Kornimate/medical-research-clean huggingface dataset:
does a home-based exercise programme affect physical capacity and quality of life in patients with pulmonary embolism?

Conditions: Pulmonary Embolism

Summary: in a randomised design the study aims to investigate whether an intervention of 8 weeks home-based exercise in addition to usual care can positively influence the physical capacity, quality of life, sick leave and use of psychoactive drugs in patients medically treated for pulmonary embolism.

background: the existing knowledge regarding pulmonary embolism is primarily focused on the diagnostic methods and medical treatment of the condition, and furthermore on the short term prognosis in terms of mortality and complications. very few studies investigate how every day life is affected in patients struck by a pulmonary embolism, although many patients display worries and concerns about their physical, emotional and social well-being after discharge. for the time being, no rehabilitation options are available for these patients in denmark. methods and materials: 140 patients medically treated for pulmonary embolism will be recruited from 6 different hospitals. after inclusion the patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, receiving an 8-week home-based exercise programme in addition to usual care. at the time of inclusion, after 2 months and after 6 months, the patients' physical capacity is measured using the incremental shuttle walk test. furthermore the patients' complete a questionnaire on quality of life (eq-5d and pulmonary embolism quality of life questionnaire), self-reported sick leave and use of psychoactive drugs. all follow-up measurements and visits take place at the hospital from which the patient was discharged. expected outcome and perspective: the investigators expect that the home-based exercise programme will improve the overall treatment outcome for the patients in the intervention group. the study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation for this group of patients, and may thereby form the basis of future recommendations in this field.

Eligibility criteria:
inclusion criteria: * objectively verified acute pulmonary embolism * treatment with anticoagulant drugs * 18-70 years of age * competency in the danish language exclusion criteria: * pulmonary embolism as a secondary finding in relation to scan performed due to another disease. * severe co-morbidity (malignant, inflammatory or psychiatric) * unable to perform the incremental shuttle walk test for other reasons (e.g. amputation or intermittent claudication).

Keywords: rehabilitation physical capacity quality of life
simplifying the world health organization (who) protocol for hand hygiene

Conditions: Hand Hygiene

Summary: non-inferiority in terms of reduction of bacterial counts will be investigated when combining the simpler three-step hand hygiene technique for the use of hand rub with a shorter application time of 15 seconds compared to the to the three steps technique with an application time of 30 seconds and the technique consisting in six steps.


Eligibility criteria:
inclusion criteria: * adult participants (≥18 years) exclusion criteria: * skin disorders as determined by a dermatologist * inability to follow procedures * insufficient knowledge of the project language * inability to give informed consent
multibending vs conventional endoscope for direct peroral cholangioscopy

Conditions: Common Bile Duct Calculi; Biliary Tract Cancer; Biliary Stricture; Bile Duct Diseases

Summary: the aim of this study is to evaluate the usefulness of a newly developed multibending ultra-slim upper endoscope for the successful direct peroral cholangioscopy (poc) without assisting accessory in comparison with conventional ultra-slim endoscope. the investigators expect that multibending endoscope will show more higher successful performance than conventional endoscope.

direct poc using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic intraductal interventions under direct endoscopic visualization in selected patients who has dilated distal cbd and widened papillary orifice. because the bile duct has anatomical position in acute angle with the duodenum, assisting accessories such as intraductal anchoring balloon, guidewire or overtube is usually required for the successful direct poc. recently, direct peroral cholangioscopes have been developed for free-hand direct advancement of the endoscope into the bile duct from duodenum. multibending ultra-slim endoscope may be expected to facilitate the advance into the bile duct by overcoming the acute angle between the bile duct and the duodenum. after randomization of enrolled patients into two groups, direct poc will be performed by using a conventional slim endoscope in control group and by using a multibending endoscope in study group.

Eligibility criteria:
inclusion criteria: * pancreatobiliary diseases that are indicated for direct poc * the patient who aged from 20 to 80 years. legally acceptable representative must be capable of giving written informed consent prior to participation in this study * the woman of child-bearing age must be negative from the pregnancy test in order to participate in this study * dilated common bile duct (\> 8 mm) * having previous sphincterotomy and/or papillary balloon dilation * the patients should not have any unacceptable conditions (e.g., physiological, familyish, social, geographical) for medical follow-up and adaptation of the study. exclusion criteria: * contraindicated for ercp * patients with stricture on papillary orifice * patients with periampullary malignancy * bleeding tendency: international normalized ratio (inr) of prothrombin time \< 1.5 or platelet count \< 60,000/mm3 * patients with other serious disease or medical condition * patients with past medical history of significant neurologic or psychiatric disorders such as dementia or seizure * unstable heart disease despite of treatment, recent myocardial infarction within 6 month (even though mi was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).

