Kornimate/medical-research-clean huggingface dataset:
clinical efficacy of polynucleotides tmj injections compared to physiotherapy.

Conditions: TMJ Disease; TMJ Pain

Summary: the main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves physiotherapy.


Eligibility criteria:
inclusion criteria: * patients who signed the informed consent * age \>18; * male and female sex; * affected by temporomandibular arthrosis exclusion criteria: * patients treated with painkillers and anti-inflammatories; * patients suffering from rheumatoid arthritis with tmj involvement; * patients with a positive history of allergies to products of fish origin; * patients suffering from alteration of the internal tmj; * patients suffering from mandibular condylar hyperplasia; * patients suffering from myofascial pain syndrome; * patients unable to express their consent for participation in the study; * patients suffering from psychiatric and behavioral disorders; * patients suffering from oncological and onco-haematological pathologies with compromised general clinical status.

Keywords: polynucleotides tmj vas physiotherapy hyaluronic acid laterality
three treatment of chronic obstructive pulmonary disease patients

Conditions: COPD

Summary: forty five copd patients will be recruited from chest disease department, tanta university hospital, tanta, egypt. the aim of the study is to compare between the effectiveness of three therapeutic options for treatment of moderate and severe copd patients .these therapeutic options include inhaled corticosteroid (ics) plus long acting b2-agonist (laba) combination, inhaled corticosteroid (ics) plus long acting anticholinergic (laac) combination and long acting b2-agonist (laba) plus long acting anticholinergic (laac) combination .

this study will be prospective randomized double blind study. the forty five copd patients will be divided into three groups: group 1: 15 patients with copd who will receive inhaled corticosteroid (ics)plus long acting b2-agonist (laba) (budesonide/formoterol combination 160/4.5 mcg, 2 inhalations bid ). group 2: 15 patients with copd who will receive inhaled corticosteroid (ics) plus long acting anticholinergic (laac) (tiotropium 18 mcg capsule inhaled once daily + budesonide ). group 3: 15 patients with copd who will receive long acting b2-agonist (laba) plus long acting anticholinergic (laac). if any worsening of dyspnea, increase of purulence, or increase of sputum production appear plus increase of peak variability more than 35% and fev1 that necessitate a change of the regular drug medication of the patient will be recorded as exacerbation. all patients will be submitted to the following analysis at the baseline, during and 12 weeks after the assigned treatment: 1. full medical history will be taken through clinical assessment of dyspnea, chronic cough and sputum production using mmrc or cat test. 2. forced expiratory volume in 1second (fev1) value measurement using spirometry. 3. measurement of the following inflammatory markers in serum and/ or plasma of patients under study . * tumer necrosis factor alpha ( tnf ) * fibrinogen * interlukin 6 ( il6 ) statistical analysis the results will be statistically calculated to evaluate its clinical significance if any before ,during and after drug therapy using (anova) system spss version 20 (2012) to compare between the three groups of patients and paired t-test will be used to compare between results before, during and after drug therapy .

Eligibility criteria:
inclusion criteria: 1. age from 30 to 40 years or older. 2. patient with 30%≥ fev1\<80% predicted and fev1/fvc \<70% predicted. exclusion criteria: 1. patients with fev1\< 30% predicted or fev1\< 50% predicted plus chronic respiratory failure. 2. patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening. 3. patients with history of asthma. 4. patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.
effects of dehydroepiandrosterone supplementation on cumulus cells gene expression under controlled ovarian hyper-stimulation in patients with diminished ovarian reserve

Conditions: Dehydroepiandrosterone; DHEAS; Gene Expression of Cumulus Cells.; Ovarian Hyper-stimulation Protocol.; Artificial Reproduction Technology.

Summary: diminished ovarian reserve (dor) is one the challenge in the field of artificial reproductive technology (art) while there is still no effective resolution of this disorder. in patents with dor, the pregnancy rate is about only 2-4%. eventually, patients with dor turn to adapt children instead. in recent studies, dehydroepiandrosterone (dheas) supplement might play a role in reverse diminished ovarian reserve and improve the prognosis of art. cumulus cells, formed cumulus-oocyte complex (coc) with oocyte, play a important role in folliculogenesis, oocyte maturation, oocyte meiosis and ovulation. growing evidences disclose there are crosstalks between oocyte and cumulus cells as paracrine regulations. aberration the crosswalks between oocytes and cumulus cells would be associated with poor prognosis of folliculogenesis and further pregnancy outcomes. in patients under ovarian hyper-stimulation protocol, the assessment of cumulus cells might be reliable indicators of folliculogenesis, embryo development, pregnancy rate and pregnancy outcomes. these genes (indicators), such as hyaluronan synthase（has2), versican (vcan), thrombospondin 1 (thbs1), runt-related transcription factor 2 (runx2), chromobox homolog 3 (cbx3),tripartite motif-containing 28 (trim28), b-cell lymphoma 2 (bcl2)，bcl2-associated x protein (bax). this study was assess the gene expressions of cumulus cells after the dheas supplement in patients with dor under ovarian hyper stimulation protocol.

