Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lertal® as an add-on to standard therapy for allergic rhinoconjunctivitis in pediatrics

Conditions: Allergic Rhinoconjunctivitis

Summary: the purpose of this study is to evaluate the efficacy and safety of lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

allergic rhinoconjunctivitis (ar) is a common chronic disorder in children, especially in developed countries. it is not characterized by nasal symptoms only (such as congestion and sneezing), but may also cause general complaints such as fatigue and cough. ar can also have detrimental effects on mood, sleep, social activities and scholastic performance. lertal® is a novel nutraceutical containing seed extracts from perilla frutescens, quercetin extracted from sophora japonica and vitamin d3, all compounds that have demonstrated their ability to reduce allergy symptoms and the use of anti-allergy drugs in adults. the aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to evaluate the efficacy and safety of lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

Eligibility criteria:
inclusion criteria: * age 6 to 12 years * male or female * diagnosis of allergic rhinoconjunctivitis * hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months * total symptoms score (tss) ≥ 15 and at least 1 for nasal congestion * written informed consent of patient and of parent or legal guardian exclusion criteria: * uncontrolled asthma * secondary rhinitis to other causes * documented evidence of acute or chronic sinusitis * nasal polyps * chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids * use of leukotriene antagonists * continuous use of antihistamines * inadequate washout of drugs: * systemic or intranasal corticosteroids: 1 month * leukotriene antagonists: 1 month * sodium cromoglycate: 2 weeks * systemic or intranasal decongestants: 3 days * cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine: 5-10 days * malformations of the nose, ear or throat * upper or lower respiratory tract infection in the last 2 weeks * participation in other clinical studies in the last month * documented hypersensitivity to the study product or its excipients * trip planned outside of the study area
risk stratification among individuals who have many moles on their skin

Conditions: High-Risk Nevus Phenotype

Summary: the investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. the investigators hope to identify features of moles that are associated with melanoma risk. the investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * high-risk nevus phenotype (≥ 50 nevi (≥ 2mm in size) and ≥ 1 atypical nevus) * first presented to mskcc for cutaneous melanoma-related care on or after april 2016 * cases: diagnoses of unequivocal invasive cutaneous melanomas (ajcc stages i-iv) confirmed by mskcc pathology on or after april 2016 * cases: completion of surgical treatment of primary melanoma * ability to sign or verbally consent to the informed consent exclusion criteria: * controls: histopathologically borderline melanocytic tumors for which melanoma could not be excluded or that were treated as possible melanomas. * known germline high-penetrance melanoma predisposition mutation (that is, cdkn2a, cdk4, and bap1) * cases: history of invasive cutaneous melanoma (ajcc stages i-iv) not confirmed by mskcc pathology * history of acrolentiginous type of cutaneous melanoma or history of mucosal melanoma * cases and controls: prior administration of systemic medications known to modify nevus phenotype, including but not limited to: mek inhibitors (trametinib, cobimetinib, etc.), braf inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). controls: history of stage 0-iv melanoma confirmed by mskcc pathology * history of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype * physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes) * known hypersensitivity to adhesive rings used for reflectance confocal microscopy * inability to give informed consent * have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion) * familial cutaneous melanoma history (families with at least one invasive melanoma and two or more other diagnoses of invasive melanoma or pancreatic cancer among first- or second-degree relatives on the same side of the family). we will confirm melanoma family history via medical record documentation, whenever possible, as recommended by previous studies that disproved about half of the reported family histories of melanoma among first-degree relatives in case-control studies. * age 70 or above
anemia management in chronic kidney disease not on dialysis patients after the european renal best practice (erbp) working group recommendations

Conditions: ANEMIA

Summary: the purpose of this study is to evaluate the impact of the last recommendations of the european anemia working group erbp in the anemia management in the achievement of the therapeutic goal of hb 11-12 g/dl.


