Kornimate/medical-research-clean huggingface dataset:
characterization of the kinetics of renal glucose reabsorption in response to dapagliflozin in healthy subjects and in subjects with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus

Summary: it is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with t2dm.


Eligibility criteria:
inclusion criteria for t2dm * diagnosis of t2dm * must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin * subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration * must have a fasting plasma glucose concentration ≤ 200 mg/dl, and hba1c ≤ 10% inclusion criteria for healthy subjects: * healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations) inclusion criteria for all subjects: * subjects with (egfr ≥ 60 and ≤ 160 ml/min/1.73m² and urinary albumin excretion \< 300 mg/g creatinine) * body mass index (bmi) of 18 to 38 kg/m² * men and women, ages 18 to 65 years, inclusive exclusion criteria for all subjects: * subjects with type 1 diabetes or uncontrolled type 2 diabetes mellitus * subjects with t2dm with fasting plasma glucose \> 200 mg/dl, healthy subjects with fasting plasma glucose \> 105 mg/dl * subjects with t2dm with hba1c \> 10.0%, healthy subjects with hba1c \> 6.8%
effects of inspiratory muscle training on lymphedema

Conditions: Lymphedema

Summary: the aim of this study is to examine the effect of inspiratory muscle training on lymphedema volume, subcutaneous tissue thickness, upper extremity functionality and sleep quality in the treatment of upper extremity lymphedema. two groups included 24 patients with lymphedema will be divided into gropus (intervetion and control) and they will compare each other.

all patients will be treated 5 days a week, 4 weeks, with each session lasting 45-60 minutes. while only decongestive treatment will be applied to the control group, inspiratory muscle training will be given to the interventional group in addition to decongestive treatment. evaluations of the patients will be made before and after of 4-week treatment program.

Eligibility criteria:
inclusion criteria: having been diagnosed with lymphedema in the upper extremity at least 6 months ago * having stage 2 lymphedema * having a 2-8 cm circumference difference between the affected extremity and the healthy extremity at any reference point * being between the ages of 18-60 * voluntarily agreeing to participate in the study * not having received any lymphedema treatment in the last 6 months. * not having any physical, respiratory, neurological and/or systemic disease that would prevent participation in the treatment program. exclusion criteria: having stage 1 and stage 3 lymphedema * it has been less than 6 months since the diagnosis of lymphedema was made * being under 18 years of age and over 60 years of age * having a circumference measurement difference of more than 8 cm and less than 2 cm at any reference point between the affected extremity and the healthy extremity * lymphedema or elephantiasis with papilloma, hyperkeratosis * uncontrolled hypertension, pulmonary edema, presence of serious cardiovascular disease * presence of active metastasis * acute inflammatory diseases

Keywords: lymphedema inspiratory muscle training decongestive treatment physical functioning sleep quality quality of life
the role of diet in periodontal inflammation: a controlled clinical study

Conditions: Periodontal Inflammation; Periodontal Diseases

Summary: diet can influence the body's healing and repair mechanisms. a dietary imbalance obviously cannot trigger periodontal disease in the absence of a primum movens, which is bacterial plaque. however, it can condition its severity and extent by altering the permeability of the oral mucosa, the effectiveness of the immune response and the reparative potential of the gingival tissues. nutraceuticals is the science that studies the effects of the so-called food-drug, i.e. those foods that contain substances capable of performing a pharmacological function, modifying the functions of the organism. in particular, some molecules that are assimilated through various foods are able to penetrate the cell nucleus and influence, through an epigenetic mechanism, the expression or otherwise of some genes. the aim of our controlled study is to understand whether a vegetarian/vegan diet can be considered as protective for periodontal health compared to an omnivorous diet. for this purpose, we used a test group of 22 omnivorous subjects and a control group of 22 vegetarian/vegan patients in which experimental gingivitis was induced.


