Kornimate/medical-research-clean huggingface dataset:
autologous bone marrow stem cells for chronic leg ulcer treatment in sickle cell disease

Conditions: Chronic Leg Ulcer; Sickle Cell Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.

implantation of bone marrow mononuclear cells, including endothelial progenitor cells and mesenchymal stromal cells, into leg ulcers has been shown to improve wound healing. in the present study the safety and efficacy of autologous bone marrow mononuclear cells implantation will be investigated in patients with chronic leg ulcers. forty cases will be enrolled. improvement in the pain, rate and extent of leg ulcer wound healing as measured by change in wound surface area will be evaluated until one year.

Eligibility criteria:
inclusion criteria: * stable sickle cell disease patients * patient hospitalized into the dermatology unit * patient with an evolutive leg ulcer since more than 1 year * no infection at the time of surgery * patient competent to give informed consent exclusion criteria: * patients with a history of corticosteroids or on active therapy * infection at the limb affected by ulcer * recurrent painful crises, * immunosuppressive drug therapy, * pregnancy, * presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer

Keywords: cell therapy sickle cell disease autologous implantation mesenchymal stromal cell edothelial progenitor cell
a study of ibandronate (boniva) to evaluate bone turnover markers in women with treatment-naive postmenopausal osteoporosis

Conditions: Post Menopausal Osteoporosis

Summary: this study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. the anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.


Eligibility criteria:
inclusion criteria: * women newly diagnosed with postmenopausal osteoporosis * naive to prior bisphosphonate therapy exclusion criteria: * inability to stand or sit upright for at least 60 minutes * inability to swallow a tablet whole * hypersensitivity to any component of ibandronate * hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months * other osteoporosis drug within last 3 months * malignant disease diagnosed within previous 10 years, except resected basal cell cancer
hyperbaric oxygen therapy (hbot) in chronic traumatic brain injury (tbi)/post concussion syndrome (pcs) and tbi/post-traumatic stress disorder (ptsd)

Conditions: TBI (Traumatic Brain Injury); Post Concussion Syndrome; Post Traumatic Stress Disorder; Chronic Post Traumatic Stress Disorder

Summary: this is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (tbi), also known as post-concussion syndrome (pcs) or chronic pcs with post-traumatic stress disorder (ptsd) secondary to blast injury.


Eligibility criteria:
inclusion criteria: * adults, 18-65 years old * one or more mild-moderate tbi's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001 * absence of acute cardiac arrest or hemorrhagic shock at time of tbi. * absence of intracranial neurosurgery post-tbi * disability rating scale of 0-3 * negative michigan alcohol screening test (mast) * negative drug abuse screening test (dast) * negative urine toxicology screen for drugs of abuse * negative pregnancy test in females * otherwise good health * less than 90% on the percent back to normal rating scale exclusion criteria: * pulmonary disease that precludes hbot * unstable medical conditions that are contraindicated in hbot * severe confinement anxiety * pregnancy * other pre-tbi neurological diagnoses * pre or post tbi history of substance abuse * pre or post tbi history of alcoholism. * participation in another experimental trial with active intervention. * high probability of inability to complete the experimental protocol. * previous hbot * history of hospitalization for past tbi, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of tbi * past or current history of mental retardation (baseline fsiq \< 71. * pre/post-tbi history of systemic illness with impact on cns (p.i.'s decision)

Keywords: chronic traumatic brain injury post concussion syndrome post traumatic stress disorder chronic post traumatic stress disorder
capecitabine and bevacizumab ± vinorelbine in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine pfs.


