Kornimate/medical-research-clean huggingface dataset:
the effects of a hybrid face-to-face and online mode of delivering a mindfulness-based dementia caregiving programme for family caregivers of persons with dementia: a randomized controlled trial

Conditions: Caregiver Burden

Summary: mindfulness-based intervention (mbi) has been shown promising effects in enhancing the well-being of caregivers of patients with dementia (pwd). however, the time schedule and the mode of delivering the conventional mbi was demanding to family caregivers of pwd, and therefore impeding the feasibility of use among caregivers. our research team had developed a hybrid mbi program which includes face to face and online mode of mindfulness sessions w. the study aims to evaluate the effectiveness of this 6-week hybrid mbi program on caregivers of pwd over a 6-month follow up. this study is a two-arm parallel randomized controlled trial. participants are family caregivers of pwd and we aimed to recruit 290 subjects. eligible participants will be recruited from three local nongovernmental organizations (ngos) in hong kong. they will be randomly allocated into mbi group and a control group (with 145 participants in each group) . the participants in the mbi group will receive 6 weekly 90-minute group-based sessions delivered through a face-to-face and online approach. the participants in control group will receive brief education on dementia care with the same group size, duration, and frequency as the sessions in the intervention group. assessment (using questionnaire) about caregiving stress and other outcomes (positive aspect of caregiving, depression, dyadic relationship, anxiety, neuropsychiatric symptoms of patients) will be assessed at baseline, immediately after the intervention and at the 6-month follow up. focus group interview will also be conducted to explore family caregivers' experience in participating in the program. we aimed to recruit 20 caregivers for the interviews via purposive sampling. it is hypothesized that compared to the control group, the mbi group will have a reduction on caregiving stress and improve other outcomes after the intervention.


Eligibility criteria:
inclusion criteria: * caregivers who are aged 18 or above * caregivers who are taking care for a family member medically diagnosed with dementia who has been residing in the community; * caregivers who are providing care to the dementia care recipients for at least 6 months prior to the subject recruitment. exclusion criteria: * caregivers who have participated in any structured psychosocial intervention or mindfulness-based intervention/training in the 6 months prior to recruitment, * caregivers who have acute psychiatric and medical comorbidities that are potentially life-threatening (e.g., suicidal ideation) or leave them with a limited ability to participate or adhere to the intervention (e.g., acute psychosis), * caregivers who do not have internet access.
comparison of aclidinium bromide and formoterol fumarate in patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this exploratory study will compare the efficacy of the fixed-dose combination (fdc) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the fdc once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. the study will assess pulmonary function and symptoms in patients with moderate to severe copd.


Eligibility criteria:
inclusion criteria: * moderate to severe copd * smoking history of greater or equal to 10 pack-years * diagnosis of stable moderate to severe copd as defined by the gold guidelines * postbronchodilator fev1 from 30% to 79% of predicted values, inclusive * postbronchodilator fev1/fvc ratio \< 0.70 exclusion criteria: * history or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm * hospitalization for an acute copd exacerbation in the 3 months prior to study entry * respiratory tract infection (including the upper respiratory tract) or copd exacerbation in the 6 weeks prior to study entry * eosinophil count of at least 600 cells/mm3 * long term oxygen therapy \> 15 hours a day

Keywords: airflow obstruction, chronic chronic airflow obstruction chronic obstructive pulmonary disease chronic obstructive airway disease chronic obstructive lung disease copd coad
pilot study evaluating the role of histopathology correlation in treatment planning

Conditions: Prostate Cancer

Summary: this clinical research study tests the uronav system. patients with prostate cancer will be asked to take part in this study. uronav system is an investigational device that is used on this study to help place markers in the patient. these are called fiducial markers and they are placed in the patient to help plan radiation treatment. radiation therapy treatment will be planned by the treating physician and will not be experimental or part of this research study. this study will also test the similarities and differences of biopsy tissue structures and the findings from the intraprostatic mri (internally guided mri).

study objectives specific aim 1: evaluate final pathology post-operatively for histopathology confirmation of multiparametric mri targets detected during treatment planning. this will be accomplished by using transperineal biopsies obtained prior to interstitial brachytherapy during the procedure, while under anesthetic just prior to the placement of the brachytherapy needles and sources. specific aim 2: evaluate the ability of the uronav system in a transperineal setting to guide biopsy needle placement using the electromagnetic guidance system and transperineal ultrasound probe stabilization device and stepper.

