Kornimate/medical-research-clean huggingface dataset:
the oslo study of clonidine in elderly patients with delirium

Conditions: Delirium

Summary: delirium ("acute confusional state")is characterized by an acute decline in attention and cognition, and is a common clinical syndrome in elderly patients. the purpose of this randomised, controlled, parallel group pilot trial is to explore superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at the acute geriatric ward. we will also study the feasibility of oral clonidine in a geriatric ward and effects of clonidine upon a variety of outcomes as a means to design a more definite study later.


Eligibility criteria:
inclusion criteria: * patient \> 65 years old admitted to the medical department * delirium or subsyndromal delirium diagnosed within the last 48 hours * signed informed consent from patient or relatives * expected cooperation of the patients for the treatment and follow up exclusion criteria: * symptomatic bradycardia, bradycardia due to sick-sinus-syndrome, second- or third- degree av-block (not treated with pacemaker) or any other reason causing hr \<50 bpm at time of inclusion * symptomatic hypotension or orthostatic hypotension, or a systolic bp \<120 at the time of inclusion * ischemic stroke within the last 3 months or critical peripheral ischemia * acute coronary syndrome, unstable or severe coronary heart disease (symptoms at minimal physical activity; nyha 3 and 4) and moderate to severe heart failure (nyha 3 and 4). * a diagnosis of polyneuropathy or pheochromocytoma * renal insufficiency (estimated gfr\<30 ml/min according to the mdrd formula). * body weight \< 45 kg. * considered as moribund on admission. * not able to take oral medications * current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin * previously included in this study * adverse reactions to clonidine or excipients (lactose, saccharose) * not speaking or reading norwegian * any other condition as evaluated by the treating physician * admitted to the icu
continuous, non-invasive monitoring of intraoperative cerebral perfusion and oxidative metabolism (cpom)

Conditions: Brain Hypoxia Ischemia

Summary: this study uses a cpom optical neuromonitor to assess the relationship between brain cytochrome c oxidase, cerebral oxygen saturation and blood pressure during surgery performed under general anesthesia.

during various surgical procedures, blood supply to the brain can be jeopardized either due to interruption of flow as occurs during carotid surgery, or due to inadequate arterial pressure which can occur in settings as diverse as heart surgery or shoulder surgery. this is a prospective observational study of brain oxygen levels, brain metabolism and blood pressure in 50 adult surgical patients under general anesthesia using a cpom optical neuromonitor. this is an observational study. the primary objective of this study is to describe the changes in redox state of brain cco (reflecting oxidative metabolism), cbfi, and brain tissue oxygen saturation in relation to systemic blood pressure in patients during general anesthesia/cardiopulmonary bypass (cpb). this study represents the first opportunity to assess this combined technology in adult patients and will provide important data to support further investigations in brain-at-risk patients. these 50 patients will be used to help the investigators to obtain pilot data about the relationship between brain cytochrome c oxidase (bcco), cerebral oxygen saturation (sco2), and blood pressure (especially hypotension) using a cpom device. cerebral auto regulation indices will also be determined. no intervention will be applied.

Eligibility criteria:
inclusion criteria: * all adult surgical patients (\>18 year-old) who require general anesthesia for their surgery * patients required an arterial line for his/her procedure exclusion criteria: * emergency surgery * unable to obtain consent * condition that preclude the use of cpom monitor (e.g. skin lesion in the forehead)

Keywords: intraoperative/methods* oximetry/methods* oxygen/metabolism brain/metabolism brain chemistry cerebrovascular circulation humans monitoring, intraoperative/methods oximetry/methods oxygen/metabolism
a follow-up study to evaluate the safety of allo-asc-dfu in allo-asc-dfu-201 clinical trial

Conditions: Diabetic Foot Ulcer

Summary: this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-dfu treatment in phase 2 clinical trial (allo-asc-dfu-201) for 23 months.

this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-dfu treatment in phase 2 clinical trial (allo-asc-dfu-201) for 23 months. allo-asc-dfu is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (vegf) and hepatocyte growth factor (hgf), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a diabetic foot ulcer.

