Kornimate/medical-research-clean huggingface dataset:
toward a real-time access to sleepers' mental content

Conditions: Memory Reactivation; Memory Consolidation; Sleepwalking

Summary: sleep is crucial for global cognitive functioning, but its exact functions and mechanisms are still poorly understood. cognitive studies of sleep typically rely on linking electrophysiological changes measured during sleep with behavioral and neural changes collected in tasks performed during wakefulness. what concomitantly happens in the mind of sleeping subjects is often ignored, certainly because it is virtually inaccessible. yet, major advances in the understanding of human behaviors have resulted from an integrated approach that combines both neural and cognitive measures of their ongoing mental processes. the goal of this study is to provide real-time measures of the cognitive processes occurring within sleep. to prompt real-time access to the sleeping mind, investigators will use auditory stimulation in people with unique sleep peculiarities: sleepwalkers whose overt behaviours may enable to objectively visualize ongoing cognitive processes during non-rem (nrem) sleep.

investigators aim to offer a quantifiable, real-time measure of memory processing during nrem sleep by using memory-related cues to influence which behaviours sleepwalkers will exhibit. because sleepwalking is characterized by complex behaviors emerging from nrem sleep, it could provide an observable window into mental activity in nrem sleep. while neuronal memory reactivations have largely been demonstrated in sleeping rodents, evidence for the existence of such reactivations in humans is at best indirect. here, investigators will use targeted memory reactivation (tmr), a tool that allows to control which individual memories are reactivated on a trial by trial basis. tmr consists in associating sensory cues with a specific learning, then re-applying these cues during subsequent sleep to trigger the reactivation of the corresponding learning. sleepwalkers will be trained on a modified version of the serial reaction time task: sleepwalkers will perform as fast and accurately as possible a sequence of gestures in response to auditory cues. investigators goals are to: i) show that playing the auditory cues during nrem sleep triggers a behavioral replay of the learned 'choreography' in sleepwalkers, ii) quantify, with a gesture recognition algorithm, how the sleep gestures differ from the wake ones (speed, accuracy, sequence fidelity), and iii) test whether this evoked replay is accompanied by a congruent dream.

Eligibility criteria:
inclusion criteria: * age between 18-35 y.o * written consent * affiliated to social security * sleepwalking (group patients only) exclusion criteria: * psychiatric or neurologic disorder * sleep disorder except sleepwalking for the patient group * surdity * pain or physical disability affecting the upper limbs * consumption of drugs altering sleep structure * subjects under legal protection

Keywords: sleepwalking sleep memory consolidation reactivation dream targeted memory reactivation
intervention for pre-frailty and frailty in thoracic surgery patients

Conditions: Frailty

Summary: frailty has been associated with poor acute and long-term outcomes after major surgery. we recently determined that nearly 70% of patients undergoing major thoracic surgery are pre-frail or frail. we are interested in assessing whether a strength training intervention for frail or pre-frail patients has an impact on surgical decision making and on surgical outcomes.


Eligibility criteria:
inclusion criteria: • age ≥60 years, • qualified to consent for participation in a research study, •thoracic disease that may require major surgery (major anatomic lung resection, esophagectomy, repair of giant paraesophageal hernia, chest wall resection, extended pleurectomy/decortication, thymectomy or major surgery for other mediastinal process),• no obvious contraindications to surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would prevent surgery), • ability to participate in physical therapy and an independent exercise program for frailty mitigation, •no need for induction chemotherapy or radiation therapy, • recent evaluation including computed tomography of the chest or chest/abdomen. exclusion criteria:• age \<60 years, •unable to provide informed consent, • no indication for major thoracic surgery, •obvious contraindication to major thoracic surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would preclude surgery),• inability to participate in physical therapy and/or an independent home exercise for frailty mitigation, •need for induction chemotherapy or radiation therapy
a study evaluating oral atogepant for the prevention of migraine in japanese participants with chronic or episodic migraine

Conditions: Chronic Migraine; Episodic Migraine

Summary: this study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in japanese participants with chronic or episodic migraine.


