Kornimate/medical-research-clean huggingface dataset:
caregiver bootcamp

Conditions: Dementia

Summary: this study will assess the preliminary efficacy of a synchronous/asynchronous psychoeducation program designed to promote caregiving mastery in the immediate time period after a dementia diagnosis. it will also study the effects on caregiver and care recipient well-being.

the caregiver bootcamp program will employ psychoeducational methods (expert instruction, expectation of active learning by participants, debriefing and coaching linked to participant reports of application of strategies and principles) to enhance the proposed mechanism of action of the intervention, the enhancement of caregiving mastery - the individual's self-acknowledgement of self-efficacy for coping with the stresses of the new caregiving role. the program is meant to provide basic orientation to the situation: recognize the reality of the condition; understand the shifts in mindset that the immediate situation demands; begin to recognize the shift in responsibility that will have to occur; and take practical steps to prepare for the future. the program will combine 5 weekly small group 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions.

Eligibility criteria:
inclusion criteria: 1. over the age of 21; 2. care partner/caregiver for a family or friend who has received a diagnosis of a form dementia from a healthcare provider in the last 6 months; 3. has access to an electronic device and/or access to broadband internet; and 4. able to speak and understand english. caregivers are not required to be co-located with the care recipient. exclusion criteria: * considering moving the plwd to an institutional setting within the next 6 months.

Keywords: caregiver dementia person living with dementia
5 year radiological and clinical results from patients operated for hallux valgus deformity.

Conditions: Hallux Valgus

Summary: retrospective study of patients operated for hallux valgus deformity at our hospital (ostfold hospital trust) 5 years ago. patients will be clinically examined, a weighted radiograph of the foot (traditional and newer parameters will be evaluated) and patient reported outcome measures (prom) scores will be collected.


Eligibility criteria:
inclusion criteria: * all patients (18-80 years at time of surgery) operated for hallux valgus deformity at ostfold hospital trust 2016-2018 exclusion criteria: * not able to speak/write/read norwegian language

Keywords: radiological outcome clinical outcome
hpv-test, cervical cancer and follow-up

Conditions: Human Papilloma Virus; Uterine Cervical Neoplasms; Recurrence

Summary: the investigators have planned this project to evaluate the follow-up program after surgery due to cervical cancer and to explore the possibilities for different tests of human papilloma virus (hpv) in contributing to the customization of the follow-up program. purpose: the investigators effort is to provide the background for an evidence-based update of the follow-up program after surgery due to cervical cancer with the purpose of early diagnosis of recurrence affecting quality of life for as few women as possible.


Eligibility criteria:
inclusion criteria: * surgery. figo stage ia-ib. \> 18 years exclusion criteria: * ajuvant oncologic treatment

Keywords: surveillance follow up
a study to evaluate the efficacy between helicobacter pylori eradication therapy and motilitone in functional dyspepsia

Conditions: Functional Dyspepsia

Summary: this is a clinical study to evaluate the efficacy between helicobacter pylori eradication therapy and motilitone in functional dyspepsia

this is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between helicobacter pylori eradication therapy and motilitone in functional dyspepsia

Eligibility criteria:
inclusion criteria: * roman iii criteria * one or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety * no organic lesion * helicobacter pylori infection exclusion criteria: * has taken prokinetics, h2 antagonists, ppis, nsaids, anticholinergics, antibiotics, antidepressants, anticoagulants within a month * had a surgery that might affect gastrointestinal motility
regional anesthesia for head and neck reconstruction

Conditions: Pain, Postoperative

Summary: by utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. it can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.


Eligibility criteria:
inclusion criteria: * subjects undergoing microvascular fibula free flap reconstruction of the head and neck * subjects undergoing primary reconstruction for both benign and malignant etiology exclusion criteria: * pregnant women * subjects with true allergies to the study drugs, reporting anaphylaxis in the past * subjects undergoing reconstruction with more than 1 free flap * subjects undergoing secondary reconstructions * subjects undergoing surgery for osteonecrosis * history of enrollment in a pain management program * any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin
transcranial electrical stimulation for mal de debarquement syndrome

Conditions: Mal de Debarquement Syndrome

Summary: the goal of this study is to determine whether external neuromodulation using transcranial electrical stimulation (tes) can reduce the perception of self-motion that is experienced by patients with mdds. mal de debarquement is translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. a similar form of rocking dizziness can be experienced without a motion trigger in individuals with certain risk factors. treatment for mdds is limited and morbidity is high.the goal of the study is to determine whether tes can suppress the rocking dizziness of mdds either as a standalone therapy or as an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic stimulation. the investigators will determine the optimal treatment duration and stimulation parameters.

