Kornimate/medical-research-clean huggingface dataset:
assessment of the risk of inhibitor formation in previously treated patients with severe hemophilia a

Conditions: Hemophilia A

Summary: most transient inhibitor formation, if any, will develop within the first 4 weeks. the study is to further monitor whether participants with severe hemophilia a will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from chinese hamster ovary (cho) cell line to kogenate-fs raised in a baby hamster kidney cell line.


Eligibility criteria:
inclusion criteria: * subjects with severe hemophilia a (\< 2% fviii:c) * subjects with no history of fviii inhibitor antibody formation * subjects with no measurable inhibitor activity * subjects with at least 200 eds with fviii concentrate in total, including 20 eds in the previous 6 months * subjects whose current treatment with any cho rfviii product * subjects with no elective surgery and/or continuous infusion fviii administration is foreseen during the study * subjects with normal prothrombin time (pt), partial thromboplastin time (ptt) compatible with fviii deficiency exclusion criteria: * subjects with any other bleeding disease beside hemophilia a (i,e., von willebrand's disease) * subjects who have known intolerance or allergic reactions to constituents of rfviii-fs or known hypersensitivity to mouse or hamster proteins * any individual with a past history of severe reaction(s) to fviii concentrates * subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry * subjects who were receiving or had received other experimental drugs within 3 months prior to study entry * subjects who require any medication for fviii infusions

Keywords: hemophilia a, inhibitor formation, rfviii
the mec90 of epidural ropivacaine blunting hemodynamic changes to pneumoperitoneum

Conditions: Laparoscopic Gastrectomy

Summary: investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.

according to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during co2 insufflation. and, for this allocation of concentration of ropivacaine, the investigators use biased coin design up-and-down method. based on the practices, the starting concentration is 0.375 %, and the step size of concentration is 0.125%.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic gastrectomy that require pneumoperitoneum * patients who has epidural catheter to manage postoperative pain control * patients who agree to our study exclusion criteria: * patients who don't agree to our study * bmi\ 35 * cardiovascular disease, pulmonary disease, renal disease * alcoholic abuser or drug abuser * any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction
computerised decision-support tool for childhood obesity management

Conditions: Childhood Obesity

Summary: the objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management.

the objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management. the effectiveness of the decision support tool was assessed through a pilot randomized controlled intervention trial (rct). the rct was initiated on may 2018 and was conducted in the endocrinology department of the "p. a. kyriakou" children's hospital and in the division of endocrinology, metabolism, and diabetes of the "aghia sophia" children's hospital in athens, greece. sixty-five overweight or obese children that were eligible to participate in the rct, were randomly and equally allocated to two study groups. those children that were randomly allocated to the intervention group (ig), were examined by health professionals (i.e. paediatricians, paediatric endocrinologists and a dietitian) who were trained in the use of the decision support tool. the latter assisted the medical professionals to assess children's weight status, to set appropriate weight management goals and provide personalised meal plans and/or recommendations to children and their families. on the contrary, those children that were randomly allocated to the control group (cg) received the usual care advice that is routinely provided to children in the two hospitals and includes child visits and follow-up appointments for weight checks with their primary care provider or dietitian. the effectiveness of the intervention was evaluated through the collection of data at baseline and at a follow-up examination after 3 months. all data were uploaded to the decision-support tool, which analysed them and extracted a report with the child's assessment, as well as with personalised diet and lifestyle optimization recommendations. more specifically, the decision support tool proposed personalised weekly meal plans adjusted to the estimated energy requirements calculated for each child, as well as personalised diet and lifestyle optimization advice recommendations for the child and/or the entire family. lastly, the decision support tool suggested a periodic re-evaluation every 3 or 6 months depending on the child's current weight status, the presence of obesity-related comorbidity in children and the presence of obesity in at least one or both parents.

Eligibility criteria:
inclusion criteria: * children aged 6-12 years old * overweight status or obesity (i.e. bmi-for-age \> 85th percentile) exclusion criteria: * age range not within the inclusion criteria

Keywords: personalised nutrition intervention children obesity health professionals
a clinical study of tranilast in the treatment of scleredema diabeticorum

Conditions: Scleredema Adultorum

Summary: 56 patients with scleredema diabeticorum will be selected to receive treatment of tranilast. after a period of time ,we can determine the efficacy of the drug by detecting the the thickness of skin before and after treatment.

