Kornimate/medical-research-clean huggingface dataset:
body constitution classification based comprehensive health management intervention on obese population

Conditions: Overweight; Obesity

Summary: this study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

this study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population, compare the differences in effectiveness between body constitution classification based management vs usual health management, and explore the influence of different food composition on the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

Eligibility criteria:
inclusion criteria: * social characteristics: * 20-55 year old, * had lived in a city for more than one year, * kept a watchful eye on losing weight or bodybuilding, * practitioner engaged in non- sensitive sectors. * physiological characteristics: * met the obesity diagnostic criteria suggested by "prevention and control guidelines for overweight and obesity of chinese adults in 2006". subjects with a bmi between 24 to 28 kg/m2 were defined as overweight, while those with a bmi greater than 28kg/m2 were obese. * met the constitution classification standards of traditional chinese medicine. according to the constitution questionnaire formulated on the base of the chinese medical association standard "chinese constitution classification and determination" (zyyxh/t157-2009), the subjects were divided into phlegm-damp type, qi deficiency type and phlegm stasis block type. exclusion criteria: * with the following major organic disease, * secondary obesity caused by diseases, * none of phlegm-damp type, qi deficiency type or phlegm stasis block type, * women who were planning to become pregnant, pregnant or lactating.

Keywords: body constitution classification health management obese population
effect of the biofire filmarray (bcid2) for the rapid detection of bloodstream infection in haematologic patients with febrile neutropenia

Conditions: Haematological Malignancy; Febrile Neutropenia; Blood Stream Infection

Summary: the goal of this observational study is to assess if the molecular diagnostic tool biofire filmarray bcid2 is more useful for the microbiological diagnosis of bloodstream infections in hematological patients with febrile neutropenia, compared to the conventional microbiologic studies. the study compares the sensibility and specificity of these two techniques.


Eligibility criteria:
inclusion criteria: * age ≥18 years * patients hospitalised for the treatment of haematological malignancy or undergoing an autologous or allogeneic hematopoietic stem cell transplant or receiving car-t cell therapy * patients presenting with febrile neutropenia (defined as axillary temperature ≥ 38.0°c and \<500 neutrophils/mm3 or \<1000 with an expected rapid decrease in 24-48 hours), * patient to whom blood cultures are ordered as standard care for the microbiological diagnosis of the febrile neutropenia episode. exclusion criteria: * axillary temperature \<37.5ºc. * high clinical suspicion of a non-infectious cause of fever at the moment when blood cultures are drawn (high suspicion of drug related fever, infusion reaction). * previously enrolled patients in whom the time between inclusion and the current episode is less than four weeks. * patients with febrile neutropenia in whom no blood cultures are drawn.

Keywords: blood stream infection bacteraemia febrile neutropenia biofire filmarray (bcid2) haematologic malignancy neutropenic cancer patients
imaging of high grade prostate cancer

Conditions: Prostatic Carcinoma

Summary: management of prostatic carcinoma varies according to stage of disease. trans-rectal ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling and random non-targeted technique. methods to improve pre-operative tumor localization and grading, including multi-parametric (mp) magnetic resonance imaging (mri) is an active area of research but requires further validation. high grade tumors can undergo comedo-type necrosis with malignant calcifications which only occurs in gleason pattern 5 tumors and which we hypothesize can be reliably detected using computed tomography (ct) and/or mri. detection of malignant calcification within tumor foci will improve the accuracy of localization and grading in prostatic carcinoma.

high grade (gleason pattern 5) tumors can undergo comedo-type necrosis producing malignant calcifications which we hypothesize can be reliably detected using computed tomography (ct) and/or mri. detection of malignant calcifications in areas of gleason pattern 5 tumor will improve the accuracy of pre-operative localization and grading in prostatic carcinoma.

