Kornimate/medical-research-clean huggingface dataset:
tooth bleaching for young patients using a hydrogen peroxide-based gel

Conditions: Tooth Discoloration

Summary: the aim of the present study was to evaluate colorimetric changes and tooth sensitivity in young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.

a randomized, controlled, clinical trial was conducted with 53 patients aged 11 to 24 years who were allocated to groups based on the use of the following commercial products: whiteness hp - fgm® (35% hydrogen peroxide); whiteness hp blue calcium - fgm® (35% hydrogen peroxide); and whiteness hp blue calcium - fgm® (20% hydrogen peroxide). after the bleaching procedure, the visual analog scale was used to measure tooth sensitivity and the classic vita® scale was used to determine changes in tooth color. statistical analysis involved the friedman, kruskal-wallis and student-newman-keuls tests, with p-value ≤ 0.05 or ≤ 0.0001 considered indicative of statistical significance.

Eligibility criteria:
inclusion criteria: * individuals aged 11 to 24 years with a diagnosis of tooth discoloration and a signed statement of informed consent. exclusion criteria: * individuals with dentofacial anomalies, those without the permanent dentition complete to the second molars, those in orthodontic or orthopedic treatment of the jaws, those who took medications that could alter tooth color and those who had previously been submitted to tooth bleaching

Keywords: tooth bleaching adolescent clinical trial
development of a clinical screening, diagnostic and evaluation tool for patients with lower limb lymphedema: aim 1

Conditions: Lower Limb Lymphedema

Summary: of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (lll). the objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with lll.


Eligibility criteria:
inclusion criteria: patient group * unilateral or bilateral, primary or secondary lower limb lymphedema (lll) * objective diagnosis of lymphedema: ≥ 5% volume difference between both legs or ≥ 2 minor/ 1 major criteria on lymphoscintigraphy or presence of icg dermal backflow * age ≥ 18 years * able to read, understand and speak dutch healthy controls - age, gender \& bmi-matched healthy controls exclusion criteria: * pregnant participants * presence of chronic venous insufficiency c4, c5, c6; deep venous thrombosis; post-thrombotic syndrome * presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion

Keywords: lymphedema measurement clinical evaluation reliability concurrent validity clinical feasibility lower limb
coagulation changes associated with covid-19 infection

Conditions: COVID; Disseminated Intravascular Coagulation; Coagulation Disorder

Summary: this study will study the potential utility of the quantra qplus system in patients inflicted with covid-19 disease.

the quantra system is a fully integrated and automated in vitro diagnostic device which uses seer sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. the qplus cartridge can measure hypocoagulable and hypercoagulable conditions resulting from the functional interaction of the enzymatic and cellular components of coagulation and therefore, can be invaluable for longitudinal monitoring of the coagulopathies reported in covid-19 patients and the response to anticoagulants. this single-center, prospective, observational pilot study will characterize changes in the coagulation status of patients with covid-19 infection during their hospital stay using the quantra qplus system.

Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * subject has a diagnosis of covid-19 and has been admitted to the hospital * subject has one or more risk factors for a poor outcome with covid-10 disease: advanced age (\>=60 years), morbid obesity, diabetes, copd, cad * subject, or subject's legally authorized representative is willing and agrees to provide informed consent. exclusion criteria: * subject is younger than 18 years of age * subject is pregnant * subject is incarcerated. * subject, or subject's legally authorized representative is unable or unwilling to provide informed consent. * subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.

Keywords: viscoelastic testing quantra covid-19
multicenter phase ii of cd26 using sitagliptin for engraftment after ubc transplant

Conditions: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Hematopoetic Myelodysplasia; Leukemia, Myelogenous, Chronic; Lymphoma, Non-Hodgkin

Summary: the main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant).

umbilical cord blood (ucb) is more commonly used for transplantation in children but is being used in adults more often. however, because adults are larger than children, the relatively smaller stem cell dose in ucb is major limitation for transplantation in adults and engraftment can be delayed. this study is trying to find out if the drug sitagliptin can be used to increase and speed up engraftment in adults receiving ucb transplantation.

