Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of an ectoine-containing cream in the treatment of mild to moderate atopic dermatitis

Conditions: Mild to Moderate Atopic Dermatitis

Summary: this study evaluates the efficacy of the topical used ectoine-formulation ehk02-01 compared to atopiclair. patients are examined at visit 2 (baseline visit). the patient topically applies ehk02-01 or zarzenda® twice daily on two symmetric lesional areas over 28 days. response to therapy is recorded at each visit.


Eligibility criteria:
inclusion criteria: * female or male individuals between 18 and 65 years in good general health diagnosed atopic dermatitis for ≥ 6 months, in active stage (active stage means severity as measured by overall iga-score between 1 and 4) * at least two comparable areas of stable atopic eczema on bilateral symmetric corresponding sides of the extremities or the body (except for head and genital area), each of at least 10 cm², with a modified, objective local scorad of the test areas \> 5 * both lesional areas of interest must have a difference in the modified, objective local scorad of ≤ 3 * willingness to adhere to the schedule of the investigation, concomitant therapy prohibitions, restrictions, treatment regimen and procedures described in the cip * written informed consent to participate in the trial, prior to any investigation related procedures, indicating an understanding of the purpose of the clinical investigation * a patient of childbearing potential agrees to use a contraceptive methods for the duration of the investigation according to cpmp/ich 286/95 note 3 exclusion criteria: * patients who are self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation * patients with any skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results (e.g. psoriasis) * patients with a known malignancy * presence of any disease and/or condition and/or history of diseases and/or conditions that according to the investigator may interfere with the conduct of the investigation or the evaluation of the results (such as abnormal laboratory values, chronic inflammatory dis-eases, immunosuppressive diseases, autoimmune diseases, liver or kidney diseases, severe infectious diseases) * patients who did not respect the wash-out periods prior to and during the clinical investigation * vaccination within 6 days prior to enrolment and during the study. * patients with a known allergy against any ingredient of the test products * patients who are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months * patients who participate in another clinical trial or have participated in another clinical trial within the last 30 days prior to the first day of investigation * patients who are involved in the organization of the clinical investigation * patients that are in any way dependant on the investigator

Keywords: atopic dermatitis ectoine treatment atopiclair medical device
antibiotic prophlaxis for high-risk laboring women in low income countries

Conditions: Postpartum Sepsis; Postpartum Endometritis; Postpartum Fever

Summary: this study, performed over a course of 3 years in 5 collaborating hospitals in cameroon, africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

this 3-arm study is a large randomized clinical trial designed to evaluate the comparative effectiveness and safety of single dose oral azithromycin or combined azithromycin+amoxicillin compared to placebo for the prevention of peripartum infections and sepsis in laboring women. we have previously shown the effectiveness of azithromycin for extended spectrum antibiotic prophylaxis in addition to the standard cephalosporin alone for reduction of post-cesarean infections. in lics, the fraction of maternal infection and sepsis from cesarean delivery is minimal. therefore, it is necessary to evaluate strategies aimed at reducing these morbidities in women who have vaginal births. there is an increased risk of infection in women who have prolonged labor or prolonged rupture of membranes. drawing from our findings with azithromycin-based extended antibiotic prophylaxis for cesarean delivery, we propose to adapt the intervention and evaluate a single oral dose of azithromycin (with or without oral amoxicillin) to prevent maternal peripartum infection and sepsis. this study, performed over a course of 3 years in 5 collaborating hospitals in cameroon, africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥18 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of amoxicillin, compared to usual care (placebo). women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

Eligibility criteria:
inclusion criteria: * women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with 1. prolonged membrane rupture (≥8 hours) or 2. prolonged labor (≥18 hours). exclusion criteria: * clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention. * allergy to azithromycin or amoxicillin * plan for cesarean delivery prior to enrollment * fetal demise or major congenital anomaly: major congenital anomalies may confound assessment of neonatal outcomes and every attempt will be made up front to exclude them from randomization. however, some unrecognized fetal anomalies may inevitably be randomized. these will not be excluded post-randomization from the primary (maternal outcome) analysis; they will be taken into consideration in the secondary analyses of neonatal outcomes.
patient reported outcomes in living donor lung transplantation

Conditions: Lung Transplantation

Summary: the purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.

in japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. however, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.