Eligibility criteria:
key inclusion criteria: * written informed consent. * able to comply with the protocol. * ecog performance status 0 - 2. * life expectancy more than 12 weeks. * known er / pr status. * confirmed her2/neu-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. * previous (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was applied more than 6 months prior to randomization. * previous adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that no more than 30% of marrow-bearing bone was irradiated. * no signs and symptoms of chf. * adequate hepatic and renal function values. * adequate hematologic function values. key exclusion criteria: * pregnant or lactating females. * previous chemotherapy for metastatic or locally recurrent breast cancer. * previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain) * evidence of spinal cord compression or current evidence of central nervous system (cns) metastases. * major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment. * history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. * uncontrolled hypertension (systolic \> 150 mmhg and/or diastolic \> 100 mmhg). clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication. * non-healing wound, active peptic ulcer or bone fracture. * history of abdominal fistula, or any grade 4 nongastrointestinal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months of randomization. * active infection requiring i.v. antibiotics at randomization. * clinically significant malabsorption syndrome or inability to take oral medication. * known hypersensitivity to any of the study drugs or excipients. * concurrent treatment with any drug interfering with study medication. concurrent participation in another clinical trial. prior participation is allowed when the last study medication was applied more than 4 weeks prior to randomization.
oral steroids in chronic rhinosinusitis without nasal polyps

Conditions: Sinusitis

Summary: chronic rhinosinusitis is a common disease that effects millions of people world wide. despite its frequency it is unclear what treatment options are the best for these patients. typically patients with chronic rhinosinusitis without nasal polyps (crssnp) are given a long term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally oral steroids. oral steroids benefit patients with chronic rhinosinusitis with nasal polyps (crswnp) however their role in non polyp patients is less clear. it is the goal of this study to see if oral steroids benefit the treatment outcomes in those patients with chronic rhinosinusitis without nasal polyps. in addition this study will look to see if a short course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference in outcomes.

the investigators will compare patients with crssnp who are treated with antibiotics/nasal steroid sprays, and compare them to chronic sinusitis patients who receive antibiotics/nasal steroid spray along with a course of oral steroids. the goal is to determine if oral steroids have a role in crssnp, and if so, the most effective dosage.

Eligibility criteria:
inclusion criteria: 1. they have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the taskforce on rhinosinusitis. 2. they have a ct-scan in the clinic or have a viewable recent (\< 3 weeks prior to clinic visit) ct-scan with a lund mackay score of 6 or greater. a lund mackay score of 6 or greater is felt to be indicative of at least moderate crs. 3. they do not have nasal polyps on initial clinic nasal endoscopy 4. they are willing to participate in a clinical study 5. they are between the ages of 18 to 80. exclusion criteria: 1. they have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded. 2. they are unable to or unwilling to take the prescribed antibiotics or steroids will excluded. 3. they have been treated with a \> 3 week course of antibiotics and/or systemic steroids will also be excluded. 4. they have variants of chronic sinusitis known to be refractory to medical therapy such as wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis. 5. they have sinusitis secondary to prior surgery, a dental procedure or anatomical variants. 6. they have nasal polyps on physical exam. 7. they are pregnant. subjects who are possibly pregnant will be excluded based on history. pregnancy testing is not standard of care for diagnostic imaging. 8. they have a lund-mackay score on ct scan of \< 6 9. they are \ 80 years old
sports participation in children and adolescents with type 1 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: on the basis of a questionnaire the participation at sports activities of children and adolescents with type 1 diabetes mellitus will be studied. the occurrence of hypoglycemia and hyperglycemia will be evaluated, as well as the measures to prevent these complications.


Eligibility criteria:
inclusion criteria: * children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the jessa hospital exclusion criteria: -

Keywords: type 1 diabetes mellitus sports child adolescent
safety, tolerability and pharmacokinetics of twp-101 in patients with advanced melanoma and urothelial carcinoma

Conditions: Advanced Melanoma; Advanced Urothelial Carcinoma

Summary: this study is a multi-center, phase ia/ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of twp-101 in patients with advanced melanoma and urothelial carcinoma. this study consists of two parts (part a and part b). part a was a dose escalation study, and part b was a dose expansion study.