Eligibility criteria:
inclusion criteria: * optimal systemic health conditions * non-smoking * absence of cardio-vascular pathologies * absence of pulmonary pathologies * non-diabetic * not pregnant * fmps \<20% * fmbs \<20% * omnivorous or vegan/vegetarian diet for at least a year * absence of periodontitis exclusion criteria: * smokers * presence of systemic pathologies * presence of cardio-vascular disease * presence of periodontitis * fmps\>20% * fmbs\>20% * pregnant women * presence of blood pathologies * taking medicines (hydantoins, nifedipine or cyclosporine) * taking oral contraceptives * bacterial, viral or fungal infections * idiopathic gingival fibromatosis * mucocutaneous disorders * allergic reactions to toothpastes and mouthwashes

Keywords: experimental gengivitis nutraceutical periodontal inflammation
hemodynamic response to exercise in hfpef patients after upregulation of serca2a

Conditions: Heart Failure, Congestive

Summary: heart failure with preserved ejection fraction or hfpef, represents nearly 50% of all heart failure cases and is particularly common in the elderly. the disease has no current treatment options. symptoms typically occur during exertion or exercise and is likely the result of increased cardiac and pulmonary congestion as a result of impaired diastolic function. istaroxime is a novel activator of serca2a, an important regulator of calcium uptake within the myocyte. we will test the hypothesis that istaroxime will improve diastolic function during exercise in hfpef patients which in turn will reduce cardiac and pulmonary congestion.

about half of all elderly patients with a diagnosis of congestive heart failure have apparently normal systolic function, so called "heart failure with a preserved ejection fraction" or hfpef. to date, no effective therapy for hfpef has been found, in part because of failure to discern key pathophysiologic pathways. an extensive amount of pre-clinical work has identified that altered sarcoplasmic reticulum (sr) ca2+ uptake, storage, and release play a major role in the changes in cardiac relaxation associated with aging, especially regarding sequestration of ca++ by the sarcoplasmic reticular ca++-atpase (serca2a), which causes cardiac muscle relaxation by reducing cytosolic ca++. istaroxime is a relatively new drug that augments lusitropic function by upregulating serca2a activity in the heart. because of the clear importance of slowed relaxation in hfpef, and the evidence that depressed serca2a activity contributes to the slowed relaxation with aging, the proposed study may be establish the "impairment of serca2a" hypothesis as a mechanism of impaired relaxation in hfpef subjects.

Eligibility criteria:
healthy senior controls inclusion criteria: * age \> 60 years exclusion criteria: * coronary ischemia * no chronic medical problems * bmi \> 30 kg/m2 hfpef subjects inclusion criteria: * age \> 60 years * signs and symptoms of heart failure * ejection fraction \> 50% * objective evidence of diastolic dysfunction exclusion criteria: * coronary ischemia * chronic kidney disease, stage 4 or greater * persistent atrial fibrillation * severe valvular disease * bmi \> 45 kg/m2
arterial line in trauma resuscitation

Conditions: Major Trauma

Summary: accident-related deaths is the 7th leading cause of death in taiwan, and most of them is due to trauma from falls and traffic accident. among trauma patients, the common cause of death is from hemorrhagic shock. thus, real-time and accurate blood pressure monitoring is important for trauma patients. incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). the current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring. with continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. in some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown. the main purpose of this study is to investigate the application of arterial line insertion in trauma patients. the study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes.


Eligibility criteria:
inclusion criteria: * glasgow coma scale (gcs) 13 or less * sbp \< 90 mmhg * respiratory rate \ 29 breaths/min * fall from height \> 6 meters * high-risk auto crash: partial or complete ejection, intrusion \> 30 cm any site, need for extrication for entrapped patient, death in passenger compartment * rider separated from transport vehicle with significant impact * penetrating injuries to head, neck, torso, and proximal extremities * skull deformity, suspected skull fracture * chest wall instability, deformity, or suspected flail chest * suspected pelvic fracture * suspected fracture of two or more proximal long bones * amputation proximal to wrist or ankle * active bleeding requiring a tourniquet or wound packing with continuous pressure * burns in conjunction with trauma exclusion criteria: * pregnancy * patient or family who are unable to obtain informed consent * known coagulopathy that is inappropriate for arterial line insertion * known peripheral arterial occlusion disease that is inappropriate for arterial line insertion * traumatic cardiac arrest

Keywords: major trauma arterial line resuscitation
research project about psychological strain, quality of life and emotional awareness in patients with tinnitus

Conditions: Tinnitus

Summary: validation of prism (pictorial representation of illness and self measure) as a assessment of quality of life and suffering in patients with tinnitus. association between experiencing, verbalizing and regulating emotions and perceived tinnitus. correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective eeg-patterns.

