Kornimate/medical-research-clean huggingface dataset:
evaluating the use of magnetic resonance imaging and contrast enhanced mammography after magtrace® use

Conditions: Breast Cancer

Summary: rationale: magtrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. however, magtrace® is known to interfere with mri during follow-up imaging when using 2 ml. no data is available for patients who received 1 ml of magtrace®, as is described in our current protocol. a contrast enhanced mammography (cem) could be an alternative for mri if it still shows artefacts. objective: the primary objective in this trial is to evaluate the use of mri and contrast enhanced mammography after using magtrace® to perform a sentinel node biopsy. study design: prospective trial in an outpatient clinic setting. study population: patients who were included in the previous magtrace study will be asked to participate in this subsequent trial. study procedure: participants will undergo mri and cem as standard 1-year follow-up. since the magtrace study started in august 2021 and finished in february 2022, this trial will start august 2022 to february 2023. main study parameters/endpoints: to evaluate the use of mri and cem, the following primary endpoints will be assessed: visibility and size of artefacts undergoing mri and cem and its consequences of the quality for image assessment. nature and extent of the burden and risks associated with participation, benefit and group relatedness: since magtrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in zuyderland mc, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.


Eligibility criteria:
inclusion criteria: * female patients of 18 years and older. * previously underwent sentinel lymph node biopsy using magtrace®. * undergoing standard follow-up for previous breast cancer exclusion criteria: * unable to comprehend the extend and implications of the study and sign for informed consent. * standard mri exclusion criteria: * implantable (electrical) devices (e.g., pacemaker, cochlear implants, neurostimulator); * any other metal implants; * claustrophobia; * mr-incompatible prosthetic heart valves. * standard cem exclusion criteria: * breast implants.

Keywords: magtrace mri mammography
the influence of physiological and psychological factors on fall syndrome

Conditions: Fall

Summary: most of previous studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. therefore, we hope to find out what changes in the elders' physiological and psychological functions after a fall.

falls are the main cause of accidental injuries that are common among the elderly. in taiwan, the incidence of falls is about 15% to 34%. falling can cause subsequent serious injuries and post-fall syndromes. post-fall syndrome is common after a fall. the symptoms of self-restricted activity for fear of falling again affect about one-fifth of older fallers. this syndrome develops within a short period of time after a fall, which not only causes serious problems but also affects psychological symptoms and dependence on daily life functions. all of these reduce the function of movement and increase the chance of falling again. however, most of the past studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. therefore, the study will investigate the changes in physiological and psychological functions after a fall among older adults who experiences a recent fall within 2 months. additionally, the physiological and psychological functions will be compared between older adults with and without a history of falls.

Eligibility criteria:
inclusion criteria: 1.60 years to 99 years old 2.fall experiences within two months 3.can understand and answer the questions 4.can give their informed consent exclusion criteria: 1.serious fracture or head trauma caused by a fall, 2.unable to perform a walking test, 3. neurological diseases

Keywords: fall syndrome, elderly,physiological,psychological
early prediction of clinical response in patients with schizophrenia treated by paliperidone er

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: paliperidone er is a new psychotropic medication for schizophrenia treatment. the studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at day 4. some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable. the primary aim of this study is to investigate: 1. . whether the early prediction model used in other atypicals could also be applied in paliperidone er. 2. . the changes of metabolic parameters and pharmacokinetics after paliperidone er treatment in this study

patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. eligible patients will receive 9mg paliperidone er first. then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. they will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * a minimal baseline total score of 60 on the panss * those who had not received long-acting antipsychotic injection for the preceding 6 months * physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators. exclusion criteria: * diagnosis of substance (including alcohol) dependence in the previous 6 months * a medical condition that could affect absorption, metabolism, or excretion of the study drug * substantial risk of suicide or violent behavior * pregnancy or breastfeeding * documented organic disease of the central nervous system * unstable or critical untreated medical illness * history of clozapine treatment in the previous 3 months * participation in an investigational drug trial in the 30 days before screening.

