Kornimate/medical-research-clean huggingface dataset:
rheumatology diet study

Conditions: Diet Habit; Rheumatologic Disease; Autoimmune Diseases; Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Dermatomyositis/polymyositis; Sjogren's Syndrome; Systemic Lupus Erythematous; Scleroderma; Fibromyalgia

Summary: this study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. the main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. it will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. the study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. it is expected that patients who changed their eating habits to healthier diets such as a mediterranean diet would report less severe autoimmune disease symptoms. there are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.


Eligibility criteria:
inclusion criteria: * adults (over 18 years old) patients * established ucf health patients * diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, dermatomyositis/polymyositis, sjogren's syndrome, systemic lupus erythematous, scleroderma, osteoarthritis, or fibromyalgia. exclusion criteria: * ucf students, faculty or staff * children or young adults under the age of 18 * adults over 65 * pregnant women * prisoners * adults to unable to consent
cardioprotection with dapagliflozin in breast cancer patients treated with anthracycline - protectaa trial

Conditions: Breast Cancer; Heart Failure

Summary: the purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.

this is a multicentre, randomised, double-blind, placebo-controlled phase iii study, evaluating the effect of dapagliflozin versus placebo on prevention of cardiotoxicity in breast cancer patients undergoing anthracycline-based chemotherapy.

Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 80 years. * diagnosis of invasive breast cancer \[stage i-iii\] and planned anthracycline treatment within 60 days. * signed informed consent to participate in the study. exclusion criteria: * urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment. * recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure. * left ventricular ejection fraction \< 50% at the time of the screening. * severe valvular heart disease. * a history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator). * a history of stroke. * cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic. * pulmonary hypertension. * uncontrolled arterial pressure or systolic pressure \< 80 mmhg at screening (at the discretion of the investigator). * bmi \> 40 kg/m2. * diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or hba1c ≥ 6,5% (48 mmol/mol). * pregnancy or breastfeeding. * lack of compliance to use highly effective method of birth control. * expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months. * taking another study drug or drugs from the group of sglt2 inhibitors up to 6 months before the screening visit. * taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit. * egfr \< 25 ml/min/1.73m2 according to ckd epi. * life expectancy \< 12 months or cancer disease stage iv according to the tnm classification. * alanine transaminase or aspartate transaminase levels above 2.5 times the local norm. * anemia with hemoglobin \< 9 g/dl. * kidney failure \> g2 (according to kdigo classification). * liver disorders, child-pugh score \> 4. * known, active infections with hiv, hbv, hcv, tuberculosis. * any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.

Keywords: breast cancer heart failure ejection fraction anthracyclines
naxitamab and gm-csf in people with neuroblastoma

Conditions: High-Risk Neuroblastoma

Summary: this is an expanded access program (eap) that will give the participants access to the drug naxitamab before it is approved by the fda. naxitamab will be combined with granulocyte-macrophage colony stimulating factor (gm-csf). participants in this study will have high-risk neuroblastoma that either went away completely after treatment (complete remission) or has come back (relapsed/refractory). researchers think the combination of naxitamab and gm-csf will be effective because naxitamab and gm-csf strengthen the immune system's response to cancer cells in different ways. naxitamab is an antibody, like the proteins made by the immune system to protect the body from harm. naxitamab helps the cells of the immune system to find and attack cancer cells. gm-csf is a protein that strengthens the immune system by increasing the number of immune cells called granulocytes. granulocytes are white blood cells that fight off cancer cells. the combination of naxitamab and gm-csf is a type of immunotherapy.


Eligibility criteria:
inclusion criteria: * patients who are ineligible to participate in study nct03363373 (irb# 18-375), will be considered for treatment under this expanded access protocol. * diagnosis of nb as defined by a) histopathology (confirmed by the msk department of pathology), or b) bm metastases or mibg-avid lesion(s) plus high urine catecholamine levels * patients must have hr-nb (mycn-amplified stage 2/3/4/4s of any age and mycnnonamplified stage 4 in patients greater than 18 months of age). * patients must be in first or greater cr or have refractory or relapsed disease * if previously treated with any anti-gd2 mab, human anti-hu3f8 antibody (haha) titer must be negative. exclusion criteria: * active life-threatening infection * pregnant women or women who are breastfeeding * haha titer positive * history of anaphylaxis ctcae grade 4 to naxitamab

Keywords: remission high-risk neuroblastoma relapsed/refractory high-risk neuroblastoma naxitamab gm-csf 20-227
positive pressure and gravity affect volumetric capnography

Conditions: Hypoventilation

Summary: volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. the aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.

in this interventional study awake and healthy volunteers will be submitted to spontaneous, pressure support and control pressure ventilation using a tight nasal mask. volumetric capnography and electrical impedance tomography (eit) will be continuously recorded during the protocol. different body positions were randomly tested. analysis of global and regional distribution of ventilation using eit will be matched with changes observed in volumetric capnography-derived parameters.