Eligibility criteria:
inclusion criteria: * adults patients with anemia secondary to chronic kidney disease (ckd) not on dialysis. * patients starting anemia treatment (naïve) after six months of the last recommendations of the european anemia working group erbp (january 2011). * patients in treatment who changed from previous esa treatment since january 2011 (converted patients exclusion criteria: * patients in erythropoiesis stimulating agents (esa) dose adjustment period. * kidney transplant patients.

Keywords: anemia in chronic kidney disease patients not on dialysis
efficiency of combined rehabilitation programs including resistance and endurance exercises on functional capacities, quality of life and daily level of activities in hemodialysis patients

Conditions: Chronic Kidney Diseases; Hemodialysis; Physical Rehabilitation

Summary: hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. our team was able to demonstrate that beyond muscle mass, muscle strength and physical activity were essential determinants of morbidity and mortality of dialysis patients. the aider santé medical team has set up an assessment of physical activities and muscle strength in the montpellier and nimes centers. in order to rehabilitate muscle strength and endurance, perdialytic exercise may be prescribed. its effectiveness can be appreciated by measuring the sppb score (short physical performance battery). recent studies established that combined training including resistance and endurance exercises was the most effective to improve functional performance. in aider santé dialysis centers, the two mainly used exercise approaches are distinguished by the time distribution of the two types of exercise: the first plans to practice both types of exercise at each session (continuous program), the second plans to alternate a week of resistance exercise with a week of endurance exercise (discontinuous program). it is established that the rehabilitation of the hemodialysis patient must include both resistance and endurance exercises, but the combination of these exercises during the same session is potentially at the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each effort. therefore, the main hypothesis of the project is that the temporal separation of resistance and endurance exercises in a discontinuous program could optimize the functional gains of combined rehabilitation and therefore be more effective than a continuous program generating a phenomenon of interference.


Eligibility criteria:
inclusion criteria: * hemodialysis started since at least 3 months * medical prescription of perdialytic combined exercise * age \< 85 * life expectancy \> 6 months exclusion criteria: * ischemic and valvular cardiopathies * lower-extremity arterial disease (stade iii and iv) * knee or hip amputation/prothesis * severe respiratory disease * bmi \> 35 * pacemaker

Keywords: perdialytic exercise combined rehabilitation functional abilities interference effect
group therapy compared with educational materials in patients with prostate cancer

Conditions: Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: developing coping strategies may help improve the quality of life of patients with prostate cancer. purpose: this randomized clinical trial is comparing the effect of group therapy with written educational materials on the quality of life of men with stage i or stage ii prostate cancer.

objectives: * determine the feasibility of providing group support, and evaluate the effect of supportive-expressive group therapy vs. written educational material on the psychological health and quality of life of men with stage i/ii prostate cancer. outline: patients are stratified by prior hormonal therapy. patients continue standard oncologic treatment concurrently with supportive-expressive group therapy. supportive-expressive group therapy consists of twelve 90-minute weekly meetings with 8-12 members and 2 cotherapists and is based on the following themes: building bonds, expressing emotions, detoxifying dying, taking time to prioritize and set realistic goals, fortifying families, and dealing with doctors. each session commences with a brief stress reduction exercise and ends with a brief cognitive restructuring imagery exercise. the main portion of the meeting emphasizes providing an environment in which patients can share their concerns, feelings, and thoughts openly and honestly. the role of the cotherapist is to facilitate expression of patients' concerns, offer empathy, and continue to encourage patients to express their feelings and thoughts. quality-of-life questionnaires are filled out at 3 and 6 months and then every 6 months for a total of 2 years. projected accrual: approximately 480 patients (including an estimated 53 minority patients) will be entered in this multicenter study.