eligible participants who meet study criteria and pass the safety screen will be invited to participate in the study. if tes is used as add-on treatment to repetitive transcranial magnetic stimulation (rtms), the training for tes application will be done on-site. however, in a portion of the study that does not involve rtms, remote training will be performed via a webcam provided that a suitable "study buddy" is available to assist the participant. participants will maintain web-based diaries of their symptoms for up to four weeks prior to treatment with tes. before the actual treatment sessions are started, the subjects will complete baseline questionnaires online which will be repeated once a week for up to 12 weeks. over the course of the study, the subjects will also keep a daily log of their sessions such as how many sessions they performed, for how long, and whether they had any side effects with each session. the studies will include a sham arm, allocated at a ratio of 1:1. on-site studies will involve the application of eeg, mri, balance, cognitive, and visual/auditory stimulation tests.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. willing and capable of interacting with the informed consent process 3. primary disorder being a persistent perception of motion with no other cause determined after a careful interview. 4. able to identity a study buddy and provide contact information exclusion criteria: 1. subjects who cannot comply with study conditions. 2. active psychiatric condition such as mania or psychosis 3. unstable medical condition 4. implanted metal in the head or neck (metal or shrapnel, deep brain stimulators, aneurysm clips, cochlear stimulators, retinal implants, etc). dental fillings are acceptable. 5. any active skin disorder that affects skin integrity of the scalp. 6. pregnant

Keywords: mdds tes tms
geographic atrophy and intravitreal ranibizumab injections

Conditions: Age-related Macular Degeneration; Geographic Atrophy

Summary: given the aging population who will be affected by wet amd and lack of effective ga treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in amd patients with ga, particularly the possible risk of ga development and enlargement. this potential adverse effect has significant implication in the discussions with patients regarding the risks and benefits of amd treatment and injection frequency. while monthly injections provide slight improvement of visual acuity at 2 years (martin et al., 2012), the risk of ga enlargement may offset this benefit in visual acuity. previous studies assessed the association between intravitreal ranibizumab injections and de novo ga development in injection-naïve eyes (martin et al, 2012, querques et al., 2012., grunwald et al., 2014), rather than ga enlargement in patients with preexisting ga. to the best of the investigators knowledge, there has been no prospective study assessing the association between intravitreal ranibizumab injections and rate of ga progression in patients with pre-existing ga. there is also no prospective study comparing the morphological features of ga between patients who are receiving intravitreal injections and those who are not, nor the concordance of ga enlargement rate between the 2 eyes among patients receiving and not receiving treatment.


Eligibility criteria:
inclusion criteria: * age \> 50 years old * patients with pre-existing ga secondary to amd not requiring intravitreal injections (i.e. dry amd) * patients with pre-existing ga and cnv secondary to amd requiring intravitreal injections (i.e. exudative amd) and are treatment-naïve patients * patients with pre-existing ga and cnv secondary to amd requiring intravitreal injections (i.e. exudative amd) and have received previous intravitreal injections. * able to maintain steady fixation in foveal and parafoveal area for fundus imaging geographic atrophy (ga), both foveal-sparing and foveal ga. foveal-sparing ga is defined as no ga within 250μm of the centre (sunness et al. 1999) * area of ga can be imaged in its entirety and is not contiguous with areas of peripapillary atrophy * adequate media clarity for quality fundus images exclusion criteria: * inability to undergo study procedures (e.g. contraindications to intravitreal injections) or attend follow-up visits cnv attributable to other causes than amd * active intraocular inflammation * any other retinopathy, including diabetic retinopathy, retinal venous occlusion, epiretinal membrane
integrating mind-body skills with physical activity to improve physical and emotional outcomes in patients with chronic pain

Conditions: Pain; Chronic Pain; Physical Activity

Summary: the aims of this study are to adapt, pilot, and examine the credibility, acceptability, and feasibility of an evidence-based mind-body program, the relaxation response resiliency program for chronic pain (p3rp), and the p3rp-digital monitoring device (p3rp-dmd), which is the p3rp integrated with a commercial dmd, the fitbit.

