Kornimate/medical-research-clean huggingface dataset:
stimulation to improve memory

Conditions: Mild Cognitive Impairment; Dementia of Alzheimer Type

Summary: this study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (mci) and dementia of the alzheimer's type (dat).

this research study is being done to learn important information about the effects of weak electrical stimulation on brain functioning in those with mild cognitive impairment (mci) and dementia of the alzheimer's type (dat). the findings will help determine "how much" stimulation is needed to enhance memory and thinking abilities, how it affects brain functioning, and who is most likely to benefit. ultimately, this information may guide treatment efforts for those at various stages of alzheimer's disease. the study will use brain imaging to see whether these treatments change how participants learn and remember information. functional magnetic resonance imaging (fmri) and positron emission tomography (pet) scans will be used. the study will also use cognitive tests and questionnaires to examine whether participants' memory (and related abilities) change because of treatment. the study will enroll participants with a diagnosis of mci or dat. it is expected but not required that participants will be co-enrolled in the university of michigan memory and aging project (um-map; hum00000382).

Eligibility criteria:
inclusion criteria: 1. diagnosis of mild cognitive impairment (mci) or dementia of the alzheimer's type (dat) 2. must be mri compatible, criteria that also apply for high definition transcranial direct current stimulation (hd-tdcs; e.g., absence of metallic or electronic implants in the upper body or head) 3. stable on relevant medications for at least 4 weeks prior to study enrollment exclusion criteria: 1. certain neurological diseases 2. certain psychiatric conditions 3. severe sensory impairment

Keywords: dementia memory cognitive rehabilitation pet scan fmri brain stimulation
evaluation of the contribution of noddi protocol tractography in brain tumor surgery

Conditions: Malignant Brain Tumor

Summary: the objective of this study is to evaluate to what extent the capacity of the noddi model can allow, in case of malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (des) which is today the reference tool. the patient's participation in this study implies an additional visit during which an mri examination without injection of contrast medium will be performed, lasting approximately 40 minutes (including installation and de-installation).

this is a single-center, prospective, open-label study of neurosurgical patients. compared to their usual management, the participation of the patient in this study implies an additional visit during which an mri examination without injection of contrast product will be performed, lasting approximately 40 minutes (including installation and de-installation). the operative time, surgical procedures and postoperative follow-up are not modified in this study

Eligibility criteria:
inclusion criteria: * patient 18 years of age or older, * patient who has read and signed the consent form for participation in the study * patient requiring surgery for a malignant brain tumor with vasogenic edema * patient with an estimated life expectancy of more than 3 months. exclusion criteria: * patient under legal protection, guardianship or trusteeship * patient not affiliated to the french social security system * contraindication to mri (patient with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patient with hemostatic clips on intracerebral aneurysms or with orthopedic implants, claustrophobic patient) * psychiatric history * refusal to be informed of an abnormality detected during the mri * pregnant or breastfeeding woman
extension study of the efficacy of the gsk 580299 vaccine in japanese women vaccinated in the primary nct00316693 study

Conditions: Infections, Papillomavirus

Summary: this extension study is conducted to assess the efficacy of the gsk 580299 vaccine against cervical intraepithelial neoplasia (cin) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (hpv)-16 and/or hpv-18 or other oncogenic hpv types for an additional two years. all subjects who participated in the primary vaccination study nct00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. in addition, safety and persistence of the humoral immune response will be evaluated in this study. this protocol posting deals with objectives \& outcome measures of the extension phase at months 36 and 48. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = nct00316693).


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol; * written informed consent obtained from the subject prior to enrolment in the extension study; * a subject previously vaccinated in the nct00316693 study. * subjects who showed, at the last nct00316693 study visit (at month 24) willingness to participate in this extension study. exclusion criteria: * use of any hpv vaccine other than the one administered in the nct00316693 study; * use of any investigational or non-registered product other than the study vaccine since last nct00316693 study visit, or planned use during the study period; * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product; * subjects who were diagnosed high grade or missing cytology at month 0 in the nct00316693 study; * pregnant females and females who were pregnant less than 3 months ago.

