Kornimate/medical-research-clean huggingface dataset:
evaluation of safety and performance of the orbix breast lift system

Conditions: Breast Ptosis

Summary: the study is using a new breast lift system to complement a breast-lift operation. in general there will be recurrence of breast-ptosis after a correcting operation. with this device we want to minimize this recurrence and provide an "internal bra".


Eligibility criteria:
inclusion criteria: 1.female subject between 30-50 years of age 2. subject is referred for mastopexy(breast lifting)due to one of the following reasons: * breast ptosis grade i or ii (minimal invasive) * breast ptosis grade i to iv (open procedure) * pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. minimal invasive: breast cup size \<c exclusion criteria: 1. pregnant or lactating women 2. history of surgical procedures involving the ribs and rib cage 3. osteoporosis 4. breast implants 5. breast carcinoma 6. auto-immune disease -

Keywords: breast ptosis, breast lift
multicenter descriptive study of the patient clinical profile that begins with disseminated her 2 + breast cancer or develops a metastasis after or during the adjuvant therapy

Conditions: Disseminated HER2+ Breast Cancer

Summary: this is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated her 2+ breast cancer or develops a metastasis after or during the adjuvant treatment.


Eligibility criteria:
inclusion criteria: * women with 18 years or over * patients with disseminated breast cancer histologically or cytological confirmed, who begins with her 2+ metastatic breast cancer or develops a metastasis after or during the adjuvant therapy * patients treated in first line treatment in metastatic disease. * patients who have positive her 2 receptor test * patients who have given their written informed consent exclusion criteria: * patients who are participating in other studies
observation of young patients with localized neuroblastoma who have undergone surgery only

Conditions: Long-term Effects Secondary to Cancer Therapy in Children; Neuroblastoma

Summary: rationale: observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. observation may help doctors see how effective surgery is in treating neuroblastoma. purpose: this phase ii trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.

objectives: primary * evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without n-myc amplification (nma). secondary * determine predictive factors of relapse and survival of patients with stage 1, 2a, or 2b neuroblastoma without nma who have undergone surgery only. outline: this is a nonrandomized, multicenter study. patients with stage 1 or 2 disease and no n-myc amplification (nma) undergo observation comprising clinical evaluation, ultrasound or ct scan of the abdomen, and chest x-ray periodically for up to 5 years. all other patients undergo additional therapy and follow-up according to national standards. patients who develop recurrent disease or disease progression may undergo surgical resection, preceded or followed by chemotherapy, according to national standards. projected accrual: a total of 140 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed neuroblastoma or ganglioneuroblastoma * meets 1 of the following international neuroblastoma staging system (inss) criteria: * stage 1 * stage 2a or 2b meeting 1 of the following criteria: * with or without n-myc amplification * no evaluation of nma * symptomatic spinal cord compression * stage 3\* * dumbbell syndrome with clinical signs of spinal cord compression\* * note: \*these patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment * has undergone complete or gross surgical resection or diagnostic surgical or needle biopsy * no metastases within 1 month of diagnosis * no skin metastases by clinical examination and mibg scan * normal liver by ct scan or ultrasonography * normal chest x-ray (in case of nonthoracic primary site) patient characteristics: * not specified prior concurrent therapy: * see disease characteristics * prior steroids allowed * no prior chemotherapy

Keywords: long-term effects secondary to cancer therapy in children localized resectable neuroblastoma localized unresectable neuroblastoma regional neuroblastoma
anti t-lymphocyte immunoglobulin with post transplant cyclophosphamide to prevent gvhd post allogeneic transplantation

Conditions: Graft Versus Host Disease

Summary: investigators hypothesize that combination of atlg with ptcy in matched or mismatched unrelated hematopoietic stem cell transplantation will reduce acute and chronic gvhd incidence. furthermore it will allow shortening of the length of post-transplantation immunosuppression with calcineurin inhibitor (cni) administration (currently administrated in addition to atg as gvhd prophylaxis in daily common practice)


