Kornimate/medical-research-clean huggingface dataset:
pcr techniques of dried sputum using a spotcard

Conditions: Tuberculosis, Pulmonary

Summary: molecular testing for mutations in m. tuberculosis genes associated to resistance of anti tuberculosis (tb) drugs is already part of standard laboratory tb diagnostic. this implicates earlier knowledge of possible resistance and thus prevents unnecessary treatment and the chance of treatment failure or treatment related toxicity. the molecular laboratory diagnostics is widely spread in high income, low tb endemic countries. however, the low income countries lack widespread facilities to test for susceptibility, either genotypic or phenotypic. performing molecular diagnostics on sputum collected with a spot card could improve accessibility to molecular testing. this study examines if sputum collected and put on spot cards could be used for multiple molecular tests for the detection, identification and susceptibility prediction of tb. this means that dna extraction of the sputum from the spot card should be feasible. the study is a pilot study with adult patients of the tuberculosis department of university medical centre groningen (umcg) beatrixoord, haren as subjects. the sputum produced will be collected, dried on spot cards, and dna extraction from the card will be tested. if molecular detection is positive for the tuberculosis bacteria additional tests will be performed. based on the present/absent of mutations in the genes associated to resistance susceptibility can be preditec, different molecular techniques will be performed to identify possible mutations. furthermore, sputum will be collected as patients produce so. sputum samples with low bacterial load can be tested as well and can test the sensitivity of the procedure. lastly, techniques like rna detection will be tested to identify the bacterial load. this can be done if more than one sample of patients were collected. subjects will be selected on age, participation in standard tdm and drug use. demographic parameters will be analysed. sputum samples will be taken twice a week (on tuesday and friday).


Eligibility criteria:
inclusion criteria: * patients is 18 years or older * pulmonary tb confirmed by culture or molecular test * producing sputum * signed informed consent exclusion criteria: * extrapulmonary tb * pulmonary tb without production of sputum
e-compared-s: comparative effectiveness research on internet-based depression treatment - spanish trial

Conditions: Major Depressive Disorder

Summary: to compare the clinical and cost-effectiveness of blended cognitive behavioural therapy (cbt) for adults with major depressive disorder (mdd) with treatment as usual (tau) in spanish population.

depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. on a population level, depression is one of the most costly diseases. the economic costs of depression were estimated at €136.3 billion (eu25) in 2010 in the eu and are still rising. european health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity. internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of internet-based treatment for depression in controlled research setting. internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (tau), but with similar levels of clinical efficacy and quality of care. the trials will be conducted in 8 european countries. in spain the trial will be carried out in routine primary, comparing the clinical and cost-effectiveness of cbt and tau for adults with major depressive disorder (mdd). respondents will be followed until 12 months after baseline (measures will be taken at bl, 3 months, 6 months and 12 months).

Eligibility criteria:
inclusion criteria: * being 18 years of age or older * meet dsm-iv diagnostic criteria for mdd confirmed by mini international neuropsychiatric interview version 5.0 * a score a score of 5 or higher on the phq-9 screening questionnaire. exclusion criteria: * current high risk for suicide according to the mini interview section c * serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the mini interview * currently receiving psychological treatment for depression in primary or specialised mental health care * being unable to comprehend the spoken and written language (spanish) * not having access to a pc and fast internet connection (i.e. broadband or comparable). * not having a smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a smartphone during the duration of treatment

Keywords: cost-effectiveness blended treatment internet based treatment efficacy depression cognitive behavioural therapy
tec4home heart failure: using home health monitoring to support the transition of care

Conditions: Heart Failure

Summary: tec4home heart failure is a randomized controlled trial (rct) that examines how home health monitoring (hhm) can support heart failure (hf) patients during the transition of care from hospital to home. the hhm solution includes a weight scale, blood pressure cuff, pulse oximeter and tablet computer, which patients use daily for 60 days to record these metrics and answer questions on their symptoms. this data is sent to a nurse who is able to monitor the patient's condition remotely. the hypothesis is that the tec4home hhm solution will be a cost-effective strategy to decrease 90-day emergency department (ed) revisits and hospital admission rates, and improve quality of life and self-management for patients living with heart failure.