Keywords: hpv vaccine cervical intraepithelial neoplasia (cin) including new onset of autoimmune disease [noad]) new onset of chronic disease (nocd) medically significant condition (msc)
randomized crossover study to test the impact of using a software for smartphones and tablets in treating type 1 diabetes

Conditions: Type 1 Diabetes; Quality of Life; Hypoglycaemia

Summary: the purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life

the hypothesis underlying this project, is that most calculations necessary for flexible intensive insulin therapy for type 1 diabetes in children can be performed using software installed on a smartphone or tablet that nowadays is carried by most parents and children. smartphones and tablets can easily communicate with each other and with a desktop computer via the internet, thereby permitting the exchange of information such as blood glucose values or types of meals among family members and physicians. finally, software collecting blood glucose values and merging values obtained on different devices easily permits reviewing these values by the patient and sending them to the physician's office, thereby avoiding consultations during which no blood glucose values are brought by the patient. we hypothesize that the webdia software, that will be tested in this randomized crossover study, will increase treatment compliance and therefore will improve diabetes self-management. we believe, the software will facilitate the adaptation of insulin schemes by physicians and therefore will lead to improved hba1c values. we also think that this software will improve the patient's quality of life.

Eligibility criteria:
inclusion criteria: * age 10 - 18 years * type 1 diabetes mellitus with positive auto-antibodies against islet antigen (ia) 2, insulin, islets, glutamic acid decarboxylase (gad) 65 or zink * disease duration equal or more than 6 months * treatment by subcutaneous insulin: by multiple daily injections of pump therapy exclusion criteria: * previous use of webdia software * absence of hardware necessary to install the webdia software

Keywords: type 1 diabetes hba1c quality of life hypoglycaemia self-management telemedicine
obstetric placement study using est

Conditions: Obstetric Pain; Anesthesia, Local

Summary: combined spinal-epidural (cse) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. the epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle cse, the catheter is untested. this study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (est) which was first described by the pi of the study for confirming placement of epidural catheters approximately 20 years ago.


Eligibility criteria:
inclusion criteria: * females, 18 years and older * american society of anesthesiologists physical status i or ii * full-term pregnancy with request for epidural early in labour (i.e. regular labor or c-section) exclusion criteria: * contraindication to regional anesthesia * allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl * use of sedatives or opioids * abnormal vertebrae anatomy * neurological disorder with lumbar involvement * implanted electronic devices

Keywords: electrical epidural stimulation test
quadrilateral surface plate (qsp) focused registry

Conditions: Acetabular Fracture

Summary: the absence of methodologically, prospectively and retrospectively collected information on the use of the quadrilateral surface plate (qsp) in the given indication requires a multicenter approach. using a registry to get more information about the effectiveness and possible benefits or complications during the surgery and during the post-operative treatment is adequate and necessary to get new insights to the use of the quadrilateral surface plate.

this registry includes six visits at which data is collected form the patinet (pre-op, post-op, 6 weeks fu, 3 months fu, 6 months fu and 12 months fu). patients can be inlucded prospectively or retrospectively. if properatively recruited patients complete two questionnaires (eq5d and merle d'aubigné) at their preoperative visits. these questionnaires are repeated after 6 and 12 months. surgeons report about the success of the surgical procedure in a specifically designed questionnaire. during the whole study period, adverse events related to the implant or surgery are collected as well as x-rays and ct (as per standard of care).

Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosis of acetabular fracture requiring surgical fixation * ability to understand the content of the patient information / informed consent form * signed and dated irb/ec-approved written informed consent exclusion criteria: * any not medically managed severe systemic disease * recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * prisoner * participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry intraoperative exclusion criteria: * intraoperative decision to use implants other than the device under investigation

Keywords: adverse events osteosynthesis quality of life
long-term clinical outcome in patients undergoing remote ischemic conditioning before primary percutaneous coronary intervention for st-elevation myocardial infarction: a follow-up study

Conditions: ST-elevation Myocardial Infarction (STEMI)

Summary: the aim of this prospective follow-up study is to investigate 5-year clinical outcome in patients with st-elevation myocardial infarction undergoing remote ischemic conditioning before primary percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * chest pain before admission to hospital within 12 h of onset, st-segment elevation of \> 0,1 mv in 2 or more contiguous leads, 18 years or older. exclusion criteria: * left bundle branch block, previous myocardial infarction, fibrinolytic treatment in the previous 30 days, previous coronary bypass surgery, left main stem stenosis requiring coronary bypass surgery, severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump.