Eligibility criteria:
inclusion criteria: * pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments * ecog score 0 or 1; * part b: at least 1 measurable lesion according to recist 1.1 exclusion criteria: * known hypersensitivity to any ingredient of twp-101; * receiving any anti-cancer drugs; * history of serious systemic diseases; * history of serious autoimmune diseases; * pregnancy or lactating women.
alterations of the microbiome during critical illness with short and long term clinical outcomes

Conditions: Critical Illness; Microbiome

Summary: this study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (micu) at the university of chicago. additionally, investigators will examine the downstream clinical effects of dysbiosis in icu patients and how patients maybe effected long term.

during this study investigators will longitudinally collect discarded stool biosamples throughout the micu admission when available. stool bio specimens will be recorded/coded and processed by the investigators. stool bio specimens will be analyzed for 16srna and metabolomics. surveys will be conducted at study entry, in addition to 6 months and 12 months following discharge. by longitudinally sampling discarded biospecimens from subjects throughout their micu admission in additionally to describing long term following up. we will be able to correlate changes in the microbiome with clinical data, and follow up surveys to identify factors that may impact the composition of the microbiome and their impact on clinical outcomes.

Eligibility criteria:
inclusion criteria: adult patients admitted to the intensive care unit exclusion criteria: none

Keywords: short term outcomes long term outcomes
the treatment of tinnitus with transcutaneous non-invasive vagus nerve stimulation

Conditions: Tinnitus

Summary: the t-vns stv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. the clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.


Eligibility criteria:
inclusion criteria: * chronic tinnitus defined as a tinnitus over more than six months * ≥31 points in the tinnitus questionnaire according to goebel and hiller * written informed consent * both gender, aged from 18 -75 years * if the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. if a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. the therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject. exclusion criteria: * objective tinnitus * participating in other tinnitus treatments within 3 months before study start * missing informed consent * pregnancy * bronchial asthma in medical history * clinically relevant internistic, neurological or psychiatric diseases * abuse of drugs or alcohol until 12 weeks before enrollment in the study * indications of structural impairment of the basal ganglia or the brain stem * active implants (e.g. cochlea implants, vns, pacemaker) * constant all-day use of hearing instruments or noisers on the left the part-time use in special situations (e.g. watching tv is no exclusion criteria * all dermatologic and infectious diseases which affect the area around the pinna and the ear canal * severe malformation of the pinna * other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

Keywords: pulsatile tinnitus ringing-buzzing-tinnitus spontaneous oto-acoustic emission tinnitus tensor palatini induced tinnitus tensor tympani induced tinnitus tinnitus of vascular origin tinnitus, clicking tinnitus, leudet tinnitus, leudet's tinnitus, noise induced tinnitus, objective tinnitus, spontaneous oto-acoustic emission tinnitus, subjective tinnitus, tensor palatini induced tinnitus, tensor tympani induced vascular origin tinnitus
study of tolerability, safety and efficacy of sensory stimulation at multiple dose levels to improve brain function (etude study)

Conditions: Alzheimer Disease, Early Onset; Alzheimer Disease; Alzheimer Dementia; Mild Cognitive Impairment; Memory Disorders; Memory Loss; Memory Impairment; Memory Disorders, Age Related; Alzheimer Disease, Late Onset; Cognitive Impairment; Dementia, Mild; Dementia, Alzheimer Type; Cognitive Decline

Summary: the etude study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.

subjects will be enrolled in two cohorts (n=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). based on initial outcomes in cohort 1 at interim analysis, the doses for cohort 2 will be escalated or decreased. subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.