Eligibility criteria:
inclusion criteria: * american society anesthesia physical status i. * age between 25-39 years old, * body mass index between 23-28 kg/m2, * non-smokers. exclusion criteria: * presence of pulmonary or cardiac diseases. * abnormal spirometry.

Keywords: volumetric capnography gravity mechanical ventilation eit
assessment of one-shot cardiac-cervical-intracranial mri in the etiological work up of ischemic stroke and transient ischemic attacks

Conditions: Ischemic Stroke; Transient Ischemic Attack

Summary: stroke is a major public health issue in developed countries. a full etiological work up within a short time is critical to implement the appropriate preventive treatment. the etiological work up is actually based on a clinical examination and on a group of paraclinical examinations. the realization of the standard strategy is time consuming, and increase the cost of the medical care. a non-invasive one-shot examination of the heart, the aorta and the cervical and intracranial arteries (cci-mri) could overcome these disadvantages.the investigator therefore propose to carry out an overall assessment of the performance of the cci-mr in the etiological work up of ischemic strokes and tias compared to the reference strategy


Eligibility criteria:
inclusion criteria: * • man or woman aged from 18 to 85 years old, * patients victims of an ischemic stroke or a tia in the 2 days before inclusion, symptoms thought to be consistent with tia were those defined by the ad hoc committee established by the advisory council for the national institute of neurological and communicative disorders and stroke65 * rankin score: mrs ≤3 * patient having given their free written and informed consent, or preliminary oral informed consent attested by a third party followed by signed informed consent as soon as possible, * affiliated to a social security scheme or equivalent, * that are not the subject of any legal protection measures exclusion criteria: * •tia symptoms limited to isolated numbness, * changes, or isolated dizziness/vertigo * agitation, severe swallowing * contraindication to an mri and the injection of gadolinium, * known history of hypersensitivity to the mri contrast product, * risk of pregnancy or known pregnancy revealed when questioned, breastfeeding, * patient unable to understand or poorly understanding french.
treatment of posttraumatic stress disorder in kosovar high school students using mind-body skills groups

Conditions: Stress Disorders, Post-traumatic

Summary: the purpose of this study is to determine whether the participation in a group program which includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques will decrease symptoms of posttraumatic stress in high school students.

the objective of this study is to determine whether participation in a group program incorporating mind-body techniques decreases symptoms of posttraumatic stress in adolescents. students will be screened for posttraumatic stress using the harvard trauma questionnaire and eighty-two qualifying students will be randomly assigned to a 12-session mind-body group program or a wait-list delayed intervention group. the program will be conducted by the teachers at a high school in kosovo and include meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques. changes in posttraumatic stress symptoms will be measured using the harvard trauma questionnaire.

Eligibility criteria:
inclusion criteria: * students having posttraumatic stress (ptsd) as defined according to a scoring algorithm of the harvard trauma questionnaire previously described by the harvard refugee trauma group and used in a kosovar albanian population. this definition of ptsd requires a score of 3 or 4, on a likert scale of 1-4, on at least one of the four of the reexperiencing symptoms (criterion b), at least 3 of the 7 avoidance and numbing symptoms (criterion c), and at least 2 of the 5 arousal symptoms (criterion d) in addition to exposure to a traumatic event (criterion a). exclusion criteria: * no specific exclusion criteria. students having ptsd symptoms as defined above may participate in the study.

Keywords: posttraumatic stress mind-body techniques war adolescents
pharmacokinetics of tacrolimus in children

Conditions: Nephrotic Syndrome

Summary: the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.


Eligibility criteria:
inclusion criteria: * patients have been diagnosed with nephrotic syndrome; * age range: 1 month to 18 years old * tacrolimus used as part of regular treatment exclusion criteria: * expected survival time less than the treatment cycle; * patients with other factors that researcher considers unsuitable for inclusion.
cognitive ability training for seniors with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \[tdcs\]) during working memory training in seniors with mild cognitive impairments.the placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tdcs.

in this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an mci by means of parallel tdcs treatment. all test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. in the randomized, double-blind, prospective therapy study, participants are assigned to either a verum-tdcs or a placebo-tdcs group. the verum-tdcs group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tdcs stimulation. to check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (nirs). furthermore, we will check whether the training increases the volume of the grey matter (draganski et al., 2004, malchow et al., 2016) and the expression of bdnf can be increased (schuch et al., 2015).

Eligibility criteria:
inclusion criteria: * suspected mci * total cerad score \<= 85.1 * mmse \>=24 * native german speaker * between 50-75 years old * right handed exclusion criteria: * impairment of daily living activities * psychiatric, neurological diseases * uncorrected hearing or vision deficits * actual psychopharmaca intake * metal parts in the head * medical electronical implants

Keywords: tdcs mci working memory fnirs
efficacy and safety of lanreotide autogel (60, 90 or 120 mg) in acromegalic patients

Conditions: Acromegaly

Summary: to evaluate the long-term efficacy and safety of repeated injections of lanreotide autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.


