Kornimate/medical-research-clean huggingface dataset:
valsartan to prevent left ventricle remodeling in pacemaker patients

Conditions: First Time Dual Chamber Pacemaker Implantation

Summary: dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. the investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of ntprobnp and distance in meters during six minute walking test.


Eligibility criteria:
inclusion criteria: * informed written consent * age ≥ 18 years * first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block * left ventricle ejection fraction ≥ 40% exclusion criteria: * significant valvular heart disease * ischaemic heart disease requiring further revascularization * symptomatic hypotension * orthostatic disorders * pregnancy, breast feeding, child bearing potential * previous use of angiotensin receptor blocking agents * known hypersensitivity to valsartan * significant liver disorders * significant renal disorders, including renal artery stenosis * hyperaldosteronism * chronic use of nonsteroid antiinflammatory drugs * chronic use of lithium salts * patient's reluctance or disability to obey protocol and/or follow the scheduled visits * any significant disease to reduce the expected life duration \< 12 months * participation in any other trial within the last 30 days before randomization * any situation that would put more risk on patient

Keywords: dual chamber pacing, left ventricle remodeling, valsartan
targeting large-scale networks in depression with real-time fmri (functional magnetic resonance imaging) neurofeedback

Conditions: Healthy Participants

Summary: the purpose of this study is to develop a technique called real time fmri neurofeedback. this technique uses a functional mri scanner, except that special software allows the researchers to measure activity in participants brain, using fmri, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the mri scanner. the larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. the researchers think that this may be helpful in managing psychiatric symptoms. this study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. therefore, this registration will include phase 2 at this time.

during the second phase of the project healthy participants (approximately 12) will have three study visits (two fmris) over 2-4 weeks. note: as the study is a feasibility/development study, alterations of the task design for the primary outcome measures will be done to achieve objectives of developing at task that recruits from the target region (salience network). in phase 1 of the study, changes to the task are ongoing, and the same may occur for phase 2 in order to develop a viable neurofeedback paradigm. therefore, detailed descriptions of the outcome measures are not entered at this time, as we don't know exactly what those are. when we do, the entry will be updated. note: as of 7/26/2024, the study is rolling back from 'completed' to 'recruiting' status in order to include more healthy controls and temporarily resume active development of the task design.

Eligibility criteria:
inclusion criteria (phase 2 participants): * ability and willingness to give informed consent to participate * not taking any medication, prescription or non-prescription, with psychotropic effects (birth control medications allowed) * if a woman of child-bearing age, not pregnant or trying to become pregnant * no history of serious neurological illness (including, but not limited to, seizures/epilepsy) or current medical condition that could compromise brain function, such as liver failure * no history of closed head injury (see protocol for more details) * ability to tolerate small, enclosed spaces without anxiety * no metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition * size compatible with scanner gantry exclusion criteria (phase 2 participants): - history of past or current mental illness (except for simple phobias), but prior history of substance dependence ok if in remission for greater than 5 years

Keywords: healthy fmri neurofeedback
evaluation of mobile apps for informal caregivers of people living with dementia

Conditions: Caregiver Burden; Stress; Dementia

Summary: the purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia.

informal caregivers of people living with dementia experience stressors that are associated with adverse health outcomes. mobile applications (i.e., apps) could potentially improve the delivery and increase access to interventions. although apps for informal caregivers of people living with dementia are available, empirical evidence to support their effectiveness is limited. the evaluation will be conducted by recruiting informal caregivers of people living with dementia. participants will be randomly assigned to one of the two app-using groups or a wait-list condition. in the rare event that a participant experiences issues downloading an assigned app (and before commencing the 2-week period), participants will be randomly assigned to one of the other two conditions. participants in the app-using groups will be asked to use their app for a 2-week period, and burden, stress, overall health, and knowledge will be assessed before, after the 2-week period, and at a 3-week follow-up. subjective app ratings and usability of apps will be collected after the 2-week period. a 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. interviews will be conducted, and textual data will be analyzed thematically to examine caregiver experiences, perceptions of caregivers in using selected apps, and preferences and needs of caregivers in the development of future apps. findings from the proposed investigation can help guide caregivers in choosing the apps that best address their needs. moreover, findings from the investigation can inform future developments of apps to address the needs of caregivers of people living with dementia.