Eligibility criteria:
inclusion criteria: * new donors for living donor lung transplantation exclusion criteria: * inability to obtain informed consent

Keywords: living donor lung transplantation health-related quality of life prognosis patient reported outcome
immunogenicity and safety of a single 0.5 ml dose of inflexal v with a 0.25 ml 2-dose regimen of inflexal v

Conditions: Influenza

Summary: the study aims to evaluate the immunogenicity of a single full (0.5 ml) dose and a 0.25 ml 2-dose regime of inflexal v in unprimed children aged 6 - \<36 months, using the ema guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.


Eligibility criteria:
inclusion criteria: * healthy male and female children * aged ≥6 to \<36 months on day 1 * born at a gestational age ≥37 weeks * written informed consent * no previous influenza vaccination exclusion criteria: * acute respiratory infection or other acute disease * acute febrile illness (≥38.0 °c) * past vaccination with an influenza vaccine, including vaccination against the influenza strain a/california/7/2009 (h1n1)-like virus * laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain h1n1 (a/california/7/2009 (h1n1)-like virus) * known hypersensitivity to any vaccine component * known history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for ≥14 days (inhaled or topical steroids are allowed) * known immunodeficiency (including leukemia, cancer, hiv seropositivity) * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * vaccination with the mmr vaccine in the past 4 weeks, or planned within the study period * participation in another clinical trial * child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee * suspected non-compliance

Keywords: influenza virus vaccination immunisation
effect of valaciclovir on inter-appointment pain in endodontic treatment of necrotic teeth

Conditions: Symptomatic Apical Periodontitis

Summary: aim: to investigate the effect of oral valacyclovir on inter-appointment endodontic pain in single-rooted necrotic teeth diagnosed with symptomatic apical periodontitis (sap). materials and methods: this study was a randomized, triple-blind, placebo-controlled clinical trial conducted on 38 teeth. participants were assigned to intervention or control groups using stratified randomization based on gender and baseline pain severity. both groups received similar root canal treatment; the only difference was the administration of valacyclovir in the intervention group and placebo in the control group. patients' pain levels were monitored and recorded at 6, 24, and 48 hours post-treatment using a visual analog scale (vas), along with their consumption of analgesic (ibuprofen).


Eligibility criteria:
inclusion criteria: * patients between 18 and 60 years of age * require primary root canal treatment (rct) in single-rooted maxillary or mandibular teeth (anterior or posterior) * diagnosed with symptomatic apical periodontitis (sap) with confirmed pulp necrosis exclusion criteria: * teeth with unrestorable crowns * presence of endodontic-periodontal or pure endodontic lesions * complex root canal anatomies as defined by the aae endodontic case difficulty assessment form * internal or external root resorption * calcified canals * root canal configuration other than vertucci's type i * pain originating from more than one tooth * marginal periodontitis * parafunctional habits * systemic diseases classified as asa class ii or higher * diagnosed migraine or other headache disorders mimicking orofacial pain * intellectual or cognitive impairments * pregnancy or breastfeeding * use of medications affecting pain perception * current use of antibiotics or antiviral agents * known allergies to study medications

Keywords: symptomatic apical periodontitis (sap) herpes viruse pain valacyclovir
a healthy volunteer study to investigate the relative bioavailability of two forms of gsk598809 capsules.

Conditions: Substance Dependence

Summary: study to compare pk of a new 100mg capsule with four 25mg capsules. this is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. as this is a new previously untested strength we need to ensure that the pk is similar to that achieved using 4 x 25mg. the study will also assess the effect of high fat food on the pk of the 100mg capsule. the study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. there will be a week wash out between each dose. in the three dosing periods subjects will either received 4x25 mg gsk598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg gsk598809 capsule in a fed state. subjects will return to the centre for follow-up 7-14 days after the final dose. it is expected that the total duration of the study should be approximately eight weeks.


Eligibility criteria:
inclusion: * healthy as determined by responsible physician. * male or female between 18 to 65 years old. * females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time. * males that agree to use appropriate method of contraception for appropriate amount of time. * neither too fat nor too thin. * capable of giving written informed consent and being compliant with requirements within the informed consent. exclusion: * any current medical or psychiatric illness. * any history of chronic medical or psychiatric illnesses. * previous or current alcohol or drug abuse/dependence including nicotine. * female subjects must not be breastfeeding or been breastfeeding for a month. * serum prolactin exceeding normal range. * personal or family history of prolonged qtc syndrome.

