Kornimate/medical-research-clean huggingface dataset:
sleep-disordered breathing and neurocognitive assessment in children and young adults

Conditions: Sleep-disordered Breathing (SDB)

Summary: one of main problems in the management of sleep-disordered breathing (sdb) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (psg). it may be useful to use additional measures together with psg to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of sdb. the primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic psg results.

one of main problems in the management of sleep-disordered breathing (sdb) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (psg). it may be useful to use additional measures together with psg to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of sdb. in addition, the clinical impact of sdb and the benefit of treatment are still not clear in children and young adults, including neurocognitive and developmental perspective. finally, the validation of simplified tools could optimize and simplify the detection of sdb in children and young adults. patients scheduled to perform a diagnostic psg for routine clinical care will have additional recordings and questionnaires as part of the study. the primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic psg results.

Eligibility criteria:
inclusion criteria: * patients aged 1 to 20 years with a suspicion of sdb or a high-risk of sdb due to their pathology and hospitalized at necker hospital for a sleep study * written informed consent exclusion criteria: * no social insurance * significant psychomotor retardation * cooperation not possible * significant agitation * acute condition and/or temporary drug treatments that may interfere with the results of psg (upper or lower airway infection) * patient under guardianship/curatorship

Keywords: sleep-disordered breathing (sdb) poly(somno)graphy (p(s)g) cerebral oxygenation cyclic alternating pattern (cap) psychological and neuropsychological tests screening questionnaires treatment of sdb
preventing fas/arnd in russian children

Conditions: Fetal Alcohol Syndrome (FAS); Fetal Alcohol Spectrum Disorders; Alcohol Abuse in Pregnancy

Summary: the purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing fetal alcohol spectrum disorders in russian children. the study will determine whether physicians, trained in a dual-focused brief motivational intervention and monitored for performance, can foster greater change in knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in russian women who are at risk than standard care.

the study is a two-arm, 20-site, site-randomized, controlled trial testing an intervention to reduce risk for alcohol-exposed pregnancies in at-risk women (at-risk drinking childbearing age women who are heterosexually active, and not consistently using contraception). the trial will assess feasibility of a dual-focused (i.e. contraception use-drinking reduction) brief physician intervention (dfbpi) and determine whether physicians, trained in dfbpi and monitored for compliance, can foster greater reduction of women's risk behaviors compared to standard care. the intervention is specifically designed to be deliverable routinely by obstetrics and gynecology physicians(ob/gyn) to large numbers of women at women's clinics.

Eligibility criteria:
inclusion criteria: * nonpregnant women * childbearing age (between 18 and 44 years of age) * fertile * at risk for an alcohol-exposed pregnancy: drinking at-risk (4 or more drinks on one occasion or more than 7 drinks per week)in the last 3 months and report having unprotected intercourse at least once in the last 6 months exclusion criteria: * unable comprehend interview questions

Keywords: alcohol pregnancy fetal exposure prevention fas alcohol-related neurodevelopmental disorder (arnd)
therapeutic effect of surgical debulking of metastatic lymph nodes in cervical cancer stage iiicr

Conditions: Cervical Cancer

Summary: this study is a prospective, multicenter and randomized clinical trial (debulk trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (ccrt) in cervical cancer stage iiicr.

bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (ccrt). however, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (ccrt) compared to ccrt only, in cervical cancer stage iiicr. this study is a phase iii, multicenter and randomized clinical trial (debulk trial). * concurrent chemoradiation therapy (ccrt) * surgical debulking of bulky or multiple lymph node followed by ccrt