Eligibility criteria:
inclusion criteria: * providing informal care for a person living with dementia (e.g., informal caregivers who are non-professionals; this may include immediate family members such as spouses, children, and other relatives, friends) * living with or providing primary care for the person living with dementia (i.e., the care recipient is not in a long-term care facility) * providing unpaid care * own a smartphone (i.e., an iphone or android and/or can access either ios or android platforms) exclusion criteria: - using an app for caregiver stress/burden

Keywords: apps mhealth
dried blood spot analysis of everolimus in cancer patients (spot-study)

Conditions: Breast Cancer; Renal Cell Carcinoma

Summary: everolimus shows a large interpatient variability with fixed dose administration. these very different exposure levels between individuals can result in supratherapeutic or subtherapeutic exposure levels and consequently in over- or undertreatment, respectively. dose individualization based on the measured drug concentration could theoretically result in less toxicity and more efficacy. nowadays everolimus exposure is determined by everolimus concentration in whole blood. therefore, a vena puncture is always necessary. this is invasive and requires patients to come to the hospital. it would be convenient for patients to have their everolimus blood concentration determined by dried blood spot (dbs) analysis. with dbs only a single drop of blood from the finger is necessary, which can be done at home and sent by regular mail for analysis. previous studies have shown the feasibility of this approach. in patients with cancer treated with everolimus 10mg once daily, the correlation between everolimus dbs concentrations and whole blood concentration is yet unknown. therefore, the investigators want to determine the everolimus concentration collected with dbs from a finger prick with everolimus concentration from whole blood and everolimus concentration collected with dbs from whole blood. in addition, possibly a relatively high everolimus concentration in saliva could be correlated with the incidence and severity of oral mucositis. determination of drug concentration in saliva has also been proven to be feasible before. therefore, in this study the investigators want to determine whether the everolimus concentration in saliva correlates with the incidence of oral mucositis and how everolimus concentration in saliva correlates with everolimus concentration in whole blood.


Eligibility criteria:
inclusion criteria: * patients currently treated with everolimus for any type of cancer * patients from whom it is possible to collect blood samples * at least 18 years of age * able and willing to sign the informed consent form prior to study assessments. exclusion criteria: * none
association between high faecal calprotectin, increased intestinal permeability and visceral hypersensitivity in ibs-d patients

Conditions: Irritable Bowel Syndrome

Summary: visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. the connexion between these abnormalities is not known. we hypothesis there is a link between them in ibs with diarrhoea.

irritable bowel syndrome (ibs) is a common functional disorder which affect around 10% of the general population. abdominal pain and discomfort are associated with transit disorders (diarrhea, constipation, alternating). ibs is defined by rome iii criteria. for clinicians, ibs remains difficult to treat while its pathophysiology remains not completely understood. visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three abnormalities found in ibs patients. visceral hypersensitivity is present in 60% of the patients, while intestinal permeability is increased in a subgroup of ibs with diarrhea. low grade inflammation could be identify with faecal calprotectin dosage. the link between this three abnormalities is not clear. the goal of our study is to describe the prevalence of these three abnormalities in ibs-diarrhea population and to look for a correlation between low grade inflammation, visceral hypersensitivity, increased intestinal permeability and clinical phenotypes.

Eligibility criteria:
inclusion criteria: * ibs-diarrhoea according to rome iii criteria, * faecal calprotectin ≤200 µg/g in the last two months * effective contraception since 1 month for women in childbearing age exclusion criteria: * patients with organic and/or inflammatory digestive disease * ibs with constipation or alternating * treatment such as anti-inflammatory, probiotic in the last three months * patient with blood dyscrasia disorder known or identified , anticoagulant or antiplatelet treatments * small intestinal bacterial overgrowth (identified by a glucose breath test) * hypersensitivity to normacol * severe renal failure * anal pathology (anal fissure, hemorrhoidal thrombosis) * pregnant or breastfeeding women * person with administrative or judicial decision or under legal protection measure * patient participating in another trial in the last two weeks * diet based in grapes

Keywords: irritable bowel syndrome intestinal permeability visceral hypersensitivity low grade inflammation
furosemide vs placebo for brain relaxation