Eligibility criteria:
inclusion criteria: * patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies * patients with biopsy proven gleason pattern 5 tumor and without comedo-type necrosis associated calcification exclusion criteria: * patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies

Keywords: ct mri
hmp (home macular perimeter) -usability trial

Conditions: Age Related Macular Degeneration

Summary: the study is divided in two stages. the purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. the purpose of the second stage is to assess the ability of the subjects to perform reliable tests .

stage i: * receive a packed hmp device. * unpack the device and install it, using a set-up guide * use an interactive tutorial to learn the task * calibrate the sensitivity of the test this stage will be completed within 1 to 5 visits, depending on personal progress rate. subjects who have successfully completed stage i will be recruited to stage ii. those subjects will: • perform 3 tests , each test in a different day

Eligibility criteria:
inclusion criteria: * age \>50 years * familiar with computer usage * capable and willing to sign a consent form and participate in the study * ability to speak, read and understand instructions in english exclusion criteria: * subject already participating in another study.

Keywords: php hmp hphp amd cnv
the influence of coronary chronic total occlusion on myocardial perfusion on computed tomography

Conditions: Coronary Occlusion; Myocardial Ischemia; Myocardial Perfusion Imaging; Percutaneous Coronary Intervention

Summary: the copacabana study is designed as a single-centre, open, prospective trial aimed to assess the influence of coronary chronic total occlusion (cto) on downstream myocardial ischemia via the novel computed tomography perfusion (ctp) imaging technique. to this end, consecutive patients with cto of a major coronary artery scheduled to undergo percutaneous recanalization of occluded coronary artery based on clinical grounds, will undergo stress ctp using state-of-the-art dual-energy ct scanner at 2 time points (before and 3 months after successful restoration of flow in the cto vessel).


Eligibility criteria:
inclusion criteria: * delivery of an informed consent and compliance with study protocol * persistent angina pectoris (ccs class ≥2) refractory to optimal medical therapy * cto of a major coronary artery (left anterior descending artery, right coronary artery, left circumflex artery) of at least 2.5 mm vessel diameter confirmed by invasive angiography * preserved left ventricular ejection fraction (\>50%) on echocardiography or cardiac magnetic resonance with preserved contractility in the cto territory (normokinesia and/or hypokinesia) exclusion criteria: * unstable angina and/or myocardial infarction * prior myocardial infarction within 4 weeks before study enrolment * occurrence of myocardial infarction and/or unplanned revascularization between the index procedure and post-procedural ctp study * impaired renal function (egfr ≤45 ml/min/m2) * contraindications to antiplatelet therapy and/or heparin * other contraindications to ctp (pregnancy, allergy to contrast media or pharmacologic stress agents, tachyarrhythmia, claustrophobia)
changes of diet, physical activity and sleep pattern and their effects on glycemic and weight control in hong kong chinese obese patients with type 2 diabetes after bariatric surgery compared to telephone intensive lifestyle counselling

