression. * signed informed consent * subject (or parents) affiliated to the french national health insurance exclusion criteria: * skeletal disease, disturbing bone strength as osteogenesis imperfect and osteoporosis. * uncontrolled coagulopathies. * marfan syndrome, with mitral valve prolapse for pectus excavatum. * atrial fibrillation * taking antiarrhythmic drug.

Keywords: pectus excavatum pectus carinatum vacuum bell dynamic compression system hearth variability autonomic nervous system