Keywords: peroral cholangioscopy ultra-slim upper endoscope multibending endoscope
measuring and restoring auditory awareness for cochlear implant listeners in noise

Conditions: Cochlear Hearing Loss

Summary: the goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native french speakers with typical hearing or with cochlear implant(s). the measures and strategies developed in this project could benefit all current and future cochlear implant wearers by improving their perception of the sound environment and their quality of life on a daily basis. researchers will compare normal hearing participant and participants with cochlear implant to describe the speech in noise and their perception of the sound environment. participants will perform audiological tests to assess their perception of the sound environment, with and without speech enhancement.


Eligibility criteria:
inclusion criteria: for all participants: * 18 years of age or over, * native french speaker, * having given their consent to take part in the research. for cochlear implant patients: * adult implanted and declaring that they have been using the implant for at least 18 months, * normal speech audiometry in silence for controls reporting normal hearing: * normal tonal audiometry (defined as a mean tonal loss not exceeding 30 decibel (db) hl) * normal speech audiometry in noise (snr between -8 db and -4db inclusive) exclusion criteria: * be under guardianship or curatorship, * deprived of liberty by judicial or administrative decision, or subject to legal protection, * non- native french speaker.
a prospective study to evaluate the implementation of shared decision making strategy for renal cell cancer (rcc)

Conditions: Renal Cell Carcinoma; Renal Cell Carcinoma Metastatic

Summary: the aim of this study is to evaluate the effect of two decision aids for renal cell carcinoma (rcc) on the decision-making process and the quality of the decision.

background: treatment options for patients diagnosed with rcc depend on the stage of the disease, histopathology and patient's preferences and values regarding outcomes. for local (non-metastatic) disease, gold standard for treatment is surgical resection of the tumour. besides this, ablative therapies or active surveillance could also be an option. for metastatic disease, targeted therapy and/or immunotherapy can be offered and new treatment options are being tested in clinical trials. the number of available treatment options for patients with rcc is increasing, but the availability of these options differs per hospital and the transparency about treatment options is limited, resulting in practice variation between hospitals. decision aids help patients to make decisions regarding treatment, particularly when there is not one medically superior treatment option. in this tools treatment options are explained, including outcome information such as possible side effects and benefits of therapy. decision aids have proven to lead to increased patient knowledge, less anxiety in patients, improved health outcomes such as physical en mental health, reductions in unwarranted variation in care and costs, greater alignment of care with patients' values. for patients with rcc, two decision aids are in development right now: one decision aid focussed on local disease and one decision aid focussed on metastatic disease. using these decision aids, patients are encouraged to make a well-informed decision together with the healthcare professional. objective: to assess how the decision aids for rcc influence the quality of the decision-making processes for rcc, defined as the extent to which elements of shared decision-making (sdm) are observed. design, setting and participants: this study includes patients clinically diagnosed with rcc, facing a decision which is addressed in the decision aids. study design will be a prospective multicenter pre-test post-test study. outcome measurements and statistical analysis: the primary endpoint of this study is the mean change in option-5 score between pre-test and post-test groups. secondary outcome measures include perceived quality of the decision-making process, quality of the decision and implementation of the decision aids.

Eligibility criteria:
inclusion criteria: * patients clinically diagnosed with rcc * patients facing a decision which is addressed in the decision aids (t1 tumor or metastatic disease) * written informed consent exclusion criteria: * patients who are not able to fill in a questionnaire or undergo an interview individually

Keywords: decision aid renal cell carcinoma
fibrosis assessment in myocardial infarction-associated ventricular aneurysm

Conditions: Acute Myocardial Infarction; Ventricular Aneurysm Following Acute Myocardial Infarction; Myocardial Fibrosis

Summary: the study will use 18f-fapi pet/ct to study myocardial fibrosis in patients diagnosed with myocardial infarction-associated ventricular aneurysm (mi-va). participants will receive the pet/ct scan during hospital stay, as well as serial echocardiography and telephonic follow-ups. analysed will focus on the characterization of myocardial fibrosis and its correlations with the clinical prognosis in the patients.

the aim of this study is to investigate the temporal and spatial distribution of myocardial fibrosis in patients diagnosed with myocardial infarction-associated ventricular aneurysm using the novel fibroblast activation imaging tracer 18f fapi-42 with pet/ct. this imaging modality allows for non-invasive visualization of activated fibroblasts, which are a key component of myocardial fibrotic remodeling after infarction. the study is expected to enroll patients diagnosed with ventricular aneurysm secondary to acute myocardial infarction (ami), who are hospitalized at renji hospital, shanghai jiao tong university school of medicine. the investigators expect to enroll 20 patients diagnosed with mi-va and 10 ami patients without evidence of ventricular aneurysm. with written informed consent, the investigators will review past medical records and document the medical history for each participant. during the hospital stay, participants will receive an 18f fapi-42 pet/ct scan. fapi uptake in the ventricular aneurysm and remote myocardium will be calculated as maximum standardized uptake value (suvmax) and mean standardized uptake value (suvmean). correlation between suvmax/suvmean and critical markers of the disease progression, such as b-type natriuretic peptide (bnp) and cardiac troponin i (ctni), will be analysed by pearson or spearman correlation coefficients. all participants will be followed for 1 year after enrolment, and serial echocardiography and telephonic follow-up will be performed. major adverse cardiovascular events (mace) will be recorded throughout the follow-up to reveal any predictive values of 18f-fapi pet/c-assessed fibrosis for the patients with mi-va.

