Kornimate/medical-research-clean huggingface dataset:
the world federation of hemophilia gene therapy registry

Conditions: Hemophilia

Summary: the aim of the wfh gtr is to provide a database in which long-term data on pwh who receive gene therapy from around the world, will be collected and housed.

the first gene therapy product for hemophilia is expected to receive marketing authorization in 2020, with several others following closely behind. with these new therapies hitting the market in the near future, it is incumbent on us as a community to ensure that we have measures in place to allow monitoring of expected, unexpected and unknown safety issues, as well as duration of efficacy, over the long term. low incidence adverse events require monitoring of a large number of patients, over a long period of time, necessitating a global initiative. to fill this need, the world federation of hemophilia (wfh), under the guidance of a multi-stakeholder steering committee, is developing and implementation the wfh gene therapy registry (gtr). the aim of the wfh gtr is to provide a database in which long-term data on pwh who receive gene therapy from around the world, will be collected and housed. the wfh gtr steering committee is made up of hematologists, clinical trialists, methodologists, epidemiologists, manufacturers and patient advocates. all stakeholders have a role in ensuring the success of this important initiative. the wfh gtr will collect a core set of demographic, safety and efficacy data, on all patients with hemophilia, who receive a gene therapy product via a clinical trial or post-marketing, from anywhere in the world. the core data set is currently in development; and the global implementation plan is being finalized. a database provider will be selected in q1 2020, based on a request for proposals which was issued to several database providers. the database for the wfh gtr will begin development in q2 2020, with the aim of having a final database ready for launch in by end of 2020, when the first gene therapy product is available to patients. at this time, we will also begin recruitment of patients who have received gene therapy through a clinical trial. patients will be recruited through hemophilia treatment centers (htc) who provide gene therapy to patients with hemophilia. investigators will recruit patients into the wfh gtr and enter baseline and follow up data over the long term. there is no determined end date for this registry. for countries who have an existing national registry, we offer the possibility of linking databases directly.

Eligibility criteria:
inclusion criteria: * people with hemophilia who have received a gene therapy product exclusion criteria: * none

Keywords: gene therapy
compare the efficacy and safety of raltegravir versus efavirenz combination therapy in treatment-naïve hiv-1 patients

Conditions: HIV-1 Infection

Summary: a pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with hiv-1 infection.

a single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(nrtis) backbone combination therapy in treatment-naïve patients with hiv-1 infection.

Eligibility criteria:
inclusion criteria: * patients who are infected with hiv-1 * patients have not yet received any treatment for hiv * patients with hiv viral rna exceeds 5000 copies per ml * ages at least 20 years exclusion criteria: * patients with acute or decompensated chronic hepatitis * patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range * patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range * patients with any medical disorder that the use of study medications is contraindicated * pregnant or breastfeeding women * patients who are lack of expectation to maintain assigned study medication during study period * patients who have received therapy with investigational drugs in the previous 3 months

Keywords: efavirenz raltegravir combination antiretroviral therapy
comparison between clavipectoral fascia block & interscalene brachial plexus block as regard adequacy of anesthesia in clavicle surgeries

Conditions: Clavicle Fracture

Summary: a newer technique called clavipectoral fascial plane block (cpb), introduced by valdés-vilches in 2017, involves injecting local anesthetic under ultrasound guidance between the clavipectoral fascia and periosteum at the injury site. this method offers a promising alternative for effective regional anesthesia in clavicular fracture surgeries. this study is aim to comparison between use of ultrasound guided clavipectroal fascia block ( cpb ) \& interscalene brachial plexus block ( isbp ) as regard adeqacy of anesthesia in clavicle fracture

clavicle fractures represent 2.6% of all fractures and are commonly seen in emergency and surgical settings, particularly among young men due to sports or traffic incidents, predominantly affecting the mid-clavicle. surgical intervention often yields better functional outcomes compared to conservative treatment. while general anesthesia is an option, it carries risks such as nausea, vomiting, and increased costs for patients. in contrast, regional anesthesia can effectively manage pain while minimizing complications associated with general anesthesia. the supraclavicular nerve innervates the skin above the clavicle, but the sensory innervation of the clavicle itself remains debated. a combination of superficial cervical plexus block (scpb) and interscalene brachial plexus block (isbp) is frequently employed during clavicle fracture surgeries. the brachial plexus includes nerves from c5-8 and t1, while the cervical plexus comprises branches from both deep and superficial cervical structures. although this combination can effectively address pain management during surgery, isbp may lead to complications like diaphragmatic paralysis due to phrenic nerve involvement.