Eligibility criteria:
inclusion criteria: * patients must have one of the following disease types: * acute myeloid leukemia (aml) with disease features as described in the protocol. * acute lymphoblastic leukemia (all) with disease features as described in the protocol. * myelodysplasia with disease features as described in the protocol. * chronic myelogenous leukemia (cml) with disease features as described in the protocol. * patients with aggressive non-hodgkin's lymphoma (nhl), including diffuse large cell lymphoma, mediastinal b-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral t cell lymphoma, who also have one of the disease features as described in the protocol. * at least 35 days following start of preceding leukemia induction cytotoxic chemotherapy. * for patients in remission, there should be no readily available consenting hla-matched related donor who is either matched fully matched or mismatched at only one locus of hla-a, -b, and drb1. * no availability of a readily available hla-matched volunteer unrelated donor (8 of 8 allele match at hla-a, -b, -c and -drb1). * patients must have a matched or partially matched ucb unit with \>/= 2.5 x10\^7 nucleated cells/kg of recipient weight at the time of cryopreservation. * no current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms). * no hiv disease. * non pregnant and non-nursing. * required baseline laboratory values as described in the protocol. * signed written informed consent. exclusion criteria: * symptomatic uncontrolled coronary artery disease or congestive heart failure. * severe hypoxemia with room air pao2\<70, supplemental oxygen dependence, or dlco\<50% predicted. * patients with central nervous system (cns) involvement refractory to intrathecal chemotherapy. * prior allogeneic or autologous hematopoietic stem cell transplant in the last 6 months. * patients who are taking other insulin secretagogues and/or insulin. * patients who have hypersensitivity to sitagliptin. * patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting hypertriglyceridemia (\> 2 x uln).
emergency department management of femur fractures

Conditions: Femur Fracture; Pain, Joint; Analgesia

Summary: comparison of emergency department management of patients presenting with isolated hip fracture: comparison of methods used in pain management, monitoring, and treatment; comparison of hospitalization durations; comparison of mortality

patient demographics, mechanism of injury, femur fracture classification, associated treatments, pre-procedural pain scoring, post-procedural pain scoring, orthopedic consultation, and patient outcomes (discharge, admission to ward or icu, mortality) will be recorded on the data form. for acute pain management, the timing of treatment administration, effectiveness of the applied method based on pre- and post-procedural pain scoring systems will be assessed. post-procedural pain scores will be collected at 30, 60, and 120 minutes. long-term complications as a result of hospitalization following emergency department follow-ups will include monitoring on days 7 and 21 for mortality and morbidity. the patients will be analyzed in 5 groups based on the treatments administered in the emergency department. 1. iv opioid 2. iv nsaid 3. iv acetaminophen 4. femoral nerve block 5. peng block the researcher will not interfere with the treatment decision made by the responsible physician or the treatment process

Eligibility criteria:
inclusion criteria: patients over the age of 18 years exclusion criteria: forensic cases patients who do not have follow-up in our healthcare system or cannot be followed up patients with allergies to opioids or local anesthetics patients with suspected neuropathy among defined complications of diabetes mellitus patients requiring treatment for ≥2 different types of fractures upon emergency department admission

Keywords: isolated femur fracture analgesia emergency department nerve block
modulation of brain blood flow using dichoptic visual and auditory stimulation

Conditions: Cerebral Arterial Diseases

Summary: modulation of brain blood flow using dichoptic visual and auditory stimulation using reviview system will be evaluated.

the participant will undergo baseline mri to measure blood flow in the brain for comparison later on. after baseline mri, the participant will observe stimulation using the reviview system for 20 minutes. the content the participants will see is a nature documentary, after which the participant will undergo additional mri imaging to assess the change in blood flow in the brain.

Eligibility criteria:
inclusion criteria: - healthy subjects exclusion criteria: * history of brain diseases * glasses * diagnosed with diabetes * diagnosed with degenerative brain diseases * inability to undergo mri
comparison of esophagectomy and chemoradiation for patients with cn0-pt1b stage esophageal squamous cell carcinoma

Conditions: Esophageal Cancer

Summary: the ad-esd trial is phase iii randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage n0 and pathological stage t1b squamous cell carcinoma (after endoscopic submucosal dissection).

esophagectomy is still the primary treatment for pathological t1b esophageal squamous cell carcinoma. however, esophagectomy is associated with high mortality and morbidity and decreased quality of life. endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. but there is no well-designed, phase iii trial to compare the two treatment for patients with pt1b squamous cell carcinoma. the ad-esd trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry. the experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. an additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance. the primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cn0-pt1b esophageal squamous cell cancer (escc) after endoscopic resection. the secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (os) and 3, 5-year relapse free survival (rfs) between the two treatments.

