Kornimate/medical-research-clean huggingface dataset:
effect of topic pirfenidone in diabetic ulcers

Conditions: Diabetic Foot Ulcers

Summary: pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of various cytokines (tnf-α, transforming growth factor-β, platelet derived growth factor and vascular endothelial growth factor, among others) that possesses anti-inflammatory and anti-fibrinolytic properties. the aim of this study is to compare the effect of topic treatment with pirfenidone compared to conventional treatment in chronic diabetic foot ulcers. the hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers (wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional treatment. this is a randomized, controlled and crossover study. patients will be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. at the end of this period they will change groups. each week ulcers will be for size, depth, length and evidence of infection. the ulcers will have proper debridement in the conventional treatment group and debridement plus topical pirfenidone application in the pirfenidone group. subjects will be instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a day.


Eligibility criteria:
inclusion criteria: 1. men or women 2. type 1 or 2 diabetes 3. age ≥ 18 years 4. wagner 1 or 2 diabetic foot ulcer 5. diabetic ulcer for more than 8 weeks duration 6. willing to participate in the study with signed informed consent exclusion criteria: 1. ankle/brachial index \< 0.4 (critic ischemia) 2. use topical or systemic antibiotics 3. inability to attend to the weekly evaluations 4. inability to do daily ulcer cleansing 5. autoimmune diseases 6. active pharmacologic topical or systemic ulcer treatment 7. treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy 8. pregnancy or lactation

Keywords: diabetic ulcer, diabetic foot
restor natural +3.0d study in japan

Conditions: Cataract

Summary: the objective of this study is to evaluate safety and effectiveness of acrysof multifocal single-piece intraocular lens (iol) model sn6ad1 when implanted to replace the natural lens following cataract removal.


Eligibility criteria:
inclusion criteria: * planned bilateral cataract removal by phacoemulsification * potential postoperative best corrected visual acuity of 0.5 or over * 1.5 diopter (d) or less of astigmatism preoperatively, measured by keratometry exclusion criteria: * poorly controlled glaucoma * progressive diabetic retinopathy

Keywords: cataract
prolong prospective, multi-center, open-label, post-market study

Conditions: Chronic Pain

Summary: spinal cord stimulation (scs) has been shown to be effective for relieving intractable chronic pain. however, a portion of patients who initially succeed with scs will eventually lose their therapeutic benefit. reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. this study will prospectively observe subjects who utilize abbott neurostimulation devices after failing to sustain pain relief with their previous scs system. the effectiveness of abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.


Eligibility criteria:
inclusion criteria: 1. patient must provide written informed consent prior to any clinical investigation related procedure. 2. patient has a spinal cord stimulator implanted for chronic, intractable pain. 3. patient has inadequate pain relief from their current scs system. 4. patient has a pain nrs ≥ 6. 5. physician has determined that the patient's original pain is still addressable with neurostimulation. exclusion criteria: 1. patient is enrolled, or intends to participate, in a competing clinical study, as determined by abbott. 2. patient is seeking care for a new pain complaint outside of the original indication for scs. 3. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical investigation or to comply with follow-up requirements. 4. physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system. 5. patient requires frequent mri. 6. patient is involved in active disability litigation related to their pain or seeking worker's compensation. 7. patient is part of a vulnerable population.

Keywords: chronic pain spinal cord stimulation abt-cip-10277 burstdr scs drg
comparison of the effect of montelukast and cetirizine on allergic inflammation in children with allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: the aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

during the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. about 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma. the aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Eligibility criteria:
inclusion criteria: * clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to aria guidelines exclusion criteria: * diagnosis of bronchial asthma * allergy to perennial allergens * specific immunotherapy * other chronic diseases * tobacco smoking * acute respiratory tract infection * excluded drugs: inhaled and systemic glucocorticosteroids

Keywords: seasonal allergic rhinitis children montelukast cetirizine
evaluation of neutrophil/lymphocyte ratio ,platelet/lymphocyte ratio and crp as markers of severity of pre-eclampsia

Conditions: Pre-Eclampsia

Summary: evaluation of neutrophil/lymphocyte ratio, platelet /lymphocyte ratio and crp as markers of severity of pre-eclampsia


