Kornimate/medical-research-clean huggingface dataset:
study assessing effects of jzp-110 on driving performance in the treatment of excessive sleepiness in narcolepsy

Conditions: Narcolepsy; Excessive Sleepiness

Summary: this trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of jzp-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.


Eligibility criteria:
inclusion criteria: 1. male or female, age 21 to 65 years inclusive 2. diagnosis of narcolepsy per international classification of sleep disorders (icsd-3) or diagnostic and statistical manual of mental disorders 5th edition (dsm-5) 3. bmi 18 to \<40 kg/m2 4. willing and able to provide written informed consent exclusion criteria: 1. female subjects who are pregnant, nursing, or lactating 2. moderate or severe sleep apnea 3. any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness 4. history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to dsm-5 criteria 5. history or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator 6. history of bariatric surgery within the past year or a history of any gastric bypass procedure 7. presence or history of significant cardiovascular disease 8. unable to washout or refrain from taking any over-the-counter (otc) or prescription medications that could affect sleep-wake function

Keywords: driving
randomized trial of financial incentives to reduce sugar-sweetened beverage purchases by low-income, latino families

Conditions: Obesity Prevention

Summary: approximately 15% of the us population is enrolled in the supplemental nutrition assistance program (snap), and 50% are children. although the goal is to improve nutritional health, preliminary data suggest that enrollment in snap is associated with obesity and metabolic risks and that snap reimburses $4 billion annually for sugar-sweetened beverages (ssbs). this pilot project tests an innovative strategy to reduce purchase of non-nutritive, ssbs by low-income families with children by combining targeted point-of-purchase education with a randomized trial of financial incentives to discourage purchase of unhealthy beverages. the study will take place at a mid-size grocery store that is located in a low-income, latino community and where 30% of purchases are made with snap. targeted beverage education will be provided to all study subjects with a traffic-light system to identify healthy and unhealthy beverages at the point-of-purchase. individual beverage purchases will be tracked by electronically stored cash register sales. supplementary validation of beverage consumption will be assessed by 24 hour dietary recall. aim 1 is to conduct a randomized controlled trial to compare purchase and consumption of ssbs by families assigned to a financial incentive to reduce purchase of ssbs with families assigned to control (no incentives). aim 2 is to compare the purchase of ssbs by families in both arms during the study period when they are exposed to the traffic-light system to a baseline period prior to traffic-light education. results of this project will provide pilot data for larger scale interventions to promote healthy choices among low-income families.


Eligibility criteria:
inclusion criteria: * purchase \>75% of groceries at targeted supermarket (regular customer) * at least one child \<= 18 years old living at home exclusion criteria: * not fluent in spanish or english * no address or phone for contact

Keywords: sugar-sweetened beverages traffic-light labels financial incentives low-income community obesity prevention
gastrointestinal tract disorders: a prospective multicenter registry

Conditions: Endoscopic Suturing; GI Tract Disorders; Gastrointestinal Disorders

Summary: the purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract for various gi tract disorders. currently, lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.

this study is a prospective, observational, medical chart review for at least six standards of care visits up to 1 year after subject consents for study participation. there will be a retrospective chart review for patients who underwent endoscopic suturing procedures from october 2014 - april 2019. those subjects will undergo no additional tests and procedures as part of this study. all data will be collected from patient's electronic health records (ehr) of the hospital in addition; a prospective chart review will be performed for patients who will undergo endoscopic suturing procedures from april 2019 to april 2021. all the subjects enrolled in prospective chart review will be first consented for their study participation. subjects will undergo a clinically indicated endoscopic suturing procedure and standard of care follow up visits.

Eligibility criteria:
inclusion criteria: * any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the gastrointestinal tract * above or equal to 18 years of age exclusion criteria: * any patient who has not undergone endoscopic suturing within the gastrointestinal tract * below 18 years of age

Keywords: sutures gi
a study based on the french national health insurance database in participants with psychotic disorders

Conditions: Psychotic Disorders

Summary: the primary purpose of the study is to compare therapy with antipsychotic medication (antipsychotic monotherapy or antipsychotic combination) versus no antipsychotic medication, and antipsychotic monotherapy versus antipsychotic combination, regarding time to psychiatric rehospitalization, in participants with a psychotic disorder (that is, schizophrenia, schizotypal disorders, schizoaffective disorders, persistent or acute or induced or non-organic delusional disorders, recurrent depressive disorder with psychotic symptoms).