Eligibility criteria:
1) inclusion criteria (1) women aged ≥ 20 years and ≤ 70 years (2) patients newly diagnosed with squamous cell carcinoma (scc), adenocarcinoma, or adenosquamous carcinoma (3) patients with a short-axis diameter of the pelvic ln or para-aortic ln under the renal vein of ≥ 1.5 cm or ≥ 2 lns with a short-axis diameter ≥ 1 cm in ct or mri (pet-ct can be used as an auxiliary tool) (4) patients with ccrt planned as a treatment for cervical cancer (5) patients whose competency is eastern cooperative oncology group performance score 0-1 (6) patients who have signed the approved informed consent form for study participants (7) patients in whom surgical debulking for ln metastasis was possible, as confirmed by radiological examination. 2) exclusion criteria (1) patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) patients who are pregnant or plans to conceive during the clinical study period (3) patients with any active infectious disease or incurable severe inflammation (4) patients who cannot undergo surgery due to internal or surgical disease (5) patients who cannot receive chemotherapy due to internal or surgical disease (6) patients with a history of pelvic rt (7) patients with a history of subtotal hysterectomy (8) patients with remote metastasis other than a pelvic or para-aortic ln (e.g., lung, subclavian, and inguinal lns)

Keywords: cervical cancer iiicr bulky or multiple lymph nodes surgical debulking of lymph nodes concurrent chemoradiation therapy
building stronger allies

Conditions: Suicide; Risk Reduction

Summary: bsa is a novel, computerized intervention specifically designed for active military personnel with the intent to reduce two risk factors known to be associated with suicide outcomes.

the investigators have focused on the identification of malleable risk factors for preventative intervention in a number of types of psychopathology including suicidality. in the case of perceived burdensomeness (pb) and thwarted belongingness (tb), theory suggests that they may be malleable, though this has received little empirical attention. taken together, the interpersonal theory of suicide and related empirical literature suggest that targeting pb/tb should offer a novel and important avenue to reduce suicidality. this inspired the investigators' efforts to create and evaluate an intervention - called building stronger allies (bsa) - designed to reduce these factors.

Eligibility criteria:
inclusion criteria: * must show at least some suicide risk based on scoring \> 0 on the columbia-suicide severity rating scale (c-ssrs). * must also own a smartphone. exclusion criteria: * no evidence of such serious suicidal risk that would indicate a need for immediate hospitalization or emergency intervention. * no planned moves/deployments for the next 3 months.

Keywords: suicide prevention risk factor intervention military
the effect of prolonged multimodal analgesic regimen on post hospital discharge opioid use and pain control after primary total knee arthroplasty

Conditions: Osteo Arthritis Knee

Summary: it is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. this multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. one potential strategy to reduce the use of opioids after tka is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. this can be equal or more effective than the regimen of opioid prescriptions used after tka. to the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary tka patients. purpose: 1. to determine whether a prolonged multimodal pain regimen after discharge from primary tka can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects. 2. to determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary tka impacts opioid consumption.


Eligibility criteria:
inclusion criteria: * patients undergoing unilateral primary tka with underlying diagnosis of osteoarthritis. * asa i - iii * spinal anesthesia * all patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. a tourniquet will be used in all cases * male and female over 18 who are willing and able to provide informed consent exclusion criteria: * opioid use within 3 months preoperatively * inability to take the protocol medications * anticoagulant other than aspirin * contraindication to regional anesthesia * non-english speaking * asa iv or greater * psychiatric or cognitive disorders * allergy/contraindications to protocol medications. * renal insufficiency with cr \> 2.0 or hepatic failure * general anesthesia * sensory/motor disorder involving the operative limb
safety and pharmacokinetics study of mt-3921 in spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetics of mt-3921 in subjects with spinal cord injury.

this is a phase 1, open-label, single ascending dose study of mt-3921 in subjects with spinal cord injury.