Eligibility criteria:
inclusion criteria: 1. patients with mds/aml 2. 18 years or older and willing and able to comply with the protocol requirements. 3. lvef ≥ 40%. 2-d transthoracic echocardiogram (echo) is the preferred method of evaluation. multigated acquisition scan (muga) is acceptable if echo is not available. 4. patients undergoing 8-10/10 hla matched unrelated and unmanipulated pbsc transplantation 5. patients conditioned with reduced intensity or reduced toxicity conditioning of fludarabine with reduced dose (2 days) or myeloabalative doses (4 days) of busulfan or with treosulfan. 6. patients must sign written informed consent. 7. adequate birth control in fertile patients. exclusion criteria: 1. patients undergoing other type of transplantation or with other type of basic disease other than aml or mds. 2. patients with respiratory failure (dlco \< 30%). 3. active congestive heart failure (new york heart association \[nyha\] class iii to iv), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. 4. psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate 5. bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit 6. creatinine \> 2.0 mg/dl 7. ecog-performance status \> 2 8. uncontrolled infection 9. pregnancy or lactation 10. cns disease involvement 11. pleural effusion or ascites \> 1 liter.

Keywords: anti thymocyte globulin cyclophospamide graft-versus-host disease stem cell transplantation
prognostic evaluation of changing endocrine therapy in women with breast cancer

Conditions: Breast Cancer

Summary: it suggests in the guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (serms) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (ais). this is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from serms to ais in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. * age of at least 45 and at most 55 years. * performance status (karnofsky-index) \>80% * steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures). * no clinical evidence of local recurrence or distant metastases. * complete staging work-up within 3 months prior to registration. all patients must have (bilateral) mammography or breast mri, chest x-ray; other tests may be performed as clinically indicated. * patients have taken the serms as endocrine therapy for 2-4 years. * patients who have had amenorrhea for at least half a year. * life expectancy of at least 10 years, disregarding the diagnosis of cancer. * adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution. * patients must be available for and compliant to treatment and follow-up. * patients registered on this trial must be treated and followed up at the participating center. exclusion criteria: * known hypersensitivity reaction to the investigational compounds or incorporated substances. * hormone receptor-negative breast cancer. * local recurrence and/or metastasis of breast cancer. * history of hysterectomy. * pregnant or lactating patients. patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration. * history of osteoporosis and/or fractures due to osteoporosis. * prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) * any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias * other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study. * concurrent treatment with other experimental drugs or any other anti-cancer therapy. * males.

Keywords: breast cancer endocrine therapy perimenopausal and recently postmenopausal patients early-stage hormone receptor-positive
descriptive analysis of changes in hepatitis b markers in people living with hiv on injectable therapy.

Conditions: Hiv Infection; Hepatitis B

Summary: in order to assess the risk of hepatitis b reactivation in people living with hiv and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis b markers in this population.


Eligibility criteria:
inclusion criteria: -hiv infected patients under injectable art exclusion criteria: -active hbv infection
cortical excitability changes induced by retigabine: a transcranial magnetic stimulation study

Conditions: Epilepsy

Summary: the objective of this study is to characterize the effects of a single-dose of retigabine on cortical excitability in healthy subjects, as quantified by means of tms.

epilepsy is a disorder of brain excitability. antiepileptic drugs (aeds) modulate this excitability and transcranial magnetic stimulation (tms) imposed itself as one of the best noninvasive methods to study cortical excitability in human subjects. based on several recent studies, we hypothesize that measuring tms parameters in the patients suffering from epilepsy can rapidly predict the effectiveness of the newly given aed and, ultimately, guide the optimization of the aed therapy. characterizing the neurophysiological properties of innovative aeds such as retigabine with tms will allow 1) to better understand how aeds modulate, in vivo, cortical excitability in humans in relation to their mode of action and 2) to establish tms as a tool for assessing individual responsiveness to a particular aed treatment and for antiepileptic treatment monitoring. the effects of most aeds on cortical excitability have been investigated. the modifications of the excitability parameters are related to the specific mode of action of each aed. for the new aed retigabine, at least two modes of action are known: 1) increase in cellular potassium efflux by changing conformation of the kv7.2-7.3 channels and 2) enhancement of gaba-a activity.