Eligibility criteria:
inclusion criteria: * at least one discharge for psychiatric hospitalization with a diagnosis of a psychotic disorder between january 1, 2014 and december 31, 2020. * at least one long-term disease record (ltd), (which is a french administrative status allowing the full reimbursement of the cost of a chronic pathology) with a diagnosis of a psychotic disorder between january 1, 2014 and december 31, 2020. * age of 18 years or older at index date (first date found in the previous conditions). exclusion criteria: • due to data management constraint, the participants with multiple or temporary identifiers in the database (indistinguishable in database) will be excluded. this happens with twins or migrants, for example.

Keywords: schizophrenia schizotypal disorders schizoaffective disorders persistent or acute or induced or non-organic delusional disorders recurrent depressive disorder
role of blood lactate level in prediction of outcome of cirrhotic patients at the intensive care unit

Conditions: Liver Cirrhosis

Summary: 1. determine in-hospital and 28-days mortality rates of critically-ill cirrhotic patients admitted to icu 2. evaluate the role of (blood lactate level, lactate/albumin ratio, lactate/bilirubin index and meld-lactate score) in prediction of mortality compared to other non- lactate containing scores. 3. study predictors of in-hospital and 28-mortality in these patients.

liver cirrhosis is a major health problem, which causes high mortality and economic burden worldwide. a large number of liver cirrhosis patients are prone to acute decompensation with organ failure, thus leading them to be admitted to intensive care unit (icu). though liver cirrhosis patients have improved outcomes in icu over the past decade, the prognosis for those patients remains poor, with in-hospital mortality. assessment of prognosis, especially in patients with cirrhosis at the icu, is of importance in order to guide therapeutic measures and improve their outcome. many prognostic scores are used to help predicting complications, expected survival and estimate the risk of various medical interventions in these patients as ctp, meld, clif-c of, clif-c ad and clif-c aclf scores. although these models are non-invasive, they have certain deficiencies as they don't consider other conditions that are associated with poor prognosis as poor tissue perfusion in critically-ill cirrhotic patients. lactate is a marker of metabolic changes resulting from tissue hypoxia or stress caused by the release of adrenaline. it was used to improve the prediction of short-term mortality of critically ill patients at icu. little is known about role of blood lactate in prediction of prognosis of critically ill egyptian cirrhotic patients at icu. therefore, the investigators will conduct their study to shed some light on this topic.

Eligibility criteria:
inclusion criteria: * cirrhotic patients who are at least 18 years old at their first icu admission in al-rajhy university hospital (according to the established admission policy) and stay more than 24 h will be included. exclusion criteria: * 1) patients admitted for liver transplantation. * 2) patients whose blood lactate data is lost at 24 hours from icu admission. * 3) patients taking drugs that increase level of serum lactate as metformin , acetaminophen, linezolid, epinephrine, beta2 agonists, propofol, nucleoside reverse transcriptase inhibitors (nrtis) as lamivudine and abacavir , and theophylline

Keywords: lactate
efficacy of a new behavioral treatment for premature ejaculation using a masturbation aid device: star-stop 3.0

Conditions: Premature Ejaculation; Cognitive-Behavior Treatment; Masturbation Aid Device

Summary: the present study included 57 patients ≥18 years who met diagnostic criteria for pe including intravaginal ejaculatory latency time (ielt) of ≤2 minutes and had a premature ejaculation diagnostic tool (pedt) score ≥11. subjects were randomized to an experimental group that used the device with exercise programme (n=18) a first control group that only used the exercise programme (n=17) and a wait-list control group (n=22). as a main outcome measure used stopwatch-measured average ielt, premature ejaculation profile (pep), and the golombok-rust inventory of sexual satisfaction (griss).


Eligibility criteria:
inclusion criteria: * participants must be heterosexual males * to be in a stable monogamous, sexual relationship with a female partner for at least 6 months, * must score = 11 in the premature ejaculation diagnostic tool (pedt). * must have a self-estimated average intravaginal ejaculatory latency time (ielt) of \<2 min. -must be in good general health with no clinically significant abnormalities as determined by medical history and clinical lab results. exclusion criteria: * to suffer an alteration or mental disorder according to the criteria of the dsm-iv. * history of alcohol abuse and dependence. * do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).

Keywords: premature ejaculation cognitive-behavior treatment device
immobilization and protein supplementation (im-pro)

Conditions: Disuse Atrophy; Aging

Summary: in the present study, the effects of 5 days of lower limb immobilization with or without twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be determined. a young group will be included to compare the changes in muscle mass and muscle fiber characteristics between young and old men.


