Kornimate/medical-research-clean huggingface dataset:
impact of antiphospholipid antibodies on thrombin generation during sars-cov2 infection (tacit2 study)

Conditions: Antiphospholipid Syndrome; COVID-19

Summary: context: until 70% of thrombotic event are reported during sars-cov2 infection. antiphospholipid antibodies (apl) tests are often positive. we aim to determine if apl positivity is involved in thrombose of sars-cov2 infection investigating the effect of apl on thrombin generation (tg) and leucocyte pathway activation (neutrophils extracellular traps (nets) and activation of triggering receptor expressed on myeloid cells 1 (trem-1)). method: we will compare plasma from five groups of subjects: patients with antiphospholipid syndrome (aps) and patients hospitalized for sars-cov-2 infection with or without apl, and as control, patients with acute venous thromboembolism event and healthy volunteers. for each subject, we will analyze apl, activated protein c (apc) resistance measured by tg and leukocytes markers as circulating neutrophils extracellular traps (nets) and soluble triggering receptor expressed on myeloid cells one (strem-1). we will control apl test at three month and analyze their persistent positivity and association with thrombotic event. results: we hypothesize that patients with covid-19 and apl will have a similar apl and level of aps resistance that patients with aps. also, we think that circulating nets and strem-1 levels will be more important in patients with covid-19 with apl than patients without apl and similar in patients with covid-19 and apl and patients with aps. conclusion: our study will be the first to analyze the potential role of apl on apc resistance measured by tg and neutrophil activation in covid-19.


Eligibility criteria:
inclusion criteria: * patient receiving a comprehensive information about the study, and not opposed to participate + one criterion among : * patient hospitalized fo a covid-19 * patient with known aps * patients hospitalized for an acute venous thromboembolism event apl positivity or covid-19 * healthy volunteers exclusion criteria: * for all participants : pregnancy, age below 18 years-old, absence of written informed consent , autoimmune or inflammatory disease except antiphospholipid syndrome * for patients with covid-19: previous apl positivity (before covid-19 infection) * for patients with aps: previous symptomatic covid-19 infection * for patients control with acute venous thromboembolism event: previous symptomatic covid-19 infection, infection or inflammatory disease in flare at the time of thromboembolism event, known apl positivity * for healthy volunteers: history of thrombosis (venous, arterial or small vessels), previous symptomatic covid-19 infection, infection or inflammatory disease in flare at the time of inclusion, known apl positivity
a multi-level trauma-informed approach to increase hiv pre-exposure prophylaxis initiation among black women

Conditions: HIV Prevention; PrEP; Women; Intimate Partner Violence (IPV)

Summary: u.s. epidemiological data indicates that black women are a high-risk hiv disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (prep) among this group is stagnant. socio-structural challenges like intimate partner violence and gendered racism can constrain prep access among black women, but few implementation studies have mitigated these challenges to improve prep initiation. the proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase prep initiation among black women with and without intimate partner violence in baltimore.


Eligibility criteria:
inclusion criteria: * self-identified black cisgender woman; * self-reported hiv-negative status, and * ≥18 years. * reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner, * have at least one substantial hiv risk factor in the past 6 months according to the 2021 centers for disease control (cdc) prep eligibility guidelines (i.e., hiv-positive sexual partner, recent bacterial sexually transmitted disease (std), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high hiv prevalence area or network), and * never taken prep exclusion criteria: * non-english speaking and * currently living with hiv
psychology of minimally invasive surgical scars

Conditions: Obesity

Summary: the purpose of this study is to examine the psychological and psychosocial impact of surgical scars after minimally invasive surgery (mis). 100 adult patients who are about to undergo bariatric procedures through the duke metabolic \& weight loss surgery program will be enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic surgery and 50 will be assigned to the percutaneous group. all patients will complete pre-operative psychometric testing to establish a baseline body-image score as well as a patient's initial subjective perceptions around surgery and surgical scars. follow-up visits will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after surgery. subjects will complete the same psychometric measures to identify differences in psychological and psychosocial responses to standard laparoscopic and percutaneous scars. patients will also complete a measure on scar satisfaction. the investigators hope to identify any differences between standard laparoscopic versus percutaneous approaches.