56 patients with scleredema diabeticorum will be selected. after the signing of the informed consent ,they will be collected the initial lesions photos,the thickness of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function.during tranilast (0.1g each time, three times a day,6 months) treatment, patients need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness.with 3 month as a time point, they were observed for two points.after the experiment, the experimental data will be arranged and the data of the thickness change of skin lesions will be statistically processed (t test) to determine whether it is meaningful.

Eligibility criteria:
inclusion criteria: * (1)clinical and histopathological examination has been proved to be scleredema diabeticorum; (2)ultrasound and magnetic resonance detection found that the thickest skin of the back was more than 5mm. exclusion criteria: * (1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)poor blood sugar control; (3)with mental disease.

Keywords: scleredema diabeticorum tranilast
cardiac effects from radiation therapy by mri

Conditions: Radiation Treatment; Cancer; Cardiotoxicity

Summary: the investigators will identify 10 patients in the department of radiation oncology who will receive standard of-care radiation therapy, and the treating radiation oncologist anticipates a mean left ventricular dose of at least 5 gy. patients will be evaluated by cmri before and within one week of the completion of rt. we will compare the pre- and post-rt cmri scans to identify changes related to radiation exposure. our primary endpoint will be changes in myocardial strain. secondary endpoints will include other cmri parameters.

cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after radiation therapy (rt) to the chest. typically, cardiotoxicity is identified years after radiation exposure. emerging clinical data show that subclinical injury can be identified immediately after treatment. early identification of subclinical injury may enable intervention to reduce the risk of progression to clinically significant toxicity. the investigators hypothesize that cardiac magnetic resonance imaging (cmri) will detect early cardiac injury after rt and that imaging changes will be associated regionally with cardiac radiation dose.

Eligibility criteria:
inclusion criteria: 1. provision to sign and date the consent form. 2. stated willingness to comply with all study procedures and be available for the duration of the study. 3. 18 - 100 years of age 4. kps ≥ 70 or ecog ≥ 1 5. will receive rt using computed tomography (ct)-based treatment planning that will involve delivery of dose to the heart 6. estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 gy exclusion criteria: 1. previous history of rt to the thorax or breast 2. implanted device that is non-mri compatible or any implanted device in chest 3. known gadolinium contrast allergy or other contraindication to cmri scan. patients needing sedation or medication for claustrophobia or anxiety will not be excluded from participating. 4. found to be pregnant or breast-feeding 5. known history of atrial fibrillation or frequent ventricular or atrial premature beats 6. known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate \< 60ml/min) 7. history of coronary artery disease or myocardial disease 8. history of hypertension, requiring \>1 antihypertensive agent to maintain blood pressure \<140/90 9. known history of valvular stenosis or regurgitation of \> moderate severity 10. known history of heart failure (defined as baseline new york heart association class iii or iv (see appendix a) 11. systolic blood pressure \< 90mmgy 12. pulse \< 50/minute 13. known history of pulmonary hypertension or elevated right ventricular systolic pressures. 14. suspicion or diagnosis of amyloidosis 15. suspicion or diagnosis of hemochromatosis
clavipectoral fascial plane block versus superficial cervical block in fracture clavicle

Conditions: Fracture Clavicle

Summary: ultrasound-guided clavipectoral fascial plane block versus ultrasound-guided superficial cervical plexus block in patients undergoing fracture clavicle operation

the clavipectoral fascial plane block (cpb) is a novel regional anesthesia technique that has been utilized for clavicular fracture surgery. it has been hypothesized that the cpb is an effective regional anesthesia technique for peri-operative analgesia since the terminal branches of many of the sensory nerves like suprascapular, subclavian, lateral pectoral, and long thoracic nerves pass through the plane between the clavipectoral fascia and the clavicle itself. the ultrasound-guided superficial cervical plexus (scp) block may be useful for providers in emergency care settings who care for patients with ear, neck, and clavicular region injuries, including clavicle fractures and acromioclavicular dislocations. the scp originates from the anterior rami of the c1-c4 spinal nerves and gives rise to 4 terminal branches (greater auricular, lesser occipital, transverse cervical, and suprascapular nerves) that provide sensory innervation to the skin and superficial structures of the anterolateral neck and sections of the ear and shoulder.