Eligibility criteria:
inclusion criteria: * patients must have histopathology confirmed prostate cancer that is gleason score ≤7(4+3) clinical stage ≤ t2bn0m0 with a prostate-specific antigen (psa) below 15 ng/ml. * patients must have mri findings reporting intraprostatic lesions suspicious for malignancy. * patient must not have had any prior treatment for prostate cancer * eastern cooperative oncology group (ecog) performance status ≤ 2 * subjects must have an international prostate symptom score of ≤ 15. * subjects must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * gleason score of ≥ 8(4+4) * psa ≥ 15 ng/ml. * clinical stage \>t2b or evidence of nodal * patients who are on anticoagulants or high dose aspirin therapy that cannot be safely stopped for greater than 10 days prior to treatment should be excluded to limit increased risk for urinary obstruction. * patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * hiv-positive patients on combination antiretroviral therapy are ineligible because of the unlikely risk of prostate cancer being life threatening in this population.

Keywords: imaging prostate multiparametric mri brachytherapy
evaluation of an app for smartphones for people with a bipolar affective disorder

Conditions: Bipolar Affective Disorder

Summary: the primary objective of the clinical trial is to evaluate the data of an app for smartphones (bip-app) with regard to sleep, movement, mood and communication behavior. the data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder. secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns. furthermore it will be evaluated whether the bip-app can find applicability in the examined patient group. study design: clinical evaluation of a medical device without ce mark; parallel study design


Eligibility criteria:
inclusion criteria: * written consent of the participant after clarification * patients with a bipolar affective disorder (group of patients) or control persons without a mental illness (control group) * age between 18 and 70 years * knowledge about using a smartphone exclusion criteria: * rejection of participation * lack of knowledge about how to deal with a smartphone * congenital / early-childhood intelligence reduction * moderate / severe dementia
drug-coated balloon for takayasu arteritis associated renal artery stenosis

Conditions: Takayasu Arteritis

Summary: takayasu arteritis associated renal artery stenosis (taras) is the biggest cause of hypertension in young people \<40 years old. hypertension caused by renal artery stenosis is usually hard to control in spite of two or more anti-hypertension drugs. percutaneous transluminal angioplasty (pta) is recommended for hypertension caused by taras. in previous clinical practice, we observed relatively effects of pta on controlling the blood pressure in patients with taras. but, high re-stenosis rate was also indicated. drug coated balloon (dcb）is a new type of pta, which could improve the re-stenosis rate significantly. in the clinical trials of peripheral vascular disease, it has been confirmed that dcb had lower re-stenosis rate than pta. however, up to date, no studies was found about the use of dbc in taras. thus, this study was design as a random, double blind trial to evaluated the effects and safety of dcb in the treatment of hypertension caused by taras.


Eligibility criteria:
inclusion criteria: 1. 18-60 years old; 2. diagnosed as takayasu arteritis according to 1990 acr classification 3. renal artery stenosis is confirmed by imaging results 4. had inactive disease, and the dose of glucocorticoids \<10mg/day 5. blood pressure \>160/90mmhg in spite of two or more antihypertensive drug 6. had no surgery of renal artery, including pta, stent, or others. exclusion criteria: 1. blood pressure \>200/120mmhg in spite of two or more antihypertensive drug 2. had severe disease conditions 3. allergy to contrast agent 4. had other autoimmune disease 5. had severe abnormal lab test result
retroversion in reverse shoulder arthroplasty

Conditions: Shoulder Osteoarthritis

Summary: the goal of this clinical trial is to compare function in reverse shoulder arthroplasty (rsa) using two different degrees of humeral retroversion (rv). the main question it aims to answer is: • does external rotation improves when using a higher retroversion? participants will randomly receive a 0 degree or 30 degree rv for their rsa. they will be followed for two years and clinical outcomes will be recorded and analyzed.


