Kornimate/medical-research-clean huggingface dataset:
clinical study on chinese children's asthma action plan

Conditions: Asthma in Children

Summary: this study is a multi-center randomized controlled trial of children with asthma. the objective of the study is to assess the efficacy of china children asthma action plan (ccaap), which is the first asthma action plan for children with asthma in china, in asthma management.

asthma is the most common chronic illness of childhood. asthma action plans have been recommended internationally for more than 20 years by the global initiative for asthma and have been shown to improve asthma-related outcomes. the first asthma action plan for children with asthma in china, which is termed china children asthma action plan（ccaap）, as well as a mobile phone-based asthma self management application(app), were developed recently. the objective of the study is to assess the efficacy of ccaap in asthma management. the study is a multi-center prospective case-controlled study.the enrollment period is 3 months. patients who is in 6-14 years of age will be randomized recruited into two groups: the asthma action plan group and the conventional group. patients in asthma action plan group will receive written ccaap and mobile phone-based asthma self-management app (youran respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and peak expiratory flow meter. patients in conventional management group will write down the symptoms and pef in asthma diary. the data of the number of asthma episodes, the improvement of fev1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, act / c-act score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of ccaap in asthma management. the study will recruit 200 cases for each group from ten children's hospitals. the study will be completed in a year.

Eligibility criteria:
inclusion criteria: * did not receive control treatment or did not reach well-control; * can perform spirometry pulmonary function tests; * parents are skilled in using smartphones and app apps (android or ios). exclusion criteria: * reach the level of asthma control; * can not use the smartphone app software; * can not cooperate the test of peak expiratory flow; * did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.); * combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.). * receiving allergen-specific immunotherapy. * undergoing trial for other medications or instruments.

Keywords: asthma children action plan china ccaap
the role of telemedical monitoring in diabetic foot ulcer care

Conditions: Diabetic Foot - Telemedical Monitoring

Summary: the role of telemedical monitoring in diabetic foot care is still uncertain. the aim is to compare telemedical + standard and standard alone outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. the primary outcome of the overall study is the time of ulcer healing. the number of amputation, hospital admissions and surgical procedure will be also reported. investigators hope to include 150 patients in this study.


Eligibility criteria:
inclusion criteria: * the patients treated in the diabetology department of chu de reims during the inclusion phase to a diabetic foot lesions ( infected or not). * patients with care of this lesion of diabetic foot externally. * patients who agreed to participate in or accepting ornicare network ( network for the transmission of information between health care professionals) (appendix 3) . * patients aged over 18 years . * patients who agreed to participate in the study . * the patients insured by a social security scheme . exclusion criteria: * patients requiring hospital care of the lesion of diabetic foot (infection requiring surgical intervention , ischemia requiring revascularization , ...). * patients are protected by law . * minor patients.
special drug use investigation for botox® (botulinum) spasticity (botox is a registered trademark of allergan, inc.)

Conditions: Mumps

Summary: the objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.


Eligibility criteria:
inclusion criteria: * subjects with upper or lower limb spasticity * subjects must use botulinum injection for the first time exclusion criteria: * not applicable
internet-cbt for gambling disorder - a randomized controlled trial

Conditions: Gambling Disorder

Summary: the study is a randomized controlled trial (total n=150; each condition n=75) of internet-based cognitive behavioral therapy (icbt), with measures at pre, weekly during treatment, post, three and at six month follow-up. participants will be assigned to either standard icbt and "spelpaus" (treatment condition), or "spelpaus" only (control condition).

recruitment will be done through online advertisement via social media and gambling-related websites. participants will self-referred to the study via a study dedicated website (www.spelstudien.se). login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the swedish ethical review authority). written information about the study will be provided on the web page. consent will be done online, with the possibility for participants to download study information and consent. consenting participants will start a screening procedure. after screening, participants will be contacted for a telephone assessment with a clinical psychologist. during this interview, participants will be assessed for gd with a diagnostic interview, as well as the inclusion criteria for utilization of "spelpaus". if meeting criteria for the study, participants will be referred to the baseline/pre-measures - which will start with an additional informed consent for the treatment phase and the icbt. inclusion will be done after the completion of the informed consent and baseline/pre-measures. after that, participant will be randomized to icbt and "spelpaus" (treatment condition), or "spelpaus" only (control condition). randomization will be conducted by a third party using a true random service, https://random.org. participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 swedish krona's when completing the post and follow up measures. participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 swedish krona's when completing the post and follow up measures.