Eligibility criteria:
inclusion criteria: 1. age from 21 to 60 years 2. both gender 3. isolated fracture clavicle. 4. asa classification 1 \& 2 exclusion criteria: 1. polytrauma patients with multiple fractures. 2. hemodynamically unstable patients. 3. patients with infection at the injection site. 4. refusal of patients. 5. patients with disturbed anatomical plane. 6. patients with a known history of allergy to local anesthetic will be used.

Keywords: fracture clavicle clavipectoral block superficial cervical block
durability of weight loss after bariatric surgery

Conditions: Obesity

Summary: the present study is a retrospective cohort study. patients older than 18 years of age and underwent roux-en-y gastric bypass (rygb) surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. patients having bmi (body mass index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. the primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one and the clinical events after surgery.

this is a retrospective cohort study. the sample size of our study includes one hundred case older than 18 years of age and underwent rygb surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. patients having bmi (body mass index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment, died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. data was collected taking in to account each patient history (age, sex, length, weight, bmi, occupation, marital status, and comorbidities) and weight record in every visit from measurements statistics. outcomes: the primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one. the secondary effects including the clinical events after surgery, micronutrient levels, incidence of diabetes, hypertension, and dyslipidemia.

Eligibility criteria:
inclusion criteria: * patients equal or over 18 years old * bmi more than 40 * complete follow up exclusion criteria: * no complete follow up * age less than 18 or more than 80

Keywords: bariateric surgery durability
effect of surgical therapy on rankl/opg (osteoprotegerin) system

Conditions: Chronic Periodontitis; Aggressive Periodontitis; RANKL/OPG Ratio; Gingival Crevicular Fluid

Summary: in the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the rankl, osteoprotegrin (opg), interleukin-1 (il-1β), il-10, il-1β levels in gingival crevicular fluid(gcf) before and after surgical periodontal treatment and search out the relationship of clinical parameters with these cytokine levels.


Eligibility criteria:
inclusion criteria: * chronic periodontitis having at least 5mm or more probing depth and aggressive periodontitis patients. exclusion criteria: * any known systemic disorder, used antibiotics and/or anti-inflammatory medications, had periodontal treatment in the last 3 months and all of them were non smokers. subjects who were lactating and pregnant were also excluded.

Keywords: chronic periodontitis, aggressive periodontitis, rankl/opg ratio, gingival crevicular fluid
18f fdg and 68ga fapi pet/mr imaging of carotid artery plaque vulnerability: a clinical study in carotid artery plaque patients

Conditions: Carotid Artery Plaque; Ischemic Stroke; PET / MR

Summary: carotid atherosclerotic plaque rupture is the main cause of ischemic stroke attacks, and early and precise assessment of plaque vulnerability can prevent ischemic stroke. high-resolution mri can reflect vulnerable plaque features such as thin fibrous caps and large lipid cores, but cannot assess their metabolic information; fibro-activated proteins (faps) of pet are specifically expressed in atherosclerosis and suggest vulnerable plaques by reflecting inflammation-induced fibrosis. the aim of this study was to apply 18f fdg\&68ga-fapi pet/mr imaging to investigate the vulnerability of carotid atherosclerotic plaques, to obtain quantitative evaluation indexes of active fibrosis within carotid plaques, and to clarify the pet/mr characteristics of unstable plaques in carotid arteries


Eligibility criteria:
inclusion criteria: -age between 18 and 80 years; presence of carotid atherosclerotic plaque confirmed by ultrasound within the past two weeks, with carotid intima-media thickness (imt) ≥ 2 mm (imt ≥ 1.2 mm is defined as carotid atherosclerosis) or carotid artery stenosis ≥ 50% as indicated by cta. exclusion criteria: * absolute or relative contraindications related to pet/mr imaging safety (e.g., metallic implants, mri phobia, etc.); patients who have undergone carotid endarterectomy (cea) or carotid artery stenting (cas); pregnant or lactating women; presence of other vascular diseases, such as vasculitis, moyamoya disease, arterial dissection, etc.; severe agitation or inability to cooperate with imaging procedures.
managed problem solving to increase treatment adherence in individuals with hiv