Eligibility criteria:
inclusion criteria: * be 19 years of age or older (age of majority in british columbia) * have one or more typical symptoms of heart failure (i.e. dyspnoea at rest or minimal exertion (includes orthopnoea, reduced exercise tolerance)) and * have one or more typical signs of heart failure (i.e. elevated jugular venous pressure, pulmonary crepitations, pleural effusions, peripheral oedema) and * have one or more objective measures of heart failure: * radiological congestion. * elevated bnp ≥ 400 pg/ml or nt-probnp ≥ 1000 pg/ml. * reduced left ventricular ejection fraction \<40% (or \<45%) in previous 12 months. * diastolic dysfunction including tissue doppler e/e' ratio \> 15 in previous 12 months. * pulmonary capillary wedge pressure \>20 mmhg. * diuretic therapy. the additional value of diuretic therapy (iv or oral) is debatable, as presumably unlikely (or unsafe) that patient with genuine hf will be discharged without diuretic. exclusion criteria: * physical barriers e.g. unable to stand on scales. * cognitive impairment (e.g. mmse \<20), unless suitable caregiver support. * language (must be able to read and understand english), unless suitable caregiver support. * documented history of current and active substance misuse (within 3 months). * lack digital connectivity or landline phone connection. * no regular care provider e.g. gp, or at least regular walk-in clinic. * existing intensive system of care: lvad, transplant, dialysis. * anticipated improvement due to revascularization (pci/cabg) or valve intervention during index hospitalization. * anticipated survival \<90 days. active palliative care, less-than level iii care, disseminated malignancy.
canadian cohort on the origin and progression of airway disease: physiology platform

Conditions: Smoking; COPD

Summary: the canadian respiratory research network (crrn) has recently been established to study the origins and evolution of airways disease in the population. the crrn is funded by the institute of cardio-respiratory health (icrh), an institute of the cihr. the physiology platform will support the other crrn platforms (biology, imaging, population health, knowledge transfer) by providing a comprehensive characterization of the nature and extent of physiological impairment of respiratory function in smokers at risk for airways disease and in those with early or mild airway obstruction. the planned studies of the physiology group (core sites located at queen's university, university of british columbia and mcgill university) will initially focus on smoking-related lung injury in those at risk for copd and in those meeting spirometric criteria for mild airway obstruction, with or without respiratory symptoms. the primary aim of this initial study is to identify and validate sensitive test(s) of peripheral airway dysfunction that may qualify as physiological biomarkers for use in future crrn studies.


Eligibility criteria:
inclusion criteria: stable patients with gold grade 1 mild copd will be included in the study if they have: a post-bronchodilator fev1≥80 %predicted and an fev1/fvc ratio \ 9, modified mrc\ 10 pack-year history) who do not meet criteria for copd (e.g., post-bronchodilator fev1\ 10. healthy, age- and sex-matched, non-smoking (\<2 pack-year history) participants with normal spirometry will be used for comparison purposes. exclusion criteria: * presence of clinically significant comorbidities that could contribute to dyspnea or exercise limitation (i.e., unstable heart disease, a pulmonary disease other than copd, uncontrolled diabetes, neuromuscular or orthopedic impairment); * history/clinical evidence of asthma; * contraindications to exercise testing; * \<40 years of age; * body mass index \ =35 kg/m2.

Keywords: smoking small airway dysfunction mild copd dyspnea exercise clinical outcomes
calcitonin in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to determine whether nasal administration of salmon calcitonin is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.

fibromyalgia is a common, chronic musculoskeletal disorder that is characterized by widespread pain and tenderness. fibromyalgia occurs in around 2% of the us general population, is more common in women and is associated with substantial morbidity and disability. treatment of fibromyalgia has been disappointing; roughly one-third of patients have had a clinically important therapeutic response to medications or no-medicinal treatment, event with the newest drugs reported in the literature. pathophysiology of fibromyalgia is unknown, but abnormalities in central neurotransmission might play a role. some studies have shown that salmon calcitonin increases peripheral and central levels of endorphins. increasing endorphins levels may decrease pain. then, it is feasible that nasal administered salmon calcitonin may decrease several of the symptoms and signs of patients suffering fibromyalgia.