Eligibility criteria:
inclusion criteria: * . patients who have isolated clavicle surgery. american society of anesthesiologists (asa) classification i-ii exclusion criteria: * 1.patient with major trauma insult " brain \\ chest \\ abdomen " 2.history of bleeding diathesis 3.patients receiving anticoagulant treatment, 4.patients known local anesthetics and opioid allergy, 5.infection of the skin at the site of the needle puncture, 6.pregnant or lactating females, 7.patients who do not accept the procedure

Keywords: clavipectoral fascia block interscalene brachial plexus block
effect of omacor on triglycerides in hiv infected subjects

Conditions: Hyper-Triglyceridemia

Summary: omacor is likely to decrease lipid parameters in hiv infected subjects. in these subjects the lipid are decrease due to haart treatment


Eligibility criteria:
inclusion criteria: * triglycerides between 200 and 800 * diagnosed hiv infection * following haart therapy exclusion criteria: * other malignant disease * not compliant * allergy against fish oil * soy or olive oil

Keywords: hiv infection
development of a manualized wireless moisture pager intervention for teaching toileting in children with autism

Conditions: Autism; Enuresis; Incontinence

Summary: this pilot study is designed to investigate the feasibility of comparing a standard behavioral intervention and an innovative intervention that incorporates the use of a wireless moisture alarm in training children with autism how to independently use the toilet for urination. we hypothesize that the study protocol will be feasible, as measured through review of achieved recruitment targets, successful randomization, and \>80% retention of subjects with com- plete data collection. our second hypothesis is that therapists will deliver experimental and standard behavioral treatment intervention with ≥80% fidelity and parents in both intervention groups will adhere to the intervention with ≥80% fidelity. a secondary aim of this study is to examine trends in outcome data by conducting a small rct (n = 30) of wireless moisture alarm and standard behavioral toilet training, with the hypothesis that the moisture alarm intervention will result in fewer toileting accidents, a higher rate of toileting success and greater parental satisfaction.


Eligibility criteria:
inclusion criteria: 1. age 3-6 years old 2. asd diagnosis confirmed by licensed professional through administration of the ados or ados-2, depending upon availability of data 3. status consistent with dsm-iv (or dsm-v, depending upon availability) diagnostic criteria for primary daytime enuresis (with exception of criterion that child is at least 5 years old), confirmed by the k- sads 4. a positive determination of readiness for toilet training, as determined through atoileting readiness checklist developed through a review of relevant literature on toilet training with children with autism (with 4 or more of 7 signs in the checklist, with 3 of these criteria required). 5. consent from parent exclusion criteria: 1. medical conditions that would interfere with toilet training procedures (e.g., physical disabilities) 2. physical disorder that may contribute to incontinence (e.g., diabetes, urinary tract infection, or seizures) 3. anticipation of medication changes to occur during the 3-month intervention period 4. medication for enuresis 5. a parent report that the child has urinated into a toilet 2 times or more when toilet trips are initiated by child, and/or 20% or more of the total instances in which a caretaker had initiated a toileting opportunity (to be estimated by study team member during initial conversation. if parent is unsure, they may be asked to monitor toileting behavior for a week, and the team member can call back to review with parent). 6. parent report that the child has participated in systematic training efforts, under the guidance of a clinician (e.g., physician, psychologist) for more than 8 weeks (total) in the previous 6months. 7. active drug or alcohol use or dependence on the part of the parent that, in the opinion of the site investigator, would interfere with adherence to study re- quirements.

Keywords: autism enuresis toilet-training
master study of the biomonitor iii and incision and insertion tool (fit onestep)

Conditions: Tachyarrhythmia; Atrial Fibrillation (AF); Syncope; Cryptogenic Stroke

Summary: this study is a post-market clinical follow-up (pmcf) study to identify and evaluate residual risks associated with the use of the biomonitor iii and biomonitor iiim that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. furthermore, this study will also provide additional data as required by regulatory authorities outside of the ce-region.