validation of prism (pictorial representation of illness and self measure). assessment of quality of life and suffering in patients with tinnitus in an observational study using different questionnaires. (thi, tf, tbf-12, bdi, bai, sf-36). thi - tinnitus handicap inventory tf - tinnitus questionnaire after goebel and hiller tbf-12 - tinnitus impairment questionnaire bdi - beck depression inventory bai - beck anxiety inventory sf-36 - short form 36 health survey questionnaire association between experiencing, verbalizing and regulating emotions and perceived tinnitus using the tas-20 (20-item toronto alexithymia scale) and the above mentioned questionnaires. eeg-studies on the spontaneous brain activity of individuals affected by tinnitus consistently report differences in the composition of the eeg-frequency spectrum between individuals with tinnitus and healthy controls. furthermore it has been shown that not only the auditory cortex but other regions of the brain are involved in the perception of the chronic ear noise as well. among them is the limbic system which is associated with the emotional processing of the human brain. correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective eeg-patterns. aim of the current study is to provide conclusive models of associated assessments of the psychological strain end emotional stress of individuals suffering from tinnitus and objective eeg-analysis.

Eligibility criteria:
inclusion criteria: * all patients older than 18 years with tinnitus who want to participate the investigation during the period of data acquisition exclusion criteria: * patients younger than 18 years, * insufficient knowledge of the german language.
validation of the therasure cni-monitor under immuno-checkpoint-therapy (hereinafter: "immunotherapy") in nsclc in palliative therapy

Conditions: NSCLC

Summary: this is a prospective, non-interventional, national study planned at three centers for patients with non-curative nsclc receiving immunotherapy. at present, pd-l1 expression or tumor mutation burden serve as surrogate parameters for response to immunotherapy. however, the problem for clinicians is that not all patients with positive findings respond to this form of therapy. cell-free dna (cf-dna) can be detected in blood plasma. tumor cells almost always have chromosomal instabilities (or "copy-number variations" (cnv)), which can be detected using next-generation sequencing (ngs), also in the cf-dna. these cnv can be quantified and given as a cf-dna copy number instability score (cni value). therasure cni-monitor is a highly sensitive method that can detect as little as 0.5% tumor dna in plasma. in preliminary work in a cohort of 56 patients with various types of cancer (including: breast, colon, lung, ovary, melanoma) in advanced stages, the therasure cni monitor was already evaluated in the monitoring of immunotherapy. in 51 of the 56 patients, increased ckd values were measured before the start of therapy compared to a normal group of 126 individuals. to predict the success of the therapy, further blood samples were used after the first and second therapy cycle and threshold values were set for the minimal expected decrease in the cni value in the event of therapy response. a therapy failure could be predicted with a high positive predictive value, cases of hyperprogression could be detected earlier than by routine imaging. in addition, pseudoprogression could be distinguished from true progression using the cni value. the cni monitor on cell-free dna is to be used prospectively in 170 patients. the primary objective of the study is the prediction of primary progression under immunomonotherapy (defined as pd within 6 months after recist) with a predictive value for progression (ppv) of ≥50%.


Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥18 years * nsclc, non-curatively treatable stage iii or stage iv with palliative treatment indication * immunocheckpoint-therapy for malignant disease (immunotherapy as monotherapy, double immunotherapy or combination with chemotherapy) exclusion criteria: * person is unable to understand the nature, importance and scope of the clinical trial * participation in an interventional study * hb value \<9g/dl
repeat nasal allergen challenge

Conditions: Hayfever

Summary: this is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

this is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Eligibility criteria:
inclusion criteria: 1. male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years. 2. otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies. exclusion criteria: 1. smokers (use of tobacco products in the previous 3 months). 2. presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (fev1 \> 80% predicted at screening).

Keywords: nasal allergen challenge allergic rhinitis timothy grass pollen inflammatory mediators
improving decision-making encounters in lung cancer using a low-literacy conversation tool

Conditions: Lung Carcinoma

Summary: this clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. this research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. the focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

primary objectives: i. conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. a subset of participants from control and intervention groups will also have their clinic conversations with providers recorded ii. conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of aim 1 participants. outline: patients are randomized to 1 of 2 groups. group i: patients review decision aid. group ii: patients receive standard of care. after completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.