Eligibility criteria:
inclusion criteria: * female patients between 18 and 50 years * fibromyalgia diagnosis (acr criteria) * must be able to apply the nasal medication * must be able to comply with study visits * must be able to understand informed consent * must be able to answer self-administered questionnaires * must have an active disease(vas \> 60mm) exclusion criteria: * comorbid conditions (i.e. hypothyroidism, diabetes mellitus, etc.) * any disturbance in the nasal tissue * use of concomitant opioid analgesics * contraindication to use salmon calcitonin (allergy, hypocalcemia, hypophosphatemia) * other rheumatic diseases * diagnosis of major depressive disorder

Keywords: salmon calcitonin endorphins treatment fibromyalgia
platelet transfusion in sepsis trial

Conditions: Sepsis; Thrombocytopenia

Summary: platelets are important mediators of an inflammatory response and a key component of the innate immune system to defend the human body against invading pathogens. however, little evidence exists regarding the number of platelets that should be used als transfusion threshold in septic patients. in this trial platelet transfusion will be performed with either \<50000/µl or \<20000/µl as a trigger.


Eligibility criteria:
inclusion criteria: * sepsis defined as alteration of sofa score (sepsis-related organ failure assessment score) \>2 points (sepsis-3 definition) * platelet count \<50.000/µl exclusion criteria: * age less than 18 years * patients with immune thrombocytopenia * major bleeding in the last 72 hours or ongoing major bleeding * patient, surrogate or physician not committed to full intensive care support * pregnancy
prevention of preterm birth using cervical pessary in pregnant women after threatened preterm labor(pecep-retard)

Conditions: Preterm Birth

Summary: placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.


Eligibility criteria:
inclusion criteria: * minimal age of 18 years * episode of threatened preterm labour exclusion criteria: * major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * spontaneous rupture of membranes at the time of randomization * cervical cerclage in situ * active vaginal bleeding * placenta previa sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).
effect of a topical spray on itch relief in moderate-to-severe childhood eczema

Conditions: Eczema

Summary: pruritus is defined as an unpleasant sensation of the skin that provoke the desire to scratch or rub. its presence is an essential diagnostic feature. according to some european studies, 91% of patients with atopic dermatitis report suffering from pruritus at least once daily. and 58.1% of them experience chronic pruritus, leading to great deterioration in quality of life. various internal and external factors may trigger pruritus. mediators secretion such as keratinocyte-derived thymic stromal lymphopoietin (tslp) and nerve growth factor (ngf) could activate nerve fibres which will eventually transmit signals to the brain causing the sensation of itching. although being one of the major annoying symptoms faced by patients with atopic dermatitis, effective anti-itching treatments are not available. there is no consistent evidence that topical antihistamines can relief itch. recently, a new spray named atoderm 'sos' is developed. the skin relief technology (by ambora extract and epigallocatechin gallate (egcg), associated to enoxolone) claimed to inhibit the release tslp and ngf which eventually could reduce nerve signals to the brain for itchy feelings. therefore, our group would like to test the efficacy of this proprietary anti-itch product with our paediatric patients using a wait-list approach as a control. it is aimed to demonstrate that the using the atoderm 'sos' spray topically whenever necessary can reduce the unpleasant itchy atopic dermatitis's symptom, improve quality of life, as well as to reduce the need for topical treatment.


Eligibility criteria:
inclusion criteria: * a pruritus frequency of more than 3 days in previous week recorded by q1 in the patient oriented eczema measure (poem) * history of known moderate-to-severe eczema * able to read chinese * voluntarily willing to participate into the study by written consents endorsed by patients and their legal guardians exclusion criteria: * no history of known eczema * concurrently participating into another clinical trial * history of known drug allergy * unable to read chinese

Keywords: itch relief childhood eczema topical spray quality of life
outcome prediction in head&neck cancer patients after radiotherapy

Conditions: Head and Neck Cancer

Summary: the primary and general objective of the clinical introduction of the standard follow-up program (sfp) as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. the clinical introduction of the sfp will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. in fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