Eligibility criteria:
inclusion criteria: 3101-303-002 completers: * eligible participants who completed visit 7, and visit 8 if applicable, of the study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (ae) that, in the investigator's opinion, may indicate an unacceptable safety risk. de novo em participants: * age of the participant at the time of migraine onset \< 50 years. * at least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ichd-3, 2018. * history of 4 to 14 migraine days per month on average in the 3 months prior to visit 1 in the investigator's judgment. * 4 to 14 migraine days in the 28-day baseline period per ediary. * completed at least 20 out of 28 days in the ediary during baseline period and is able to read, understand, and complete the study questionnaires and ediary per investigator's judgment. exclusion criteria: * requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment. * participants with an ecg indicating clinically significant abnormalities at visit -1 (de novo episodic migraine participants) or visit 1 (3103-303-002 completers). * hypertension as defined by sitting systolic bp \> 160 mm hg or sitting diastolic bp \> 100 mm hg at visit 1. * significant risk of self-harm based on clinical interview and responses on the (columbia-suicide severity rating scale \[c-ssrs\]), or of harm to others in the opinion of the investigator. * any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease. de novo em participants only: * difficulty distinguishing migraine headaches from tension-type or other headaches. * has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ichd-3, 2018. * has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ichd-3, 2018. * has \>= 15 headache days per month on average across the 3 months prior to visit 1 in the investigator's judgment. * has \>= 15 headache days in the 28-day baseline period per ediary. * usage of opioids or barbiturates \> 2 days/month, triptans or ergots \>= 10 days/month, or simple analgesics \>= 15 days/month in the 3 months prior to visit 1 per investigator's judgment or during the baseline period.

Keywords: chronic migraine episodic migraine atogepant
poznan prospective study of type 1 diabetic patients

Conditions: Microangiopathy; Macroangiopathy; Insulin Treatment Overcorrection; Insulin Resistance

Summary: the purpose of this study is to evaluate the development and progression of chronic complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular events) in patients with type 1 diabetes treated from the onset of the disease with recommended method of intensive insulin therapy. all patients attended a five-day structured training program during first hospitalization and re-education once year during the observation. after five years of observation and next - once a year chronic complications are assessed. the investigators would like to evaluate also the relationship of the management of the disease, knowledge about the treatment and diabetes, insulin resistance and inflammatory markers with development and progression of chronic complications.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 1 diabetes mellitus with features of complete insulin deficiency (serum c-peptide level \<0.05 ng/ml, acetonuria, blood gases disturbances such as: ph \<7.30, be\< -6 mmol/l, hco3 \<18 mmol/l) * age \< 35 years old * educational course in intensive insulin therapy started at the onset of the disease after treatment of ketoacidosis * written consent exclusion criteria: * uncertain type of diabetes mellitus * kidney failure (serum creatinine level \> 1.1 mg/dl) * liver dysfunction (aspat \> 31 u/l, alat \> 34 u/l) * acute inflammatory process * other concomitant diseases (i.e. neoplasm)
mma embolization for refractory chronic migraine

Conditions: Migraine

Summary: this is a prospective, multi-center, feasibility study to investigate safety and effectiveness of trufill n-bca liquid embolic system in bilateral middle meningeal artery (mma) embolization for the treatment of refractory chronic migraine.


Eligibility criteria:
participant inclusion criteria, candidates for this study must meet all the following inclusion criteria: 1. patient is between 18 and 65 years of age (inclusive) at the time of consent. 2. age of onset of chronic migraine ≤ 64 years. 3. age of onset of migraine diagnosis \< 50 years. 4. patient has a current diagnosis of refractory migraine. 5. patient has a current diagnosis of chronic migraine. participant exclusion criteria, candidates will be excluded from participation if any of the following apply: 1. patients with a history for the last 2 years of other types of headache. 2. patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. patients with current regular use of opioids, cannabis, medical marijuana, etc. 6. women who are pregnant, lactating, or who are of childbearing age. 7. current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. sponsor approval is required.
safety and efficacy of isatuximab in lymphoblastic leukemia

Conditions: T-cell Type Acute Leukemia-Precursor; T-lymphoblastic Lymphoma/Leukaemia

Summary: primary objective: to evaluate the efficacy of isatuximab. secondary objectives: * to evaluate the safety profile of isatuximab. * to evaluate the duration of response (dor). * to evaluate progression free survival (pfs) and overall survival (os). * to evaluate the pharmacokinetics (pk) of isatuximab in participants with t-all or t-lbl. * to evaluate immunogenicity of isatuximab in participants with t-all or t-lbl. * to assess minimal residual disease (mrd) and correlate it with clinical outcome.

the study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.