Eligibility criteria:
inclusion criteria: * aged 18-75 years old * diagnosed with stemi or nstemi (acc/aha guidelines) * half male and half female * undergo cag and pci treatment; * receive either echocardiography or cmr to identify a ventricular aneurysm; * written informed consent exclusion criteria: * patients under the age of 18 years old; * patients who are pregnant/breastfeeding; * patients who has a previous history of allergy to radio tracers.
radically open dialectical behaviour therapy in patients with anorexia nervosa

Conditions: Anorexia Nervosa; Anorexia Nervosa in Remission; Anorexia Nervosa Restricting Type

Summary: randomized controlled clinical trial to evaluate the efficacy of "radically open dialectical behaviour therapy" in patients with eating disorders: a proof-of-concept study.

background: up to 20% of patients with anorexia nervosa (an) die and 50% relapse after the first episode, being its treatment a great challenge for clinicians. most therapies excessively focus excessively on nourishment, which translates to temporarily restored weight with no improvements in psychosocial life. radically open dialectical behaviour therapy (ro-dbt) is a transdiagnostic treatment designed to treat overcontrol, a key aspect in the functioning of patients with an. to date no clinical trial (ct) has proved its efficacy on these patients or has demonstrated its biological underpinning mechanisms. methods: a randomized ct in an patients will be conducted, where one group will receive treatment as usual (tau) and the other one tau with plus ro-dbt, being psychosocial adjustment the main outcome; other secondary variables will be ed symptoms, overcontrol characteristics, autistic traits and neuroimaging changes. discussion: the results will fill the a knowledge gap in an treatment, expecting that patients who receive tau with ro-dbt will have better social adjustment and less relapses at one year follow up. this is the first study examining neuroimaging changes in ro-dbt to better understand its underlying mechanisms

Eligibility criteria:
inclusion criteria: * female patients * aged between 18 to 65 years old, * having a diagnosis of an (dsm 5 criteria), * having had weigh restoration treatment (normal bmi considered \>19 kg/m2) * having an overcontrol personality style assessed with the styles of coping word-pair checklist scale (asc-wp) exclusion criteria: * diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder) * diagnosis of borderline personality disorder (bpd) or positive result in mclean screening instrument for bpd * mental retardation * being under standardized psychotherapy at the baseline * being illiterate or not able to understand spanish language, * being left-handed * being pregnant for mri requirements.

Keywords: anorexia nervosa, rodbt
quality of life after conservative and surgical treatment of pelvic organ prolapse

Conditions: Pelvic Organ Prolapse; Quality of Life; Incontinence

Summary: this is an observational study that gives baseline and follow-up information, that does not directly influence the allocation of patients to various treatment options (conservative and surgical therapy of pelvic organ prolapse) but the knowledge gained of the data will help to develop treatment strategies.


Eligibility criteria:
inclusion criteria: - pelvic organ prolapse (pop) exclusion criteria: * \< 18 years * patients unable to understand an informed consent * patients unwilling to participate * emergency operations * pregnancy * overactive bladder without descensus * stool incontinence without pop
real life dosing of remicade for rheumatoid arthritis in austria monitored over 9 infusions (study p03756)(completed)

Conditions: Rheumatoid Arthritis

Summary: this is a prospective, open-label, 1-arm, multicenter observational study to determine the average remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (ra)

this study population was chosen from a non-probability sample.

Eligibility criteria:
inclusion criteria: * severe ra (indication according to austrian labeling). exclusion criteria: * according to summary of product characteristics (spc).
different proprioceptive neuromuscular facilitation (pnf) technique in patients with knee osteoarthritis

Conditions: Muscle Weakness; Balance Disorders; Knee Pain; Knee Osteoarthritis

Summary: the aim of this study is to investigate the effects of 6-week physiotherapy and rehabilitation programs involving different 'proprioceptive neuromuscular facilitation' (pnf) techniques in patients with knee osteoarthritis on pain, proprioception, postural control, muscle strength, range of motion and knee functions

the results obtained from this study will contribute to the selection of pnf technique which is most suitable for physiotherapies working on knee osteoarthritis in clinics as well as demonstrating the efficacy of pnf which has been studied in the literature very few times. as a result of this study, the evidence value of the pnf technique will be determined in the physiotherapy and rehabilitation program of patients with knee osteoarthritis, and the efficacy of this technique, which is theoretically adopted, will be demonstrated scientifically. it will also determine the most ideal of the two pnf techniques to be applied in patients with knee osteoarthritis