Keywords: myocardial infarction remote ischemic conditioning clinical outcome
serum copeptin as a predictor of the risk of hyponatremia after transurethral prostatectomy

Conditions: Benign Prostatic Hyperplasia

Summary: hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (turp). copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. the aim of our the study was to assess the utility of serum concentration of copeptin (cpp) and brain natriuretic peptide (nt-probnp) for the prediction of postoperative alterations of serum sodium concentration. study population comprised 43 patients with benign prostatic hyperplasia (bph) undergoing transurethral resection of the prostate gland. in a forward stepwise multiple regression only serum copeptin before the surgery and the duration of turp significantly explained the variation of sodium concentration for 12 hours from the start of the surgery. serum nt-probnp before the surgery did not predict hyponatremia 12 hours after turp.conclusion serum copeptin before turp surgery but not nt-probnp may be a clinically useful marker of a decrease of serum sodium after turp surgery.

introduction.hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (turp). copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. the aim of our the study was to assess the utility of serum concentration of copeptin (cpp) and brain natriuretic peptide (nt-probnp) for the prediction of postoperative alterations of serum sodium concentration. methods. study population comprised 43 patients with benign prostatic hyperplasia (bph) undergoing transurethral resection of the prostate gland (turp) serum sodium and copeptin (cpp) were measured before the procedure and 12 hours after its completion. and sserum nt-probnp was assessment at baseline. total amount of fluids and sodium administered intravenously and to flush the bladder during turp was calculated in each patient. receiver operator characteristics (roc) curve analysis was used to determine the value of of copeptin (cpp) and nt-probnp for that could prediction of the decrease of serum sodium after turp

Eligibility criteria:
inclusion criteria: - glomerular filtration rate estimated from serum creatinine with ckd-epi formula (egfr) \>45 ml/min. exclusion criteria: * acute infection * heart failure (nyha stage 3 or 4) * diabetes insipidus * nephrogenic diabetes insipidus * other sodium homeostasis abnormalities * impaired consciousness * psychogenic polydipsia * alcohol abuse.

Keywords: transurethral prostatectomy copeptin hyponatremia risk prediction
vitamin d supplementation requirement in obese subjects

Conditions: Vitamin D Deficiency

Summary: vitamin d deficiency is common in obese patients. most of vitamin d supplementation studies were done with non-obese subjects. this study looks at vitamin d supplementation requirements in obese patients as compared to non-obese subjects. this study also looks at changes in vitamin d level in obese patients undergoing medical weight loss. it is thought that obese patients have vitamin d deficiency through storage of vitamin d in the fat compartment not readily available for blood measurement. the investigators' hypothesis is that with medical weight loss vitamin d levels will increase in obese subjects.

we intend to study changes in serum 25(oh)d level with calorie restricted weight loss in obese subjects. this will be a double dummy, placebo controlled randomized trial. subjects whose serum 25(oh)d level is below 80 nmol/l will be assigned randomly to either the vitamin d supplemented or the placebo group. those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(oh)d level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. changes in serum 25(oh)d level will be obtained with weight loss through restricted caloric intake. to study the 25(oh)d dose-response curve with vitamin d supplementation in obese subjects, vitamin d supplemented group will receive initial daily vitamin d3 supplementation dose based on their baseline serum 25(oh)d level as described in methods and procedures section. serum 25(oh)d levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(oh)d levels between 80 and 140 nmol/l. the dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. serum 25(oh)d level will be obtained at 16 weeks and compared with the data available from non-obese subjects.

Eligibility criteria:
inclusion criteria: * healthy men or women between the ages of 18 and 70 years old who are enrolled in our weight management program with baseline bmi \> 30 kg/m2. exclusion criteria: * pregnancy, * serum 25(oh)d level greater than 80 nmol/l, * hypercalcemia (serum calcium level greater than the upper limit of normal), * recent surgery or illness, * those with chronic use of medications that influence calcium/vitamin d metabolism such as anti-convulsants, lithium and steroids. thiazide diuretics for hypertension will be acceptable. * subjects with sarcoidosis will be excluded. * those who do not qualify to participate in the weight management program will be excluded. they include subjects with active substance abuse and unstable cardiac disease.
long-term effectiveness of liraglutide for treatment of type 2 diabetes in daily practice

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this study is to investigate long-term effectiveness of liraglutide for treatment of type 2 diabetes in daily practice.