Eligibility criteria:
inclusion criteria : * participants must had a known diagnosis of acute lymphoblastic leukemia (all) of t cell origin, including t-lbl and t-all with extramedullary involvement at relapse confirmed by biopsy. * participants must be previously treated for t-all or t-lbl and have relapsed or are refractory to most recent treatment. participants in first relapse were be eligible regardless of the first remission duration. * participants must had been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue). * no more than 3 prior salvage therapies. exclusion criteria: * prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. must have recovered from acute toxicity before first study treatment administration. * prior stem cell transplant within 4 months and/or evidence of active systemic graft versus host disease and/or immunosuppressive therapy for graft versus host disease within 1 week before the first study treatment administration. * clinical evidence of active central nervous system (cns) leukemia. * t-all with testicular involvement alone. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
magnetic resonance elastography for assessment of liver fibrosis (mk-0000-132)(completed)

Conditions: Liver Fibrosis; Hepatitis C Virus

Summary: this study will assess the repeatability of magnetic resonance elastography (mre) in both healthy volunteers and hepatitis c virus (hcv)-infected patients with fibrosis and lay the groundwork for the validation of mre as an alternative to liver biopsy.


Eligibility criteria:
inclusion criteria: * male or female and at least 18 years of age * generally good health * willing to fast for 8 hours prior to each study visit hepatitis c virus (hcv) inclusion criteria: * positive serology for hcv and detectable hcv ribonucleic acid (rna) in blood within 12 weeks of screening; for part i, known fibrosis stage of at least =f2 (metavir) or =f3 (ishak) from biopsy performed within 3 months of screening; for part 2, known fibrosis stage of f1-f4 (metavir) or f1-f6 (ishak) * never been treated for hcv healthy participant inclusion criteria: * documented absence of hepatitis b virus, hcv, acute hepatitis a virus, and human immunodeficiency virus (hiv) within 12 weeks of screening exclusion criteria: * history of stroke, seizures, or neurological disorders * consumption of excessive amounts of alcohol * use of products containing nicotine * unable to hold a breath for 20 seconds * claustrophobia * use of illicit drugs or history of drug or alcohol abuse hcv-positive exclusion criteria: * evidence or history of chronic hepatitis not caused by hcv * hiv

Keywords: staging of liver fibrosis prior to clinical trials for treatment of hepatitis c virus
evaluation of clot stability induced by solulin: evaluation of new solulin mutants lacking protein c activation capacity

Conditions: Hemophilia A

Summary: hemophilia a is a rare x chromosome-linked recessive bleeding disorder that concerns one individual in 5000. in its severe form, hemophilia a is a life-threatening, crippling hemorrhagic disease. the treatment of bleeding episodes in hemophilia a patients involves the administration of exogenous human fviii to restore normal hemostasis. the main complication of the substitutive treatment of hemophilia a is the development, in 15 to 30% of the cases, of anti-fviii antibodies (fviii inhibitors) that neutralize the pro-coagulant activity of therapeutically administered fviii. in 2003, the average annual cost of care for a patient with hemophilia a was evaluated to be equal to 63,000 euros (2), which, in france (6000 patients), represents an annual budget of 378 million euros. in order to reduce the cost of treatment and to bypass this complication, different therapeutic strategies (new products or adjunctive therapeutic options) have been explored, including platelet infusion, tranexamic acid, amino caproic acid, molecules that block tissue factor pathway inhibitor, combination of phospholipid -factor xa- factor xiii and antibodies directed to the tissue factor inhibitor pathway (tfpi). recently, soluble thrombomodulin (solulin) have been developed. this molecule may be used to partially correct the premature lysis defect in factor viii deficient plasma through an activated tafi - dependent mechanism. with a long half-life (15- to 30-hour) and effective dose range estimated to range from the sub-nanomolar to approximately 40nm, solulin could potentially be administered on a weekly basis and provide the basis for a factor-sparing regime that would cut costs and make therapy more widely available. however, before proceeding to advanced trials, safety concerns stemming from the anticoagulant properties of solulin must be addressed. the development of solulin mutants lacking protein c activation capacity would make this concern redundant. at the same time, such mutant molecules are likely to possess an effective dose range. our project is to compare the behavior of recombinant solulin and mutants of solulin lacking protein c activation capacity with respect to their ability to stabilize fibrin clots in whole blood of humans with different coagulation factor deficiencies (hemophilia a, hemophilia b and rare blood coagulation deficiencies (factor x, vii, v).


