Kornimate/medical-research-clean huggingface dataset:
eargenie: assessment of a minimum viable product

Conditions: Hearing Impaired Children

Summary: the goal of this clinical trial is to evaluate safety and preliminary efficacy of a novel device (eargenie mvp) to assess hearing function in infants, using a small number of infants with normal hearing. the main questions it aims to answer are: * is our device safe? * does the device provide preliminary results consistent with previous results from a commercial functional near infrared spectroscopy (fnirs) research device? participants will attend one test session and have their hearing assessed with the eargenie mvp device.

this is a first-in-human study to evaluate safety and preliminary efficacy of our prototype hearing assessment system (eargenie mvp). eargenie mvp uses fnirs technology to assess an infant's brain response to hearing speech sounds, or discriminating between different speech sounds. it includes software to automatically run analysis in real time, and has a user interface allowing clinicians to operate the tests and receive result reports. the test methods and analysis software have been developed using our commercial fnirs research system, but the eargenie mvp has been designed for easy use in paediatric audiology clinics. 10 infants with normal hearing will be recruited for the study, and undergo one test session each with the eargenie mvp. safety data will be documented and the results of the tests examined to see if they are consistent with the results expected from our experience using the commercial device in 36 infants with normal hearing.

Eligibility criteria:
inclusion criteria: * is between the ages of 1 and 24 months at the time of fnirs testing. * has no known hearing loss * has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. exclusion criteria: * there are no exclusion criteria other than not meeting the inclusion criteria.

Keywords: fnirs early intervention
nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery: analysis of quality of voice

Conditions: Voice Quality; Endoscopic Pituitary Surgery

Summary: the purpose of this study is to determine nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery. furthermore, the quality of voice is assessed, also.


Eligibility criteria:
inclusion criteria: * patients who underwent endoscopic endonasal transsphenoidal skull base surgery exclusion criteria: * patients under 18 year * patients cannot following command including loss of conscious * patients cannot speak including patient on tracheostomy tube * patients who has nasal tumor, nasal polyp, sinusitis * patients who has cleft lip cleft palate or submucosal cleft * patients who underwent adenotonsillectomy or palatoplasty in same setting with endoscopic pituitary surgery
prospective radiomics study for breast cancer

Conditions: Breast Cancer

Summary: the goal of this prospective study is to develop mri-based models representing tumor microenvironment in participants with invasive breast cancer. the main purpose of this study is to analyze the association of diffusion-, t2-, and dynamic contrast-enhanced t1-weighted images of 3t mri before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens for this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on mri of participants with invasive breast cancer before treatment.

the written informed consents for the participation into this prospective study is done in participants who are diagnosed with invasive breast cancer before surgery with curative intent. after enrollment, breast mri is done for particpants and diffusion-, t2-, and dynamic contrast-enhanced t1-weighted images are extracted from the results of mri of participants. the tumor tissue samples are archived from participants before surgery through core-needle biopsy and the immunohistochemistry is done to assess the components of tumor microenvironment including intraturmoal and peritumoral components through volume histochemical assessment. radiomic feature selection and prediction model building are performed using the least absolute shrinkage and selection operator and linear regression analysis, respectively. the investigators apply fivefold cross-validation to prevent overfitting, and the performance is evaluated using the area under the receiver operating characteristic curve (auc) and the delong test.

Eligibility criteria:
inclusion criteria: * diagnosed with invaseiv breast cancer exclusion criteria: * diagnosed with other cancers
is there a worse outcome when the systolic blood pressure is lower than heart rate in those adult trauma patients with isolated head/neck injury

Conditions: Traumatic Brain Injury

Summary: a systolic blood pressure (sbp) lower than the heart rate (hr) could indicate a poor condition in trauma patients. in such scenarios, the reversed shock index (rsi) is \<1, as calculated by the sbp divided by the hr. this study aimed to clarify whether rsi could be used to identify high-risk adult patients with isolated traumatic brain injury (tbi).