Keywords: healthy volunteer relative bioavailability.
effects of sucrose added blind to the diet over eight weeks on body mass and weight in men

Conditions: Overweight

Summary: background: sugar intake, especially in liquid, correlates with obesity. yet, whether it is a special cause of obesity is less clear. few experimental studies exist. aim: to replicate the investigators' previous 4 week experiments on women with men over 8 weeks to ascertain if: they gain weight given sucrose soft drinks; mood is affected; energy intake is affected. participants: 80 men bmi 25-35, aged 30-55. procedure: after a week of baseline, over eight weeks single blind 40 men received soft drinks containing sucrose (1650 kj, 97g carbohydrate per day), 40 received control drinks. a three-day food diary with mood ratings and activity levels was completed during baseline and weeks 1, 4 and 8 of the experiment. body mass was recorded weekly with other anthropometric measures.


Eligibility criteria:
inclusion criteria: * bmi 25-35 exclusion criteria: * diabetes, * other health problems, * medication, * dislike of soft drinks

Keywords: sucrose sugar carbohydrate weight gain men
bone metabolism after bariatric surgery

Conditions: Obesity; Osteoporosis

Summary: the purpose and objective of this study is to determine the changes in bone metabolism after bariatric surgery in postmenopausal women. this is a prospective cohort study that will enroll up to 40 postmenopausal female subjects with class ii and iii obesity from the duke center for metabolic and weight loss surgery. the study team will enroll subjects that are already being scheduled for either sleeve gastrectomy or roux-en-y gastric bypass. the osteoclast activity, the osteoblast activity, and the bone mineral density will be measured in all subjects preoperatively and 12 months postoperatively through research specific blood tests and dual energy x-ray absorptiometry (dexa) scans. the primary endpoints are change in osteoclast activity as measured by c-terminal telopeptide of type i collagen and change in bone density as measured by dexa scan. these are continuous variable and given the small sample size the investigators will use a nonparametric wilcoxon rank-sum test to compare the difference in one year change in these variables. there is a slight risk of loss of confidentiality. every effort will be made to protect all phi. there is also the risk of increased exposure to radiation from the dexa scans performed twice with each subjects participating in the study.


Eligibility criteria:
inclusion criteria: 1. postmenopausal women as determined by having a history of no menstrual bleed for greater than one year. 2. body mass index ≥35 kg/m² and stable weight for the previous 3 months. 3. able to speak and read english. 4. being scheduled for either roux-en-y gastric bypass or sleeve gastrectomy. exclusion criteria: 1. a documented history of osteoporosis or currently receiving medical treatment for osteoporosis with bisphosphonates, teriparatide, raloxifene, or denosumab. 2. weight greater than 295 pounds as this is the weight limit for our dual-energy x-ray absorptiometry machine. 3. current or past (less than 1 year from enrollment) usage of estrogen hormone replacement therapy. 4. current smoker 5. any history of glucocorticoid use greater than one year in duration or current use of glucocorticoids.

Keywords: bone mineral density sleeve gastrectomy roux-en-y postmenopausal females bone loss
local subfascial and intramuscular tranexamic acid administration in pediatric patient undergoing scoliosis surgery, double blind randomized control trial

Conditions: Blood Loss, Surgical; Scoliosis

Summary: we hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery

spine surgery in paediatrics is frequently associated with substantial blood loss. blood product adminestration in children has many complications that are not fully known. there are many modalities currently available to reduce blood loss in pediatric patients. tranexamic acid is tissue plasminogen activator inhibitor that reduce perioperative blood loss. to date, no studies have investigated effect of local administration of tranexamic acid in pediatric population undergoing scoliosis surgery.