Eligibility criteria:
inclusion criteria: - preeclampsia from 25_45years exclusion criteria: * chronic diseases primary hypertension
hiit in patients with a first-episode psychosis

Conditions: First-episode Psychosis

Summary: this study aims to estimate the effect of a 3-month high intensity interval training on antipsychotic-induced weight gain in patients with a first episode of psychosis, as well as to determine whether these effects are maintained 9 months after the intervention has ended.

weight gain associated with antipsychotic medication has been recognized for years as a very common side effect, occurring mainly during the first months after the start of antipsychotic treatment. patients with schizophrenia have a risk of obesity 1.5-2 times higher than the general population and the chances of developing physical problems such as hypertension, diabetes, metabolic syndrome, and coronary heart disease are also higher. patients diagnosed with schizophrenia have a life expectancy of up to 25 years lower than the general population, with cardiovascular disease being the main cause of premature death. the first months of treatment constitute a critical period for the implementation of strategies that could prevent or mitigate this side effect of the medication, as well as the adverse consequences derived from weight gain. this project is the response to the need to implement physical exercise interventions to prevent weight gain in patients with a first psychotic episode.to date, there is little evidence from randomized clinical trials that have used physical exercise as the only intervention to prevent weight gain in the first weeks from the start of antipsychotic treatment. numerous systematic reviews and meta-analyses have evaluated non-pharmacological interventions to reduce weight in people with severe mental illness, including chronic psychotic disorders. however, there is little research on this type of intervention in patients with a first episode of psychosis. studies are needed that implement physical exercise programs from the initial phases of antipsychotic treatment, and that are capable of defining the parameters used in the design of an effective physical exercise intervention for the prevention of weight gain in first psychotic episodes.

Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤40 years. * treatment with antipsychotic medication ≤6 weeks. * diagnosis of first episode psychosis, for inclusion in the itpcan clinical program. exclusion criteria: * pregnancy or breastfeeding * poorly controlled diabetes. * moderate or severe intellectual disability. * current high intensity interval training program. * any systematic disease that contraindicates high intensity interval training.
ventralex vs stratafix for primary ventral hernias

Conditions: Ventral Hernia

Summary: randomised controlled trial comparing ventralex hernia patch with stratafix suture for repair of primary ventral hernias in the midline.

primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery. mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. in recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. however, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery. the investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.

Eligibility criteria:
inclusion criteria: * defect 1-4 cm * primary ventral hernia in the midline * bmi\<35 exclusion criteria: * defect \>4cm * bmi\>35 * recurrent hernia
local levobupivacaine for pain relief after endoscopic submucosal dissection for esophageal lesions

Conditions: Endoscopic Submucosal Dissection; Levobupivacaine

Summary: endoscopic submucosal dissection (esd) is commonly performed for (pre)cancerous lesions in the esophagus. following esd, post-procedural chest pain is seen in many patients. studies have shown that local bupivacaine (bp) into the residual submucosal layer of the resection wound after gastric esd could reduce post-procedural pain rates effectively. levobupivacaine (lb) is equipotent to bp regarding analgesic effects, but has a better safety profile. no studies have been performed to evaluate the efficacy of lb after esophageal esd to reduce pain. therefore, we want to evaluate the effect on post-procedural pain of local application of lb during esophageal esd.


Eligibility criteria:
inclusion criteria: * patients age ≥18 years at time of consent * visible lesion in the esophagus, minimum diameter of the lesion ≥20 mm * scheduled for esophageal esd * informed consent exclusion criteria: * presence of multiple lesions requiring two or more separate endoscopic resections * history of esophageal surgery other than fundoplications * history of esophageal ablation therapy * history of radiotherapy of the esophagus * esophageal varices * prior endoscopic resection in the same area * uncontrolled coagulopathy * severe medical comorbidities precluding endoscopy * allergy to lb or other amide-type local anaesthesia * current regular use of opioids * other aetiology causing pain similar to post-esd pain * inability to assess pain due to severe psychiatric or neurological disease * insufficient command of dutch language * brugada syndrome * incapacitated patients

Keywords: endoscopic submucosal dissection esd esophagus analgesic
montalcino aortic consortium: precision medicine for heritable thoracic aortic disease