the study has three phases. in phase i, the investigators are adapting the 3rp as a multidisciplinary team, and then conducting two focus groups. in phase two, the investigators are piloting the p3rp and p3rp-dmd. in phase three, the investigators are conducting a small randomized-controlled trial of the p3rp versus p3rp-dmd.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18 years or older * have nonmalignant chronic pain for more than 3 months * able to perform a 6-minute walk test * owns a smartphone with bluetooth 4.0 * willingness and ability to participate in the 3rp intervention and to comply with the requirements of the study protocol (including weekly sessions and dmd use) * free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, or stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose * cleared by a medical doctor for study participation * leads a sedentary lifestyle exclusion criteria: * diagnosed with medical illness expected to worsen in the next 6 months * serious mental illness or instability for which hospitalization may be likely in the next 6 months * current suicidal ideation reported on self-report * lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence * current substance use disorder, within the past 6 months * practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less * regular use of dmd in the last 3 months * engagement in regular intensive physical exercise for \>30 minute daily * unable to walk without use of assistance (e.g., wheelchair, walker)

Keywords: chronic pain physical activity mind-body
safety and efficacy study of botulinum toxin type a for the treatment of neurogenic overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type a in treating overactive bladder in patients with spinal cord injury.


Eligibility criteria:
inclusion criteria: * urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury * inadequate response to anticholinergic medication used to treat overactive bladder exclusion criteria: * history or evidence of pelvic or urologic abnormality * previous or current diagnosis of bladder or prostate cancer * urinary tract infection at time of enrollment
development of a virtual reality spatial retraining therapy to improve neglect in stroke survivors

Conditions: Stroke; Spatial Neglect

Summary: participants in this study will help test and develop a virtual reality (vr) system that is being designed to help people with spatial neglect after stroke.

participants in this study will be tested to see if they have spatial neglect after their stroke, and the severity of such. spatial neglect is a disorder that may occur after a stroke that leads to a person paying more attention to one side of their body over the other. each testing session, they will perform paper and pencil neglect tests before and after playing a vr video game that is being designed as a potential future treatment. they will also give feedback on the game after the session is over. people who have spatial neglect after stroke are encouraged to apply.

Eligibility criteria:
inclusion criteria: * read and speak english fluently * have a history of one stroke event that injured one cerebral hemisphere * presence of moderate to severe spatial neglect exclusion criteria: * history of progressive neurological disorders * history of significant psychiatric disorders * history of vestibular disorders * living outside a 50-mile radius of kessler foundation (located in west orange, nj)
effects of caffeine in tinnitus

Conditions: Tinnitus

Summary: caffeine intake is reported by many authors to enhance the perception of tinnitus. the aim of this study is to determine the effects of 1 month caffeine intake reduction in the scores of validated questionnaire tinnitus handicap inventory (thi) and in a visual-analog scale (vas).

a group of 50 patients who takes more than 3 small cups (50 ml) of caffeine daily and have tinnitus will be asked to reduce caffeine intake for 1 month. scores of thi and vas will be taken before and after this period.

Eligibility criteria:
inclusion criteria: * tinnitus for more than 6 months * thi \> 38 * no central acting drugs in the last 6 months * tympanogram type a-n * daily intake of caffeine greater than 150 ml exclusion criteria: * vascular and muscular tinnitus * concomitant tmj disorders * abnormal otoscopy * mixed and conductive hearing losses * ménière disease

Keywords: tinnitus caffeine
trial to evaluate the effects of opc-34712 on qt/qtc in subjects with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to establish pharmacodynamics (pd), pharmacokinetics (pk), and adverse event (ae) profile of opc-34712 administered to schizophrenic/schizoaffective subjects. the goals of this trial are three-fold: * to determine the effect of opc-34712 on the individual qt interval (qtci) corrected for placebo * to determine the effect of moxifloxacin on qtci * to examine the concentration-effect relationship of opc-34712 and moxifloxacin on qtci


Eligibility criteria:
inclusion criteria: * male and female subjects between 18 and 55 years of age, inclusive, with a diagnosis of schizophrenia or schizoaffective disorder as defined by dsm-iv-tr criteria. * body mass index of 19 to 35 kg/m2. exclusion criteria: * females who are pregnant or lactating. a negative serum pregnancy test must be confirmed prior to the first dose of trial medication for all female subjects. * subjects presenting with a first episode of schizophrenia or schizoaffective disorder based on the clinical judgment of the investigator. * subjects who have received continuous medication therapy to treat schizophrenia or schizoaffective disorder for less than 6 months prior to washout. * subjects with schizophrenia or schizoaffective disorder that are considered resistant/refractory to antipsychotic treatment by history, who have a history of failure to clozapine, or who are responsive only to clozapine treatment. * subjects with a current dsm-iv-tr axis i diagnosis other than schizophrenia or schizoaffective disorder. * hospitalization for an exacerbation of schizophrenia or schizoaffective disorder within 3 months prior to randomization. * subjects who have a history of or who have evidence of other medical and/or neurological conditions that would expose them to an undue risk of a significant ae or interfere with assessments of safety or efficacy during the course of the trial. * subjects with a history of neuroleptic malignant syndrome. * subjects with a history of seizure disorder. * subjects who meet dsm-iv-tr criteria for substance dependence within 6 months prior to randomization.