Eligibility criteria:
disease characteristics: * biopsy-proven prostate cancer diagnosed within 1 year prior to entry * clinical stage i/ii (t1b-c or t2, n0 or nx, m0) disease * pathologic local upstaging (e.g., to t3) allowed * no nx disease if pathologic or partial pathologic (e.g., lymph node biopsy or dissection) staging performed * no major psychiatric illness requiring hospitalization or medication other than depression or anxiety for less than 1 year * no second malignancy within 10 years except nonmelanomatous skin cancer * clinical follow-up by a urologist, medical oncologist, or radiation therapist required at least semi-annually patient characteristics: age * not specified performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * see disease characteristics prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer psychosocial effects of cancer and its treatment
evaluation of a boosting regimen with oral cholera vaccine

Conditions: Cholera

Summary: data demonstrates that shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. this study examines the immune protection and safety of providing a one and two dose boosting regimen of shanchol™ given five years after the initial dose.


Eligibility criteria:
inclusion criteria: all subjects must be presently enrolled in the phase 3 niced rct of shanchol™ and satisfy the following criteria at study entry: 1. male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection. * the subject should be able to continue in the study for the next 6 weeks * the subject (or parent/guardian) should be willing to provide 3 blood samples 2. written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years. 3. healthy subjects as determined by: * medical history * physical examination * clinical judgment of the investigator exclusion criteria: 1. individuals who are too weak to get out of bed to receive the vaccine 2. pregnant women (identified through verbal screening) 3. those less than 6 years of age 4. receipt of cholera vaccine following 2009 (time of licensure and availability of shanchol™ in india)

Keywords: killed oral cholera vaccine boosting vaccine regimen safety and immunogenicity
endoscopic sphincterotomy vs. balloon dilation for assessment of pancreatitis

Conditions: Pancreatitis

Summary: one of the major elements of successful endoscopic retrograde cholangiopancreatography ( ercp) is the timely and uncomplicated cannulation of the common bile duct (cbd) . various factors may adversely affect the cannulation procedure of the cbd leading to complications (acute pancreatitis after ercp, perforation of the duodenum , bleeding ). endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). during sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. complications due to sphincterotomy are known: bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. as an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. as a result, bleeding complications and scarring as late effects might be prevented. current data is limited in terms of the risk of acute pancreatitis after ercp when using a balloon catheter. this study aims to evaluate the incidence of acute pancreatitis and other complications after ercp. balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.


Eligibility criteria:
inclusion criteria: * independent indication for ercp * age ≥ 18 years * patient is able to understand informed consent exclusion criteria: * s/p sphincterotomy * pancreatic or cbd-stent in situ * pregnant patient * known chronic pancreatitis * acute pancreatitis prior to intervention

Keywords: endoscopic sphincterotomy balloon dilation adverse events pancreatitis bleeding
determine the effect of azd3161,injected intradermally, on quantitative sensory testing variables in normal and ultraviolet-c (uvc) exposed skin in healthy volunteers

Conditions: Peripheral Neuropathic Pain; Nociceptive Pain

Summary: the purpose of this study is to investigate the effect of azd3161 on mechanical pain sensitivity and axon reflex flare in normal and ultraviolet c irradiated skin.


Eligibility criteria:
inclusion criteria: * healthy caucasian male and female volunteers aged 18 to 55 years inclusive with suitable veins for venepuncture * the subject belongs to skin type ii or iii according to fitzpatrick skin type scale * females must have a negative pregnancy test at screening and at admission, must not be lactating and must be of non-child-bearing potential * have a body mass index (bmi) between 18 and 30 kg/m2 inclusive and weigh between 50 kg and 100 kg inclusive * male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with investigational product. exclusion criteria: * presence of skin disorders, tattoos or other skin conditions that may interfere with the qst measurements, as judged by the investigator * recent exposure to significant amount of uv light, as judged by the investigator. * use of any prescribed or non-prescribed analgesics (including paracetamol/acetaminophen or drugs affecting blood flow (including nasal anticongestants), prior to the first administration of investigational product that may interfere with the study objectives. * history of severe allergy/hypersensitivity, or ongoing allergy/hypersensitivity as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to azd3161. * plasma donation within 1 month of screening or any blood donation/blood loss \>500 ml during the 3 months prior to screening