Conditions: Aortic Aneurysm; Aortic Dissection; Aortic Diseases

Summary: the montalcino aortic consortium (mac) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (h-tad) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of h-tad.

the mac will provide the infrastructure to assemble large cohorts of patients with mutations in known h-tad genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers and other biomarkers of h-tad. recruitment of large numbers of patients world-wide will improve the precision of data used to predict disease risks. retrospective and prospective study designs will be used to fully characterize the different stages of h-tad (i.e. susceptibility, presymptomatic, and symptomatic) and other complications associated with the h-tad genes, and examine clinical and environmental factors that define risk of aortic dissections. the data from mac will provide the critical clinical information for precise management of thoracic aortic disease and other complications caused by mutations of these genes and improve the medical management and outcome of patients with genetically triggered, lethal vascular diseases.

Eligibility criteria:
inclusion criteria: * patients and their relatives with a confirmed pathogenic, likely pathogenic variant, or variant of unknown clinical significance in at least one of the h-tad genes (i.e. tgfbr1, tgfbr2, smad3, tgfb2, tgfb3, acta2, myh11, mylk, prkg1, mat2a, mfap5, lox, col3a1, foxe3, and fbn1). * patients of all ages, sex and race for which informed consent can be obtained. exclusion criteria: * patients without a confirmed causative variant for h-tad.
preliminary evaluation study of therapeutic education on overweight people in addition to a hydrotherapeutic cure

Conditions: Obesity

Summary: the goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients. the therapeutic education program at the thermal baths of brides-les-bains is composed of a dietary follow-up, a physical activities program, working group.

the participants are people that come to the thermal baths in order to follow an hydrotherapeutic cure (of about 3 weeks). for the action group, they also follow a course of therapeutic education where they are given advices on how they should eat and have a regular physical activity. this therapeutic education in addition of the hydrotherapeutic cure should help them lose weight and not gain in again. the participants are followed for 18 months (17 months after leaving the thermal baths).

Eligibility criteria:
inclusion criteria: * body mass index (bmi) over 27 kg/m² (or equal) * has a valid email address, has access to the internet and to a telephone line * has a domestic scale compatible with its weight * signed the consent form * susceptible to accept the obligations generated by the study * has a health insurance exclusion criteria: * has a progressive illness at the time of the study (cancer, neurodegenerative disease...) * is pregnant * follows the hydro-therapeutic cure in order to cure rheumatism * trying to lose weight prior to a surgery * has a diagnosed eating disorder * has no physical activity due to a handicap or a serious osteoarthritis * has taken a weight-loss drug (orlistat) in the past month or will likely do so in the future * is taking a desmopressin-based drug * is unable to understand or follow the protocol * is deprived of liberty * is under judicial protection

Keywords: therapeutic education
evaluation of neurocap® in the treatment of symptomatic neuroma

Conditions: Neuroma

Summary: prospective cohort evaluation of neurocap® in the treatment of symptomatic neuroma (protect neuro) this post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the polyganics nerve capping device (neurocap®) for reduction of the development of peripheral symptomatic end-neuroma.

1. device description neurocap®, a bioresorbable nerve capping device based upon the neurolac® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. neurocap® is composed of the same biocompatible, bioresorbable copolyester composing the neurolac® nerve guide, poly(68/32\[15/85 d/l\] lactide-ԑ-caprolactone) (plcl). 2. objective this post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the polyganics nerve capping device (neurocap®) for reduction of the development of peripheral symptomatic end-neuroma. 3. study design this post-market surveillance study consists of a cohort study to provide post market surveillance information regarding long-term performance and ease of use of the neurocap® for reduction of the development of peripheral symptomatic end-neuroma in the upper and lower extremity. sub analyses will be performed regarding demographics and medical background.