Eligibility criteria:
inclusion criteria: * subjects of age above 18 years as per victoza® smpc par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011 exclusion criteria: * none. available data from all eligible patients for each center, will be included
analysis of the effects of the osteopathic manipulative treatment in carriers of temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: the purpose of this study is to determine whether osteopathic manipulative treatment associated to dentistry care and speech therapy improves pain and function in individuals with temporomandibular disorders.

a standardized tmd examination was executed in all patients by a dentist following the research diagnostic criteria for temporomandibular disorders (rdc/ tmd) questionnaire, axis i and ii, portuguese version. the rdc/ tmd is compound by a 31 items questionnaire and a ten items clinical exam. all these items are related to patients symptoms and signs; to mandibular functional impairment; and social-demographics, social-economics, psychological e psychosocial data. the first part as axis i tend to clinical assess and classify the tmd and the second, as axis ii propose a chronic pain score that could quantify the psychosocial impairment and present a subjects profile. others assessment instruments utilized on the research were the vas consists in a 10 cm horizontal line with "no pain" on the left side and "worst pain" on right side, then the subjects were instructed to vertical risk the level of pain. the digital caliper with a 0,03 mm precision was used to measure the maximal mouth opening (mmo) as the maximal inter-incisal vertical distance of the incisors. the subjects were seated at 90° with neutral head position and solicited to open their mouths the maximum they can unassisted and without pain, maximum unassisted opening and maximum assisted opening. also, a portable digital pressure algometer for measuring sensitivity to pressure before it became painful. the masseters and temporalis muscles trigger point location were used as reference to guarantee the reproducibility of the proceeding as well as to assess the always the same site. the statistical analysis was performed using the means comparisons for the parametric tests through student t test and for the non-parametrical data, wilcoxon. also, it was made the descriptive statistical with frequencies analysis.

Eligibility criteria:
inclusion criteria: * subjects of both genders with tmd diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (vas) who need dental treatment. exclusion criteria: * continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to tmd and being under orthodontic or tmd treatment.

Keywords: temporomandibular disorder osteopathic manipulative treatment rigid splint speech therapy
hypnosis for sleep quality in caregivers of individuals with alzheimer's disease

Conditions: Poor Quality Sleep; Caregiver Stress; Alzheimer's Disease (Incl Subtypes)

Summary: the long-range goal is to identify an efficacious and practical intervention to improve sleep quality and duration for family caregivers of individuals with alzheimer's disease and related dementias (adrd). the main goal of this study is to determine feasibility of a self-administered hypnosis intervention with caregivers of individuals with adrd by randomizing eligible participants into one of two study arms, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group). the investigators are also examining the feasibility of accrual, outcome measures (diaries, actigraphy) and study design.

study objectives aim 1: determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among caregivers of individuals with adrd. feasibility will be determined by (1) drop-out rate, (2) participants' rating of the program, and (3) participants' rating of treatment satisfaction. adherence will be determined through at-home practice logs. essential experience on accrual and retention data as well. aim 2: determine feasibility of measures: psqi, actigraphy recordings, and sleep diaries to assess sleep quality and duration, as well as feasibility of secondary self-report outcome measures of insomnia severity, stress, cognition, and pain among caregivers. aim 3: determine perceptions of hypnosis and potential barriers for the caregiver population and feedback. participant selection and recruitment plan a sample of 20 caregivers, both male and female, of individuals with adrd, who suffer from poor sleep will be enrolled in the study. a screening checklist will be used for screening participants who are interested. potential participants will be identified (1) via advertisements and press releases, (2) via physician referral, and (3) targeted mailings. participants eligibility will be determined by criteria listed on a screening checklist. the investigators have used these strategies in prior studies and have demonstrated ability to accrue the required number of participants.

Eligibility criteria:
inclusion criteria: 1. active caregiver to an individual with alzheimer's disease or its related dementias 2. self-reported sleep duration of 6 or less hours per day/night as indicated on the psqi 3. signed informed consent 4. access to a computer or mobile device with reliable internet connection that will allow for the completion of study visits and study materials online exclusion criteria: 1. use of any prescription or over-the-counter therapy for sleep 2. severe or unstable medical or psychiatric illness 3. current use of hypnosis for any condition 4. inability to speak or understand english