Conditions: Diabetes Mellitus Type 2 in Obese

Summary: nutrition therapy is recognized as one of the crucial components for the standard treatment of diabetes along with physical activity and drug therapy. of note, dietary habits are culture specific and hence understanding the dietary intake, eating behavior and physical activity level of the local population is important to formulate effective nutrition and lifestyle strategies. weight control is a major therapeutic challenge because many conventionally used anti-diabetic agents, such as sulphonylurea and insulin, can cause weight gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing levels of free fatty acids from adipose tissues . although intensive face-to-face lifestyle intervention program has showed that even modest weight loss in people with type 2 diabetes (t2dm) who were overweight or obese was associated with improvements in glycemic control and associated conditions, it may not be feasible in public hospital setting in hong kong due to factors such as limited resources, scheduling, patient's employment and willingness for frequent travel to the clinic. hence, alternative strategies such as a combination of face- to-face individual dietary and lifestyle consultation together with telephone intensive lifestyle reinforcement program will likely to be an useful strategy to engage those obese t2dm patients through frequent individual contacts. on the other hand, bariatric surgery has emerged as an impressive therapeutic option for poorly control obese t2dm patients. realizing there is a knowledge gap in understanding the lifestyle factors in the hong kong chinese obese t2dm patients, we therefore propose to conduct a 1-year prospective clinical trial with two main objectives: 1. to study and compare the glycemic and weight improvement after bariatric surgery versus a telephone intensive lifestyle intervention program for 1 year in hong kong chinese obese patients with type 2 diabetes. 2. to investigate the effect of lifestyle factors including dietary intake, eating behaviors and physical activity level on the glycemic and weight control of hong kong chinese obese patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. age 18 - 65 years 2. chinese ethnicity 3. bmi ≥27.5 kg/m2 4. diagnosis of t2dm 5. no active cardiovascular diseases 6. asa grade ii or below (for the bariatric surgery group) 7. able to read chinese and give informed written consent exclusion criteria: 1. type 1 diabetes mellitus 2. end-stage renal failure requiring dialysis or chronic kidney disease (ckd) stage 4 or above 3. malignancy diagnosed within 3 years 4. major psychiatric illness 5. pregnancy or lactation 6. significant anaesthetic risk asa grade iii or above (for the bariatric surgery group) 7. any medical illness or condition as judged by the investigators as ineligible to participate the study
observational study of patients using novorapid® or soluble human insulin for treatment of type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with novorapid® or soluble human insulin under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * treatment with insulin aspart (novorapid®) or soluble human insulin for minimum 3 months and maximum 3 years exclusion criteria: * patients with an end-stage renal failure * patients with a serious liver disease * patients with concomitant malignant disease
menthol for dyspnea relief in health and copd

Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease

Summary: menthol inhalation (mi) is a novel and promising treatment option for acute relief of dyspnea, however, the underlying ventilatory and/or neural related mechanisms for this relief in symptoms remain unknown. the overall aim of this research project is to systematically examine the mechanisms of dyspnea relief from mi in healthy individuals and those with copd.

the project is structured in 4 work packages (wp), each including a different sample of healthy volunteers (wp1, 2) or patients with copd (wp3, 4), respectively with a 1:1 female/male ratio in each wp. each wp will be single-blind, placebo-controlled cross-over trial to investigate the effects of mi compared to placebo in healthy volunteers during resistive loaded breathing (wp1), in healthy volunteers during cycling exercise (wp2), in people with copd who have dyspnea at rest (wp3), and in people with copd during cycling exercise (wp4).

Eligibility criteria:
inclusion criteria: * age: 18 years of age or older * able to speak, read, and write dutch or english * normal pulmonary function: forced expiratory volume in 1 second (fev1) to forced vital capacity ratio\>0.70; fev1≥80%predicted (wp1 and 2 only) * non-smoker or former smokers (smoke-free ≥12 months prior to enrolment) (wp1 and 2 only) * clinically stable copd (based on clinical judgment of the study physician that have not had exacerbations requiring escalation of medical therapy (i.e., short course of oral corticosteroids or antibiotics) within the preceding 14 days (wp3 and 4 only) exclusion criteria: * contraindication to exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease; see table 4 from ers/ats consensus statement) * significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could influence dyspnea and/or impair exercise capacity (with the exception of copd in wp3 and 4) * body mass index \ 35 kg/m2 * an ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery * severe facial trauma including cribriform plate disruption (bone separating brain from nasal cavity) * allergies to latex and sensitivities to local anesthetics * inability to give informed consent, including those with significant cognitive impairment * alcohol consumption within 12 hours of study visit * current smoker\* * history of early menopause (age \<45 years) * pregnancy or desire to become pregnant while in trial

Keywords: menthol
little nirvana for pediatric pain and anxiety

Conditions: Acute Pain; Procedural Anxiety; Pediatric ALL; Emergency Medicine; IV Access

Summary: the aim of this study is to test the feasibility of using little nirvana (augmented reality (ar)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (piv) insertions. the investigators hypothesize that little nirvana plus a numbing cream will reduce pain and anxiety for patients undergoing piv placement in the emergency department (ed) when compared to the cream alone. it is anticipated that using the little nirvana will not increase the ed length of stay, failed piv placement attempts, or the need for additional intervention.

this is a two-group randomized clinical trial of 65 dyads of subjects and their parent and 65 proceduralists. children will be randomly assigned to either the little nirvana intervention group or a standard of care control group. legal guardians of children in both groups will answer questions about their child's prior history of needle procedures, current pain/anxiety, medications taken prior to ed arrival, and video game experience. children assigned to the intervention will play the game during the piv placement, while children in the control group will receive the standard of care. the proceduralist performing the piv placement and the parent will answer questions after the piv placement about their perception of the child's pain and anxiety and questions about the little nirvana experience for those children who were in the intervention group. this study has one visit that is completed during their ed stay.