Eligibility criteria:
inclusion criteria: * patients \> 60 years * primary rotator cuff arthropathy * implantation of reverse shoulder arthroplasty exclusion criteria: * previous surgeries in the shoulder * post-traumatic arthropathy
to evaluate the efficacy and safety of envlo tablet or envlomet sr tablet in patients with type ii diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this observation study is designed as a prospective, multi-organ observation study to confirm the blood sugar control effect and safety of envlo tablet or envlomet sr tablet administration for 24 weeks in patients with type 2 diabetes who are scheduled to administer envlo tablet in the actual treatment environment.

this observational study planned recruit population of type 2 diabetes patients who are scheduled to administer envlo tablet or envlomet sr tablet according to the medical judgment of the researcher (doctor in charge) based on permission (efficacy \& effect, usage \& dose, usage precautions, etc.) in the actual treatment environment. this observational study will be conducted in an actual treatment environment regardless of whether envlo tablet or envlomet sr tablet was administered or not. information such as demographic information, body measurement, and vital signs performed will be collected up to 24 weeks after envlo tablet or envlomet sr tablet administration. data will be collected based on medical records recorded in the actual treatment environment, and there is no mandatory visit, examination, or treatment in this observation study.

Eligibility criteria:
inclusion criteria: 1. an adult male and female over 19 years of age 2. a person who is a type 2 diabetic and is planed to take envlo tab or envloment sr tab for the first time according to the medical judgment of the investigator based on the permit 3. a person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied exclusion criteria: 1. persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.) 2. a person who is prohibited from administering in accordance with the permission of envlo tab.'s * patients who overreact to envlo tab. or envlo tab. components and have a history of it * egfr (estimated global filtration rate) patients below 30 ml/min/1.73 m2, end-stage renal disease or on dialysis * patients with moderate and severe liver failure (ast or alt \> 3x normal upper limit, total bilirubin \> 2x normal upper limit, hepatitis or liver failure) * class iii or iv by classification of the new york heart association (nyha) 3. patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of enrollment 4. pregnant women and lactating women 5. a person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices 6. a person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators
evaluation of the results of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors.

Conditions: Tumor of Pancreas

Summary: the indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature. the reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). the benefit in terms of survival remains to be evaluated. the resipatne study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. the evaluation of the results of this type of resection may be useful for the selection of patients for treatment.


Eligibility criteria:
inclusion criteria: * major subjects (≥18 years old) * subject having had a first pancreatic resection for net with resections of synchronous metastases * subject having had a first pancreatic resection for net followed by a delayed resection of synchronous metastases * subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research exclusion criteria: * subject who expressed their opposition to participating in the study * pregnant women * subject under safeguard of justice * subjects under guardianship or curatorship

Keywords: tumor of pancreas metastatic neuroendocrine tumors hepatic resection pancreatic resection
incipave study: incidence of ventilator acquired pneumonia in children

Conditions: Pneumonia, Ventilator-Associated

Summary: rationale : ventilator associated pneumonia (vap) has been extensively studied in adults, however, few data exist regarding vap in the paediatric intensive care population. the centers for disease control (cdc) definition for vap is regularly updated trying to homogenised practice, and the last version for paediatrics has been published in 2015. according to the latest cdc definition, the investigators aim to study incidence of vap in different paediatric intensive care units (picus), diagnostic methods of identifying vap, microbiology of vap, and utilisation of empirical antimicrobial therapy. methods and population : a prospective multicentre observational study will be conducted in european picus for one year. all patients admitted to picu aged more than 28 days and \< 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. clinical data, ventilation settings, and risk factors for vap are inserted daily in an electronic database on the internet. the investigators are going to identify patients, who presented one or more episodes of vap during picus stay, analysing onset circumstances, diagnostic methods, bacteria pathogens identified, and antibiotic treatment. vap incidence will be reported as number of events per 1,000 ventilator-days. risk factors associated to vap will be identified by univariate and multivariate analysis. results and perspective : the investigators aim to define for the first time the incidence of vap among european picus with a prospective and multicentre study. the identification of risk factors, diagnostic methods, epidemiology, treatment strategies will define the basis to start prevention manoeuvres and improve the clinical strategies for vap in paediatric intensive care population.


Eligibility criteria:
inclusion criteria: * admitted to pediatric intensive care unit * aged more than 28 days and \< 18 years * mechanically ventilated either by endotracheal or tracheostomy tube exclusion criteria: -

Keywords: mechanical ventilation pediatrics cross infection intensive care diagnosis
estimation of level of erap1 expression in lesional and non lesional skin of psoraitic patients and healthy controls.