Keywords: allodynia hyperalgesia paresthesia
comparative safety and efficacy of vaginal misoprostol versus lidocaine-prilocaine cream in levonorgestrel iud insertion

Conditions: Contraception

Summary: the aim of the present study is to compare the safety and efficacy of vaginal misoprostol versus lidocaine-prilocaine cream in reducing pain during levonorgestrel iud insertion in women delivered only by cesarean deliveries


Eligibility criteria:
inclusion criteria: * women who delivered only by previous cesarean delivery and requesting lng-iud insertion exclusion criteria: * women who delivered vaginally, active vaginal or cervical infections and contraindications to iud insertion or study drugs
an informative video before planned external cephalic version

Conditions: Breech Presentation

Summary: a randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.

women with a breech presentation scheduled to undergo an external cephalic version that meet the criteria are recruited in the emergency room by offering every woman that is scheduled to undergo an external cephalic version to participate. women who agree to participate are asked to sign an inform consent, and are randomized to intervention group and control group. in the emergency room sonographic data is collected including amniotic fluid index, engaged presenting part, sonographic and clinical estimation of fetal weight, place of the placenta and various angles between the fetus and the bladder (these data are collected for the study). all participants in the intervention group watches an informative video on recruitment. this video describes in detail the expected external cephalic version process. before the external cephalic version and an hour after a successful or an unsuccessful external cephalic version the situation-specific anxiety is measured using the state-trait anxiety inventory score (attached).

Eligibility criteria:
inclusion criteria: * women between ages 18-45 * with a singleton gestation * at gestational week of 36 weeks 0 days until 38 weeks 0 days * who admitted labor word for external cephalic version . exclusion criteria: * women who had a past cesarean section * women with oligohydramnios (amniotic fluid index \< 5 cm) * women who had a past external cephalic version * women with a failed external cephalic version in current pregnancy * women who take medication for depression/anxiety disorders * women with a complicated pregnancy including fetal anomalies, polyhydramnios...

Keywords: breech presentation external cephalic version maternal anxiety informative video
evaluation of wound biofilm in acute and chronic wounds

Conditions: Wounds

Summary: patients who present to a wound care center for management of their wounds will be evaluated clinically to establish if their wounds are chronic or acute. these patients will undergo standard of care management of their wounds. if debridement is indicated for the patient, the patient will be asked to participate in a study. once the standard of care debridement is complete, the material debrided from the wound, instead of being discarded into a biohazard bag, will be prepared for shipment. the samples will then be shipped to the center for biofilm engineering where microscopic evaluation will be conducted on the material. conclusion will be made from that analysis.

a planktonic concept of the bacteria present on the surface of a chronic wound is no longer viable. microscopic studies show that biofilm is present on chronic wounds yet does not seem to be prominent on the surface of acute wounds. biofilm is able to neutralize our host defenses and commandeer host systems, and possesses an impressive array of defenses and virulence factors. clinically we see a significant difference in the healing behavior between chronic and acute wounds. also, suppression of biofilm using multiple simultaneous strategies including debridement, anti-biofilm agents, specific biocides, antibiotics and advanced technologies improves wound healing. this suggests biofilm plays an important role in delayed wound healing.

Eligibility criteria:

Keywords: acute and chronic wounds
longitudinal study of children with concussions

Conditions: Concussions

Summary: for children and adolescents who have had a concussion resulting in prolonged symptoms (\>3 months), the investigators will: 1. measure post-concussion symptoms, cognitive and emotional function during the 3 years post-injury. 2. determine length of recovery and frequency of return to prior level of sports participation. 3. determine the incidence of and risk factors for subsequent concussion during the 3 years post-injury.


Eligibility criteria:
inclusion criteria: 1. patients between the ages of 8-17 years old who present to one of the lurie sports medicine clinics for care of a concussion. 2. english-speaking patients exclusion criteria: 1. patients outside of the 8-17 years old age range 2. patients who show structural abnormalities on neuroimaging. 3. non-english speaking patients