Eligibility criteria:
inclusion criteria: * male * aged from 18-35 years and from 65-75 years * 18.5 \< bmi \< 30 kg/m2 exclusion criteria: * smoking * performing regular resistance training in the previous 6 months * hypertension (according to who criteria) \[52\] and/or cardiovascular disease * any back/leg/knee/shoulder complaints which may interfere with the use of crutches * systemic use of antibiotics within 3 weeks prior to the study visit * current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin * type 2 diabetes mellitus * any history of thrombosis * any family history (1st grade) of thrombosis * all co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis). * myocardial infarction within the last 3 years * use of anti-coagulants * any (history of) gastrointestinal disease that interferes with gi function * indications related to interaction with the study product: * known allergy to milk or milk products * known galactosemia

Keywords: immobilization protein supplementation
non-invasive auricular fiber vagus nerve stimulation (afvns) for treatment of autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: non-invasive vagus nerve stimulation for the symptomatic improvements in autism spectrum disorder

a single arm open-label study in autism spectrum disorder (asd) for evaluating treatment effects of non-invasive vns, specifically auricular fiber vagal nerve stimulation (afvns). a total of 20 patients diagnosed with asd will be recruited to evaluate the feasibility of home healthcare application of afvns and for assessment of short-term treatment effects on symptoms and comorbidities. asd patients will receive 1 x hour per day afvns treatment over 14 days with a fixed neuromodulation protocol. the primary outcome measure is feasibility assessed from completion success and neurostimulation tolerance. secondary outcome measures include changes in scores pre- and post- afvns treatment for clinician global clinical impression (cgi-i), clinician global impression severity (cgi-s), children's anxiety sensitivity index (casi-r), parent-rated anxiety scale for asd (pras-asd), autistic behavior checklist (abc), cleveland adolescent sleep questionnaire (casq), verbal fluency and biomarker measures in autonomic physiology.

Eligibility criteria:
inclusion criteria: * written informed consent * age: between 7 and 26 years * participants and parent/ guardian must read and write english * diagnosis of asd as defined by ados-2 and dsm-5 criteria * full scale iq of \>80 from wasi * suffering from anxiety (total score of \>49) on casi-r at baseline exclusion criteria: * severe psychiatric disorders (e.g. bipolar, major depressive disorder) * severe neurological disorders (e.g. stroke, epilepsy) * bradyarrhythmia * history of head trauma (surgery or tumor) * active medical implants (cochlear, vns or pacemakers) * cerebral shunts * auricular skin disease that compromises placement of electrodes * pregnancy
alveolar ridge preservation with different grafting strategies

Conditions: Bone Resorption

Summary: the aim of the present study was to compare the half-packed grafts that are covered with either a collagen or a nonresorbable membrane to the conventional alveolar ridge preservation procedures involving full-packed grafts and collagen membrane. the primary purpose was to evaluate the bone dimensional changes between the groups, and the secondary objective was to assess the potential contributing factors to clinical, radiographic and implant-related outcomes under different alveolar ridge preservation procedures.

regarding different surgical approaches in alveolar ridge preservation, limited studies directly compare collagen and non-resorbable membrane, and the comparison between half- and full- grafting strategy in clinical and radiographic outcomes was still lacking. the comparable effect of dimensional preservation between groups was shown except for more radiographic bone gain in full-grafting group. contributing factors, including thin bone thickness , vertical root fracture related sockets, non-molar sites and large bpd might attenuate the effect of arp. at implant placement, similar results in bone quality and keratinized mucosal width was found in all groups, while thicker vertical mucosal thickness was obtained when using nonresorbable membrane. all surgical modalities in alveolar ridge preservation yield stable peri-implant health 1 year after implant placement.

Eligibility criteria:
inclusion criteria: 1. ≥ 20 years old 2. presence of one or more hopeless teeth requiring extraction and subsequent implant placement due to reasons such as crack tooth, vertical root fracture, endodontic failure, unrestorable caries and severe periodontitis 3. the extraction socket should have more than two walls for arp, which includes type i-ii sockets (palatal/ lingual defects were also included) 4. participants should have a stable periodontal condition or history of periodontitis that is well-controlled with good oral hygiene. the pocket depth of the adjacent tooth around the socket should be less than 3 mm as assessed with a periodontal probe (hu-friedy, chicago, il, usa). exclusion criteria: 1. heavy smokers consuming more than half pack of cigarettes daily 2. women who were pregnant, lactating, or planning to be pregnant 3. history of psychiatric disorders 4. uncontrolled and complicated medical conditions that might hinder wound healing or bone metabolism, including poorly controlled diabetes, autoimmune disorders, receiving current radiotherapy in the head and neck regions, taking bisphosphonate and other antiresorptive agents.