this study was designed as a prospective case-control study to assess the gene expression of cumulus cells after dheas supplement. patients with diminished ovarian reserve under ovarian hyper-stimulation protocol were evaluated at kaoshiung veteran general hospital from january 1, 2013 through october 31, 2013. approval for the study was obtained from the hospital's ethic committee, and informed consent was obtained from all patients (vghks13-ct11-17)

Eligibility criteria:
inclusion criteria: * dor: antral follicle count (afc) less than 5, antimullerian hormone (amh) less than 1.0 ng/ml, and previous total retrieved oocyte less than 5. * normal control: antral follicle count (afc) equal to or more than 5, antimullerian hormone (amh) equal to or more than 1.0 ng/ml, and previous total retrieved oocyte equal to or more than 5. patient provided signed informed consent. exclusion criteria: * patient who has the allergic history or contraindication to dheas usage.

Keywords: dehydroepiandrosterone dheas gene expression of cumulus cells. folliculogenesis. oocyte maturation. ovarian hyper-stimulation protocol. artificial reproduction technology.
syd985 in patients with her2-expressing recurrent, advanced or metastatic endometrial carcinoma

Conditions: Endometrial Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of syd985 in recurrent, advanced or metastatic endometrial cancer.

this is an open-label, single-arm study in patients with her2-expressing recurrent, advanced or metastatic endometrial carcinoma. her2-expression is defined as a 1+, 2+ or 3+ score on immunohistochemistry (ihc) or positive by in situ hybridization (ish). eligible patients for this study should have progressed on or after first line platinum-based chemotherapy. patients who have had two or more lines of chemotherapy for advanced/metastatic disease are not eligible. eligible patients will receive syd985 until disease progression or unacceptable toxicity. patients who have stopped study treatment for other reasons than disease progression will continue their tumor evaluations in an observation period until disease progression or start of a new anticancer therapy.

Eligibility criteria:
main inclusion criteria: * females with histologically confirmed recurrent, advanced or metastatic endometrial carcinoma * eligible patients should have progressed on or after first line platinum-based chemotherapy for advanced/metastatic endometrial cancer. patients who have had two or more lines of chemotherapy for advanced/metastatic disease are not eligible, taking into account the following: * patients may have received up to one additional line of chemotherapy if given in the neoadjuvant or adjuvant setting. if such treatment was completed less than 6 months prior to the current tumor recurrence or progression it is to be considered first-line treatment; * no more than one line of non-cytotoxic systemic cancer therapy (such as immunotherapy, trastuzumab or protein kinase inhibitors) is allowed. * her2 tumor expression defined as a 1+, 2+ or 3+ score on ihc or positive by ish * at least one measurable cancer lesion as defined by the response evaluation criteria for solid tumours (recist version 1.1); * eastern cooperative oncology group (ecog) performance status ≤ 2; exclusion criteria: * current or previous use of a prohibited medication as listed in the protocol; * history of infusion-related reactions and/or hypersensitivity to trastuzumab; * history of keratitis; * severe, uncontrolled systemic disease at screening; * left ventricular ejection fraction (lvef) \< 50%, or a history of clinically significant decrease in lvef during previous treatment with trastuzumab; * history of clinically significant cardiovascular disease; * symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization; * history or presence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan.
the gallop-11 study

Conditions: Gastro-intestinal Stromal Tumors

Summary: an observational, multicenter study will be performed. regular 3-12 monthly follow-up by ct-scan will be compared to results of ctdna analysis. blood for analysis of mutation in ctdna will be collected at the same moment a ct-scan is performed. all samples will be analyzed at the reference pathology laboratory at the umcg. a part of the samples will also be analyzed in other institutions to implement the ddpcr. primary endpoint is concordance between ct-scan and ctdna analysis results, from which the negative predictive value (npv) of our ddpcr assay will be calculated.