Eligibility criteria:
inclusion criteria: * body mass index 35 to 45 * undergoing bariatric surgery exclusion criteria: * body mass index \ 45 * previous bariatric surgery

Keywords: bariatric standard laparoscopic surgery minimally invasive scars psychology
antisense oligonucleotide for spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: this is a longitudinal, multiple-center, observational study of patients genetically confirmed chromosome 5q sma to monitor the efficacy, safety, tolerability of spinraza® (nusinersen) for up to 24 months.

spinraza® (nusinersen) is an antisense oligonucleotide (aso) designed to treat sma caused by mutations in chromosome 5q that lead to smn protein deficiency. nusinersen, approved by the fda for treatment of sma in 2016, was approved by the chinese national medical products administration in 2019. this is a prospective, longitudinal, multi-center, observational study designed to evaluate the efficacy, safety, tolerability and of nusinersen in patients genetically confirmed chromosome 5q sma in china. subjects with sma i/ii/iii who are planning to initiate treatment with nusinersen will be enrolled in this study. all patients will be treated by their physicians according to standard clinical practice. spinraza® (nusinersen) is administered as an intrathecal injection. a total of 5ml of cerebrospinal fluid (csf) will be removed prior to administration of spinraza® (nusinersen), which will be collected by the study. neurofilament light chain (nfl) in csf and blood will be assessed for the efficacy of nusinersen, as well as motor and pulmonary function. there will be a total of nine visits. all the patients with 5q sma receiving nusinersen will be visited face to face at baseline, day 14, day 28 and day 63 after treatment initiation, and then 4-month intervals through month 24/22.

Eligibility criteria:
inclusion criteria: * patients genetically confirmed 5q sma including types i, ii and iii, who are planning to initiate treatment with spinraza® (nusinersen) as part of their clinical care plan. * non-5q sma patients undergoing clinical standard lumbar puncture * non-sma subjects including asymptomatic carriers of sma, relatives of sma patients and carriers, and patients undergoing clinical standard lumbar puncture * participants or parent(s)/legal guardian(s) willing and able to complete the informed consent process exclusion criteria: * contraindication for lumbar puncture * inability to access intrathecal space for nusinersen injection

Keywords: spinal muscular atrophy antisense oligonucleotide neurofilament light chain
accuracy of teledentistry for diagnosis and treatment need in dental caries detection versus clinical examination on a group of egyptian children: a diagnostic accuracy study

Conditions: Teledentistry

Summary: the aim of this study is to assess the accuracy of teledentistry for diagnosis and treatment need in dental caries detection versus clinical examination on a group of egyptian children.

the objective of this study is to assess the precision of using the mobile photographic method of teledentistry for dental caries diagnosis and treatment need of pediatric egyptian children. this will be assessed by measuring the diagnostic accuracy of the mobile photographic method versus direct clinical oral examination for the same group of participants.

Eligibility criteria:
inclusion criteria: * egyptian pediatric patients aged 4 to 12 years with a chief complaint of dental caries with or without pain. * both genders are included. exclusion criteria: * egyptian pediatric patients with systemic conditions that will affect their treatment needs. * refusal of participation. * refusal to sign the informed consent.

Keywords: teledentistry in diagnosis and treatment planning teledentistry
safety and tolerability study of cerdulatinib gel, 0.37% in adults with vitiligo

Conditions: Vitiligo

Summary: this is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo


Eligibility criteria:
inclusion criteria: * male and female subjects age 18 and older with a confirmed clinical diagnosis of vitiligo for at least 3 months, including ≥0.5% to ≤30% bsa involvement. * females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study * capable of giving informed consent exclusion criteria: * diagnosis of segmental vitiligo * subjects with concurrent conditions or history of other diseases (e.g., current or chronic history of liver disease) that could affect the safety of the subject or the implementation of this study * use of any prohibited medication within the indicated period before the first dose of study drug * pregnant or lactating females * ultraviolet (uv) light therapy or prolonged exposure to natural or artificial sources of uv radiation within 8 weeks prior to the baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's vitiligo * the subject has received an investigational product within the following time period prior to the first dosing day: 4 weeks or 5 half-lives (whichever is longer). * evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (cv) system abnormalities or laboratory test value abnormality that will affect the health of the subject or interfere with interpretation of the results * history of sensitivity to the study drug, or components thereof or a history of drug or other allergy that contraindicates the subject's participation in the study;
light therapy and binge eating disorder treatment (bed light study)

