Kornimate/medical-research-clean huggingface dataset:
treatment of suicidal ideation in the emergency department using nitrous oxide

Conditions: Suicidal Ideation; Emergency Psychiatric; Nitrous Oxide

Summary: suicide prevention is a major public health concern, with nearly 9,000 suicides and over 200,000 suicide attempts reported each year in france. suicide attempts and suicidal ideation are among the most frequent reasons for emergency room visits and psychiatric hospitalizations. although there is no approved pharmacological treatment for suicidal crises, some psychiatric treatments appear promising. ketamine, an n-methyl-d-aspartate (nmda) receptor antagonist, has shown promising results in reducing suicidal ideation. however, its use is limited due to its side effects. nitrous oxide, another nmda receptor inhibitor commonly used in anesthesia and pain management, has demonstrated rapid antidepressant effects and few side effects. given its rapid and lasting effects, nitrous oxide could swiftly alleviate suicidal ideation.


Eligibility criteria:
inclusion criteria: * active suicidal ideations * beck scale for suicidal ideation score greater than or equal to 8 * french speaking * patient admitted to psychiatric emergency department * capable of wearing a facial mask * having signed an informed consent * affiliated with social security exclusion criteria: * psychotic disorder, neurodegenerative disease, known substance use disorder (excluding caffeine or tobacco), substance intoxication, unstable somatic pathology * pregnancy or breastfeeding * contraindication to the use of nitrous oxide * legal incapacity * participation in another drug clinical trial * patient subject to compulsory care measures
pediatric guideline adherence and outcomes- argentina

Conditions: TBI (Traumatic Brain Injury)

Summary: pediatric traumatic brain injury (tbi) is the leading killer of children worldwide but effective treatments for tbi are limited. although evidenced-based pediatric tbi guidelines exist, adherence to these guidelines is low,leading us to develop a new pediatric guideline adherence and outcomes (pegasus) program to increase tbi guideline adherence. we propose to test the pegasus program's ability to improve tbi guideline adherence and outcomes.

specific aim 1: determine the relationship between pegasus program implementation and tbi guideline adherence (aim 1a), and assess system, provider, patient, implementation and guideline factors associated with tbi guideline adherence (aim 1b). hypothesis: centers that receive the pegasus program have higher tbi guideline adherence (main outcome), as well as better discharge survival and 3-month glasgow outcome scale-extended (gose) score (secondary outcomes) than centers who receive usual care. specific aim 2: create a value stream map (vsm) to identify value-added processes of care associated with tbi guideline adherence. hypothesis: icu activity flows of tbi care during the first 72 hours will reveal value-added as well as non-value-added processes in severe tbi care. pegasus program implementation will result in more value-added tbi care processes and better tbi guideline adherence. specific aim 3: use computer simulation to develop and disseminate a real-world best practices blueprint for tbi guideline adherence. hypothesis: this model will identify the impact of the pegasus program on key performance indicators (kpis), outcomes (aim 1), and process activities (aim 2). iterative computer simulations will then demonstrate the relationship among pegasus program components and how relative changes in these components impact the magnitude, direction and choice of operations downstream in tbi care and patient outcomes to inform development of a blueprint for wide dissemination of best-practice guidelines.

Eligibility criteria:
inclusion criteria: * mechanism or head ct consistent with tbi * \<18 years old * glasgow coma scale (gcs) score ≤8 at any point during hospital admission, motor gcs≤5 if intubated exclusion criteria: - none

Keywords: guideline adherence implementation fidelity pediatric
clinical benefits of the closed loop stimulation in sinus node disease

Conditions: Sinus Node Disease

Summary: the study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (sustained paroxysmal af/persistent af or stroke/tia) occurrence in a follow up period of 3 years, between closed loop stimulation (cls) on versus off, on top of a ddd pacing in patients with pacemaker or icd indication who require dual-chamber pacing due to sinus node disease (snd), with or without atrioventricular (av) block.

the benefits of rate-responsiveness on top of dual-chamber pacing still need to be definitively assessed in sinus node dysfunction (snd). although many rate responsive (rr) sensors have been developed, no large clinical trials evaluated their benefits in terms of clinical endpoints such as clinically relevant atrial fibrillation (af) and stroke. electromechanical sensors (piezoelectric accelerometers) have been widely used for their simplicity and overall reliability. however there is some evidence indicating the closed loop stimulation as one of the more efficient and physiological sensors. two randomized clinical studies have been conducted so far, showing that in the brady-tachy syndrome the cls algorithm was associated with a significantly lower overall atrial arrhythmia burden as compared both with a dddr mode based on a standard accelerometric sensor and an atrial overdrive approach. both studies yielded consistent results, albeit with a parallel and intraindividual comparison designs, respectively. the atrial arrhythmic burden is an important but surrogate endpoint, not necessarily related to long-term clinical outcome. the cls effects on af (if any) should be investigated in terms of time to first new onset of clinically relevant af. in the light of these considerations, it appears interesting to run a large randomized study coherently collecting data on the overall clinical benefit of cls, primarily in terms of af and stroke, in a population indicated for pacemaker or icd and needing dual-chamber pacing due to snd.