this is an observational, non-interventional, multicenter study. the study will be performed within the dutch gist consortium (nki-avl, erasmus mc, radboud umc, lumc and umcg). patients diagnosed with gist with a kit exon 11 mutations that can be detected by our ddpcr assay are eligible. in this way we will study a homogenous patient population with gist that (usually) responds very well to initial tki treatment. therefore, the kit mutation status must be known. patients can enter the study at any time point of their disease trajectory. patients included in gallop-11 will have follow-up as described in the european society of medical oncology and dutch guidelines but with blood draws for ctdna assessment at similar time points. the primary objective is the negative predictive value (npv) of the ddpcr assay result in relation to the results of the ct-scan and/or mri scan (according to recist 1.1) at the same time point. concordance of these results will be determined, from which the negative predictive value (npv) of our ddpcr assay will be calculated. this is considered the most important value, as the most harmful scenario would be to miss progressive disease because not seen on ctdna while it could have been seen on ct (and/or mri). that would mean that ctdna analysis is not reliable enough to replace ct-scan (and/or mri) follow-up in the future. to determine the negative predictive value, at least 250 patients need to have an evaluable follow-up strategy. to pursue a solid follow-up period within an achievable timeline, patients with at least four ctdna measurements, accompanied by a ct-scan (and/or mri scan), will be considered evaluable for the npv analysis. patients who have progression within four scans are always evaluable, since a positive outcome outweighs negative outcomes because it is known that ctdna should have had measured change once it is seen on ct-scans (and/or mri scans).

Eligibility criteria:
inclusion criteria: 1. patients with gist with a biopsy confirmed primary kit exon 11 mutation covered by our kit exon 11 ddpcr assay (mutation/deletion within target sequence of c.1665_1736); 2. patients with an indication for at least 4 ct-scans concomitant with regular laboratory examination in a neoadjuvant, adjuvant and/or palliative care trajectory within the time frame of the study; 3. age ≥18 years; 4. written informed consent provided. exclusion criteria: 1. patients who are unable to comply with study procedures and follow up.
sex differences in e-cig perception: study 1

Conditions: Nicotine Addiction; E-Cig Use; Cigarette Smoking; Sex Differences

Summary: the primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.

this study looks at the effect of sex on the sensory effects of flavor components in e-cigarettes. regular combustible tobacco users will sample 3 different flavored e-cigarettes containing nicotine in a human lab paradigm.

Eligibility criteria:
inclusion criteria: * 21-44 years old * able to read/write * current cigarette smoking * recent e-cig exposure (\>/= 10 uses in past 6 mo.) * urine cot \>200ng/ml * willing to abstain from nicotine/tobacco 6-8hrs prior to lab session * not looking to quit exclusion criteria: * untreated chronic medical conditions * non-stable rx medication * illicit drug use * pregnant, trying to become pregnant, breastfeeding * not fully vaccinated for coronavirus (e.g. covid-19)
taking into account the patient/parent preference in the galenic choice in atopic dermatitis. feasibility and impact on treatment adherence

Conditions: Atopic Dermatitis

Summary: atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood. the treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. however, approximately 70% of patients do not adhere to therapy. studies have shown that this treatment failure is caused by the complexity of the treatment, the time required for its implementation, the cost of treatment, the dosage of the products, fear of side effects or misunderstanding about the chronicity of these diseases inflammatory conditions of the skin. this study aims to evaluate the consideration of patient preference in the choice of excipient used for the topical treatment of eczema.

day 0 : * inclusion, collecting non-opposition * presentation of the samples: 4 products presented in the same packaging (pump bottle 200 ml) and ranked in order of their fat content: * cold cream: 88% * modified cerat galen (national formulary): 66% * cold cream fluid: 32% * ointment: 21% the 4 products are all equally effective and suited in the treatment of atopic dermatitis. the patient choose the cream it will apply from 4 presented. a total of two bottles will be given to the patient. a bottle containing only the emollient applied to dry areas and another bottle in which 30% will be added diprosone (topical steroid) to be applied on areas of eczema). * remitting the questionnaires * severity scoring of atopic dermatitis (scorad) day 30: * remitting the questionnaires * treatments delivery for 2 months * scorad / po scorad * treatment weighing day 90: * scorad / po-scorad * treatments weighing * remitting the final questionnaire

Eligibility criteria:
inclusion criteria: patients experiencing treatment failure despite appropriate treatment. patients minors aged between 3 and 15 years for children age 7 and non-autonomous children in the application of treatment, the parent at the initial consultation should be the one who treats the child. information from both parents or parental authority and collection of non-opposition the patient must have a computer to do its po-scorad between consultations. patient who used a topical treatment for atopic dermatitis in the week preceding the study. exclusion criteria: patient refusal to participate in the clinical study. adults and children over 15 years.

Keywords: atopic dermatitis, feasibility, adherence to treatment
european quality improvement programme for acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: the main hypothesis to be tested is that the use of a quality improvement programme will lead to measurable improvements in the management of care and use of evidence based treatments for patients presenting to hospital with non-st elevation acute coronary syndromes.