Eligibility criteria:
inclusion criteria: * age 18-50 years * being "healthy" * willing to participate and able to understand study and provide informed consent exclusion criteria: * intake of psycho-active drugs (aeds, antidepressants, benzodiazepines, neuroleptics, hypnotics, ...) * alcohol or drug abuse * antecedent of seizure * contra-indication to tms (metal in the head, skull fracture) * contra-indication to retigabine.

Keywords: retigabine cortical excitability transcranial magnetic stimulation
virtual reality in rehabilitation of executive functions in children with mild or moderate traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) causes lifelong disability. children with tbi often have difficulties in attention regulation and executive functions affecting their daily living. need for rehabilitation is often long-lasting and there is an increasing demand for timely, cost-effective, and feasible rehabilitation methods, where the training is targeted to support daily life functional capacity. the use of virtual reality (vr) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations. the aim of this research project is to develop a novel effective vr rehabilitation method for children with deficits in attention, activity control, and executive functions by using a virtual environment that corresponds to typical everyday life. in this randomized control study, vr glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress. the researchers expect that; 1) intensive training improves the attention regulation, activity control skills, and executive functions of the children in the intervention group 2)training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3)the duration of the training effect does not depend on the success of the vr training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.


Eligibility criteria:
inclusion criteria: * mild to moderate traumatic brain injury (icd-10: s06.0-s06.6 and s06.8-s06.9 and criteria defined in the current care recommendation, 2021) and * the challenges of attention and executive function identified in the assessment of a neuropsychologist/experienced psychologist and * age 8-12 years and * finnish as a native language exclusion criteria: * sensitivity to flashing light, * epilepsy (icd-10 g40), * mental retardation (icd-10 f70-f79), * pervasive developmental disorders (icd-10 f84), * inflammatory diseases of the central nervous system (icd-10 g00-g09), * severe cerebral palsy syndrome (icd-10 g80, gmfcs 4-5, macs 3-5), * brain tumour, and * multiple pregnancy

Keywords: traumatic brain injury attention executive function virtual reality child
bioactive composite versus resin-modified glass ionomer liners: 2-year clinical trial

Conditions: Dental Caries

Summary: compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.

patients were enrolled in the clinical trial. each patient had two deep carious lesions, one on each side of the mouth. after selective caries removal, cavities were lined with bioactive ionic resin composite (activa bioactive liner/base) or resin-modified glass ionomer liner (riva light cure rmgi). all cavities were then restored with nanofilled resin composite (filtek z350xt). all materials were placed according to the manufacturers' instructions. clinical evaluation was accomplished using world dental federation (fdi) criteria at baseline and after 6 months, one year, one and half years, and two years.

Eligibility criteria:
inclusion criteria: * presence of two deep carious lesions, one on each side of the mouth (icdas 5 or 6) * vital teeth * no sensitivity to teeth percussion * no spontaneous pain * no radiolucency in the periapical or furcation area of teeth * complete and normal occlusion * good oral hygiene exclusion criteria: * poor oral hygiene * severe or chronic periodontal problems * periapical lesions * heavy bruxism * non-vital teeth * visibly cracked teeth * spontaneous dental pain * sensitivity to teeth percussion
nosocomial influenza surveillance of 2022 - 2027 seasonal period