Eligibility criteria:
inclusion criteria: * biopsy proven with esophageal squamous cell cancer. * clinical n0 stage diagnosed by imaging examinations. * pathological t1b stage confirmed by endoscopic submucosal dissection. * age: 18-75. * tumor located at the thorax. * performance status eastern cooperative oncology group (ecog) performance status 0-1. * written informed consent. exclusion criteria: * prior intervention treatment before endoscopic submucosal resection. * inability to accept any treatment component. * prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease. * distant metastasis. * the circumference of the lumen over 3/4 * main tumor size \> 5cm assessed by endoscopy * inability to understand the informed consent.

Keywords: esophagectomy chemoradiation esophageal cancer endoscopic submucosal dissection
rituximab in interstitial pneumonitis

Conditions: Lung Diseases, Interstitial; Pneumonitis, Interstitial

Summary: this project will address rare immune mediated inflammatory diseases (imids) involving the lungs, i.e. interstitial pneumonitis (ip). the main objective of this study is to assess the effects of rituximab (rtx) as a rescue therapy for progressive imid-ip patients. the primary study parameter is pulmonary function. the secondary objectives are to explore the application of imaging with radiolabeled rtx as early predictor for efficacy of rtx, to study the effects of rtx treatment on quality of life, and to further elucidate the pathophysiology of imid-ip by analyzing biochemical markers.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in the study, subjects must meet all of the following criteria: * age 18 to 70 years * no previous therapy with rituximab * at least 2 pulmonary function tests within past 6 months * diagnosis of co-existing imid and a severe and / or progressive ip characterized by 3 out of the following items: * respiratory symptoms consistent with interstitial lung disease * diagnosis of usual interstitial pneumonia (uip), non-specific interstitial pneumonia (nsip), organizing pneumonia (op) or a mixed form of uip / nsip / op by either of the following: * open or video-assisted thoracic surgery (vats) lung biopsy showing definite or probable uip / nsip / op * high resolution computer tomography (hrct) scan showing definite or probable uip/nsip/op/mixed * forced vital capacity (fvc) \< 50% predicted and/or diffusing capacity of the lung for carbon monoxide (dlco) \< 40% predicted or worsening of lung function as demonstrated by any one of the following within the past year: * \> 10% decrease in fvc * \> 15% decrease in dlco * therapy resistance to 1st (corticosteroids) and 2nd line therapy(cyclophosphamide or azathioprine) exclusion criteria: a potential subject who meets any of the following criteria will be excluded from participation in this study: * residual volume \>120% predicted at screening * dlco \<25% of predicted value at screening + resting oxygen saturation (sao2) without external oxygen \<90% * history of unstable or deteriorating cardiac or neurological disease * pregnancy or lactation * hematology lower than specified limits (leucocytes) * positive hiv, hepatitis b or c serology * pre-existing conditions which lead to a life expectancy of less than 6 months * receipt of any vaccine, particularly live viral vaccines, within 4 weeks before first rituximab dose * hypersensitivity for murine proteins note: * fever (\>37,9 °c) at presentation is reason to delay therapy by 1 week * evidence of active infection is reason to postpone rituximab treatment until no further signs of active infection * severe renal impairment is not a contraindication for rituximab therapy, however, if patients (might) require dialysis frequently they will be excluded from the study group

Keywords: imid interstitial pneumonitis rituximab immuno pet pet/ct
low-dose aspirin therapy in patients with ischemic stroke and microbleeds

Conditions: Ischemic Stroke

Summary: the purpose of this study is to investigate the safety and efficacy of low-dose (50mg) aspirin as a secondary prevention drug in patients with non-cardioembolic ischemic stroke accompanied by cerebral microbleeds.