Eligibility criteria:
inclusion criteria: * screen positive for gd, as measured with the gambling disorder identification test (total score ≥20 gdit). * fulfilling gd, assessed according to the structured clinical interview for gambling disorder (sci-gd). * utilization of "spelpaus", 3 months from treatment start. * ≥18 years of age. * able to provide digital informed consent. exclusion criteria: * other ongoing psychological treatment for gd. * severe depression, screened according to the montgomery åsberg depression rating scale (total score \>34 madrs-s). * suicidality, screening of ≥4 points on item 9 of the madrs-s
safety and efficacy evaluation of orbital atherectomy system in de novo calcified lesions

Conditions: Angiography; Coronary Calcification

Summary: this is a french, prospective, single-arm, multi-center registry to confirm the safety and efficacy of the diamondback 360 tm orbital atherectomy system in the preparation of de novo calcified coronary lesions before implantation of a coronary endoprothesis in adult subjects. the primary safety endpoint is 30-day mace and the efficacy endpoint is procedural success.

treatment of calcified lesions, caused in 6 to 20% of patients, remains a challenge. presence of coronary calcifications complicates stent placement resulting in up to 50% malapposition or under-expansion of the stent and is associated with a higher frequency of major adverse cardiac events (mace). in order to reduce these risks, preparation of these lesions before the implantation of a coronary stent is essential. the arrival on the european market of a new orbital atherectomy system leads to consider its use in the preparation of such lesions. the orbital atherectomy system uses a diamond-coated eccentric crown that abrades calcified plaque and develops pulsatile forces on the wall. it reduces calcified plaque and modifies plaque with fractures, facilitating stent placement and allowing for optimal stent expansion. orbit i and orbit ii clinical trials were conducted in the united states to evaluate the safety of using the orbital atherectomy system in de novo calcified coronary lesions in adults. these 2 trials demonstrated that orbital atherectomy not only facilitated stenting, but also improved clinical outcomes compared to historical outcomes. the recent obtaining of ce marking allows the use of this very promising medical device in france.

Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years * patients with a clinical indication for coronary angioplasty and presenting a de novo calcified lesion * the target vessel reference diameter must be \>= 2.5mm and \<= 4.0 mm. * lesion length \<= 40 mm * the target vessel must be a coronary artery with a stenosis of \>70% * patients able to understand and provide informed consent * patients with social security coverage exclusion criteria: * patients with an lvef \< 25%. * patient with hypersensitivity to egg, soy or peanut proteins or to one of the active substances or one of the excipients of viperslide lubricant. * pregnant or breastfeeding woman * unwilling or unable to sign the informed consent * patients under judicial protection, tutorship or curatorship * angiographic criteria: intra-stent stenosis, presence of a chronic total occlusion (cto), bypass lesion, target vessel excessively tortuous, presence of a thrombus, presence of a single permeable vessel
improving treatment engagement for adolescents with bulimia nervosa

Conditions: Eating Disorders

Summary: although 4.7% of adolescents suffer from symptoms of bulimia nervosa (bn), only 1/5 seek treatment. hesitation to seek treatment is likely related to ego-syntonicity and fear of disclosing symptoms to parents and clinicians. furthermore, the physical symptoms of bn often go unnoticed by parents and clinicians. in order to eliminate the barriers that prevent adolescents from seeking treatment, this study will offer anonymous access to online self-help cognitive behavioral therapy (cbt) for bn. online cbt (traditional, non-anonymous delivery) has been found to be effective and acceptable treatment for adolescents with bn. furthermore, in adults, this method has been found to be as effective as specialized treatments, and more cost efficient. to remain anonymous and accessible, the self-help approach in this study will be provided in a non-guided, or pure format (only online sessions). studies support that a pure self-help methodology is as effective as a guided version. although anonymity may improve accessibility, this study design could also pose challenges in areas such as recruitment, treatment completion and obtaining adequate informed consent. therefore, before embarking on a larger randomized control trail, we would like to propose a small, non-controlled feasibility study to assess potential issues in these areas. primary hypotheses: recruitment: based on communication with public health nurses in the high schools we plan to recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month period from each of the 5 schools, and 1-5 from social media outlets such as instagram, twitter, facebook for a total of 5 participants over a 4-month period. treatment completion: based on pervious studies of self-help for adolescent bulimia, we hypothesize that approximately 15% of participants will not complete any sessions, and many will only complete about half of the sessions. informed consent: based on information from large randomized control studies in the uk, we hypothesize that adolescents will be capable of providing online consent, and that we will be able to adequately obtain consent without verbally communicating with participants. secondary hypothesis: we hypothesize a non-guided (pure) version of online cbt-bn offered in an anonymous manner will decrease bn symptoms after treatment completion, and at 3-month follow-up compared to baseline.


