Kornimate/medical-research-clean huggingface dataset:
a comparison of pcle based targeted biopsy and wle based standard biopsy in staging the operative link on gastric intestinal metaplasia (olgim): a randomized，cross-over study

Conditions: Gastric Intestinal Metaplasia; Confocal Laser Endomicroscopy; Operative Link on Gastric Intestinal Metaplasia; Biopsy

Summary: gastric intestinal metaplasia (gim) is an important premalignant lesion for gastric cancer. precisely surveillance of patients with gim may result in early detection and improved prognosis. though important, it is not necessary to recommend surveillance endoscopy for all patients with gim, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.


Eligibility criteria:
inclusion criteria: * patients aged 40 years or older with helicobacter pylori infection; * histologically verified gim, atrophic gastritis or dysplasia. exclusion criteria: * patients with gastrectomy, acute gi bleeding and advanced gastric cancer; * conditions unsuitable for performance of pcle, such as coagulopathy, impaired renal function or allergy to fluorescein sodium; * pregnancy or breastfeeding; * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
post-operative outcomes of low thermal dissection vs. traditional electrosurgery

Conditions: Breast Cancer; Mastectomy; Perfusion; Complications; Hemostasis

Summary: low thermal dissection devices have been introduced as a tool to improve surgical outcomes. plasmablade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection device. thus, low thermal devices would improve flap perfusion by decreasing the thermal injury resulted by the dissection. looking into the use of low thermal devices in cases of mastectomy and immediate breast reconstruction has not been documented. the aim of this study is to determine if there are clinical flap perfusion, surgical site drainage, and pain scores differences between mastectomy flaps created using low thermal dissection device and those done with the standard care of bovie cautery in order to warrant a formal study.

this is a single-blinded, randomized, controlled clinical trial comparing postoperative flap perfusion and surgical site drainage between patients randomized to breast flap creation by plasmablade (low thermal dissection intervention) on one breast and by a bovie cautery (control) for the contralateral breast flap. candidates will have elected to undergo bilateral post-mastectomy immediate breast reconstruction (ibr). participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery. patients and the plastic surgeon will be blinded in regards to intervention randomization. only the oncology surgeon has knowledge of which device used for each breast flap. however, after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order to complete the reconstruction procedure using the same dissection device on the same side it was used for in the mastectomy procedure. patient-specific surgical details will be recorded intraoperatively. following the surgery, post-operative flap perfusion will be recorded using spy imaging system. surgical site drainage will be measured until drainage removal. post-operative pain (visual analog scale for pain) and the occurrence of adverse events will be recorded up until discharge and 30-days postoperative follow up visit.

Eligibility criteria:
inclusion criteria: * women aged 18-75 years. * choose bilateral mastectomy followed by immediate breast reconstruction. * have no inflammatory breast cancers. * have not had radiotherapy before mastectomy. * understand the study purpose, requirements, and risks. * be able and willing to give informed consent. exclusion criteria: * active connective tissue disease. * history of, or plan to undergo irradiation of the breasts.

Keywords: breast cancer mastectomy perfusion hemostasis
a safety, tolerability and efficacy study of transcon hgh in children with growth hormone deficiency

Conditions: Growth Hormone Deficiency, Pediatric; Endocrine System Diseases; Hormone Deficiency; Pituitary Diseases

Summary: a 26 week trial of transcon hgh, a long-acting growth hormone product, administered once-a-week. approximately 150 children (males and females) with growth hormone deficiency (ghd) will be included. all study participants will receive transcon hgh. this is a global trial that will be conducted in, but not limited to, the united states, canada, australia, and new zealand.


Eligibility criteria:
inclusion criteria: 1. investigator-determined ghd diagnosis prior to the historical initiation of daily hgh therapy. 2. 6 months to 17 years old, inclusive, at visit 1 1. if 3 to 17 years old, are taking daily hgh at a dose of ≥ 0.20 mg hgh/kg/week for at least 13 weeks but no more than 130 weeks prior to visit 1 2. if ≥ 6 months but \< 3 years old, are either hgh treatment-naïve or are taking daily hgh at a dose of ≥ 0.20mg hgh/kg/week for no more than 130 weeks prior to visit 1 3. tanner stage \< 5 at visit 1 4. open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males) 5. written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the irb/hrec/iec exclusion criteria: 1. weight of \ 80 kg at visit 1 2. females of child-bearing potential 3. history of malignant disease 4. any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism) 5. poorly-controlled diabetes mellitus (hba1c \>8.0%) or diabetic complications 6. known neutralizing antibodies against hgh 7. major medical conditions, unless approved by medical monitor 8. pregnancy 9. presence of contraindications to hgh treatment 10. likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver) 11. participation in any other trial of an investigational agent within 30 days prior to visit 1 12. prior exposure to investigational hgh