for head and neck squamous cell carcinoma (hnscc), radiation therapy is one of the mainstays of therapy either as definitive therapy alone or in combination with systemic therapy or following surgical resection as postoperative treatment. nowadays there's great attention for personalized medicine which aims at offering a patient the treatment that best suits the individual patient and its tumor characteristics. to apply personalized therapy, we need accurate outcome prediction models for disease control, treatment related toxicity and quality of life. the main factors used for predictive/prognostic nomograms are clinical factors, like patient-, tumor- and treatment related factors (1). standard examples of these include age, gender, co-morbidity, smoking history, hemoglobin levels, tumor site, tnm stage, tumor volume, hpv-status, and others. for larynx cancer the nomogram was made publicly available on www.predictcancer.org. however, we anticipate that other factors will contribute to the (improvement of) prediction models. these factors may include genomic analysis of tumor specimens, quantitative image analysis (radiomics), blood biomarkers, and/or tumor-tissue markers (2). in addition, treatment-related parameters also need to be considered and these not only include factors like overall treatment time, use of systemic therapy, prescribed radiation dose and fraction dose. with new techniques using epid dosimetry, it is now possible to measure the delivered radiation dose and compare this to the prescribed dose (3,4). this offers the potential to apply dose guide radiotherapy (dgrt), which especially in hnscc may have a large impact, because anatomical changes during fractionated therapy are known to occur and lead to dose changes to targets and organs at risk (5,6). the final objective of this study is to integrate all potential prognostic factors and develop reliable nomograms both for tumor control as well as complications.

Eligibility criteria:
inclusion criteria: all patients planned for curatively intended primary or postoperative radiotherapy exclusion criteria: all patients planned for palliative radiotherapy

Keywords: head and neck cancer
chronic intestinal pathologies analytical cohort at toulouse

Conditions: Inflammatory Bowel Diseases; Colon Cancer

Summary: in the general population, the percentage of people with at least one digestive disease is 16.7%. among these digestive diseases, inflammatory bowel disease (ibd), irritable bowel syndrome (ibs) and patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( fit) in the stool will be studied. the aim of this project is to build a biological collection with associated clinical data for research projects.

in the general population, the percentage of people with at least one digestive disease is 16.7%. among these digestive diseases, two of them namely inflammatory bowel disease (ibd) and irritable bowel syndrome (ibs) will be more particularly studied. this interest is based on the increasing frequency of these two pathologies, their chronicities but above all the limited physiopathological data available. in addition, it seems interesting to study a third population, namely patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( fit) in the stool. the study of this population is part of an improvement in knowledge on the carcinogenesis of colorectal cancer. to study these populations, blood, serum, plasma and tissues from colonous biopsies or surgical samples will be collected. this cohort will make it possible to study, among other things, the pathophysiology of chronic diseases of the small intestine and the colon (ibd, ibs, screening) in order to improve their management through the development of new biomarkers and therapeutic targets.

Eligibility criteria:
inclusion criteria: * patient requiring endoscopic explorations for screening or follow-up in the context of a suspected ibs or ibd or colorectal cancer or * patient with ibd requiring surgical management * patient over 18 years old * patient able to read and understand the information leaflet * patients who have given their consent to participate in the study * patients affiliated to a social security system (including ame) exclusion criteria: * patients who have received antibiotic treatments in the 10 days preceding endoscopic exploration * pregnant or breastfeeding patients * patients under 18 years old * patients under guardianship or curatorship * patients unable to sign a free and informed consent

Keywords: intestinal bowel syndrome inflammatory bowel disease colon cancer screening data and biological collection
comparative analysis in detection of atrial arrhythmia and ecg quality in three different insertable cardiac monitors

Conditions: Arrhythmias, Cardiac

Summary: comparative analysis of available ilr devices models abbot confirm rxtm, medtronic reveal linqtm, and biotronik biomonitor., evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

all devices have different algorithms for arrhythmia detection and structural design. consequently, these devices vary in sensitivity of arrhythmia detection and data transmission.therefore, we aim to expand a comparative analysis of available devices, evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Eligibility criteria:
inclusion criteria: patients \> 18 years of age with appropriate indication for ilr for atrial arrhythmia management. exclusion criteria: inability to give consent

Keywords: cardiac arrhythmias implantable loop recorder comparative analysis
meropenem and piperacillin plasma concentrations during crrt

Conditions: Sepsis; Infection; Antibiotic; Renal Replacement Therapy; Hemolysis

Summary: this observational study reports meropenem and piperacillin plasma concentrations in patients treated with either antibiotic and simultaneous continuous renal replacement therapy (crrt).


Eligibility criteria:
inclusion criteria: * patients treated in the study icu and * simultaneous crrt and antibiotic treatment with either meropenem or piperacillin-tazobactam. exclusion criteria: * none