Eligibility criteria:
inclusion criteria: * patient having documentation supporting diagnosis of active acromegaly in one of the following definitions: * patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an igf-1 level at least 1.3 times the upper limit of the age-adjusted normal range, * patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an igf-1 level at least 1.3 times the upper limit of the age-adjusted normal range. exclusion criteria: * patient having had pituitary surgery within the previous 3 months * patient having received radiotherapy for acromegaly disease within the previous 36 months * patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period * patient having received lanreotide autogel at any time before the study
open-label extension study to evaluate the safety of efgartigimod in adult patients with primary sjögren's syndrome

Conditions: Primary Sjögren's Syndrome

Summary: efgartigimod contributes to successfully treat pss and has the potential to improve disease manifestations by the reduction of igg autoantibodies in pss. this open-label extension study will evaluate the long-term safety of efgartigimod in participants with pss who have completed the treatment period of the qualifying efgartigimod studies (including argx-113-2106).

argx-113-2211 is a long-term, single-arm, open-label, multicenter extension study of the pss-qualifying efgartigimod studies designed to evaluate the long-term safety of efgartigimod in adult patients with pss. participants will be enrolled from both active and placebo arms of qualifying efgartigimod studies and receive efgartigimod 10 mg/kg over 48 weeks in the extension study without knowledge of their treatment assignment in the qualifying study. eligible participants must have completed the treatment period of the qualifying study and must not have permanently discontinued the imp in that study.

Eligibility criteria:
inclusion criteria: * is at least the legal age of consent for clinical trials when signing the icf * is capable of providing signed informed consent and complying with protocol requirements * agrees to use contraceptive measures consistent with local regulations and the following: wocbp must have a negative urine pregnancy test at baseline before receiving imp * has completed the qualifying efgartigimod pss studies and agrees to continue study drug treatment without interruption in the extension study exclusion criteria: * clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk * pregnant or intention to become pregnant during the study * any severe systemic pss manifestation that may put the participant at undue risk based on the investigator's opinion
medical economic evaluation of bilateral allograft of hands and forearms

Conditions: Bilateral Traumatic Amputation of Upper Limbs

Summary: the double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities. the management of these patients is nearly exclusively through the use of prostheses. certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution. since january 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the hospices civils de lyon. this first study reported the feasibility of the graft. the functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. we have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration. the rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. these results are confirmed by international experience that is of the same order. only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis. a new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. the results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.


Eligibility criteria:
inclusion criteria: inclusion criteria common to the 2 groups of patients (allograft group and protheses group): * adult aged 18 to 60 years * double amputated of both forearms transplant eligibility criteria (for allograft group) * minimum interval between amputation and graft of three months (no maximal delay) * absence of previous psychiatric history contraindicating the graft and psychological maturity, according to two psychiatrists who have evaluated the patient * no previous history of malignant tumor in remission for less than 5 years * american society of anesthesiology (asa) score ≤ 2 * new york heart association (nyha) grade ≥ 1 * creatinine clearance ≥ 60 ml/min/1.73m² * absence of badly controlled sever hypertension exclusion criteria: * mono amputated patients * malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%

Keywords: bilateral amputation of the forearms bilateral allograft prosthetic forehands medical economic evaluation
covid-19 convalescent plasma for the treatment of hospitalized patients with pneumonia caused by sars-cov-2.

Conditions: COVID-19

Summary: the purpose of this study is to see if this plasma can be safely used in humans with covid-19 and to see if it improves patients' health as compared to not using it in patients with pneumonia caused by sars-cov-2.

this open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to covid-19. this study will enroll adults 18 years old and older, including pregnant women. a total of 80 eligible participants will be randomized to receive either 2 units of convalescent plasma collected from abo-compatible donors who have recovered from covid-19 and standard of care (treatment arm) or standard of care alone (control arm). participants in the treatment arm will receive 2 units of convalescent plasma on study day 1 in addition to standard of care. participants will be assessed on study day 1 (pre-dose), 30 minutes after each unit of plasma, on all study days while hospitalized, and study days 15, 22, 29, and 60. all participants will undergo a series of safety and efficacy, assessments. blood samples will be collected on days 1 (prior to plasma administration), 3, 8, 15, 29, and 60. oropharyngeal or endotracheal samples will be collected on days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.

Eligibility criteria:
inclusion criteria: 1. adult ≥18 years of age 2. laboratory-confirmed sars-cov-2 infection as determined by pcr or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment. note - an exception must be requested to the sponsor if ≥72 hours since positive test. 3. hospitalized in participating facility. 4. documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or ct scan). 5. abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as: * room air saturation of oxygen (sao2) \< 93%, or * requiring supplemental oxygen, or * tachypnea with respiratory rate ≥30 6. patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements exclusion criteria: 1. contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator. 2. clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than covid-19 3. receipt of other investigational therapy as a part of another clinical trial. note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.

Keywords: convalescent plasma