Eligibility criteria:
inclusion criteria: * patients with class i or ii recommendations for permanent pacing due to snd, with or without av block according to the current guidelines; * patients for whom dual-chamber pacing is indicated or preferred; * patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment; * closed loop stimulation function was not previously activated; * no stroke events from implant; * patient implanted for the first time; exclusion criteria: * permanent af (permaf) * nyha class iv heart failure * stage v kidney dysfunction * any indication to cardiac resynchronization therapy (crt) * life expectancy \< 1 * minors * pregnant or breast-feeding patients * participation in another interventional trial * atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery \< 3 m

Keywords: closed loop stimulation atrial fibrillation stroke heart failure pacemaker icd
tenofovir disoproxil fumarate in hiv-infected patients who have not had success with other anti-hiv drug combinations

Conditions: HIV Infections

Summary: the purpose of this study is to make tenofovir disoproxil fumarate (df) available to hiv-infected patients who have failed other anti-hiv drug combinations, who have few treatment choices available, and whose disease may get worse. this study will allow patients to obtain tenofovir df before it is approved for marketing.

patients receive daily doses of tenofovir df.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have a viral load (level of hiv in the blood) of at least 10,000 copies/ml by pcr within the previous 2 months. * have a cd4 count of 100 cells/mm3 or lower within the previous 2 months. patients with a cd4 count above 100 and as high as 200 cells/mm3 may also be eligible if they had an opportunistic (aids-related) infection within the past 90 days. * have failed treatment with at least 2 protease inhibitors (pis) or at least 1 pi plus a nonnucleoside reverse transcriptase inhibitor (nnrti). * are not able to get effective treatment with a combination of currently approved anti-hiv drugs. * are at least 18 years old. * have a negative serum pregnancy test. * are willing to use a barrier method of birth control (both males and females) while on the study and for 30 days after taking the drug. exclusion criteria patients will not be eligible for this study if they: * have or have had kidney disease or bone disease. * are pregnant or breast-feeding. * abuse alcohol or drugs. * are taking, or have taken within 7 days of enrolling in the study, adefovir dipivoxil or drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, foscarnet, intravenous (iv) amphotericin b, iv pentamidine, iv vancomycin, and chemotherapy (e.g., cisplatin). * have any medical conditions or have had any medications that the study investigator believes will make him/her unsuitable for the study.

Keywords: hiv-1 disease progression reverse transcriptase inhibitors anti-hiv agents 9-(2-phosphonylmethoxypropyl)adenine
clinical evaluation of different bulk-fill composite restorations on posterior teeth

Conditions: Carious Teeth

Summary: different bulk-fill composites will be applied in different posterior cavities then compared

patients must be in middle age(25-55) age,able to regularly follow up,not pregnant and at least have 4 carious molars

Eligibility criteria:
inclusion criteria: * at least 4 carious molars exclusion criteria: * pregnancy patient * not able to regularly follow up * bad oral hygiene

Keywords: bulk-fill composite, posterior cavities
the cedid study (covid-19 early diagnosis in doctors and healthcare workers)

Conditions: Covid19

Summary: this is a prospective observational cohort study of healthcare workers working in high-risk covid-19 clinical areas, monitoring heart rate, sleep and temperature, correlating with daily self-reported symptoms, oxygen saturations and pcr swabs. it will provide information about how many healthcare workers develop covid-19, what their clinical observations and symptoms are.

during the covid-19 pandemic, doctors and other healthcare workers who work in covid+ wards, intensive care unit and the accident and emergency department are at high risk of developing covid-19 infection. in april 2020, 14.6% of doctors were off sick with suspected or confirmed covid-19 infection. meanwhile, 17.9% of covid+ patients are thought to be asymptomatic. therefore, healthcare workers are also high-risk of spreading infection to patients, colleagues and their families. this is a prospective observational cohort study that leverages wearable medical device technology and data analytics to develop an algorithm for early detection of covid-19 infection in healthcare workers. a total of 60 healthy healthcare workers working within high-risk covid-19 clinical areas will be asked to wear a wearable medical device that measures their heart rate, skin temperature and sleep during non-working hours. they will take daily swabs for covid-19 from themselves, measure their oxygen levels daily, and answer a survey of self-reported symptoms daily for the 30 day study period. these will then be analyzed to develop an algorithm for early detection of covid-19 in healthcare workers, and help to inform future workforce decisions, to promote welfare and prevent the spread of covid-19.