Eligibility criteria:
inclusion criteria: 1. subjects who are treated with allo-asc-dfu sheet in phase 2 clinical trial of allo-asc-dfu-201. 2. subjects who are able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. subjects who are considered not suitable for the study by the principal investigator.
exercise in pediatric cancer patient undergoing anti-cancer treatment

Conditions: Childhood Cancer

Summary: today about 80% childhood cancer patients become long-time survivors. in spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood. so the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (qol). although exercisel intervention studies in this field are generally scarce, the results of these studies are promising. up to now studies during the acute phase of treatment are missing almost completely. the aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year. across two years cancer patients of the children's hospital of the university clinic of heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited. all participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning qol and motivation, at baseline and every three months following one year


Eligibility criteria:
inclusion criteria: * pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors * date of diagnosis not longer than 8 weeks ago exclusion criteria: * severe cardiac impairment * bone metastasis inducing skeletal fragility * other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements.

Keywords: exercise pediatric oncology physical performance quality of life feasibility during primary anticancer treatment
the microvascular function of glp-1 and its analogues

Conditions: Type 2 Diabetes; Obesity

Summary: incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. however little is known about a potential benefit of glp-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in animals. particularly little is known about clinically relevant benefits of glp-1 and its analogues on the microvascular system of individuals with type 2 diabetes. the vascular effect could be medicated by endogenous glp-1 (9,36) amide, the breakdown product of glp-1 (7,36) amide which has a low affinity for the glp-1 receptor. the investigators hypothesis is that the co-administration of dpp-iv inhibitors will lack the beneficial effects of glp-1 on the vascular system as glp-1 (9,36) amide will not be produced by the body. the study aims to examine the response of glp-1 and its analogues on small blood vessels and examine the effect of the addition of dpp-iv inhibition in healthy lean individuals, obese individuals and subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * lean bmi ≤ 25.0 kg/m2 * obese bmi ≥30.0kg/m2 * non diabetic subjects and subjects with type 2 diabetes on stable medication for at least 3 months exclusion criteria: * cardiovascular disease * raynaud's disease * current treatment with any anti-hypertensive * lipid lowering therapies * severe hepatic impairment * pregnancy and lactation * subjects with type 2 diabetes on insulin therapy * subjects with type 2 diabetes on sulphonylureas * subjects with type 2 diabetes on incretin based therapies * subjects with type 2 diabetes and peripheral vascular disease * subjects with type 2 diabetes and history of advanced retinopathy * subjects with type 2 diabetes and advanced nephropathy * subjects with type 2 diabetes with uncontrolled diabetes (hba1c \> 8.5%)

Keywords: glp-1 dpp-iv inhibitor microcirculation exenatide liraglutide linagliptin
immune responses to autologous langerhans-type dendritic cells electroporated with mrna encoding a tumor-associated antigen in patients with malignancy: a single-arm phase i trial in melanoma

Conditions: Melanoma

Summary: this study is being done to see if the investigators can help the immune system to work against melanoma. a dendritic cell is another type of white blood cell. it has most, if not all, of the proteins needed to make t cells work to destroy cancer cells. however, dendritic cells do not normally have the cancer proteins on their surface. the challenge then is to combine the antigens with dendritic cells to make a vaccine. the investigators think that the body's t cells might then react against the tumor and help destroy it. this study will see if altered dendritic cells will make t cells work against tumor cells. the dendritic cells will be made in a lab and will carry the antigens. these cells then will be injected under the skin. in this study, the investigators are trying to help the body make a stronger immune response against the cancer. the patient will get the same kind of dendritic cell vaccine used in the earlier study, but with one major difference. the dendritic cells will contain messenger-rna (mrna). cells use mrna to make proteins. the mrna will be put into dendritic cells by a laboratory method called electroporation. the mrna is never given to the patient directly. this mrna will help the dendritic cell make a tumor antigen like what the cancer expresses. the dendritic cell can then put this tumor antigen on its surface so that the body could make a stronger immune response against the tumor.