Eligibility criteria:
inclusion criteria: * adolescents with symptoms of bn (full threshold or subthreshold) defined by self-reported symptoms of binging and compensatory behaviours (self-induced vomiting, laxative abuse, diet pills, and diuretics). excessive exercise and fasting will not be included due to the potential for subjectively in a self-report format. * ages of 16-18. * consent from the adolescent. exclusion criteria: * adolescent is actively engaged in psychological treatment for bulimia nervosa.

Keywords: eating disorders self help anonymous cbt
treatment of bacterial vaginosis combined with human lactobacilli

Conditions: Bacterial Vaginosis

Summary: the primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against bacterial vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

nine of the vaginal lactobacillus strains isolated from healthy swedish women and characterized in the present study were selected for the clinical trial.all women with symptomatic bv fulfilling the inclusion criteria were consecutively offered to participate in a prospective study of adjuvant lactobacilli given in addition to antibiotics. women included were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. exclusion criteria were patients with hormonal intrauterine device without regular menstruation; women infected with chlamydia trachomatis or with trichomonas vaginalis, or with a clinical candida infection.

Eligibility criteria:
inclusion criteria: * were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. exclusion criteria: * exclusion criteria were patients with hormonal iud without regular menstruation; women infected with chlamydia trachomatis or with trichomonas vaginalis, or with a clinical candida infection

Keywords: treatment, lactobacilli
study of post-operative complications after laparoscopic outpatient nephrectomy

Conditions: Kidney Cancer

Summary: the purpose of this study is to compare to assess the incidence of post-operative complications related to nephrectomy, which occur up to 1 month after the operation.

this is an observational, prospective, open, non-comparative (single arm), single-centre study. the study population consisted of adult patients diagnosed with localised kidney cancer and scheduled for outpatient partial or total laparoscopic nephrectomy. patients eligible for outpatient surgery will be identified during the initial consultation with the urological surgeon. when the indication for surgery has been validated at the multidisciplinary consultation meeting and is planned to be performed as an outpatient procedure, the study will be proposed to the patient by the investigator during the preoperative consultation.

Eligibility criteria:
inclusion criteria: * patients over 18 ; * localised kidney cancer ; * validation of curative treatment at a multidisciplinary consultation meeting; * partial or total laparoscopic nephrectomy scheduled on an outpatient basis; * membership of a social security scheme or receiving state medical aid; * patient able to understand the information relating to the study, to read the information leaflet and who has given his/her oral non-objection. exclusion criteria: * emergency intervention ; * patient not eligible for outpatient treatment; * long-term curative anti-coagulant treatment ; * resident more than 100km from the clinic; * home alone on the first night; * patient of protected age (under guardianship or curatorship, or deprived of liberty).
a prospective, randomized comparison of subcutaneoous and transvenous implantable cardioverter defibrillator therapy

Conditions: Ventricular Arrhythmias

Summary: this randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (icd) compared to the transvenous icd.

background of the study: the use of implantable cardioverter defibrillators (icds) is an established therapy for the prevention of death from ventricular arrhythmia. recently a new subcutaneous icd has been introduced, eliminating the need for transvenous lead placement in or on the heart which is mandatory in the transvenous icd. the new subcutaneous icd therapy already proved to be feasible and safe and is an approved therapy in europe. it is likely that the eliminated need for transvenous lead placement substantially reduces the implantation related complications and elongates lead longevity and thus reduces inappropriate shocks associated with lead fractures. on the other hand it is unclear whether the lack of capability to provide antitachy-pacing (atp) in the subcutaneous icd may be a limitation for patients with frequent recurrent ventricular tachycardia. this randomized controlled trial will outline the advantages and disadvantages of the subcutaneous icd. objectives of the study: (1) to compare the subcutaneous icd to the transvenous icd for major adverse events (i.e. inappropriate shocks, acute and chronic implant related complications and lead- or device related complications). (2) to determine to which degree the lack of atp function leads to more appropriate shocks in patients with a subcutaneous icd. study design: multicenter, prospective, randomized controlled trial with either treatment with the transvenous icd or subcutaneous icd (1:1). study population: 2x425 patients with class i or iia indication for icd therapy without an indication for pacing.