Conditions: Binge-Eating Disorder

Summary: binge eating disorder (bed) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. its pathophysiology remains poorly understood and the investigators have few therapeutic options. following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of bed by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. the study is prospective, interventional, randomized, double-blind, monocentric (hcl). 52 patients with bed will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (\<500 lux). treatment will be delver every day during 30 days. assessments will take place on d0, d30 and d60. the main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (stroop, go / no go, sst, bart, prospective time estimation task, switching task), liking / wanted for different food categories and carbohydrate metabolism (crp, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-oh vitamin d3).


Eligibility criteria:
inclusion criteria: * aged between 18 and 55 years old * binge eating disorders or other eating disorders according to dsm v criteria * patient with bes score (with " bing eating scale " ) \> 18 * patient with bmi \> 18.5 kg/m2 * patient who agrees to be included in the study and who signs the informed consent form * patient affiliated to a healthcare insurance plan exclusion criteria: * patients with other psychiatric comorbidities, including a disorder bipolar mood * unstabilized diabetic patient with or retinopathy * patient with sleep disorder (delay or phase inversion) * patient with psychotropic treatment unstabilized (except anxiolytic treatment) * recent eye surgery or eye problem preventing exposure to bright light. * medication making the skin more sensitive to light (eg. tablets against malaria) * patient who does not understand french/is unable to give consent * mentally unbalanced patients, under supervision or guardianship * patient already included in a research study * pregnancy or desire to be pregnant during the study
brain genomics superstruct project

Conditions: Autism Spectrum Disorders

Summary: the purpose of this study is to explore the effects of genes and genetic variation on brain structure and function. investigators at harvard plan to explore the relationship between candidate genes that affect cognitive performance and brain structure/function. since brain phenotypes reflect more proximal sequelae of gene activity, neuroimaging measures may show greater sensitivity than cognitive performance to measure gene effects.


Eligibility criteria:
inclusion criteria: 1. 13 years or older 2. subject must have a current dsm-iv diagnosis of high functioning asd, based on past evaluations at the bressler clinic. 3. subjects must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. 4. each subject must understand the nature of the study. the subject must sign an irb approved informed consent. exclusion criteria: 1. iq \< 70 bassed on evaluation in the bressler clinic. 2. contraindication to mri including presence of metal or surgical devices (plates, implants, braces or other items). 3. neuropsychiatric conditions (such as dementia) which sufficiently impair cognition such that a surrogate consent would be required. 4. neurological disorders associated with gross brain pathology (other than atrophy), e.g., stroke, tumors, or demyelinating diseases. 5. pregnancy.

Keywords: autism spectrum disorders brain imaging genetics
calcium dobesilate versus cabergoline for prevention of ovarian hyperstimulation syndrome

Conditions: Infertility

Summary: the purpose of this study is to compare the effect of oral calcium dobesilate to oral cabergoline in the prevention of ovarian hyperstimulation syndrome (ohss) in high-risk women underwent intracytoplasmic sperm injection (icsi).

two hundred and twenty women at risk of ovarian hyperstimulation syndrome during icsi cycles will be randomly scheduled into two equal groups. in group a, (calcium dobesilate group), 1 cap / 8 hs doxium ( 500mg) will be given at day of hcg injection and for 21 days; while in group b (cabergoline group), 1 tab/day cabergoline( 0.5 mg) will be given at day of hcg injection and for 8 days.

Eligibility criteria:
patients enrolled in the study were infertile women undergoing icsi with one of the following criteria: previous episodes of ohss, polycystic ovaries (i.e., \> 24 antral follicles present on baseline ultrasound examination), high amh (\> 3.0 ng/ml), large number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high s.e2 at hcg trigger (e2 \>3000 pg/ml or rapidly rising s.e2), presence of \> 20 follicles by ultrasound on day of retrieval or large number of oocytes retrieved (\> 20). exclusion criteria: * none

Keywords: infertility icsi ohss calcium dobesilate cabergoline
evaluation of the safety and performance of the ness l300 plus system

Conditions: Foot Drop; Thigh Muscles Weakness (Hamstrings or Quadriceps); Upper Motor Neuron Injury or Disease

Summary: the study is designed to evaluate the safety and efficacy of using the l300 plus as a neuroprosthesis device for walking in patients following an umn injury or disease. the clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study.

this is a prospective, one-center, single group, repeated measures, non inferiority study. forty-five (45) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease will be evaluated for this study. each subject will be in the study for six weeks. clinical benefits will be measured through an assessment of the gait performance. in particular it will test the hypothesis that the ness l300 plus system which involves foot drop correction with thigh muscles activation, may achieve walking enhancements not inferior to those gained from using a system that only corrects foot drop (i.e. ness l300).