Eligibility criteria:
inclusion criteria * healthy healthcare professionals of any age exclusion criteria * previous pcr/antibody positive test for covid-19 * not working in high-risk covid-19 area (icu, a\&e, covid positive wards) * involved in covid-19 vaccine trial

Keywords: covid-19 wearable medical devices data analytics doctors
cognitive training in mild cognitive impairment

Conditions: Insomnia; Mild Cognitive Impairment

Summary: older adults (60+ years of age) who meet criteria for mild cognitive impairment and insomnia will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and arousal at baseline, and post-intervention. for cognitive training, participants will be provided with login information to access the computerized training, and will complete 8 weeks (45 mins 3x/week) of cognitive training. for trivia training, participants will receive weekly emails that contain trivia assignments that they will complete for 8 weeks (45 mins 3x/week). we will evaluate short-term (i.e., post-training) effects of the two training conditions on subjective anxiety, sleep, arousal, and subjective and objective cognition.


Eligibility criteria:
inclusion criteria: 1. 60+ yrs of age 2. meet criteria for mild cognitive impairment 3. no neurological or psychiatric illness or dementia 4. non-gamers (\<2 hour of video/brain training games/week over last 2 yrs) 5. proficient in english (reading and writing) 6. meet clinical dx criteria for insomnia (e.g., insomnia complaints for 6+ months, complaints occur despite adequate opportunity and circumstances for sleep, consist of one of the following: difficulty falling asleep, staying asleep, or waking up too early, and daytime dysfunction due to insomnia) exclusion criteria: 1. unable to provide informed consent 2. unable to undergo randomization 3. other sleep disorder (e.g., sleep apnea, restless legs syndrome) 4. severe untreated psychiatric comorbidity 5. psychotropic or other medications that alter sleep (unless stabilized for 6 months) 6. uncorrected visual/auditory impairments 7. participation in nonpharmacological tx for sleep/fatigue/mood/cognition outside the current study

Keywords: cognitive training insomnia mild cognitive impartment older adults sleep cognition
comparative efficacy & safety study of esomeprazole versus placebo for the prevention of gastric and duodenal ulcers with nsaid

Conditions: Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago

Summary: the purpose of this study is to assess the efficacy of esomeprazole (d961h) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (nsaid) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers


Eligibility criteria:
inclusion criteria: * medical history of gastric and/or duodenal ulcer * a diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily nsaid use,at least 20 years of age exclusion criteria: * having gastric or duodenal ulcer in active or healing stage according to the sakita/miwa classification * history of esophageal, gastric or duodenal surgery * having severe liver disease or chronic renal disease

Keywords: gastrointestinal gi nsaid japan japanese gastric ulcer duodenal ulcer
molecular modulation of the growth plate

Conditions: Growth Plate Injury

Summary: the researchers are trying to identify molecular mechanisms that control growth plate mediated limb growth and identify agents that can be used to enhance or slow growth.


Eligibility criteria:
inclusion criteria: * skeletally immature children/adults undergoing surgical procedures where growth plate cartilage is removed as a normal part of their procedure; or patients undergoing surgical procedures where bone is removed as a normal part of their procedure. exclusion criteria: * skeletally mature children/adults
a chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis

Conditions: Diaphragm Issues; Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure; Breath Shortness; Diaphragmatic Paralysis

Summary: a retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis.


Eligibility criteria:
inclusion criteria: * patients who underwent phrenic nerve reconstructive surgery for the treatment of diaphragmatic paralysis. exclusion criteria: * age 18 and below.

Keywords: grounded theory mixed methods chart review diaphragmatic paralysis
mesenchymal stromal cells in adults with recessive dystrophic epidermolysis bullosa

Conditions: Recessive Dystrophic Epidermolysis Bullosa

Summary: to assess whether intravenously administered third-party bone marrow-derived mesenchymal stromal cells (mscs) are safe and have an impact on disease severity in rdeb

this is a phase i/ii clinical trial with a key objective of evaluating safety of third party bone mscs intravenous infusions in 10 adults with the inherited severe skin fragility disorder, recessive dystrophic epidermolysis bullosa (rdeb). the main objectives of our study are to: (1) to assess the spectrum of clinical responses in adults with rdeb receiving intravenous mscs; (2) to identify the best cohort of individuals to target for future trials and therapies; (3) to improve our understanding of in vivo and in vitro responsiveness to mscs; (4) to identify candidate molecules germane to activating mscs and making them clinically more potent, independently of the permissive conditions of the patient and (5) to assess its impact on reducing disease morbidity/severity in this population. this is a prospective, non-randomised, open label study. all study participants will receive two intravenous msc infusions at baseline day 0 and day 14 and will be followed up for a 12 month period following the first infusion. each subject will undergo an initial screening including physical examination, assessment of vital signs and disease severity assessment.