Eligibility criteria:
inclusion criteria: * adult patients having isolated tbi with a head abbreviated injury scale (ais) ≥ 3 and without severe injury to other regions (other ais ≤ 1) were included exclusion criteria: * patients with incomplete registered data were also excluded

Keywords: systolic blood pressure reversed shock index traumatic brain injury mortality
the provider and organization in asthma guidelines

Conditions: Asthma

Summary: the purpose of this study is to examine the interaction between the personal attributes of clinicians and the organizations in which they work and the effect of interventions on their ability to implement an asthma disease management program. +

less than 20% of primary care providers adhere to national asthma guidelines. interventions to improve provider adherence to guidelines have had modest success. we believe that changing provider behavior must be viewed in the context of the provider's environment. we hypothesize that providers who are most successful in implementing and sustaining asthma management programs will have a set of personal attributes, related to asthma, characterized by readiness to change, high self-efficacy, positive outcome expectancies and high outcome value and will work within organizations that facilitate and support such activities. we propose a two phase study. in phase 1 (year 1) survey instrument development and testing and provider meetings to discuss the interventions will occur. providers in 49 practices/clinics that are using an asthma management program called easy breathing, will complete these surveys that will characterize the organization and organizational culture of the clinics/practices and the provider personal attributes surrounding asthma. in years 2-5, a randomized, controlled study of either a behavioral intervention, an organizational intervention or no intervention (control) will be performed in 36 of these clinics/practices. clinics/practices in the behavioral arm will receive an intervention consisting of expert modeling, program-, clinic- and provider-specific feedback, and use of opinion leaders and academic detailing. clinics/practices in the organizational arm will receive an intervention consisting of benchmarking, leadership capability training and team building and incentives/ rewards. the primary outcome variable is the number of easy breathing surveys completed by provider and by clinic/unit of time. we have previously shown that enrollment in easy breathing (which was adapted directly from the national asthma guidelines) as demonstrated by completion of a survey is a surrogate indicator of inhaled corticosteroid use and is associated with decreased medical services utilization. this study will thus investigate the complex interactions between provider personal attributes and the organization and the effect of targeted interventions on provider performance to implement an asthma disease management program. these data will then be used in future studies to determine how to better tailor interventions in a cost constrained environment.

Eligibility criteria:
inclusion criteria: * must have used easy breathing disease management program for more than one year. exclusion criteria: * none

Keywords: children self-efficacy organization process of care
diagnostic utility of volatile organic compounds in human breath for acute clinical malaria in ethiopia

Conditions: Malaria

Summary: this is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. the investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in ethiopia. upon enrollment, blood for malaria rdt, microscopy and pcr will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. g6pd testing will be performed concurrently to identify prevalent g6pd variants.


Eligibility criteria:
malaria cohort * age ≥5 years of age * malaria microscopy and / or malaria rdt confirmed malaria infection * fever (axillary temperature ≥37.5⁰c) or history of fever in preceding 48 hours * written informed consent febrile controls * age ≥5 years of age * fever (axillary temperature ≥37.5⁰c) or history of fever in preceding 48 hours * absence of a malaria episode confirmed by malaria microscopy * written informed consent
comparison of knotless barbed suture and standard suture in knee replacement patients

Conditions: Knee Osteoarthritis; Hip Osteoarthritis

Summary: barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries. the goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). the traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. both knotless barbed suture and the traditional sutures have similar suture size. patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits). secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.


Eligibility criteria:
inclusion criteria: * primary joint replacement exclusion criteria: * no prior joint surgery * no infection

Keywords: joint replacement knee replacement wound healing hip replacement
evaluation of the efficacy and safety of afq056 in reducing moderate to severe l-dopa induced dyskinesias in patients with parkinson's disease

Conditions: Parkinson Disease; Dyskinesias

Summary: this phase iib study is designed to determine the safe and efficacious dose or dose range of afq056 for the treatment of patients with moderate to severe parkinson's disease with l-dopa induced dyskinesias.