Eligibility criteria:
inclusion criteria: patients with a good clinical history of acs and at least one of the following: * new or transient st or t wave changes on the ecg consistent with acute myocardial ischaemia * elevation of troponin or other cardiac markers to levels indicative of myocardial necrosis according to local laboratory values exclusion criteria: * evidence of persistent st elevation on the ecg * use of early reperfusion therapy * patients \>80 years * patients transferred from another hospital

Keywords: acute coronary syndromes quality improvement
the sun protective effect of melatonin

Conditions: Sunburn

Summary: the aim of this study is to investigate the sun protective effect of melatonin, when used as a cream applied before sun exposure. sun exposure induces erythema as indication of an inflammatory reaction in the skin. it is proven that the amount of free radicals in the skin are increased by uv exposure. furthermore, it is known that melatonin is a potent antioxidant. it is hypothesized that melatonin can be protective against the uv induced release of free radicals by acting as a radical scavenger and thereby protect against uv-induced cellular damage.

this study investigates the sun protective effect of melatonin when used as a creme applied before sun exposure. the study is a randomized, placebo-controlled, double-blinded study conducted on healthy volunteers. the volunteers will have 5 squares of 8 cm\*8 cm on their backs, which each will be randomized to receive one of following: melatonin cream 0,5%; melatonin cream 2,5%; melatonin cream 12,5%; placebo cream (vehicle) and no treatment. after randomization and received treatment the volunteers will be exposed to strong midday sun (uv-index of approximately 9) for 40 minutes. the outcomes parameters (degree of erythema and pain sensation) are measured at baseline and 1,4,8 and 24 hours post exposure.

Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes. * skin type 1-3 according to fitzpatrick skin type scale. * no sun exposure on skin area tested in the study 4 weeks prior to the study. exclusion criteria: * active skin disease * participant that do not react to the given sun exposure with a change in a-value \>5 are excluded from the data. * pregnancy * previous malignant or pre malignant skin disease.

Keywords: melatonin sunburn erythema sunlight ultraviolet rays
rebreathing-induced hypoxia and glucose levels

Conditions: Hypoxemia

Summary: the aim of this research project is to determine the effect of repeated maximal voluntary apneas on glucose uptake during an oral glucose tolerance test in healthy individuals, individuals with prediabetes and patients with type 2 diabetes.

it is predicted that 1 in 3 adults will develop diabetes by 2050, implying that a large percentage of the population will become at high risk for cardiovascular disease, the most common cause of death in patients with type 2 diabetes. while regular exercise reduces insulin resistance and the elevated glucose levels associated with type 2 diabetes, only 28% of the adult population with diabetes meet physical activity recommendations. there is therefore an urgent need to identify alternative, non-pharmacological interventions that prevent and treat type 2 diabetes. a reduced oxygen availability, or hypoxia, is widely implicated in the development of insulin resistance. paradoxically, hypoxia also triggers glucose uptake independently from the actions of insulin. indeed, breathing low levels of oxygen stimulates glucose uptake in skeletal muscles by activating 5' adenosine monophosphate-activated protein kinase (ampk). discrepancies on the effect of hypoxia on glucose homeostasis may be attributed to the duration and type (nocturnal vs. diurnal) of hypoxic exposure. for example, the many severe hypoxic bouts associated with obstructive sleep apnea are associated with a worsened glycemic control while hypoxic exposure consisting of a limited number of short bouts of moderate hypoxia improves glycemic control. therefore, an intervention that can induce brief hypoxic conditions, as observed through a reduced fraction of inspired oxygen, could attenuate the postprandial increase in glucose levels. fraction of inspired oxygen can be reduced by rebreathing into a low-volume closed-circuit system containing ambient air for few minutes. thus, the aim of this research project is to determine the effect of few bouts of rebreathing-induced hypoxia on glucose uptake during an oral glucose tolerance test in healthy individuals, individuals with prediabetes and patients with type 2 diabetes. if our expected outcomes are met, our next step will be to determine whether repeated sessions of rebreathing-induced hypoxia (5 sessions per week over 1-3 months) results in improvements in glycemic control.

Eligibility criteria:
inclusion criteria: * men and women aged 18 to 80 years old exclusion criteria: * have uncontrolled stage 2 hypertension (˃140/90 mmhg) * are smokers * are pregnant * have a history of cardiovascular disease or indication of cardiovascular disease such as myocardial infarction, left ventricular hypertrophy, ischemic heart disease (or prior ischemia), stroke, and/or other vascular disease * have a history of lung disease * are taking insulin or more than one antihypertensive medication * have poorly controlled diabetes: hba1c levels ˃ 9% * have been previously diagnosed with diabetic complications (nephropathy, neuropathy, retinopathy) by their family doctor