Eligibility criteria:
inclusion criteria: 1. subjects who are able to provide a written informed consent prior to participating in the clinical investigation. 2. subjects who are able to comply with the follow-up or other requirements. 3. subjects who are ≥ 18 years old. 4. subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb. 5. subjects with a positive tinel's sign. 6. symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with xylocaine (lidocaine) - pain relief defined as minimally 50% reduction in vas questionnaire score. 7. subjects that are indicated for surgery to treat symptomatic neuroma. exclusion criteria: 1. subjects who do not complete the informed consent. 2. subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization). 3. subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months. 4. subjects with congenital neuropathy. 5. insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. use of the device over a joint is advised against. 6. subjects who have had historical radiotherapy in the area of the (end-) neuroma. 7. subjects who have a known allergy to anesthetic agent or bioresorbable copolyester poly(68/32\[15/85 d/l\] lactide-ε-caprolactone) (plcl). 8. proximal nerve end \> 8mm. 9. pregnancy.
assessment of the functional significance of accessory pudendal arteries

Conditions: Prostate Cancer

Summary: for patients with prostate cancer advances in medical technology have enabled us to identify "accessory" (additional) pudendal arteries (called apa) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). apas running near the prostate gland are identified in approximately 1 in 3 to 4 patients. however, large apas, like the ones looked for in this study, are identified in 15-18% of all patients. these arteries are preserved more than 80% of the time, depending on their size and location.with this study, we plan to evaluate whether apas supply blood to the penis and male erections, as well as the amount supplied.

overall, approximately 50% of patients become impotent (inability to achieve or maintain an erect penis; also called erectile dysfunction) after radical prostatectomy (removal of the prostate). it is already known that postoperative (after surgery) erectile dysfunction does not depend solely on the preservation of the nerves going to the penis, but also to the preservation of the arteries bringing blood to the penis. although, the presence and frequency of apas have been studied, and the ability to preserve them has also been noted, we still do not know how much these arteries contribute to a male's erection. with this study, we plan to evaluate whether apas supply blood to the penis and male erections, as well as the amount supplied. while there is no immediate benefit to you for participating in the study, these findings will further help our understanding of apa's and the importance in preserving them during surgery. the primary aim of this study is to determine the proportion of men with apas for whom apas contribute to penile blood flow. the secondary aim is to describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the apa.

Eligibility criteria:
inclusion criteria: * they have selected a lrp, with or without robotic assistance, by jonathan colelman, md, bertrand guillonneau, md, vincent laudone, md, raul parra, md, or karim touijer md for definitive treatment of their prostate cancer after a full discussion of treatment options. exclusion criteria: * patients undergoing open radical prostatectomy * patients with prior history of insulin dependent diabetes mellitus * patient who have received prior radiation therapy to the pelvis or prostate * patients requiring anticoagulation postoperatively * known allergy to phenylephrine, alprostadil, papaverine or phentolamine * patients whose systolic blood pressure is below 90 mmhg at the time of evaluation despite routine measures taken by the anesthesiologist at his best criteria. * patients with labile hypertension or history of prior priapism * patients with penile scarring or penile prosthesis * patients with an international index of erectile function score \< 24
a randomized controlled trial to test the effects oxytocin and vibration have on heat pain threshold after uv-b burn

Conditions: Sunburn

Summary: this study aims to answer the question: does oxytocin increase the pain threshold on thermal heat pain in the presence of vibration on an area of skin exposed to a mild sunburn?

the goal of this clinical trial is to test whether intravenous oxytocin increases the analgesic effect of vibration on heat pain threshold of skin that has been exposed to ultraviolet-b (uv-b) burn (mild sunburn). researchers will compare oxytocin (a hormone that naturally occurs in the body) to a placebo (a look-alike substance that contains no drug) to see if oxytocin works to increase the pain threshold (the lowest intensity at which one begins to perceive or sense a stimulus as being painful).

Eligibility criteria:
inclusion criteria: * male or female \> 18 and ≤55 years of age, body mass index (bmi) \<40 * generally in good health as determined by the principal investigator based on prior medical history, and as assessed to be american society of anesthesiologists physical status 1, 2, or 3 * fitzpatrick scale rating i through iii exclusion criteria: * history of skin cancer * dark enough skin complexion that would make it infeasible to determine the minimal erythematous dose of uv-b irradiation. anyone fitzpatrick scale score \>3 will be excluded * neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis * pregnancy or currently breast feeding * subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged qt interval * subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, ssri's, maoi, or the recreational drug ecstasy * subjects with a known latex allergy

Keywords: healthy volunteer uvb burn burn pain