Eligibility criteria:
inclusion criteria: * outpatients with parkinson's disease (pd), treated with l-dopa, experiencing dyskinesias for at least three months exclusion criteria: * surgical treatment for pd * cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) * advanced, severe or unstable disease (other than pd) that may interfere with the study outcome evaluations other protocol-defined inclusion/exclusion criteria may apply

Keywords: parkinson disease l-dopa levodopa dyskinesia
tdcs and aphasia therapy in the chronic phase after stroke

Conditions: Aphasia Following Cerebral Infarction; Aphasia Following Nontraumatic Intracerebral Hemorrhage

Summary: this study evaluates the neuromodulatory effect of combined tdcs and aphasia therapy in patients in the chronic phase after stroke. half of the participants will receive aphasia therapy and tdcs, the other half will receive aphasia therapy and sham-tdcs.

aphasia is present in about one third of all stroke patients in the chronic phase. the first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. language recovery in aphasic stroke patients involves reorganization of brain functions. longitudinal fmri studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. left re-lateralization, if possible, seems to be the most effective in restoring language function. for a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. therefore, non-invasive techniques (nibs) such as transcranial direct current stimulation (tdcs) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tdcs is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 ma - 2 ma) between two electrodes. these weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. the effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. it has been found that tdcs not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. it was suggested that long-term potentiation (ltp) and long-term depression (ltd) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.

Eligibility criteria:
inclusion criteria: * diagnosed with mild to moderate aphasia (token test score between 7 and 40) after a first left hemispheric ischemic or hemorrhagic stroke * inclusion \> 6 months post-stroke * age 18 - 85 years * being right-handed (\> +8 on the questionnaire for handedness, van strien) * mothertongue: dutch * imaging (ct or mri) prior to inclusion (in patient file), standard of care in the acute phase * signed informed consent (attachment 1) exclusion criteria: * history of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders * serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in the anamneses) * prior brain surgery * excessive use of alcohol or drugs * new neurological symptoms between the acute stage and inclusion
efficacy and safety of hrs-7535 tablets in adults with type 2 diabetic kidney disease

Conditions: Type 2 Diabetic Kidney Disease

Summary: the study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase ii clinical study. the aim of this trial is to evaluate the efficacy and safety of hrs-7535 in subjects with type 2 diabetic kidney disease.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, 18-75 years of age at the time of signing informed consent; 2. body weight ≥50 kg, 20.0 kg/m2 ≤bmi ≤40.0 kg/m2; 3. diabetic kidney disease was diagnosed, and the egfr≥30 ml/min/1.73 m2; 4. had a history of t2dm at least 3 months, or had diabetic retinopathy as assessed by the investigators; 5. uacr ≥300 and \<3000 mg/g; 6. hba1c ≥6.5% and ≤10.0%; 7. acei/arb was used for ≥3 months and acei/arb was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks; 8. use hypoglycemic drugs for ≥3 months (the dosage of sglt2i remains stable if used); 9. able and willing to provide a written informed consent; exclusion criteria: 1. have type 1 diabetes mellitus or specific type of diabetes; 2. acute kidney injury or dialysis treatment within 6 months; 3. kidney transplantation is planned during the trial; 4. history of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 5. any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix; 6. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 7. female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
beneficial effects of natural products on management of xerostomia

Conditions: Xerostomia; Diabetes Mellitus; Hypertension; Post COVID-19 Condition

Summary: xerostomia, the subjective feeling of oral dryness, is a symptom most frequently accompanied by either decreased salivary flow or an altered composition of saliva. hyposalivation, on the other hand, is the objective measured reduction in salivary flow rate. xerostomia is a relatively common complaint, particularly among older people, and can lead to major consequences with regard to the quality of their general and oral health and wellbeing. xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis c virus infection, and hiv disease.

multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients suffering from that complaint which were based on the stimulation of the salivary gland flow. salivary glands can be stimulated to produce saliva mechanically (for example, by chewing gum, using different formulated mouthwashes or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting enzyme inhibitors and angiotensin-receptor antagonists) overall, the available interventions do not appear to provide an effective, comprehensive and long-term management of xerostomia. this has strengthened the need for further investigation of other interventions for the management of xerostomia as egypt is considered a low-income country, therefore, the general properties of ideal saliva substitutes to be used should be inexpensive, edible, hydrating, safe-to-swallow but retainable in the mouth. given the importance of the oral health status of in patients suffering from dry mouth with the associated problems, and the limited availability of proper remedy for xerostomia in the egyptian market. this study is designed to evaluate the efficiency of different and natural treatment as a mix of (manuka honey -green tea) mouth rinse in management of xerostomia.

Eligibility criteria:
inclusion criteria: * - both genders, aged above 19 years. * all patients must have complaint of xerostomia. * objective dry mouth score from (2-5). * subjective dry mouth score from (1-4). * patients must be able to make reliable decision or communications. exclusion criteria: * - smoking, alcohol. * patient with history of any serious illness as malignancy. * patients with any autoimmune disease. * vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals. * known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

Keywords: manuka honey green tea natural products
single-photon emission computed tomography, computed tomography lymphoscintigraphy, and intensity-modulated radiation therapy in treating patients who have undergone surgery for stage i or stage ii breast cancer

Conditions: Breast Cancer; Lymphedema

Summary: rationale: diagnostic procedures, such as single-photon emission computed tomography and computed tomography lymphoscintigraphy, may help lower the dose of radiation therapy after surgery, and help prevent lymphedema. purpose: this clinical trial is studying single-photon emission computed tomography and computed tomography lymphoscintigraphy followed by intensity-modulated radiation therapy to see how well they work in treating patients who have undergone surgery for stage i or stage ii breast cancer.

objectives: * to assess the feasibility of integrating philips precedence spect/ct® images with ge pet/ct fusion software to reduce radiation dosimetry delivered to lymph nodes draining the arm in patients after surgery for stage i or ii breast cancer. * to examine the differences in radiation dosimetry in these patients using 3-d conformal radiotherapy with vs without the philips precedence spect/ct®. * to compare reduction in lymph node radiation dosimetry in these patients using single photon emission computed tomography (spect) and computed tomography (ct) with 3-d conformal radiotherapy vs intensity-modulated radiotherapy. outline: patients receive filtered technetium tc 99m sulfur colloid (tcsc) intradermally and undergo single photon emission computed tomography (spect) and computed tomography (ct) imaging at the time of tcsc and 2 hours after injection. patients then undergo intensity-modulated radiotherapy of the whole breast, including the low axilla and lymph nodes identified by the phillips precedence spect/ct® at a dose determined by computer analysis of the imaging information. patients complete a lymphedema screening questionnaire at baseline and at 12 and 24 months after treatment.

Eligibility criteria:
disease characteristics: * biopsy-proven primary invasive breast cancer, meeting one of the following criteria: * stage i or ii disease with negative sentinel or axillary node dissections * stage ii disease with micrometastases (defined as \< 2.0 mm focus) in 1-2 lymph nodes and/or a single positive axillary node ≤ 1 cm with no extracapsular extension * completed all surgical intervention (e.g., lumpectomy, mastectomy) * planning adjuvant whole breast irradiation including the low axilla * no bilateral or recurrent breast cancer patient characteristics: * ecog performance status 0-2 * not pregnancy or nursing * negative pregnancy test * able to complete questionnaire(s) alone or with assistance * no active infection * no history of invasive cancer within the past 5 years, except basal cell or squamous cell skin cancers prior concurrent therapy: * see disease characteristics * no prior surgery or radiation to the ipsilateral breast or axilla * no concurrent neoadjuvant chemotherapy or radiotherapy

Keywords: lymphedema stage i breast cancer stage ii breast cancer