Keywords: schizophrenia qtc interval
the safety and effectiveness of gatekeeper training in first nations communities

Conditions: Applied Suicide Intervention Skills Training

Summary: gatekeeper training is where people in the community are trained to recognize and identify those who are at risk for suicide and assist them in getting care. gatekeeper training has been widely implemented around the world. there are two types of gatekeepers: 1) designated gatekeepers - individuals who have been trained in helping professions (medicine, psychology, social work, nursing), and 2) emergent gatekeepers - individuals who are not in caregiving roles (family members, police, teachers, clergy). applied suicide intervention skills training (asist) has been implemented in manitoba. however, a recent randomized controlled trial in first nations community members (emergent gatekeepers) from the swampy cree tribal council (northwestern manitoba) demonstrated that the training had no positive impact on self-reported gatekeeper skills or behavior. also, compared to a resilience retreat, the asist training was associated with a slightly higher likelihood of reporting suicidal ideation. the demonstrated lack of efficacy and the possibility of adverse effects associated with this training program in this vulnerable group have raised concerns about the safety and efficacy of asist. there were several key limitations of the previous study. first, the study only recruited community members (emergent gatekeepers), therefore findings may not be generalizable to designated gatekeepers (clinicians, nurses, counselors). second, the study had a small sample size (n=55) and may have not been large enough to detect small effects that are often associated with educational interventions. finally, the increase in distress in the asist trained group may not have been directly related to the training. to overcome the above limitations, we aim to conduct a larger evaluation of the safety and effectiveness of gatekeeper training that is occurring in manitoba first nations, inuit and metis communities. based on previous work that suggests designated gatekeepers are more likely to benefit from gatekeeper training than emergent gatekeepers, we will examine these groups separately. hypotheses: 1) asist will be associated with an increase in gatekeeper skills and behaviors; 2) asist will have a stronger impact on designated gatekeepers than emergent gatekeepers; 3) asist will not be associated with an increase in suicidal ideation or distress.


Eligibility criteria:
inclusion criteria: * english speaking * currently living or working in first nations, inuit, or metis communities in manitoba * 16 years of age or older exclusion criteria: * does not speak english * \<16 years of age

Keywords: asist, gatekeeper, suicide, intervention, first nations, aboriginal, educational, prevention, safety
efficacy of an intranasal stent on nasal obstruction at night

Conditions: Nasal Obstruction

Summary: this study aims to demonstrate a decrease with normalization of nasal resistance in the forward decubital position and with an intra-nasal stent in patients with nasal obstruction.

all patients consulting for nasal obstruction at night and who have functional nasal test with pathological resistance in decubitus position are included. functional nasal test (non invasive tests) will be performed before and after intranasal introduction of a stent: anterior rhinomanometry to measure nasal function by the measure of resistance and acoustic rhinometry to measure the geometry of nasal fossa by the measure of minimal sectional cross area sitting, after 30 minutes of decubitus then new measurements with a stent in decubitus position in each nostril .

Eligibility criteria:
inclusion criteria: 1. volontary patient 2. over 18 years old or more. 3. complain of a nasal obstruction more important (or only) at night (in decubitus position) exclusion criteria: 1. unability to sign the consent form 2. allergy of stent component 3. perforation of nasal septum 4. haemostasis disorder or anticoagulant therapy 5. bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities
bio-repository of dna in stroke: an epidemiological and genetic study

Conditions: Stroke; Stroke, Ischemic; Stroke Hemorrhagic

Summary: the bio-repository of dna in stroke (brains) recruits all subtypes of stroke as well as controls from two different continents, europe and asia. subjects recruited from the united kingdom (uk) will include stroke patients of european ancestry as well as british south asians. stroke subjects from south asia will be recruited from india and sri lanka. subjects are also recruited in qatar. south asian cases will also have control subjects recruited.


Eligibility criteria:
cases inclusion criteria: * patients should be aged \> 18 years at the time of enrolment. * diagnosis of haemorrhagic or ischemic stroke using world health organization guidelines confirmed by clinical examination and imaging (ct or mri). * all patients with cerebral arteriovascular malformations and aneurysms. * south asian or caucasian ethnic backgrounds. * patient or relative written informed consent. exclusion criteria: * unable to provide consent themselves or through surrogate. * stroke not defined on ct or mri. controls inclusion criteria: * patients should be aged \> 18 years at the time of enrolment. * no previous history of stroke. * able to provide written consent.