Conditions: HIV Infections

Summary: this study will determine whether a managed problem solving intervention can help patients with hiv better follow their anti-hiv drug regimen and can control hiv better than the standard of care.

haart is considered to be the most effective treatment for hiv. however, sustained and consistent adherence to haart is necessary for long-term success. issues such as memory problems, lack of social support, medication side effects, depression, and substance abuse can significantly reduce patient adherence to haart. this study will evaluate the effectiveness of a managed problem solving strategy to increase haart adherence in patients with hiv. both treatment-naive and treatment-experienced participants will be recruited for this study. the treatment part of this study will last 12 months. participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months. participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study, and 1 phone call every month for the following 9 months. at each study visit, participants will identify barriers to adherence. during the phone calls, participants will be asked about any steps they have taken to improve their adherence. a medication event monitoring system (mems) will be used to assess participants' treatment adherence. mems uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. blood collection at the beginning and end of the study will be used to measure viral load and cd4 count. follow-up phone interviews will be conducted every year for 3 years after the end of treatment. study hypothesis: managed problem solving will result in better adherence to highly active antiretroviral therapy (haart) and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care.

Eligibility criteria:
inclusion criteria for all participants: * hiv infected * infection likely to be susceptible to a specific treatment regimen * have access to a telephone * willing and able to comply with all study requirements exclusion criteria for all participants: * live in a care facility that provides medications on schedule inclusion criteria for treatment-experienced participants: * restarting haart after a treatment interruption of at least 3 months or after virologic failure with a viral load greater than 1,000 copies/ml * on a treatment regimen for less than 2 weeks prior to study entry

Keywords: hiv aids problem solving antiretroviral therapy, highly active patient compliance
endomina diverticulum

Conditions: Oesophageal Disease

Summary: esophageal diverticulum is a rare disease. majority comes form the pharyngo-esophageal junction (70 % zenker's diverticulum), 10% are mediothoracic and 20% epiphrenic. zenker's diverticulum is well treated with endoscopy (efficacy around 80%, complications around 5%) (1). for medio or epihrenic diverticulum, the classic treatment is surgery (diverticulectomy with or without anti-reflux surgery) but is associated with 33% morbidity and 9% mortality (2). recently another technique involving magnet was described (3). five patients were treated with success. considering the surgical risk, other techniques need to be evaluated. using the endomina device, sutures can be apposed between the foot of the diverticulum and the esophageal lumen. if necessary the bridge between the diverticulum and the esophagus can be cut with needle knife as described in zenker's diverticulum treatment.


Eligibility criteria:
inclusion criteria: 1. symptomatic medio or epiphrenic diverticulum. 2. age between 18-80 years; 3. must be able to comply with all study requirements for the duration of the study as outlined in the protocol. this includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations; 4. must be able to understand and be willing to provide written informed consent; 5. must live within 75 km of the treatment site; exclusion criteria: 1. achalasia and any other esophageal motility disorders. 2. severe esophagitis 3. gastro-duodenal ulcer 4. severe renal, hepatic, pulmonary disease or cancer; 5. gi stenosis or obstruction; 6. pregnancy, breastfeeding or willing to become pregnant in the coming 18 months; 7. anticoagulant therapy; 8. currently participating in other study

Keywords: endoscopy mini invasive
a study of galcanezumab in participants with episodic cluster headache

Conditions: Episodic Cluster Headache

Summary: the main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic cluster headaches.


Eligibility criteria:
inclusion criteria: * have a diagnosis of cluster headache as defined by international headache society (ihs) international classification of headache disorders (ichd)-3 beta guidelines with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of \>=1 month. * participants are able to distinguish cluster headache attacks from other headaches. exclusion criteria: * current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device. * current use or any prior exposure to any calcitonin-gene-related peptide (cgrp) antibody, any antibody to the cgrp receptor, or antibody to nerve growth factor (ngf). * are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia. * a history of migraine variants that could implicate or could be confused with ischemia. * known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins. * a history or presence of other medical illness that indicates a medical problem that would preclude study participation. * evidence of significant active or unstable psychiatric disease, in the opinion of the investigator. * women who are pregnant or nursing.