Eligibility criteria:
inclusion criteria: * diagnosis of melanoma, ajcc stage iib, iic, iii, or iv (mia), with histologic confirmation by the department of pathology at mskcc. * patients must be hla-a\*0201 positive, based on high resolution dna level typing. * expected survival of greater than 3 months. * karnofsky performance status of 70 or higher * all patients should have undergone surgical treatment appropriate to their stage of disease * patients may not have received chemotherapy, immunotherapy, or radiation within a minimum of 28 days (minimum of 42 days for nitrosoureas or mitomycin) before participation in this protocol. exclusion criteria: * pregnant or lactating women because of unknown risks to the fetus or infant. * patients requiring systemic corticosteroids or comparable exogenous immunosuppressive agent(s) (no exclusion for use of nsaids). * patients with a known immunodeficiency (e.g., infection with htlv-1,2, hiv-1,2; etc.). * patients with coexisting autoimmune diseases, except vitiligo. * patients with baseline impairments of hematologic, hepatic, or renal function (ctcae v4.0 \> grade 1, anc \ 3x uln, creatinine \> 1.5xuln), all assessed within four weeks of study entry. * patients with organ allografts. * patients who are status post splenectomy or status post splenic irradiation. * patients with a history of documented pre-existing retinal/choroidal disease.

Keywords: vaccine stage iib stage iic stage iii stage iv (mia) langerhans-type dendritic cells immune responses 10-229
prevalence, associated factors points and implementation of care procedures of chronic obstructive pulmonary disease exacerbation in healthcare institution

Conditions: COPD Exacerbation

Summary: chronic obstructive pulmonary disease (copd) is a public health problem responsible for high mortality rate and significant costs for society. the disease evolution is punctuated by exacerbations worsening the health state of patients. many guidelines of care procedures have been written but many disparities persist in medical practices. this pilot prospective observational study is an overview of current local practices in the university health center of grenoble alpes and it is the first step towards developing a regional observatory in order to standardize and improve patient cares. the primary outcome is to compare the international guidelines to the local practices regarding the prescription of key treatments of exacerbation, especially antibiotics.


Eligibility criteria:
inclusion criteria: * patient older than 18 years (included) * known or suspected chronic obstructive pulmonary disease * admitted for copd exacerbation in emergency department or pneumology department or intensive care unit of university health center of grenoble alpes during the period of data collection. exclusion criteria: * opposition to participate at the study * patients under the law

Keywords: copd exacerbation prospective observational professional practices guidelines
optical imaging of gastrointestinal biopsy samples and their correlation with histology

Conditions: Gastrointestinal Disease; Gastrointestinal Dysfunction

Summary: to develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.

the investigators have previously developed optical imaging systems that have been able to provide highly detailed images of tissue structures in multiple application areas including cardiology, gastroenterology, and pulmonology. they are looking to continue the advancement of these various technologies under development. the population will include subjects who are undergoing elective esophagogastroduodenoscopy with biopsy, colonoscopy with biopsy, and/or endo-mucosal resection.the endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies. the study will be optical imaging of the ex vivo gi specimens that are being collected. specimens will be collected for research purposes only. offline analysis of the samples will be performed, and optical imaging findings will be correlated with the pathology findings. this will require review of the medical record to link the findings of the imaging with the pertinent medical information. samples will be de-identified and subjects will be assigned a unique number. the tissues will be placed in marked containers labeled "for research purposes only". the samples collected will be brought to the tearney research laboratory for imaging and processing. the optical imaging of the tissue samples will not affect the standard of care procedure.

Eligibility criteria:
inclusion criteria: • scheduled for an elective esophagoduodenoscopy and/or colonoscopy exclusion criteria: • according to standard of care at mgh endoscopy department.

Keywords: oct optical coherence tomography biopsy gi disease endoscopy screening endoscopic screening
efficacy, safety and adherence of patients infected with hepatitis c virus in retreat with infergen (interferon alfacon1)

Conditions: Hepatitis C

Summary: this is a phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes infergen for clinical practice. no medication was provided by the sponsor. the planned observation time is 48 weeks and 24 weeks of follow-up. each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.


Eligibility criteria:
inclusion criteria: 1. willing to consent to data being collected 2. considered by the investigator as an appropriate patient for treatment with infergen in retreatment.

Keywords: hepatitis c retreatment failures infergen interferon alfacon-1
new versus approved methyl-aminolevulinate photodynamic therapy (mal-pdt) regime in basal cell carcinoma (bcc)

Conditions: Skin Neoplasms; Carcinoma, Basal Cell

Summary: basal cell carcinoma (bcc) is the most common malignant skin lesion in white adults. it is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. methyl aminolevulinate cream plus photodynamic therapy (mal-pdt) for bcc is currently approved for a procedure using 2 treatment sessions 1 week apart. this procedure is considered quite time- and resource-consuming. introducing a single treatment session, with a new pdt session for treatment failures after 3 months, might represent an attractive simplification. this randomised controlled single-blinded multi-centre study primarily aims to compare bcc lesion response rate of two treatment schedules: (a) 1 single treatment of metvix-pdt with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard metvix(r) pdt treatments 1 week apart. secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.