Eligibility criteria:
inclusion criteria: * \>= 50 years old * mmse 24 - 30 * prodromal alzheimer's disease (ad), ad or mild cognitive impairment (mci) due to ad * participation of a caregiver / care partner * amyloid positive pet scan exclusion criteria: * profound hearing or visual impairment * seizure disorder * use of memantine (namenda or namzaric) * implantable devices (non-mr compatible)

Keywords: dementia alzheimer's disease memory loss
the band-frail study: a provincial intervention to outweigh diabetes and frailty in new brunswick

Conditions: Type 2 Diabetes; Frailty

Summary: the goal of this study is to test whether psychological, social, and physical health outcomes of older adults living with type 2 diabetes and frailty are improved when participating in the band-frail program.

individuals considered fragile or frail and living with type 2 diabetes (t2d) have a 5-fold increased risk of being moved to a long-term care facility and a 4-fold increased risk of an emergency department visit. in 2013, the mid-frail study found that 16 weeks of combined exercise, diet, and education intervention significantly improved functional abilities in older adults living with t2d and frailty. the goal of the band-frail study is to implement an adapted version of the mid-frail program in new brunswick (nb), while ensuring its sustainability by leveraging existing resources in the future as nb has one of the highest rates of diabetes in canada and one of the highest average age of residents. this project will include adults aged 65 years and above living with t2d and frailty across the province of new brunswick (nb). participants will meet in groups of 4-8 people twice a week for 16 weeks. one session will consist of diabetes management education delivered by a certified diabetes educator and elastic band resistance training, while the second session will only involve the elastic band resistance training. participants will undergo pre- and post-testing including questionnaires, physical function tests, and interviews to assess the viability of this program in the province and determine the physical and psychological benefits.

Eligibility criteria:
inclusion criteria: * aged over 65 years old * classified as frail or pre-frail on fried's frailty scale * self-reported diagnosis of type 2 diabetes * not physically active (3+ days of physical activity per week) exclusion criteria: * aged under 65 years old * classified as robust of fried's frailty scale * not diagnosed with type 2 diabetes * regularly physically active (3+ days of physical activity per week)

Keywords: elastic band resistance training exercise intervention aging community intervention
postoperative delirium in hip fracture patients

Conditions: Delirium

Summary: risk factors for postoperative delirium in hip fracture patients.


Eligibility criteria:
inclusion criteria: * hip fracture * age 65 or older exclusion criteria: * critical ill/ dying * aphasia

Keywords: delirium pathophysiology risk factors pain dementia
zinc effect on inflammation and cardiovascular risk in hiv

Conditions: Inflammation; Cardiovascular Diseases; Zinc Deficiency

Summary: to study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among hiv infected patients on stable anti-retroviral therapy

this study will focus on subjects with documented zinc deficiency (levels \<75 µg/dl) as group most likely to benefit from the zinc supplementation. the investigators also acknowledge that zinc may be beneficial in all hiv subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.

Eligibility criteria:
inclusion criteria: * hiv-1 infection * documentation of an hiv-1 rna level of ≤400 copies/ml in the last 4 months prior to study entry * male or female age ≥18 years * zinc level ≤0.75 mg/l in the last 60 days exclusion criteria: * pregnancy/lactation * known cardiovascular disease * uncontrolled diabetes

Keywords: zinc inflammation cardiovascular diseases risk
effects of antibiotic therapy on the short and long-term results of periodontitis treatments

Conditions: Periodontitis, Adult

Summary: antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. the multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). the care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.


Eligibility criteria:
inclusion criteria: * patient over 18 years old * patient treated for periodontitis between 01/01/2012 and 07/31/2021 * patient whose medical and periodontal file contains all the elements necessary for data analysis * subject not having expressed, after information, his opposition to the reuse of his medical data for the purposes of this research. exclusion criteria: * patient who expressed his opposition to participating in the study * patient without periodontitis * patient smoking more than 10 cigarettes / day * patient presenting a dilapidated oral state (untreated caries, unrestored teeth), oral infectious foci whose management requires antibiotic treatment during the initial treatment * impossibility of giving the subject informed information * subject under safeguard of justice * subject under guardianship or guardianship

Keywords: periodontitis inflammatory diseases periodontal teeth aesthetic morbidity cardiovascular risk supragingival subgingival biofilms prosthetic restorations