Eligibility criteria:
inclusion criteria: * patients with congenital blood disorder (hemophilia a and b), * inform consent exclusion criteria: * patients with acquired blood disorder. * allo-immunisation against blood coagulation factor concentrates (fviii inhibitor)
bridge reinvention

Conditions: Spinal Cord Injuries

Summary: the goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with sci who are transitioning from inpatient rehabilitation to home. the overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy.

the goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with sci who are transitioning from inpatient rehabilitation to home. the overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy. there were three aims of this study: aim 1: self-efficacy - to examine the ability of a six-week, manualized, cognitive-behaviorally based group educational intervention (re-inventing yourself after sci-bridge) to improve both sci-specific and general self-efficacy for people who are early in the process of community reintegration; aim 2: psychosocial adjustment - to assess the ability of the re-inventing yourself after sci-bridge intervention to improve psychosocial adjustment of people with sci who are early in the community reintegration process; and, aim 3: participation - to determine the ability of the re-inventing yourself after sci-bridge intervention to improve societal participation for people with sci who are early in the community reintegration process.

Eligibility criteria:
inclusion criteria: 1. history of sci at any level; 2. completed initial inpatient rehabilitation but are no more than 6 months post-discharge; 3. 18 years of age or older at the time of study enrollment; 4. english speaking in order to complete study measures and participate in group interactions; and 5. able to provide informed consent to participate. exclusion criteria: 1. history of moderate or severe traumatic brain injury; 2. current participation in another rct; 3. live beyond a reasonable commuting distance from craig hospital; 4. unable to verbally communicate; 5. unable to attend group sessions; 6. active participation in another formal clinical group or psychological therapy; 7. are currently experiencing severe depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 20 or higher on the personal health questionnaire-9; 8. report any current suicidal ideation on the personal health questionnaire-9; or 9. have any condition that, in the judgment of the investigators, precludes successful participation in the study.

Keywords: self efficacy participation satisfaction with life
epidemiology of carbapenemase-producing bacteria in a swiss tertiary care hospital

Conditions: Infections With CPB

Summary: this retrospective and prospective study is to investigate the incidence of carbapenemase-producing bacteria (cpb) at the university hospital basel, the time to detection of cpb and to initiation of infection control measures, the risk factors associated with carriage of cpb, type and duration of previously administrated antibiotic medication, antibiotic treatment, as well as to assess the outcomes of the affected patients.


Eligibility criteria:
inclusion criteria: * patients with detection of carbapenemase-producing bacteria from january 1st , 2008 until december 31st , 2028 exclusion criteria: * patients with documented refusal of subsequent use of their data

Keywords: carbapenemase-producing klebsiella pneumoniae antibiotic resistancy infections with carbapenemase-producing bacteria (cpb) carbapenemase-producing bacteria
role of soft tissue therapy in plantar fasciitis

Conditions: INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION

Summary: plantar fasciitis (pf) is a frequently and commonly reported heel pain present in every age with multifactorial etiology. it is the most common reason for constant heel pain in adults affecting both young active and older sedentary individuals. pf is reported approx. 11%-15% of all foot symptoms demanding professional care among adults. instrument-assisted soft tissue massage (iastm) refers to a technique that utilizes instruments to eliminate scar tissues and work with mending measure through development of new extracellular lattice proteins like collagen that may be effective in providing immediate and quick pain relief by covering a larger area. on the other hand, numerous options with conservative measures has been frequently documented in treating plantar fasciitis that may include stretching, massage, orthosis, anti-inflammatory agents and surgery etc. although, transverse friction massage has been considered to be one of the best treatment option in reducing pain, releasing tight areas and promoting flexibility. besides, several studies reported the usefulness of potential assessment tools for remote monitoring of patients that can be utilized by clinicians for wider range of purposes. to the best of author's knowledge, limited studies has been conducted till date utilizing the iastm technique in comparison to conservative treatment options with standardized assessments in treating pf. therefore, this study aims to investigate the effectiveness of iastm to assess thickness, pain, and foot function by using ultrasound for the management of plantar fasciitis patients. the findings of this study may be useful to establish an effective treatment protocol to enhance the quality of life of the target population.


Eligibility criteria:
inclusion criteria: -pre-diagnosed adults (18-55 years) with plantar fasciitis of both genders. exclusion criteria: * pathological bone spurs of the calcaneus * burn scars * polyneuropathies * corticosteroid injections

Keywords: musculoskeletal pain myofascial release plantar fasciitis