Eligibility criteria:
inclusion criteria: * aim 1: suspected lung cancer * aim 1: english fluency * aim 1: \> 6-month life expectancy * aim 1: score of ≥ 3 on the cognitive impairment screener * aim 2 participants: participation in aim 1 * aim 2 clinicians: discussing lung cancer treatment decisions with aim 1 participants
ambispective study evaluating the clinical results of sagitta evl r revision stems

Conditions: Hip Arthropathy

Summary: this clinical study is conducted to collect data on hip arthroplasty with the sagitta evl-r revision femoral stems manufactured by serf. in order to reflect current practice, a comprehensive and continuous series of patients will be included. this study will confirm the performance and safety of the sagitta evl r revision femoral stems within the framework of mdr 2017/745 and in relation to the recommendations of the meddev guide 2.7.1. rev 4 (clinical evaluation guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.


Eligibility criteria:
inclusion criteria: * patient over 18 years old at the time of surgery, * patient implanted with a sagitta evl r revision femoral stem within its indications between 01/01/2016 and 31/12/2018, * affiliated to french health insurance system exclusion criteria: * patient who has not expressed consent for data collection and participation in the study, * patient unable to understand the surgeon's instructions or to perform postoperative follow-up. * patient with a contraindication to the use of the sagitta evl r revision femoral stem * patient implanted with a sagitta evl r revision femoral stem outside its indication

Keywords: total hip prosthesis revision
estrogen modulation of mood and cognition following monoaminergic depletion in post-menopausal women

Conditions: Menopause

Summary: this study will examine whether estrogen administration in postmenopausal women can alter the response to changes in brain chemistry brought about by dietary manipulation. women who are recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (\>70 yrs. of age) will take estrogen or placebo for three months. at the end of that time they will participate in three challenges using dietary techniques to briefly change the relative amounts of neurotransmitters in the brain that are believed to be related to mood regulation (serotonin, dopamine, and norepinephrine). previous research has shown that these dietary manipulations can briefly produce negative changes in mood. the investigator hypothesizes that estrogen administration will blunt or buffer these negative effects in a quantifiable way. the investigator believes that this will provide a direct test of the ability of estrogen to meaningfully change the brain chemistry of mood in a clinically measurable and positive way. the proposed procedure will also allow assessment of the effects of estrogen on brain neurotransmitter systems after many years of very low estrogen levels.


Eligibility criteria:
inclusion criteria: * postmenopausal * non-smoker * bmi \<30 * healthy * without surgically-induced menopause * not on hrt or \>1 year post hrt * normal mammogram within last year * no cardiovascular disease other than mild hypertension
investigating veregen ™ 15% ointment treatment for non-facial verrucae in pediatric patients: a pilot study

Conditions: Verruca, Warts

Summary: the purpose of this study is to investigate topical treatment with veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. this novel treatment modality may be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.

the purpose of this study is to investigate topical treatment with veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. the investigators will compare the single and combination treatment modalities over identical time points in patients with non-facial verruca vulgaris. one of the current options for care for non-facial verruca includes cryotherapy, which is a painful and destructive method performed in the pediatric dermatology clinic. this study aims to establish the safety, non-invasivenature, efficiency, and efficacy of veregen ™ 15% ointment as monotherapyfor non-facial verruca vulgaris in the pediatric population. the investigators hypothesize that veregen ™ 15% ointment monotherapy will non-invasively treat non-facial verruca vulgaris with similar efficacy as combination therapy with a single cryotherapy treatment followed by topical application of veregen ™ ointment. this novel treatment modality will be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.

Eligibility criteria:
inclusion criteria: * male or female of any ethnic background * age between 6 years old and 16 years old * a clinical diagnosis of non-facial verruca vulgaris * able to adhere to study visit schedule, veregen ™ treatment requirements, and baseline cryotherapy treatment in half of patients * verruca size greater than 5 mm exclusion criteria: * medically unstable patients * patients with immunosuppression * families who decline participation * verruca may not have been treated in preceding 4 weeks prior to enrollment * verruca may not be located on the face or genitalia * verruca size less than 5 mm
efficacy and safety study of zinc acetate to treat wilson's disease in japan.

Conditions: Wison's Disease

Summary: the purpose of this study is to determine whether zinc acetate is effective and safe in the treatment of wilson's disease among japanese.


Eligibility criteria:
inclusion criteria: * wilson's disease(adult,infant,pregnant woman) exclusion criteria: * acute hepatitis * malignant tumor