Conditions: Brain Swelling; Brain Edema; Dehydration

Summary: increased brain bulk may be problematic during brain surgery for tumors because it may limit surgical exposure and access to the surgical site. mannitol, an osmotic diuretic, is commonly given to alleviate brain bulk, and sometimes furosemide in a small dose is added if mannitol alone is insufficient. it is unclear if adding this furosemide truly helps to diminish brain bulk, and it is possible that furosemide may cause too much diuresis, leading to dehydration and its side effects (e.g., low blood pressure). our purpose is to investigate what the effects of furosemide are in the setting of brain surgery for tumors, specifically with regards to decreasing brain bulk and/or causing dehydration. study hypothesis: the addition of furosemide to mannitol will result in improved brain relaxation in human subjects undergoing craniotomy for brain tumor resection than that seen with mannitol alone. however, the combination of mannitol and furosemide will also lead to more significant intravascular volume depletion than that seen with mannitol alone.

rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable 1. = brain adequately relaxed under dura, acceptable 2. = brain slightly tense under dura, acceptable 3. = brain very tense under bulging dura, unacceptable

Eligibility criteria:
inclusion criteria: * inclusion criteria include: * asa ps i-iii * age 18 or older * presenting for elective resection of primary or metastatic supratentorial brain tumor(s) exclusion criteria: * • asa ps iv or v * age less than 18 * emergency surgery due to severely elevated icp/impending brainstem herniation * concurrent use of diuretics for any indication * infratentorial/posterior fossa/cerebellar tumor resection * moderate/severe cardiac disease with limitation in contractility as measured by preoperative echocardiogram (ef \< 30%) * severe pulmonary hypertension as measured and/or observed by preoperative studies * preoperative use of steroids (within 6 months, including those on standing doses) * pregnancy

Keywords: brain swelling brain edema dehydration
opioid free vs. standard perioperative pain regimen for anterior cervical discectomy and fusion (acdf) surgery

Conditions: Opioid Use; Spinal Diseases; Surgery--Complications; Surgery; Postoperative Pain

Summary: patients undergoing 1-3 level anterior cervical discectomy and fusion (acdf) at the levels between c2 and t1 will be enrolled into this randomized prospective study. all patients enrolled in this study will undergo a trial of non-surgical treatment prior to the recommendation for surgery. after enrollment, patients will be randomized utilizing a block randomization strategy to one of two treatment groups - a standard opioid-containing postoperative pain regimen versus a non-opioid postoperative pain regimen. postoperative outcomes will be assessed.

patients will be followed for 12 months and the following specific aims will be assessed: aim 1: evaluate whether utilization of a non-opioid postoperative pain regimen after acdf leads to lower rates of new chronic opioid use when compared with postoperative pain regimens utilizing opioids. aim 2: evaluate whether utilization of a non-opioid postoperative pain regimen after acdf results in equivalent postoperative pain scores in the early postoperative period. aim 3: evaluate whether utilization of a non-opioid postoperative pain regimen after acdf leads to equivalent clinical outcomes when compared with postoperative pain regimens utilizing opioids at 3 months and 12 months. aim 4: evaluate whether utilization of a non-opioid postoperative pain regimen after acdf leads to fewer postoperative complications when compared with postoperative pain regimens utilizing opioids.

Eligibility criteria:
inclusion criteria: * radiographic evidence of degenerative cervical spine disease * failure of conservative therapy * age ≥18 years * skeletal maturity. exclusion criteria: * preoperative chronic opioid use as determined by self report (\>45 out of past 90 days) * history of chronic kidney disease * revision cervical spine surgery * concurrent posterior cervical fusion * does the patient have an intolerance to nsaids (non-steroidal anti-inflammatory drugs)? * does the patient have any preexisting health condition the study physician believes will be exacerbated by participating in this study?
gastric content ultrasound monitoring prior to extubation in critically ill children

Conditions: Fasting; Pediatric ALL; Aspiration

Summary: nearly half of critically ill children are intubated and enterally fed according to recent guidelines. however, no evidence-based recommendation are available regarding fasting times prior to extubation. when an extubation is planned, children do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. extubation may also fail and require re-intubation with similar risks. thus, pre-operative fasting guidelines are often transposed to the paediatric critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. however, the gastric and gut motility pathophysiology is significantly different in critically ill children (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery children. the extrapolation of practice validated in the latter population may be inadequate. the stomach may be empty more or less rapidly than expected, leading to unnecessary prolonged fasting times or inappropriately short fasting times respectively. gastric ultrasounding monitoring may help assessing gastric content prior to extubation. investigators hypothesise gastric content clearance may be different in critically ill children prior to extubation, compared to pre-operative paediatric guidelines for elective surgery.