Eligibility criteria:
inclusion criteria: * children aged 2-12 years * of both sexes * american society of anesthesiologist (asa) physical status classification class i * undergoing general anesthesia for scoliosis surgery exclusion criteria: * parents' refusal of regional block * known allergy to tranexamic acid * bleeding disorders (inr \>1.4,platelet count\< 75000)
observational study of misuse of high dose buprenorphine (subutex® or generic) in opiate-addicted patients in france (study p05186am1)(completed)

Conditions: Buprenorphine; Naloxone; Opiate-related Disorders; Opiate Dependence; Drug Abuse

Summary: the purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. approximately 1250 patients taking subutex (schering-plough) or its buprenorphine high dose (bhd) generic (arrow laboratories) will participate in this study. data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.

approximately 380 physicians will participate in this study. patients will be enrolled in chronological order of consultations.

Eligibility criteria:
inclusion criteria: * eligible patients will be those already having a prescription for subutex or its bhd generic, or being proposed a prescription for subutex or its bhd generic for the first time when consulting the participating physician. * the patient must have been informed orally and in writing via the information notice and have signed it. exclusion criteria: * criteria of non-eligibility will be related to the contraindications in the marketing authorization (ma) of subutex or its bhd generic

Keywords: subutex
clinical application of dual sentinel lymph node staining method in breast cancer patients

Conditions: Breast Cancer

Summary: this study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (icg) with radioisotope(ri), and ri only. to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using ri only has several disadvantages such as invisibility, interference. as icg can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.

using mixture of indocyanine green (icg) with radioisotope (ri) can guide surgeons to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast to the axillary lymph node basin. last pilot study, sentinel lymph node was successfully identified by using dual method of icg and ri in 5 patients. in this study, when radiolabeled colloid is used, a gamma probe identifies radioactivity in the lymph nodes in the axilla. if icg, ri both used, near infrared fluorescence camera visualized during surgery. as investigators measure node detection time from axillary approach moment, investigators are going to compare detection rate. (icg+ri or ri only). and determine the accuracy. sentinel lymph node mapping with both icg and radiolabeled colloid mapping agents was recommended to maximize the likelihood of sln identification and to minimize the possibility of missing slns, which could result in a false-negative event.the protocol required that 130 patients who receive neoadjuvant chemotherapy. in this study investigators expects using mixture of indocyanine green (icg) with radioisotope (ri) has potential to improve sentinel lymph node (sln) mapping in breast cancer patients who receive neoadjuvant chemotherapy. sentinel lymph node mapping with both icg and radiolabeled colloid mapping agents was recommended to maximize the likelihood of sln identification and to minimize the possibility of missing slns, which could result in a false-negative event.

Eligibility criteria:
inclusion criteria: * breast cancer patients who receive neoadjuvant therapy (chemotherapy,hormonal therapy, targeted therapy) * cn1-cn2 or cn3( but must be complete response status)on tumor lymphnode metastasis classification( tnm) after neoadjuvant therapy. * ecog performance status 0 or 1 * consented patients with more than 20 years, less than 70 years exclusion criteria: * history of breast cancer * early stage breast cancer * history of excisional or incisional biopsy or axillary dissection * inflammatory breast carcinoma * cn3 on tumor lymphnode metastasis classification(tnm) * stage 4 breast cancer * pregnancy

Keywords: neoadjuvant chemotherapy indocyanine green (icg) radioisotope (ri) near infrared fluorescence camera
chronic remote ischemic conditioning in vascular cognitive impairment: a dose escalation study

Conditions: Age-related Cerebral White Matter Changes; Cognition Disorder

Summary: to evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in patients with age-related cerebral white matter hyperintensities on mri, in preparation for a subsequent larger efficacy trial.

objective: the objective of this early phase study is to evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in preparation for a subsequent larger efficacy trial. in addition, we will evaluate the tolerability and adherence to the treatment protocol. aim: we aim to measure blood biomarkers in response to daily remote ischemic conditioning (ric) using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on mri. hypothesis: we hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion.

Eligibility criteria:
inclusion criteria: 1. age ≥55 years 2. head mri in the past 6 months showing no more than moderate age related cerebral white matter changes (fazekas score 0-2). 3. able to walk without assistance \& independently perform basic activities of daily living. 4. able to understand this study and agree for a valid consent. exclusion criteria: prior non-lacunar (cortical) stroke. 2. unable to cooperate with the use of the conditioning device. 3. confounding illness that might interfere with the interpretation of results (such as active malignancy or multiple sclerosis). 4. contraindication to transient arm ischemia in either arm (such as symptomatic peripheral artery disease).