Eligibility criteria:
inclusion criteria: * patient is at high risk of developing a clinically important cardiac arrhythmia; or * patient is undergoing investigation for symptoms such as palpitations, pre- syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or * patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or * patient is planned for af ablative procedure or has already undergone an af ablative procedure. * patient is able to understand the nature of the study and able to provide written informed consent. * patient is willing and able to perform all follow-up visits at the investigational site. * patient is willing and able to use the cardiomessenger and accepts the biotronik home monitoring concept. exclusion criteria: * patient is implanted with an icd or pacemaker. * patient is pregnant or breast-feeding. * patient is less than 18 years old. * patient's life-expectancy is less than 12 months. * patient is participating in another interventional clinical investigation.
metabolic characteristics of type 2 diabetes mellitus combined with acute myocardial infarction: a untargeted metabolomics study

Conditions: STEMI

Summary: this study is a retrospective case-control study. in this study, through untargeted metabolomics, investigators identified several specific changed serum metabolites in t2dm patients with or without ami and their functions/category. moreover, researchers selected several endogenous candidate biomarkers with larger fold change for validation in expanded population to find biomarkers which effectively predict the development of stemi in patients with t2dm.


Eligibility criteria:
inclusion criteria: * stemi patients meet the diagnostic criteria of "guidelines for the diagnosis and treatment of acute st-segment elevation myocardial infarction (2015)". * stmei patients undergoing emergency pci should undergo emergency pci within 12 hours of onset at beijing friendship hospital affiliated to capital medical university. * all diabetic patients meet the diagnostic criteria for type 2 diabetes. * they agreed to be enrolled in the trial and signed the informed consent. exclusion criteria: * combined with severe valvular disease or congenital heart disease, hypertension, chronic kidney disease, stroke, hyperlipidemia, previous history of coronary artery disease. * involved in acute infection, severe hepatic dysfunction, tumor, rheumatic immune disease. * incomplete clinical information.

Keywords: stemi metabolomics biomarkers type 2 diabetes mellitus
effectiveness of nefopam in breast cancer surgery

Conditions: Breast Neoplasm Malignant Primary

Summary: breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. the investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.


Eligibility criteria:
inclusion criteria: * total mastectomy * modified radical mastectomy * nipple-sparing mastectomy * american society of anesthesiologists physical status i or ii * postoperative use of intravenous patient-controlled analgesia exclusion criteria: * chronic analgesia medication * pregnancy * lactating women * previous operation history due to breast cancer * cooperation with other surgery * contraindication of nefopam
study evaluating the safety, tolerability, and efficacy of lecozotan sr in outpatients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease * current use of cholinesterase inhibitor * able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study exclusion criteria: * significant neurological disease other than ad * diagnosis of major depression * history of stroke or other heart disease

Keywords: alzheimer's disease cholinesterase inhibitors outpatients
post-bariatric abdominoplasty: skin sensation evaluation

Conditions: Obesity; Hypesthesia

Summary: the purpose of this study is to quantify the skin sensation of the anterior abdominal wall of the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining. additional purposes were: quantify topographically the abdominal skin sensation of the normal weight, morbid obese and former morbid obese after bariatric surgery (before and after the abdominoplasty - excess skin surgical removal without flap undermining -\> anchor line abdominoplasty).

abdominoplasty performed in post-bariatric patients presents more post-operative complications than in non post-bariatric patients. surgical techniques that provokes less complications are required. anchor-line abdominoplasty is a technique published in the years 1950 as well the first bariatric proceedings. abdominoplasty without flap undermining is feasible in pendular abdominal wall of the former morbidly obese women with scarred abdomen. classical abdominoplasty (with flap undermining) is known to impair significantly the skin sensation. post-bariatric abdominoplasty without flap undermining keeps the skin sensation unaltered since the early post-operative period. now that the post-bariatric anchor-line abdominoplasty improves the abdominal wall contour by removing the exceeding, pendular and striated skin saving the perforant skin sensory nerves. could this technique improve the skin sensation of the anterior abdominal wall of the post-bariatric patients?