Eligibility criteria:
inclusion criteria: additional screening criteria check may apply for qualification: * provide written informed consent prior to beginning any study procedures * cervical spinal cord injury, asia impairment scale grade a, b, and c with the international standards for neurological classification of spinal cord injury (isncsci) neurological level of injury between c4 and c8 * male or female subjects aged between 18 and 65 years * body mass index (bmi) \<35 * has had stabilization surgery (if needed) following their sci and prior to receiving mt-3921 exclusion criteria: additional screening criteria check may apply for qualification: * any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations * poly-traumatic injury as defined by injury severity score (iss) values \> 25 * penetrating spinal cord injuries * traumatic transection of the spinal cord or spinal cord contusion size \> 3 cm determined by mri * any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iinvestigator, may increase the risks associated with study participation * subjects with hiv, hbv or hcv positive * psychoactive substance use disorder * history or presence of malignancy within the last 5 years prior to screening * pregnant or nursing women * subjects with hereditary fructose intolerance * history of anaphylaxis or significant allergy
somatostatin receptor imaging in npc, ebv related cancers

Conditions: Nasopharyngeal Cancer; Epstein-Barr Virus Related Carcinoma

Summary: the study aims to describe the avidity of somatostatin receptors in locally advanced, metastatic and locally recurrent nasopharyngeal cancer (npc) and to determine the proportion of npc patients with high somatostatin receptor density that may benefit from future somatostatin targeted therapeutic trial plans. the investigators also aim to determine the presence of somatostatin receptors in other ebv related cancers.


Eligibility criteria:
inclusion criteria: * locally advanced, metastatic or locally recurrent npc that are going for fdg pet as part of their investigations * patients that have gone for ga-68 dotatate imaging before are eligible for repeat imaging * histologically confirmed npc * above 21 years of age exclusion criteria: * patients below 21 years of age * pregnant and breast feeding ladies

Keywords: somatostatin ebv npc rare cancer
assessement of the prevalence of lysosomal acid lipase deficiency in liver post-transplant patients

Conditions: Liver Post-transplant Patients

Summary: lysosomal acid lipase (lal) deficiency is a rare, autosomal recessive storage disease linked to decrease enzymatic activity of lal, responsible for intracellular accumulation of cholesterol esters and triglycerides. the accumulation of lipid is in hepatocytes, kupffer cells and macrophages leading to a fatty liver, hepatic fibrosis that can evolve up to cirrhosis. lal deficiency is responsible for significant morbidity and early mortality in children, adolescents and adults in connection with a multi visceral disease reaching the liver, gastrointestinal tract and the vascular endothelium. the disease is caused by homozygous or heterozygous mutations in the gene (lipa chromosome 10q23.2-23.3) which is responsible for the synthesis of the lal. the disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto blotting paper. patients with this deficiency lal, have no or reduced activity of this enzyme. because of its rarity, the deficit in lal is under diagnosed or is diagnosed in patients with liver biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis (nash), the steatosis (nafld), the cryptogenic cirrhosis or wilson disease. inclusion period of 12 to 18 months (100 patients).


Eligibility criteria:
inclusion criteria: * liver post-transplant patient * patients with cryptogenic cirrhosis, nash exclusion criteria: * patients without metabolic syndrome clinical, biological or radiological.

Keywords: liver transplant lysosomal acid lipase
investigating outcomes of lower limb trauma

Conditions: Trauma

Summary: this is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. this will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb salvage surgery following a traumatic injury to their lower limb.

in the setting of severe trauma, the decision whether to amputate or save a limb is common, and extremely difficult to make. due to improving reconstructive surgical techniques there are currently no clear criteria for amputation. although limb salvage appears desirable in most situations, numerous articles in the scientific literature have shown that it is associated with increased pain, complications, duration of hospital stay, rehabilitation time, and overall costs. these factors may be acceptable if the patients benefited from improved functional outcome. however, studies comparing amputation to limb salvage consistently report no significant difference in functional outcome between the two groups. a major limitation in the methodology of the fore mentioned studies is the use of self-reported questionnaires to determine functional outcome. questionnaires are subjective, and often lack specificity, and therefore may not be truly representative of functional outcome. furthermore, lack of useful information during long-term post-operative care prevents adaption and optimisation of rehabilitation strategies. the investigators plan on using a wearable sensor to develop an objective mobility assessment tool for patients having either amputation or limb salvage surgery after lower limb trauma. this would result in a reliable and accurate comparison, which may help healthcare professionals make an informed decision between amputation and limb salvage in the future.