Eligibility criteria:
inclusion criteria: * patients 18 years and older * patients with class i or iia indication for icd therapy according to the acc/aha/esc 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death exclusion criteria: * patients with documented therapy refractory monomorphic ventricular tachycardia * patients having an indication for pacing therapy * patients with ventricular tachycardia less than 170 bpm * patients failing appropriate qrs/t-wave sensing with the s-icd ecg patient screening tool provided by cameron health/boston scientific * patients with incessant ventricular tachycardia * patients with a serious known concomitant disease with a life expectancy of less than one year * patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.) * patients who have had a previous icd implant * patient who receive cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy. * patients who are unable to give informed consent

Keywords: heart rhythm disturbances implantable cardiac defibrillator
impacts of a combined berry extract supplement on vascular function and oxygen utility capacity in young adults

Conditions: Healthy

Summary: the purpose of this study is to investigate the impacts of a combined berry extract supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in healthy young adults.

there are several proposed mechanisms that are thought to contribute to the development of cardiovascular diseases. although the process is extremely complex, it is well-accepted that elevated levels of reactive oxygen species (ros) production and inflammation contribute to the systemic vascular dysfunction in cardiovascular diseases. these factors often partially contribute to endothelial dysfunction, elevated blood pressure, reduced oxygen utility capacity, and reduced muscle function. therefore, by reducing ros and inflammation, there may be protective effects against vascular dysfunction and thus protection against cardiovascular disease manifestation. intake of natural anthocyanins and polyphenols derived from fruits and vegetables has been shown to reduce excessive ros and inflammation in several populations. therefore, the purpose of this study was to investigate the impacts of a combined berry extract supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in healthy young adults.

Eligibility criteria:
inclusion criteria: * otherwise healthy adult exclusion criteria: * cardiovascular disease * neurological disorder * metabolic disorder * respiratory disorder * renal diseases * musculoskeletal injury * bleeding disorder * allergy to fruit * pregnant/breast feeding * taking daily medication (prescription or over-the-counter)

Keywords: anthocyanin endothelial function oxygen vascular function blood pressure antioxidant
fractional co2 laser with topical pentostam treatment for cutaneous leishmaniasis.

Conditions: Leishmaniasis

Summary: the investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional pentostam to fractional co2 laser with topical application of pentostam. outcome will be final scar appearance assesd by two dermatologist and pain measurement by vas.

20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be recruited. half of the lesions will be treated with intra-lesional injections of pentostam, and the other half by co2 laser with topical application of pentostam. each lesion will recieve 3 treatments, one month apart between treatments. the patients will scale pain level of each treatment. final scar appearance will be assessed by two dermatologists, without knowing what treatment was applied to each lesion.

Eligibility criteria:
inclusion criteria: * objective cutaneous leishmaniasis diagnosis. * more than one lesion exclusion criteria: * previous treatment * abnormal scarring
cariatide (compliance of aromatase inhibitors assessment in daily practice through educational approach)

Conditions: Breast Cancer

Summary: this observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of ais, anastrozole or letrozole, according to the current product smpcs. there is no investigational medicinal product (imp) to be taken in this observational study. the adjuvant ai medication must not have exceeded thirteen weeks. in cariatide (compliance of aromatase inhibitors assessment in daily practice through educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.


Eligibility criteria:
inclusion criteria: * postmenopausal woman with hormone sensitive early breast cancer * documented decision of treatment with upfront adjuvant ai (either anastrozole or letrozole) according to current smpc or current treatment with ai (either anastrozole or letrozole) according to current smpc, that has not exceeded thirteen weeks exclusion criteria: * upfront adjuvant ai medication which has exceeded thirteen weeks at randomisation * concomitant adjuvant treatment with tamoxifen or exemestane * previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks

Keywords: breast cancer hormone therapy aromatase inhibitor