Eligibility criteria:
inclusion criteria: 1. individuals with a diagnosis of rdeb confirmed by dna analysis and skin immunofluorescence for partial or complete absence of type vii collagen. 2. individuals ≥ 18 years and ≤ 65 years of age, both male and female 3. individuals that have voluntarily signed and dated an informed consent form (icf) prior to the first study intervention. exclusion criteria: 1. subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase. 2. subjects who have received immunotherapy including oral corticosteroids for more than 1 week (intranasal and topical preparations are permitted). 3. subjects with a known allergy to any of the constituents of the investigational product. 4. subjects with a medical history or evidence of malignancy, including cutaneous squamous cell carcinoma. 5. subjects who are pregnant or of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the investigator, for the duration of the treatment phase.
decompensation detection study

Conditions: Heart Failure

Summary: to gather data and analyze decompensation events.


Eligibility criteria:
inclusion criteria: * patients implanted with an approved guidant crt-d hf device programmed to crt therapy in vdd or ddd mode. * patients prescribed to the latitude(r) system configured for at least weekly device interrogations and symptoms reporting. * patients willing to use the latitude(r) enabled weight scale. exclusion criteria: * patients that require adaptive rate pacing (rate-responsive modes). * patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days. * both
blunt needles do not reduce needlestick injuries to doctors during suturing after child-birth

Conditions: Needlestick Injuries

Summary: the hypothesis for this study is that use of blunt tipped needles used during the repair of an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries to the surgeon.


Eligibility criteria:
inclusion criteria: * obstetric laceration requiring suturing exclusion criteria: * \< 18 years old

Keywords: blunt needles obstetric lacerations needlestick injuries needlestick injuries to physicians
a clinical study to evaluate the safety and efficacy of aliskiren alone and in combination with ramipril in hypertensive, diabetic patients.

Conditions: Hypertension, Diabetes Mellitus

Summary: to demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus


Eligibility criteria:
inclusion criteria * patients with essential hypertension * patients with a documented diagnosis of type 1 or type 2 diabetes mellitus. * patients who are eligible and able to participate in the study exclusion criteria * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined exclusion criteria may apply

Keywords: hypertension, aliskiren, blood pressure, diabetes mellitus, ramipril
remote ischaemic preconditioning (ripc) in partial nephrectomy for the prevention of ischemia/reperfusion injury

Conditions: Reperfusion Injury

Summary: "remote ischaemic preconditioning" (ripc) is performed prior to partial nephrectomy. postoperative calprotectin dynamics and blood oxygen-level-dependent (bold) mri are used to to demonstrate the potential renoprotective effect of ripc

partial nephrectomy represents the gold standard in organ sparing kidney surgery. cold ischaemia prevents major bleeding but can yet be associated with impaired kidney function due to reperfusion injury to the tubuli. patients undergoing partial nephrectomy (any surgical technique, open, retroperitoneoscopic, transperitoneal, da vinci assisted) will be treated with "remote ischaemic preconditioning" (ripc). ripc is delivered with a standard blood pressure cuff placed on the upper arm and another standard blood pressure cuff placed on the upper thigh. the cuffs are then simultaneously inflated to 200 mm hg and left inflated for 5 minutes, then deflated to 0 mmhg and left uninflated for 5 minutes. this cycle is repeated twice, so that the ripc protocol takes 20 minutes in total. if the systolic blood pressure is \> 185mm hg the cuffs are inflated to 15 mmhg above that level. several studies already demonstrated the reno- and cardioprotective potential of "remote ischaemic preconditioning" (ripc). it was shown that urinary calprotectin can be used to monitor tubular damage after nephron sparing surgery. postoperative calprotectin dynamics will be monitored in order to demonstrate the potential renoprotective effect of ripc. additionally a bold mri will be performed to to visualize ischemia/reperfusion injury.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (appendix informed consent form) * kidney tumor (any entity, benign, malign) * partial nephrectomy (any surgical technique, open, retroperitoneoscopic, transperitoneal, da vinci assisted) * 18 years of age * sufficient perfusion of all 4 extremities * palpable distal pulses: a. radialis and a. dorsalis pedis or a.tibialis post. exclusion criteria: * women who are pregnant * significant peripheral arterial disease affecting upper and/or lower limbs or history of * significant renal disease (gfr \<15 ml/min/1.73m2) or undergoing haemodialysis * concomitant therapy with glibenclamide or nicorandil (due to potential inference with ripc) * urothelial cancer * acute urinary tract infection * international normalized ratio (inr) \>2 (haematoma risk at cuff site)

Keywords: partial nephrectomy, ripc, reperfusion injury