Eligibility criteria:
inclusion criteria: * all patients undergoing piv line placement (peripheral iv order placed while patient is in the ed); * patients 2-8 years of age (inclusive) exclusion criteria: * non-english speaking (little nirvana is currently only available in english and dutch); * those for whom utilizing ar is deemed not feasible by the attending ed physician (e.g., critical illness)

Keywords: ar pain anxiety augmented reality distraction
a study to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous populations in guatemala

Conditions: ¨Maternal Morbidity¨; ¨Perinatal Mortality¨

Summary: a matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (huehuetenango, quiche, alta verapaz and san marcos) of the republic of guatemala, using the health clinic as the unit of randomization. no external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts. the package includes 3 interventions: 1) to train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (pronto); 2) to design and implement a social marketing strategy that promotes institution-based delivery; and 3) to integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (tba) and public health units. a fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.

overall goal to evaluate the impact of a package of three interventions aiming to increase institution-based delivery and improve emergency obstetric and neonatal care on perinatal mortality, in the four districts with the highest maternal mortality ratios in guatemala. specific objectives * measure the impact of this intervention package on perinatal mortality rates. * measure the impact of this intervention package on the proportion of institution-based delivery among study facilities. * evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (pronto: emergency obstetric and perinatal training program). primary outcome of interest: 1. increase in the proportion of institutional deliveries in intervention vs. control clusters. 2. decrease perinatal death rate in intervention vrs control clinics

Eligibility criteria:
inclusion criteria: * rural women * indigenous * poor * facilities at rural area * clinic attending vaginal deliveries exclusion criteria: * facilities considered too close geographically to risk contamination of intervention to control facilities * clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event * clinic or hospital visits by women who present to intervention or control clinics in the post partum period
tot, tvt and burch colpo-suspension for treatment of female mixed urinary incontinence

Conditions: Treatment

Summary: this prospective interventional randomized controlled trial will recruit women with mui scheduled for surgical treatment where patients will be randomized to either burch colposuspension, tot or tvt. regular postoperative follow up will be planned for at least 2 years. the primary outcome measures will be the objective and subjective cure rates.


Eligibility criteria:
inclusion criteria: * women with mixed urinary incontinence. exclusion criteria: * women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (isd), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study. * women who improved on medical treatment with persistence of stress element only were also excluded.

Keywords: mixed urinary incontinence transobturator tape (tot) tension-free vaginal tape (tvt) burch colposuspension urinary incontinence
sotatercept on central cardiopulmonary performance and peripheral oxygen transport during exercise in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.


Eligibility criteria:
inclusion criteria * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * nyha class ii-iv. * lvef ≥ 40 % within the preceding year. * no recent initiation of pulmonary vasodilator in the last 60 days. * pulmonary arterial hypertension by right heart catheterization (mean pa pressure ≥ 20 mmhg with pvr\>2 wood units) with no evidence of heart failure with preserved ejection fraction (exercise pcwp \<25 mm hg). * symptomatic pah patients with plan to undergo exercise rhc for reassessment of exertional symptoms. exclusion criteria * myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening. * planned coronary, carotid, or peripheral artery revascularization. * any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease). * wheelchair bound or orthopedic inability to exercise. * chronic hypoxemia with inability to exercise without oxygen supplementation. * skeletal muscle myopathy. * history of rhabdomyolysis. * participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening. * receipt of any investigational medicinal product within 30 days before screening. * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator. * any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.