Keywords: human growth hormone hgh ghd rhgh pediatric growth hormone deficiency long acting growth hormone somatropin prodrug growth failure growth hormone replacement therapy sustained release growth hormone growth hormone deficiency transcon gh
administration of dhea in patients with poor response to ovarian stimulation for ivf

Conditions: Efficacy of DHEA; Pregnancy Rate; Diminished Ovarian Reserve; Changes in AMH

Summary: poor responders to ovarian stimulation represents one of the most frustrating problems in reproductive medicine. the investigators hypothesize that ovarian response of those patients could improve by treating these patients with 25 mg dhea tid for 12 weeks prior to stimulation.

patients diagnosed with poor ovarian response will be included in the study. the definition of poor response was based on the presence of at least one of the following criteria: age \> 40 years old, day 2 fsh \>9.5 miu/ml, amh \< 2ng/ml ,at least one previous coh with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of hcg. all patients will be counseled regarding their prognosis and other treatment options including oocyte donation as well as adoption were also presented and discussed in detail. all patients will be aware that the use of dhea is experimental and informed consent was obtained for those agreeing to use the medication. women in the dhea group will receive 25 mg of dhea three times a day for at least 12 weeks. during this period, women will be subjected to monthly measurements of early follicular phase fsh and estradiol. anti-mullerian hormone (amh) will be measured prior to the initiation of treatment and at the end of the observation period. patients will be stimulated with a short gnrh-antagonist protocol. briefly, all women will have measurements of serum fsh and estradiol and a pelvic sonogram on the second day of their cycle. providing that serum fsh is \< 17 miu/ml and estradiol is \< 70 pg/ml on day 2 , ovarian stimulation will be initiated with 450 iu of gonadotropins either in the form of a combination of highly purified urinary fsh and lh or with a combination of rec fsh and rec lh. all patients will be re-evaluated on day 5 of the stimulation, and dosage adjustments will be made and the antagonists (cetrorelix or ganirelix 0.25 mg/day) will be initiated. when at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000iu of hcg ( pregnyl, organon, greece inc.). oocyte retrieval will be performed 34 to 36 hours later. all patients will undergo icsi. patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval.

Eligibility criteria:
inclusion criteria: * women with poor response to ovarian stimulation. the definition of poor response was based on the presence of at least one of the following criteria: age \> 40 years old, day 2 fsh \>9.5 miu/ml, amh \< 2ng/ml ,at least one previous coh with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of hcg. exclusion criteria: * all other women that do not fulfill the above mentioned criteria

Keywords: dhea, pregnancy, ovarian reserve, amh
assessment of peng block analgesia versus intra-articular infiltration in hip prosthesis surgery

Conditions: Analgesia

Summary: after hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. pain management (analgesia) after hip prosthetic surgery remains a challenge. a bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact. the different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits. a new peripheral nerve block, the peng block has shown very encouraging results on postoperative analgesia quality. in this context, this research is based on the hypothesis that ultrasound-guided peng block could provide more effective analgesia than intra-articular infiltration during mini-invasive anterior hip prosthesis surgery.

each year, around140 000 patients undergo total hip arthroplasty. after hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. however, more and more patients want to no longer suffer after surgery. indeed, if postoperative pain is moderate at rest, it is often exacerbated by movement. severe pain occurs in 50 % of patients at rest and in 70% of patients during mobilization. pain management (analgesia) after hip prosthetic surgery remains a challenge for the anesthesiologist. a bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact. quality analgesia is therefore essential to reduce post-operative pain and improve functional rehabilitation in patients undergoing hip surgery. the different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits: rapid and non-lasting effect of analgesia or poor targeting of all nerves of hip joint. a new peripheral nerve block, the peng block, identified during a recent anatomical study in 2018, has shown very encouraging results on postoperative analgesia quality on several small series of patients. in this context, this research is based on the hypothesis that ultrasound-guided peng block could provide more effective analgesia than intra-articular infiltration and therefore reduce the intraoperative opioid consumption during mini-invasive anterior hip prosthesis surgery under general anaesthesia.

Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years old. * patient scheduled for hip prosthesis placement via the anterior approach exclusion criteria: * patient with local anesthesia contraindication. * patient with a high level of dependency, defined by level 1 or 2 of iso ressources group (gir).
effect of virtual reality environment created in preoperative area and hand massage on patient outcomes

Conditions: Preoperative Patients; Surgical Procedures, Elective; Anxiety

Summary: the aim of this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. in addition, it's examined that if virtual reality glasses and hand massage execution is convenient way of to reduce anxiety in patients before surgery. the main questions it aims to answer are: * is there a significant difference between the study groups in terms of post-application anxiety level? * is there a significant difference between the study groups in terms of post-application vital signs, pain and patient satisfaction? researchers will compare responses to anxiety scales before and after the hand massage and virtual reality videos to see if they reduce anxiety levels. participants will: * in the virtual reality group, they will answer the questions on the surgical anxiety scale, watch the video with vr glasses and answer the questions on the scale again. * in the massage group, they will answer the questions on the surgical anxiety scale, and after the researcher gives them a hand massage, they will answer the questions on the scale again.

surgical anxiety scale: the scale was developed by burton et al. in 2018 to assess preoperative anxiety levels. each item of the 17-item scale is answered between 0 and 5 points. it consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. health-related anxiety is calculated by adding the scores given to items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by adding the scores given to items 2, 14, 16, and 17; and procedure-related anxiety is calculated by adding the scores given to items 1, 3, 4, and 5. the total score of the scale is calculated by adding the scores of all sub-dimensions and the scores of the three items not included in the sub-dimensions. a minimum of 0 and a maximum of 68 points can be obtained from the scale. although there is no cut-off point for the scale, it can be said that surgical anxiety increases as the total score of the scale increases.

Eligibility criteria:
inclusion criteria: * patients who will undergo elective surgery and whose general condition is asa (american society of anesthesiology) classification i, ii or iii * patients who are not sedated * patients over the age of 18 * patients without a psychiatric or behavioral diagnosis * patients who do not have a communication barrier due to hearing loss or spoken language exclusion criteria: * vertigo and motion sickness * carpal tunnel syndrome * hand cuts

Keywords: preoperative anxiety preoperative patients complementary and alternative therapies massage virtual reality
concurrent pet d2/d3 receptor imaging and fmri smoking cue reactivity in smokers

Conditions: Nicotine Dependence; Smoking Cue Reactivity; Relapse to Smoking

Summary: this trial aims to determine whether dopamine d3 receptors are elevated in smokers versus nonsmokers and whether correlations exist between d3 receptor binding potential (bp) and functional mri (fmri) reactivity to smoking cues, which has been associated with smoking relapse vulnerability. neuroimaging measures of d3 bp and smoking cue fmri reactivity will be collected concurrently in otherwise healthy nicotine-dependent smokers and age-matched nonsmokers using a 3 tesla mri scanner configured to conduct fmri and positron emission tomography (pet). we will measure d3 receptor bp using radiolabeled \[11c\]-(+)-phno, which has a relatively higher affinity for d3 versus d2 receptors. we hypothesize that d3 bp will be elevated in smokers versus nonsmokers and that in smokers, there will be a positive correlation between smoking cue fmri reactivity and d3 bp.


Eligibility criteria:
inclusion criteria: * competent to provide written informed consent * smokers: self-report of smoking 15 or more cigarettes/day for the past year, self-report of smoking first cigarette of the day within 30 minutes of awakening, meets dsm-iv criteria for nicotine dependence, provides expired breath carbon monoxide reading of \> 10 ppm at enrollment * nonsmokers: self-report of consuming \<100 cigarettes in their lifetime, none in the last 6 months, provides expired breath carbon monoxide reading of \< 9 ppm at enrollment * women of childbearing potential: negative stat serum beta-human chorionic gonadotrophin pregnancy test before scanning exclusion criteria: * pregnant or able to become pregnant and not willing to undergo blood pregnancy test * unstable medical illness with likely hospitalization for treatment within 6 months * life-threatening arrhythmia, cerebro-vascular or cardiovascular event within 6 months of enrollment; liver function tests elevated over 2.5x normal; cns tumor or seizure disorder * users of other tobacco- or nicotine-containing products (gum, patches, e-cigarettes) * lifetime history of dsm-iv bulimia, organic mental disorder, brain injury or psychotic disorder * 6 month history of non-nicotine substance use disorder or major depression * history of multiple adverse drug reactions * current use of excluded concomitant medications (smoking cessation medications) * known history of allergic reaction to the pet ligand \[11c\]-phno, its components, or any medication
using a infrared thermometer to the early detection of catheter related infections