Keywords: paliperidone treatment response schizophrenia early prediction pharmacokinetics
exploring the mechanism of primary resistance to third-generation egfr-tkis as first-line treatment in egfr-positive advanced nsclc (precise study)

Conditions: Lung Cancer, Non-small Cell; EGFR Gene Mutation; EGFR-TKI Resistant Mutation; Primary Resistance; Circulating Tumor DNA

Summary: lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (nsclc) accounting for 80%-85%. epidermal growth factor receptor tyrosine kinase inhibitors (egfr-tkis), especially the 3rd-generation egfr-tkis have demonstrated strong antitumor effects in egfr-positive patients. however, approximately 20% of egfr-positive were primarily resistant to 3rd generation egfr-tkis, i.e., clinical non-response or disease progression in the short term. this study aimed to clarify the molecular indicators that predict the benefits of 3-rd egfr-tkis as first-line therapy in nsclcpatients with egfr-positive. further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of nsclc disease.


Eligibility criteria:
inclusion criteria: 1. age \>18 years; 2. histological or cytopathological diagnosed nsclc; 3. according to the american joint committee on cancer (ajcc) eighth edition of the lung cancer staging manual, the clinical stage is unresectable iiib-iv or recurrence and metastasis after surgery; 4. at least one measurable lesion can be evaluated according to the response evaluation criteria in solid tumours v1.1 (recist1.1) criteria; 5. positive egfr mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.); 6. use of third-generation egfr-tkis approved by the nmpa for nsclc as first-line therapy; 7. cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development; 8. agree to participate in this study and sign an informed consent form. exclusion criteria: 1. patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form; 2. pregnant and lactating women; 3. other malignant neoplastic diseases within 3 years; 4. patients who have undergone other clinical drug trials; 5. received systemic anti-tumor therapy within 2 years;
medical imaging in the diagnosis of ganglion cysts of the hand

Conditions: Ganglion Cyst of Both Hands

Summary: the aim of this study is to investigate if inexpensive, readily available and portable wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a cart-based ultrasound device before surgery.


Eligibility criteria:
inclusion criteria: * flexor tendon sheath ganglion cyst * dorsal ganglion cyst * palmar ganglion cyst * male and female patients minimum age 18 years * mri of the affected area exclusion criteria: * pregnancy, lactation * malignant disease * insufficient mental possibility of cooperation * medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study

Keywords: portable ultrasound diagnostics mobile ultrasound hand held ultrasound wireless ultrasound
prevalence and effect of detecting common mental disorders in long-term sickness absence

Conditions: Psychiatric Disorders; Common Mental Disorders; Depression; Anxiety; Somatoform Disorder

Summary: the hypothesis was that a large fraction of individuals with common mental disorders were undetected in long-term sickness and that detection of the disorders by screening, a psychiatric diagnostic examination and feedback to the individuals, primary care, and rehabilitation officers improved return to work, improved quality of life and reduced psychological distress.


Eligibility criteria:
inclusion criteria: * first sick-listing between august 30, 2004 and august 29, 2005 in six municipalities (118,000 inhabitants) exclusion criteria: * unable to understand danish and absence due to pregnancy

Keywords: sickness absence, return to work, psychiatric examination, feedback, psychological distress, quality of life, attrition analysis, multiple imputation
pilot study of the safety and efficacy of anakinra in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension (pah) can result in right ventricular failure and death. anakinra has been used in patients with left sided heart failure, and the present study looks to determine if anakinra is safe and effective in patients with pah. to accomplish this goal, we plan to evaluate for exercise improvement (as assessed by cardiopulmonary exercise testing) in 10 patients with pah on anakinra.

patients with pulmonary arterial hypertension will undergo cardiopulmonary exercise testing (cpet) at baseline and at 2 weeks. after the initial cpet, all patients will receive anakinra as a daily injection for 2 weeks. patients will be instructed in the use of anakinra during their initial visit. our primary outcome will be the difference in the exercise capacity of patients with pah, as measured by maximal uptake of oxygen on cpet.