Eligibility criteria:
inclusion criteria: * male/female above 18 years of age * written informed consent * 1 or more primary histologically verified bcc, clinically assessed as of either superficial of nodular type exclusion criteria: * pregnancy * breastfeeding * gorlin's syndrome * porphyria * xeroderma pigmentosum * history of arsenic exposure * known allergy to mal * concomitant treatment with immunosuppressive medication * physical or mental conditions that most likely will prevent patients attending follow-up sessions

Keywords: photochemotherapy methyl 5-aminolevulinate
the use of selenium to treat secondary lymphedema - breast cancer

Conditions: Breast Neoplasms; Lymphedema

Summary: the primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.


Eligibility criteria:
inclusion criteria: * patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy) * patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy * ecog performance 0-2 * informed consent exclusion criteria: * active cellulitis/skin infection of the limb * venous thrombosis of the upper limbs * active malignancy * any other medical condition or congenital or traumatic injury involving either limb * patients already on selenium medication * patients participating in another clinical study related to lymphedema
development and validation of a novel functional eye-tracking software application for alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study aims to develop and validate a sensitive and non-invasive eye-tracking software application. this study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by alzheimer's disease and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. the study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of alzheimer's disease and associated cognitive changes.


Eligibility criteria:
inclusion criteria: * for all participants: 1. able to provide informed consent 2. aged 18 years or older at the time of enrollment 3. able to read in either french or english 4. visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted) * for patients only: 1. confirmed diagnosis of ad based on the niaaa diagnostic criteria of probable ad 2. having undergone a full neuropsychological evaluation within the last 6 months or having a planned full neuropsychological evaluation within the next 6 months. 3. ad diagnoses supported by fdg-pet scan or amyloid biomarkers (csf or amyloid pet) exclusion criteria: * for ad participants: 1. diagnosed with one of the following dementia subtypes: fronto-temporal dementia, lewy-body dementia, or creutzfeldt-jakob disease. 2. incapacity to provide informed consent or inability to adequately understand the task instructions. * for all participants: 1. evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control. 2. presence of comorbid neurological conditions to avoid eye movement anomaly confounds (strabismus, cranial nerve palsy, stroke-causing hemianopsia). 3. diagnosis of macular edema or other pre-existing ocular conditions (e.g., glaucoma, cataracts) that would prevent from performing the eye movement assessments. 4. unstable medication use: recent (less than one month from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to have an effect on ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period of an eye movement assessment. 5. diagnosed with an active substance use disorder. 6. history of stroke. 7. recent traumatic brain injury (within the last 6 months). * for healthy controls only: 1. evidence or history of significant neurodegenerative disorder affecting brain function (e.g., ms, pd, als, non-ad dementia)

Keywords: alzheimer's disease eye movement biomarkers eye-tracking
a clinical trial into the efficacy of rtms treatment for treating anorexia nervosa and bulimia nervosa

Conditions: Eating Disorders; Anorexia Nervosa; Bulimia Nervosa

Summary: this is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rtms) in treating individuals with anorexia nervosa and bulimia nervosa. the main objective of this study is to determine the short and long-term efficacy of repetitive transcranial magnetic stimulation (rtms) in reducing eating disorder symptoms (i.e. binging, purging, restricting, intense fear of gaining wait, etc;) in anorexia nervosa and bulimia nervosa. the investigators will also be comparing the brain activity patterns of individuals with anorexia nervosa and bulimia nervosa to healthy controls using electroencephalography (eeg). further, the investigators would like to examine if the activation patterns in these patients change after receiving rtms.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of anorexia nervosa or bulimia nervosa, must pass rtms screening questionnaire exclusion criteria: * diagnosis of another psychiatric disorder, except mdd. * any rtms counter-indications: * history of seizures * metal in head * currently pregnant * having received rtms for any reason in the past as this would interfere with participant blinding.

Keywords: rtms