Eligibility criteria:
inclusion criteria: * 0 to 17 year old children admitted to pediatric intensive care unit * intubated (oral or nasal tracheal tube) * gastric enteral feeding affording at least 25% of the nutritional target (estimated with schofield equations) * no opposition from one of the 2 parents (or legal representatives) exclusion criteria: * anatomical anomaly of the stomach location (e.g. post surgery) * difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.) * mobilization to right lateral decubitus at risk

Keywords: fasting extubation pediatric critical care gastric ultrasound aspiration
risk factors for progressive suction loss in corneal refractive surgery

Conditions: Refractive Surgery

Summary: the goal of this prospective observational studiesis to characteristics of progressive suction loss.

the goal of this prospective observational studiesis to characteristics of progressive suction loss. the main question\[s\] it aims to answer are: • characteristics of people who do not develop progressive aspiration characteristics of people with progressive aspiration participants will the differences between the two groups were compared

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. stable refractive state in the last 2 years, with yearly change in refractive power ≤ 0.50 d; 3. spherical power ≤ -10.00d, cylindrical power ≤ -3.00 d; 4. best corrected visual acuity (bcva) ≥ 16/20; 5. no use of corneal contact lenses two weeks before surgery. exclusion criteria: 1. eye diseases or histories beyond myopia and astigmatism, such as keratoconus; 2. previous eye surgeries or histories of systemic illnesses; 3. severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor.
sodium hyaluronate injection and corticosteroids in trochanteric bursitis: a randomized controlled study.

Conditions: Osteoarthritis

Summary: trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. when pain is persistent after conventional therapies, anesthetic and corticosteroid (cs) injections can provide short term to intermediate relief of pain, but relapse is common. only one retrospective study showed the efficacy of intra-bursal trochanteric injections with ha and cs. they concluded that the pain release is significant with large effect sizes for both treatment. however, the efficacy of cs appeared to be short lived and it was shown that the efficacy of ha at 6 and 12 months is significant compared to cs (p\<0.05). in this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.

see brief summary

Eligibility criteria:
inclusion criteria: * male or female, 18 years and older, but \<75 years; * vas for pain \> 30mm; * diagnosis of trochanteric bursitis as suggested by brinks et al with symptoms for more than 3 months (3); * failure of conservative therapy of more than one month; * written informed consent; * available for the duration of the investigation. exclusion criteria: * previous surgery in the same region; * current other problem(s) in the affected extremity; * diabetes mellitus; * patient who received a local (cs) injection within 3 months from the baseline visit; * allergic or hypersensitive to cs or ha; * patients suffering (chronic) low back pain with or without sciatic pain; * patients with radiographic signs of moderate or severe hip osteoarthritis (kellgren and lawrence \>1); * pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.
efficacy of topical 95% tca in the treatment of cin 1 or less after low-grade abnormality of screening test

Conditions: CIN1; Trichloroacetic Acid

Summary: to evaluate the efficacy of topical 95% tca in the treatment of cin 1 or less after low grade abnormality of screening test

the patients meeting inclusion criteria were initially divided into two groups which are no lesion and having lesion at cervix on colposcopic examination. participant in no lesion group were divided into two group, recieving 95% trichloroacetic acid (intervention) plus aceteic acid (commonly apply at cervix during colposcopic examination) applying to the cervix at t-zone and acetic acid alone group. we follow-up each group for 6 months to evaluate the outcome using cytologic examination, hpv testing and colposcopic examination (also biopsy if lesion is seen) compare to previous result (before treatment) in the group having lesion at cervix, we initially biopsy the lesion and wait for pathologic result. if the pathologic results are high-grade lesion e.g. hsil, we exclude them from this study. on the contrary, if the pathologic result s are low-grade lesion, we divided them into two group, normal pathologic exam and low-grade abnormality on pathologic examination. both of them are divided into two groups and follow-up for 6 months, similar to the no lesion group \* during colposcopic examination, we also repeat cytologic examination and hpv testing as well \*\* pregnancy test is done before applying 95%trichloroacetic acid and at the time of follow-up. if positive at any point of time, participants are excluded from the study

Eligibility criteria:
inclusion criteria: * women who have low-grade abnormality result such as asc-us, lsil, hpv 16/18 positive, persistent hpv infection after cervical cancer screening test * no history of endometrial or cervical cancer * pregnancy test negative * good communication in thai language * vouluntarily participate to the study exclusion criteria: * pregnancy test positive after participate in the study * pathologic result from colposcopic biopsy (before intervention) is high-grade abnormality such as hsil, cin2-3 or ais