Eligibility criteria:
inclusion criteria: * age over 18 * functional class ii or iii symptoms of right ventricular failure despite optimal pah therapy * mean pulmonary artery pressure \>25mmhg on previous right heart catheterization * pulmonary arterial wedge pressure \<15mmhg on previous right heart catheterization * pulmonary vascular resistance \>3 wood units on previous right heart catheterization exclusion criteria: * pah due to connective tissue disease * angina or electrocardiograph changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ekg changes that limit the ability to detect ischemia * recent (\<14 days) use of anti-inflammatory drugs (not including nsaids), chronic inflammatory disorder, malignancy, active infection, or any comorbidity limiting survival or ability to complete the study * sever kidney dysfunction (egfr \<30ml/min) * thrombocytopenia (\<50,000/mm3), or neutropenia (absolute neutrophil count \<1500/mm3) * refusal by a woman of childbearing potential to use a medically acceptable form of birth control * history of hypersensitivity to anakinra or e. coli products * latex or rubber allergy * inability to give informed consent * non-english speaking
photodynamic therapy mediated by topical application of 5- ala for the treatment of actinic keratoses

Conditions: Actinic Keratosis

Summary: the purpose of this study is to compare the treatment of skin growths called actinic keratoses (ak) with 5-ala pdt, an fda-approved treatment, versus treatment with other conventionally used fda-approved agents such as cryotherapy, imiquimod, or 5-fluorouracil (5-fu).


Eligibility criteria:
inclusion criteria: * 18-95 years old * diagnosied with actinic keratoses. exclusion criteria: * patients who have had isotretinoin therapy less that 1 year prior to screening. * patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures). * history of porphyria

Keywords: actinic keratosis skin lesions 5-ala ak blu-light
compare the effect of a remote monitoring system using the exact tool to reduce hospitalizations due to chronic obstructive pulmonary disease (copd) exacerbations. exact = exacerbations of chronic pulmonary disease tool.

Conditions: Remote Patient Monitoring in COPD Patients

Summary: the purpose of this pilot study is to evaluate a remote patient monitoring (rpm) system using a daily pro tool (exact = exacerbations of chronic pulmonary disease tool), in preventing hospitalization from chronic obstructive pulmonary disease (copd) exacerbations in a copd population at high risk of exacerbation, compared to those managed by usual care.

this study uses two parallel groups of approximately 100 patients in each arm. after a screening period to confirm eligibility, patients will be randomized to either the rpm system group, or the usual care group. both groups will be followed for 52 weeks until the end of study. there are only 4 planned study visits and patients will continue on their usual treatment. the remote patient monitoring system will issue an alert to the clinical site once the established threshold change has been reached. the alert notification will require the clinical site to contact the patient and treat the patient based on clinical judgment and clinical practice. patients in the usual care arm will be managed through their normally nurse/physician contact.

Eligibility criteria:
inclusion criteria: * outpatients with a diagnosis of chronic obstructive pulmonary disease (copd), gold grade 2 or higher as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, updated 2011, including: * current or ex-smokers with a smoking history of at least 10 pack years nt * post-bronchodilator forced expiratory volume in one second (fev1) \< 80% of the predicted normal value within 12 months prior to screening or at screening * post-bronchodilator fev1/fvc (forced vital capacity) \< 70% within 12 months prior to screening or at screening * a documented history of at least 2 copd exacerbations requiring treatment with systemic corticosteroids and/or antibiotics in the previous 12 months prior to the screening visit, at least one of which required hospitalization. exclusion criteria: * use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * patients who have a copd exacerbation not clinically resolved within 30 days prior to screening. * patients with a history of asthma, indicated by (but not limited to) the onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40 years.