cerebral microbleeds are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. aspirin is the most widely used anti-thrombotic drug in the secondary prevention of patients with non-cardioembolic ischemic stroke. studies have shown that conventional doses of aspirin can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. for such patients, how to carry out effective and safe anti-thrombotic therapy is still unclear. the aim study aims to provide reliable data on the effects of low-dose aspirin (50mg target recruitment 200) in patients with non-cardioembolic ischemic stroke and cerebral microbleeds compared to conventional dose (100mg target recruitment 200). patients presenting with acute (\<3 weeks) non-cardioembolic ischemic stroke and microbleeds (≧1 microbleeds in swi scans) will be randomly assigned to the secondary stroke prevention therapy of low-dose or conventional dose aspirin for 6 months.

Eligibility criteria:
inclusion criteria: 1. patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke; 2. age ≥ 18 years; 3. onset time ≤ 3 weeks; 4. at least one cerebral microbleeds lesion was found on swi; 5. informed consent was signed. exclusion criteria: 1. patients with symptomatic intracranial hemorrhage; 2. no microbleeds or bleeding lesion \> 10 mm was found on swi; 3. vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present; 4. clear anticoagulant indications (such as atrial fibrillation); 5. there are contraindications for aspirin use; 6. the focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy; 7. patients with coronary heart disease or other diseases need to take antiplatelet drugs; 8. serious systemic diseases; 9. refusal to sign informed consent or poor compliance.

Keywords: ischemic stroke microbleeds clinical trial aspirin
systematic assessment of self-help tools for the management of chronic tinnitus

Conditions: Tinnitus, Subjective

Summary: with this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients. furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.

a smart-phone app running on ios devices will be used to give self-help tips to the chronic tinnitus patients.

Eligibility criteria:
inclusion criteria: * chronic tinnitus, duration at least 6 monhts exclusion criteria: * acute psychosis, depression, substance abuse * psychopharmaca * epilepsy or other disease of the central nervous system * other tinnitus treatments in the last 3 months * drug, medication or alcohol abuse in the last 12 weeks
a multi-center clinical trial to evaluate chinese herbal medicines in the treatment of severe hand-foot-mouth disease

Conditions: Hand, Foot and Mouth Disease

Summary: the aim of this study is to evaluate the effectiveness and safety of chinese herbal medicines for severe hand-foot-mouth disease.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by china's ministry of health 2. not more than 24 hours of occurrence of severe symptoms 3. age of 1-13 years 4. patients or their guardians agree to participate in this study and signed the informed consent form exclusion criteria: 1. suffering from neurogenic pulmonary edema, heart or lung failure. 2. complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc 3. the history of allergies on chinese medicine 4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon 5. using hormonal therapy 6. attending other clinical studies on hand-foot-mouth disease 7. patients or their guardians suffering from mental illness

Keywords: chinese medicines severe hand-foot-mouth diseases effectiveness safety
study to assess the safety and effects of autologous adipose-derived stromal cells delivered into patients with multiple sclerosis

Conditions: Multiple Sclerosis; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Nervous System Diseases

Summary: the intent of this clinical study is to answer the questions: 1. is the proposed treatment safe 2. is treatment effective in improving the disease pathology of patients with multiple sclerosis and clinical outcomes?

this will be an open-label, non-randomized multi-center patient sponsored study of adipose-derived stromal cells (asc) implantation performed intrathecally and intravenously. ascs will be derived from the patient's adipose-derived tissue. liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Eligibility criteria:
inclusion criteria: * males and females between age 18 and 80 years. * duration of disease: \>5 years * failure to respond or intolerance to the currently available multiple sclerosis (ms) immunomodulatory treatments (ie interferons, copaxone, immunosuppression): the lack of response to these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the expanded disability status scale (edss) score during the last year or the appearance of at least two major relapses of ms during the same period of time (under treatment) or intolerance to these agents. * up to date on all age and gender appropriate cancer screening per american cancer society . exclusion criteria: * females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * active infectious disease. for patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status * any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * patients on chronic immunosuppressive transplant therapy * systolic blood pressure (supine) ≤90 mmhg; * resting heart rate \> 100 bpm; * active clinical infection. * cerebrovascular accident within 6 months prior to study entry * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * unwilling and/or not able to give written informed consent.