Conditions: Infection Viral

Summary: hospital-acquired influenza (hai) is closely linked to the intensity of influenza in the community. hai is associated with significant morbidity, mortality and extra costs due to prolonged hospital stay. the incidence of laboratory confirmed hai has been reported rarely. the proportion of hai among influenza cases was 11.38% (95% confidence interval: 5.19%-19.55%) in a meta-analysis of 14 studies. in france, a prospective surveillance study of adults with influenza-like illness (ili) over 11 years, reported that 35.6% of the influenza cases diagnosed at hospital were hospital-acquired. hai is transmitted via respiratory droplets and by hand contacts. the spread is facilitated by health care professionals (hcps), patients and visitors. prevention and control of hai is of upmost importance to preserve patient safety and limit the related economic costs. while vaccination of hcps has been shown to contribute to the reduction of hai, less is known on the impact of patient vaccination on the risk of hai during hospitalization. the aim of this study is to describe the hospital-acquired influenza in a french university hospital.


Eligibility criteria:
inclusion criteria: * any volunteer adult patient (≥ 18 years of age) hospitalized for at least 24 hours on a study unit, who had a nasopharyngeal swab taken as part of care for the purpose of diagnosing influenza by pcr testing and who had an influenza-like illness meeting the following definition: * fever greater than 37.8°c in the absence of antipyretics; and/or * cough or pharyngeal pain. exclusion criteria: * any person who does not meet the above definition or who has expressed opposition.

Keywords: influenza hospital nosocomial
a study of the safety and efficacy of mk-0773 in women with sarcopenia (loss of muscle mass)(mk-0773-005)

Conditions: Sarcopenia

Summary: a study to evaluate the safety, tolerability, and efficacy of mk-0773 in women with sarcopenia (loss of muscle mass).


Eligibility criteria:
inclusion criteria: * patient is a woman who is 65 years of age or older * patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population * patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or activity measure for post acute care (am-pac)\<66 exclusion criteria: * patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions * patient has a history of certain types of cancer

Keywords: sarcopenia (loss of muscle mass)
observational study with innolet® in daily clinical practice

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to review the efficacy and safety of insulin treatment with innolet® in daily clinical practice.


Eligibility criteria:
inclusion criteria: * diabetes mellitus (type 1 or type 2) * need insulin treatment
immune reconstitution in naïve hiv patients with cd4 <100 cells/ml when treated with lopinavir or efavirenz.

Conditions: HIV Infection

Summary: pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with cd4 count below 100 cells/ml, when treated with tenofovir and abacavir together with lopinavir or efavirenz.


Eligibility criteria:
inclusion criteria: * hiv-infection * antiretroviral-naive * cd4 cell count below 100 cells/mm3 exclusion criteria: * pregnancy * current opportunistic infection requiring parenteral therapy * current malignancies requiring parenteral chemotherapy * any contraindication to the study drugs
quality of life in advanced gastric cancer patients receiving neoadjuvant chemotherapy

Conditions: QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy

Summary: the purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients.

preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was included in the 2018 version of the national comprehensive cancer network (nccn) guideline as an optional treatment (category 2b) for prospective resectable advanced gastric cancer cases (≥ct2, any n).at home and abroad, the research on neoadjuvant chemotherapy for advanced gastric cancer mainly focuses on the safety and long-term survival, and there are few studies on the quality of life. this study, according to eortc qlq-c30 and qlq-sto22 assessment scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in patients with advanced gastric cancer.

Eligibility criteria:
inclusion criteria: * patients age older than 18 years (including 18 years old); * diagnosis of adenocarcinoma of the stomach * the clinic stage is ≥t2 and any n stage * patient had curative surgical resection, including proximal, distal, or total gastrectomy exclusion criteria: * psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires * non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke) * early gastric cancer.
early diagnosis and treatment standardization of delirium

Conditions: Delirium

Summary: 1. observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors 2. design a guideline for delirium, diagnosis or treatment

the study is consisted of two parts; first, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records. second, designing a guideline for treating delirium patients in korea using the study data and reviewing other studies, guidelines.

Eligibility criteria:
inclusion criteria: * curable malignant gastric cancer exclusion criteria: * gastrointestinal stromal tumor * uncurable cancer

Keywords: gastric cancer postoperative subsyndromal delirium quality of life