Keywords: copd, remote patient monitoring, hub, exacerbations, exact
safety and efficacy of quadriderme® in the treatment of impetiginous eczema (study p05134am4)

Conditions: Dermatitis, Atopic; Eczema, Atopic; Skin Diseases, Eczematous

Summary: this is a parallel-group, randomized, active-controlled, double-blind, phase 4 trial comparing three creams in the treatment of impetiginous eczema: * arm a: quadriderme® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) * arm b: combination of betamethasone diproprionate cream and gentamicin sulfate cream * arm c: betamethasone diproprionate cream at 7 sites, in portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. note: this study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). statistical analyses were not performed. further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.


Eligibility criteria:
inclusion criteria: * minimum age: 12 years * good general health confirmed by clinical history and a physical and skin examination (excluding area of skin with impetiginous eczema). * diagnosis of impetiginous eczema. * ability to understand the procedures of the protocol and follow the requirements during the course of the study. * results of routine laboratory tests - hemogram with leukogram and platelet count, creatinine, glucose, sed. rate, ige level and transaminases; along with plasma cortisol and adrenocorticotropic hormone (acth) levels prior to the start of the treatment. these results must all be within normal limits or not clinically relevant in order to be included in the trial. exclusion criteria: * pregnant participants or women of childbearing age who are not using birth control methods considered reliable by the attending physician. * participants with a history of hypersensitivity to any of the components of the medication being studied. * participants in whom the extent or severity of the lesions requires treatment of a different type than what is planned for this trial. * participants who need any other type of topical or systemic medication during the trial that might affect the course of the disease. * participants who have been treated with other topical medications during the 14-day period prior to the start of the trial. * participants who have received systemic corticosteroids or any other immunosuppressant medication during the 28-day period prior to the start of the study.

Keywords: impetiginous
effectiveness of volume spirometry and deep breathing exercise for dyspnea during third trimester of pregnancy

Conditions: Dyspnea; Pregnancy Related

Summary: during pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. dyspnea is a common complaint in pregnancy related to change in respiratory centre threshold and sensitivity. pregnant women who engaged in regular exercise have less pregnancy induced discomforts like dyspnea and leg cramps than who did not engage in exercise. during pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. purpose of this study was to evaluate the efficacy of volume spirometry and breathing exercise on dyspnea in third trimester of pregnancy. rationale of the study was to find the effects of volume spirometry and breathing exercise on dyspnea with focus on method of deep breathing exercise and volume spirometry and outcomes. significance of this study was to improve functional capacity and quality of life in pregnancy induced dyspnea. subjects were randomly allocated to either two groups both groups received baseline treatment while interventional group received volume spirometry and deep breathing exercise. estimated sample size of 48 divided into 24 in either group by randomization. modified borg scale and visual analog scale were used to collect the findings. non-parametric tests were used and analyzed by using spss22.


Eligibility criteria:
inclusion criteria: * bmi 18.5-30 * primigravida and multigravida with 3rd trimester * singleton and twin pregnancy exclusion criteria: * cardiac and respiratory disorders * smoker * obesity * any type of allergy * autoimmune disorders
open versus laparoscopic assisted pancreaticoduodenectomy

Conditions: Pancreas Neoplasm

Summary: compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. it is still associated with very high morbidity and mortality. \[1\]. pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers\[2,3\]. in recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers \[4,5\]. laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy\[6\]. several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy\[7,8\]. limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.so the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

Eligibility criteria:
inclusion criteria: 1. age less than 70 years. 2. resectable tumour, 3. fit for surgery exclusion criteria: 1. patients with jaundice with serum bilirubin above 200mml/dl. 2. patients with bleeding tendency until corrected. 3. patients with advanced and metastatic malignancy. 4. patients with cardiopulmonary diseases.
perclot to control bleeding in endoscopic sinus surgery

Conditions: Sinusitis

Summary: a prospective, single centre, single arm study designed to collect clinical data on perclot when used in subjects undergoing endoscopic sinus surgery.


Eligibility criteria:
inclusion criteria: * subjects having endoscopic sinus surgery * subjects who will have perclot used as a haemostatic agent * subjects willing and able to give consent * subjects over 18 years old exclusion criteria: * subjects unable or unwilling to give consent for their data to be collected