Eligibility criteria:
inclusion criteria: * to have sustained a lower-limb trauma and undergone limb salvage surgery or amputation with fitting of prosthesis exclusion criteria: 1. contralateral (or other) limb impairment 2. 18 \> age \> 65 3. currently a hospital inpatient 4. psychological disorder

Keywords: trauma limb reconstruction amputation functional outcome sensing
influence of three different formulations of lachrymal substitutes on tear film thickness and other signs and symptoms in patients with moderate to severe dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. topically administered lubricants are the basis for treatment of this disease. however, exact information about influence on tear film thickness and corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. recently a new method for assessment of tear film thickness based on ultra-high resolution optical coherence tomography (oct) has become available. the aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular thealoz duo® eye drops, optive® eye drops and systane ultra® eye drops in patients with moderate to severe dry eye disease. in addition, standard tests for dry eye syndrome, such as the ocular surface disease index (osdi©), schirmer i test, corneal fluorescein staining and determination of tear break up time (but) will be performed to compare the product effects.


Eligibility criteria:
inclusion criteria: 1. men and women aged over 18 years 2. signed and dated written informed consent 3. history of dry eye syndrome for at least 3 months 4. tear break up time (but) ≤ 10 seconds or schirmer i test ≤ 5 mm and ≥ 2mm 5. osdi ≥ 22 6. normal ophthalmic findings except dry eye syndrome, ametropia \< 6 dpt. 7. no administration of topical lubricants 24 hours before the screening examination exclusion criteria: 1. presence of an ocular pathology judged by the investigator as incompatible with the study. 2. any other clinical relevant ocular abnormality except des. 3. history of allergy, known hypersensitivity to one of the components: the study medications or fluorescein. 4. history of known clinically relevant allergy. 5. medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, haematological disease; severe psychiatric illness, etc.). 6. history of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (day 0). 7. pregnancy, lactation. 8. pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised. 9. participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses). 10. subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment. 11. participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study. 12. subject is a ward of court.
apixaban, warfarin and aspirin prevents portal vein thrombosis in patients after laparoscopic splenectomy（esawaapt）

Conditions: Cirrhosis; Splenectomy; Status; Venous Thrombosis; Hypertension, Portal

Summary: the purpose of this study is to determine whether apixaban, warfarin and aspirin anticoagulation are effective and safe in prevention of portal vein thrombosis in liver cirrhotic patients after laparoscopic splenectomy

after successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. the baseline doppler parameter will be recorded and the patient will be randomized into apixaban, warfarin or aspirin group. from postoperative day three, patients in apixaban group will receive oral apixaban 2.5mg bid for six months, patients in warfarin group will receive oral warfarin 2.5mg qd with titration of dose to maintain a target inr of 2-3 for six months, patients in aspirin group will receive oral aspirin enterie ccoated tablets 100mg qd for six months. all groups will be along with five days of subcutaneous injection of low molecular weight heparin and three months of oral dipyridamole. every three months the doppler screening for the occurrence of portal vein thrombus (pvt) or spleno-mesenteric thrombosis will be done for all patients. all groups will receive the therapy for six months irrespective of the doppler findings in relation to portal vein thrombus occurrence. then six months monitoring will be done in the three groups as per the primary or secondary outcome.

Eligibility criteria:
inclusion criteria: * a clinical, radiological or histologic diagnosis of cirrhosis of any etiology * splenomegaly with secondary hypersplenism * no evidence of pvt or spleno-mesenteric thrombosis by ultrasound evaluation and angio-ct * informed consent to participate in the study exclusion criteria: * hepatocellular carcinoma or any other malignancy * hypercoagulable state other than the liver disease related * drugs- oral contraceptives, anticoagulation or anti-platelet drugs * base line inr \>2 * child-pugh grade c * recent peptic ulcer disease * history of hemorrhagic stroke * pregnancy * uncontrolled hypertension * human immunodeficiency virus (hiv) infection

Keywords: cirrhosis venous thrombosis portal hypertension apixaban warfarin aspirin splenectomy laparoscopy