Eligibility criteria:
inclusion criteria: * former morbidly obese women with body mass index superior of 40kg/m2. * post-bariatric surgery: roux en y gastric bypass. * clinical conditions to perform a plastic surgery. exclusion criteria: * diabetes. * peripheral neuropathy. * deny to sign the informed consent term.

Keywords: bariatric surgery plastic surgery abdominal wall skin sensation abdominoplasty
evaluation of perforator phase contrast angiography in developing surgery plans for patients with breast cancer undergoing breast reconstruction with free-flap methods after mastectomy

Conditions: Mammoplasty Patient

Summary: this phase ii trial studies how well an imaging technique called perforator phase contrast angiography (ppca) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. free flaps are units of tissue transferred from one area of the body to another with an intact blood supply. ppca uses magnetic resonance imaging (mri) to create images of blood vessels inside the body. using ppca may help doctors develop better surgical plans for patients with breast cancer undergoing post-mastectomy reconstruction surgery with free flap methods.

primary objectives: i. to assess the quality of surgical plans prepared under the guidance of the non-contrast, ionizing-radiation-free perforator phase contrast angiography (ppca) against plans based upon the current gold standard, the x-ray-based, contrast-enhanced computed tomographic angiography (cta). secondary objectives: i. to assess whether ppca is more accurate than cta for vessel size measurement. ii. to assess the impact of ppca-based surgical planning on the clinical outcomes of abdominal-based free flap surgery. iii. to obtain and analyze cost/expenditure information for ppca-guided abdominal-based free flap procedures. outline: patients undergo standard of care cta and undergo ppca mri for up to 60 minutes before surgery. after surgery, patients will be followed up at 24 hours, 1 week, 3 months, 1 year and 2 years.

Eligibility criteria:
inclusion criteria: * subject must weigh =\< 350 lbs. * subject must be scheduled to receive uni- or bilateral breast reconstruction using one of the abdominal-based free flap techniques (deep inferior epigastric perforator \[diep\] flap, superficial inferior epigastric artery \[siea\] flap, or free-transverse rectus abdominis musculocutaneous \[tram\] flap) within the next 12 months. * subject must have received, or be scheduled to receive at least one preoperative cta prior to the surgery. * subject must be able to lie in both prone and supine positions for at least 30 minutes. exclusion criteria: * subjects who are determined to be incompatible for mri based on local policy. * subjects with previous history of abdominal-based free flap surgery. * severe anxiety or claustrophobia that would prohibit the required study procedures from being conducted. * any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with the subject?s safety, the informed consent procedure, or compliance to the study protocol, in the opinion of the investigator.
follow up of moderate aortic regurge after mitral valve replacement

Conditions: Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve Replacement

Summary: aim of the study is to follow of of moderate aortic regurge after mitral valve replacement to figure out if the aortic regurge has been improved or it is getting worse

a considerable proportion of patients who require mitral valve replacement present with a coexisting pathology of the aortic valve (av). rheumatic fever remains the leading cause for combined disease (1) early series found that one-third of rheumatic hearts exhibited involvement of both mitral and aortic valve. the rate increased to 99% when the follow-up period was extended to 20 years the treatment of choice in cases in which one of the valves is moderately affected is questionable. because combined aortic and mitral valve replacement is usually associated with higher risk and poorer long-term survival than replacement of either of the two valves alone (2) in patients with moderate aortic regurgitation who undergo mitral valve surgery). according to 2021 esc/eacts guidelines, the decision to treat the aortic valve is controversial, as data show that progression of moderate aortic regurgitation is very slow in patients without aortic dilation (3) in contrast , in 2020 aha guidelines recommended concomitant aortic valve replacement for moderate aortic regurgitation in patients undergoing surgery for ascending aorta, coronary artery bypass grafting (cabg),or mitral valve surgery (4-10) because of this is a point of conflict we aim in this study to evaluate the saftey to leave moderate aortic regurge without intertvention as regarding operative time ,postoperative morbidity and mortality and progression of aortic valve regurge.

Eligibility criteria:
inclusion criteria: * patients underwent mitral valve replacement for rheumatic heart disease and having moderate aortic valve regurge grade 2 in assuit university hospitals exclusion criteria: * non rhumatic heart disease ,severe aortic regurge ,moderately severe aortic regurge ,combined ischmic and valvular heart diseaese