Eligibility criteria:
inclusion criteria: * upper motor neuron lesion * thigh muscle weakness - hamstrings or quadriceps strength of less than 4/5 according to manual muscle testing * foot drop - toe drag during walking * lower limb spasticity - 0-4 according to the modified ashworth scale * responsible mental state, able to follow multiple step directions * between 18 and 80 years old * available for participation in the study * able to understand and sign the informed consent form * able to walk independently or with an assistance device (e.g. cane, walker etc.) / spot guarding for at least 10 meters * sufficient response to electrical stimulation (visible muscle contractions in a seated or prone position of each designated muscle separately) exclusion criteria: * subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant * cancerous lesion of lower limb, present or suspected * medical condition that prevents participation or would likely lead to inability to comply with the protocol \[e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc\] * severe cognitive impairment (mmse\<21) * severe neglect (star cancellation test\<30) * skin lesion at the site of the stimulation electrodes * change in bone-joint structures of the lower limb, such as contractures or deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation * pregnancy * diagnosis of major depression or psychotic disorder * participation in another investigation that may directly or indirectly affect the study results * unable to tolerate electrical stimulation

Keywords: foot drop thigh muscle weakness upper motor neuron injury or disease
mesh suture for internal load bearing closures

Conditions: Suture; Complications, Mechanical; Suture; Complications, Infection or Inflammation; Suture, Complication

Summary: determine whether mesh suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. mesh suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs

sutures are flexible linear elements that appose tissues and are "self-holding" with a surgically created knot. when tissues are under tension, such as the closure of an abdominal wall after laparotomy, the sutures cut through the tissues in what is known as "suture pull-through" and create incisional hernias. the hernia rate after primary laparotomy depends on the patient population, but is over 10%. in some high-risk populations, even with a small 3 cm laparoscopy incision, the hernia rate is over 30%. in primary hernia repair, use of sutures alone yields a 60% hernia recurrence rate at 10 years. mesh has become commonplace in order to decrease incisional hernia recurrence rates in primary hernia repairs. a novel mesh suture, designed at northwestern university (chicago, il) by dr. gregory dumanian, has shown improved outcomes in pre-clinical animal models and these results are included at the end of this document. dr. dumanian has employed the concept of using a mesh-like suture already in his clinical practice. he has cut strips from an fda-approved piece of hernia mesh, and used them as sutures, tying them with knots. based on improved outcomes in pre-clinical and analogous clinical data in comparison to standard suture, dr. dumanian now proposes the use of a medical grade mesh suture of his design and fabrication in the load bearing internal tissue approximations. these are internal permanent sutures and will not be removed. they are made of the identical material (polypropylene) used in standard sutures. mesh sutures are larger than standard sutures and they automatically flatten to help resist suture pull-through. tissue ingrowth around the filaments and into the suture improves their hold.

Eligibility criteria:
inclusion criteria: * deep orthopedic soft tissue approximation exclusion criteria: * pregnancy * age less than 1 year old * repair of skin or other epithelial surfaces * poor subcutaneous tissues * ongoing infection

Keywords: suture suture pull-through suture sinus
epidemiology of helicobacter pylori infection among shanghai children

Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Summary: epidemiology of helicobacter pylori infection among shanghai children.

to get an understanding of the hp infection general situation and provide evidence for hp control, we are planning to run a free physical examination and lab test for a group of children. we are going to proceed with hp-igg test, 13c urea breath test and salivary hp urea antigen test together to screening and diagnosing it.

Eligibility criteria:
inclusion criteria: * age 3\~18 * not been clinical diagnosis of exclusion criteria: * had antibiotics in the past week * had bismuth or ppi