Keywords: alveolar ridge preservation sealing material resorbable membrane non-resorbable membrane dental implants
standardization of anti-seizure medications withdrawals after seizure remission in young patients with epilepsy

Conditions: Epilepsy; Epilepsy in Children

Summary: the proper period of anti-seizure medication (asm) treamtment is important for decreasing side effect of asm and recurrence of seizure. we evaluate reliable risk factor analysis for safe withdrawal of asm in children with epilepsy. futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of asm.

the proper period of anti-seizure medication (asm) treamtment is important for decreasing side effect of asm and recurrence of seizure. we evaluate reliable risk factor analysis for safe withdrawal of asm in children with epilepsy. futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of asm. the enroll criteria as follow: 1. patients with epilepsy or acute provoked seizure accroding to the ilae definition 2. patients who have been 2 years of seizure free with or without asm the patients with seizure recurrence during follow-up or end of follow-up period of 24 months will end this stutdy.

Eligibility criteria:
inclusion criteria: * patients with epilepsy or acute provoked seizure according to the ilae guideline * patients with 2 years of seizure free periods exclusion criteria: * uncertain diagnosis of epilepsy or acute provoked seizure * patients who do not want to participate in the study
mirnas profiling in parkinson's disease

Conditions: Parkinson Disease

Summary: micrornas (mirnas) regulate fundamental cell processes. dysregulation of mirna expression and function is reported in various diseases including cancer, metabolic disorders as well as neurological disorders. circulating mirnas have been proposed to mirror physiological and pathological conditions suggesting their use as biomarkers for various diseases. the study will focus on a case-control study cohort (n=1000) of subjects recruited at the irccs neuromed for which a deep clinical characterization and genome-wide sequencing data are available. this study will enable to identify novel circulating biomarkers for parkinson's disease (pd). further, the project will give new insights on the involvement of mirnas in the etiology of pd and in the understanding of the genetics of the disease thus opening avenues for novel therapeutic strategies.

hypothesis and significance: the project intends to identify novel biomarkers for pd and clinical parameters related to the pd etiology. to do that circulating mirna profiling through a next-generation sequencing will be performed using a single sample approach in the case-control study cohort and identified mirnas will be validated by qrt-pcr and functional analyses. in addition, the project will contribute expanding the knowledge of the genetic architecture of pd taking advantage of genetic characterization of the study sample. mirna genes and target genes will be used to prioritize genetic variants to be tested for association with pd to detect novel genes and functional variants that confer disease risk. specific aim 1: profile of circulating mirnas in the serum of pd patients and controls by next-generation sequencing in individual samples. correlation between identified mirnas and pd-related parameters and validation in independent cohorts specific aim 2: bioinformatics prediction of target genes and mirna functional validation specific aim 3: identification of genes/genetic variants in mirna pathways predisposing to pd expected outcomes: the study will allow to discover novel circulating mirnas as biomarkers for parkinson's disease. as the deep phenotype characterization of the study sample, the project expects to find new associations of identified mirnas with disease-related parameters and define the role of mirnas in the physiological pathways in which those parameters are involved and in the etiology of pd. also, the understanding of the genetics of the disease will open avenues for novel therapeutic strategies.

Eligibility criteria:
inclusion criteria for cases: * presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to l-dopa (levodopa) exclusion criteria for cases: * previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on ct or mri, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders. exclusion criteria for controls: personal or family history for neurodegenerative diseases
immediate load of dental implants, placed in atrophic upper and/or lower jaw of partial or complete edentate patients, according to flapless technique

Conditions: Dental Implants

Summary: this study will evaluate the placement of implants with minimal invasive techniques. immediately after the placement of the implants, functional loaded synthetic teeth will be placed.


Eligibility criteria:
inclusion criteria: * 18 years of age or older
biting force in heat cured acrylic resin versus cad/cam maxillary single denture bases

Conditions: Bites, Human

Summary: measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.

measuring difference in biting force using i-load device with followup period of 6 months

Eligibility criteria:
inclusion criteria: 1. patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge. 2. mean age of 50-75 years of age. 3. the edentulous ridges should be covered by firm healthy mucosa. 4. systemically free; no history of diabetes, chemotherapy, and radiotherapy. 5. co-operative patients. exclusion criteria: 1. patients with severely resorbed maxillary ridge 2. previous history of radiotherapy or chemotherapy. 3. patients with xerostomia 4. patients with neuromuscular and hormonal disorders 5. patients with severe bony or soft tissue undercuts 6. patients with large tongue 7. patients with limited mouth opening 8. patients with known history of allergy, especially to acrylic resin