Eligibility criteria:
inclusion criteria: * between the ages of 45-65 * the diagnosis of stage 1-2 osteoarthritis by the orthopedist * volunteerig for research * no hearing, vision and speech impediment exclusion criteria: * patients with intra-articular contracture, * no meniscus and no ligament problems * presence of any neurological or cardiopulmonary disease that may affect the results of the study
effect of bitter melon seed oil on body weight

Conditions: Weight Gain

Summary: to investigate the metabolic benefits of bitter melon seed oil (bmso), overweight or obese healthy taiwanese adults (n=60) were randomly assigned to receive capsules containing either olive oil (oo; placebo) or bmso at 4.5 g/d dose for 12 week. across intervention period, body weight, bmi, waist-to-hip ratio, and body fat mass were measured. blood were collected before and after intervention for measurements of blood lipid and inflammatory cytokines. the anti-obesity effect of bmso was further assessed by stratification of participants according to ucp1 rs1800592 polymorphism.

bitter melon is a common asian vegetable. its seed is not edible and discarded as a waste product. however, the seed oil is enriched in cis9, trans11, trans13-conjugated linolenic acid or alpha-eleostearic acid (alpha-esa). investigators previously demonstrated the anti-obesity functions of bitter melon seed oil (bmso) in animal trials. herein, a rct was conducted to test the potential of bmso in developing as a functional culinary oil for weight control. considering ucp-1 played a pivotal role in anti-adiposity function of bmso as demonstrated in animal studies, the anti-obesity effect of bmso was further assessed according to ucp1 rs1800592 polymorphism. healthy taiwanese adults with overweight or obesity were recruited by advertisement and were assessed by a family medicine physician for eligibility. all participants signed the consent form. blocked randomization was used to randomly assign participants into one of two groups to receive indicated supplement (bmso or oo capsules with identical appearance; 4.5 g oil/d) for 12 week. subjects were requested to maintain their usual diet and physical activity during the study period (0-12 week). anthropometric measurements were done on week 0, 4, 8 and 12. three-day food records, collection of blood samples and physical health check were conducted on week 0, 4 and 12. indirect calorimetry was done on week 0 and 12. questionnaires about self-reported side effects, such as trouble sleeping, constipation, diarrhea, increased heartbeat, palpitations, headache, anxiety, or dizziness, were collected in each visit. group allocation was concealed.

Eligibility criteria:
inclusion criteria: * adults with overweight or obesity (bmi ≥ 24 kg/m2 or waist circumference \> 90 cm in males and \> 80 cm in females) * 20-64 y of age * not currently using any weight-reducing agent exclusion criteria: * diabetes * endocrine disease * uncontrolled high blood pressure (systolic ≥ 180 mm hg or diastolic ≥ 110 mm hg) * liver, kidney, or cardiovascular disease * gastrointestinal disease * psychological diseases * pregnancy or lactation * asthma and allergies * smoking * use of any drugs or dietary supplements that potentially affected body weight, blood lipids, blood pressure, or inflammatory responses.

Keywords: bitter melon seed oil olive oil weight control ucp1 polymorphism
surveillance of non-invasive streptococcus pneumoniae infections in belgium

Conditions: Pneumonia; Otitis Media; Sinusitis Bacterial

Summary: the investigators will conduct a prospective observational study of non-invasive s. pneumoniae infections in belgium and characterize serotype distributions to evaluate national vaccination programs.

the investigators will conduct a surveillance of non-invasive s. pneumoniae infections in belgium (september 2020-may 2025). monthly, 12 peripheral hospitals will send the first 15 unduplicated clinical s. pneumoniae samples (coming from patients diagnosed with pneumonia, otitits media or sinusitis) to the investigators. the investigators will determine the serotype and the antibiotic resistance profile of these clinical isolates. whole genome sequencing will be performed on a subset of these isolates. from may 2021, 13 extra participating centers have been added to the study.

Eligibility criteria:
inclusion criteria: * patients living in belgium at the time of the study, * from whom unduplicated s. pneumoniae isolates were collected in routine practices, * from non-invasive upper (e.g.: pus/fluid from nasal sinus or from otitis media fluid) or lower respiratory tract (e.g. sputum bronchial or endotracheal aspirate, bronchoalveolar fluid (bal),...) clinical samples, * from patients diagnosed with pneumonia, sinusitis and otitis. exclusion criteria: • patients for whom s. pneumoniae was simultaneously isolated from blood or another usually sterile specimen