Conditions: Infection

Summary: this is a pilot study which aims to show the temperatures measured on body surface with an infrared thermometer on inpatients who need a central venous catheter (cvc) for medical care. because the local temperature could be altered, at least during local infectious processes, seems to be reasonable to think that this approach could be helpful to its early diagnosis.

by convenience sampling, it was expected that during 4 months, a minimum of 30 inpatients of the metabolic, clinical or intensive care wards, at the clinical hospital of ribeirão preto medical school, são paulo, brazil, would have their data collected

Eligibility criteria:
inclusion criteria: * need of a central venous catheter for medical care. * be an inpatient of the metabolic, clinical or intensive care wards exclusion criteria: * be in treatment course of a catheter related infection.

Keywords: body temperature thermometry infrared rays catheter related infection
the effect of exercise on wound healing while off-loading

Conditions: Diabetic Foot Ulcer

Summary: this study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. hypothesis: consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

the purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer. while benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. it is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. if exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.

Eligibility criteria:
inclusion criteria: * have diabetes * have an active plantar ulceration * with or without peripheral neuropathy * able to safely exercise * receiving care for their plantar ulceration, including off-loading exclusion criteria: - presence of an untreated infection, osteomyelitis, or gangrene

Keywords: diabetes off-loading exercise
prospective validation of a pre-specified algorithm for the management of conduction disturbances following tavr

Conditions: Conduction Disturbances; Transcatheter Aortic Valve Replacement; Permanent Pacemaker Implantation

Summary: the high incidence and variety of conduction disturbances post-tavr represents a major challenge in the periprocedural management of tavr recipients. despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of a large proportion of such patients. the implementation of a pre-specified treatment strategy translating into a more uniform practice regarding the management of conduction disturbances post-tavr applied to a large cohort of patients would permit to identify the benefits and drawbacks of each specific aspect of the treatment algorithm proposal. this may also help to improve both the management and clinical outcomes of the complex group of patients with conduction disturbances associated with tavr. in the end, the final objective of a pre-specified strategy for managing conduction disturbances post-tavr should be to obtain a low rate of ppm without increasing the risk of sudden death or life threatening arrhythmic events following hospital discharge, and all this while avoiding an excessive prolongation of the hospitalization period following the tavr procedure.

the objectives of the study are: * feasibility: to validate and determine the applicability of a pre-specified algorithm for managing conduction disturbances in consecutive patients undergoing tavr, also evaluating the percentage of patients included in each group of the algorithm strategy. * efficacy: (i) to evaluate the rate of permanent pacemaker implantation in-hospital and at 30 days compared to that of the year prior to the implementation of the protocol, (ii) to determine the incidence of sudden death at 30 days and at 1-year follow-up.

Eligibility criteria:
inclusion criteria: -patients with aortic valve disease undergoing transcatheter aortic valve replacement exclusion criteria: * prior permanent pacemaker * failure to provide signed informed consent for data collection * impossibility for a follow-up * unwillingness to follow the pre-specified strategy for the management of conduction disturbances

Keywords: atrioventricular block complete heart block high-degree atrioventricular block intraventricular conduction delay left bundle branch block permanent pacemaker implantation right bundle branch block
a study investigating the efficacy and safety of intravitreal (ivt) injections of anx007 in participants with geographic atrophy (ga)

Conditions: Geographic Atrophy

Summary: the primary purpose of the study is to determine if ivt injections of anx007 every month reduce vision loss in participants with ga secondary to age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * diagnosis of ga of the macula secondary to amd as determined by the investigator and confirmed by the independent central reading center. exclusion criteria: * geographic atrophy due to other causes than amd such as stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye. note: other protocol-defined inclusion and exclusion criteria may apply.