Conditions: Psoriasis

Summary: a 4mm punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients as well as of 30 controls. skin biopsy from patients (psoriasis lesional and non lesional) \& control will be kept in lysis solution (which contains rnaase inhibitor) for the stability of the parameter to be assessed. erap-1 gene expression will research template 5 final version: 8/3/2 016 be detected by quantitative real time -pcr, which include rna extraction, cdna synthesis \& pcr.


Eligibility criteria:
inclusion criteria: * patients with psoriasis vulgaris * patients over 18 years of age * both sexes exclusion criteria: * patients on treatment for psoriasis within the last two months * assoiciated autoimmune diseases eg sle * pregnancy
dapagliflozin evaluation in patients with inadequately controlled type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

study classification: safety, efficacy and pharmacokinetics/dynamics

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes mellitus (t1dm) * central laboratory c-peptide \< 0.7 ng/ml (0.23 nmol/l) * insulin use for at least 12 months per patient reported or medical records * method of insulin administration (mdi or csii) must have been unchanged for at least 3 months prior to screening * subjects must be on a total insulin dose of ≥ 0.3 u/kg/day for at least 3 months prior to screening * if on mdi insulin administration, subject must be on ≥ 3x injections per day * screening visit: central laboratory hba1c ≥ 7.7% and ≤ 11.0% * body mass index (bmi) ≥ 18.5 kg/m2 exclusion criteria: * history of type 2 diabetes mellitus (t2dm) or maturity onset diabetes of the young (mody), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity * taking metformin and/or thiazolidinediones within 2 months prior to screening * taking any antidiabetic medication (other than insulin), within 1 month prior to screening - taking glp-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration * history of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening * history of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening * frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening * history of addison's disease

Keywords: dapagliflozin efficacy safety add on to insulin oral antidiabetic type 1 diabetes
first trimester screening for preeclampsia and intrauterine growth restriction using three dimensional doppler angiography

Conditions: Pre-Eclampsia

Summary: introduction: preeclampsia (pe) and intrauterine growth restriction (iugr) are two major pregnancy complications, related to a chronic utero-placental hypoperfusion. nowadays, there isn't a screening or diagnostic test in clinic for utero-placental vascularization deficiency. since 2004, 3d power doppler angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (vi), flow index (fi) and vascularisation-fi (vfi). a high intra and inter-observer reproducibility and its potential interest for placental function study were reported. the investigator's main hypothesis is that these 3dpd indices could provide predictive values for pe and/or iugr occurrence much higher than those observed with the currents other markers. objectives: the main objective of this study is to determine differences in 3dpd indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, pe (mild and severe) and iugr in nulliparous women. methods and analysis: this is a prospective study. the investigators expect to include 2200 women in 4 french centers: centre hospitalier universitaire de nancy, paris-port-royal (assistance publique - hôpitaux de paris), strasbourg and belfort (hôpital nord franche-comté). the nulliparous pregnant women will be recruited during their 1st trimester consultation for routine down syndrome screening (11-13+6 gestation weeks). especially for the study, the 3dpd and uterine artery doppler (uad) acquisition, which last less than 10 min, will be included in the current routine 11-13+6 gestation weeks ultrasound screening. also, additional blood samples will be taken for biomarker analysis (papp-a and p1gf) and biological collection. utero-placental vascularization indices (vi, fi, vfi) will be quantified using vocal® software. for each subgroup (uncomplicated pregnancy, pe and iugr) mean values in 3dpd indices will be computed and compared using a pairwise t test with a bonferroni correction p value adjustment.


Eligibility criteria:
inclusion criteria: * singleton nulliparous pregnant women between 11 and 13+6 gestation weeks. * mandatory enrolment in a social security plan, * patient (or a third person, independent from the investigator and the sponsor, in case of inability to read or write) having signed an informed consent. exclusion criteria: * patients under a measure of legal protection. * patient under 18, * absence of social insurance, * patient participating simultaneously to other interventional research trial to test a pharmaceutical treatment and protocols are not compatible, * inability to understand and accept the protocol.