Kornimate/medical-research-clean huggingface dataset:
a goal-setting with mentoring lifestyle modification intervention to reduce risk of dementia in later life

Conditions: Risk Reduction Behavior; Reduce Risk of Dementia

Summary: this is a 5-year project. in the 1st year of this study, a pilot randomized controlled trial evaluating the feasibility and acceptability of a goal-setting behavior change intervention aim at reducing modifiable risk factors for preventing cognitive decline. the aim of 2nd to 5th year of this study to investigate whether this multidomain intervention to optimize self-management of cognitive decline risk factors in older individuals, delivered through a mentor- supported interactive internet platform, can reduce the risk of cognitive decline.

lifestyle factors playing a role in the development of late-life cognitive decline may be modifiable. there is a need for robust evidence about the potential for prevention of cognitive decline through behavior change interventions. this study involves the development, implementation and initial testing of a behavior change intervention. at the 1st year, a small-scale randomized controlled trial (rct) will investigate the implementation of a goal-setting intervention aim at promoting behavior change of personal modifiable risks for cognitive decline in the community for \>55 years with at least one of the 7 modifiable risk factors for dementia. these older participants in the community (n = 100) will be randomized to either control (had a discussion regarding health and daily activity) or goal-setting with mentoring (the goal-setting interview involving identification of up to five personal goals of personal modifiable risks). all participants will be reassessed after 12 months. the 2nd to the 5th year, is a multisite, prospective, rct with 36 months intervention. recruitment of 300 older people (≥55 years) with at least one of the 7 modifiable risk factors for dementia will take place in northern taiwan. participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of dementia risk factors, with remote mentoring by a mentor.

Eligibility criteria:
inclusion criteria: * in northern taiwan * at least one of the 8 modifiable risk factors for dementia (hearing loss, hypertension, obesity, smoking, depression, physical inactivity, social isolation, and diabetes) * living independently * in the local community exclusion criteria: * can't speak chinese
g-csf+dac+bucy vs g-csf+dac+bf conditioning regimen for raeb-1,reab-2 and aml secondary to mds undergoing allo-hsct

Conditions: Myelodysplastic Syndrome; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning

Summary: allo-hsct is the most effective way to cure mds and aml secondary to mds. at present, the best conditioning regimen for mds and aml secondary to mds undergoing allo-hsct remains in discussion. in this prospective study, the safety and efficacy of g-csf+dac+bucy and g-csf+dac+bf conditioning regimens in raeb-1, reab-2 and aml secondary to mds undergoing allo-hsct are evaluated.

allo-hsct is the most effective way to cure mds and aml secondary to mds. at present, the best conditioning regimen for mds and aml secondary to mds undergoing allo-hsct remains in discussion. our previous study has showed that g-csf+dac+bucy conditioning regimen could reduce the relapse and improve the survival compared with bucy conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (nrm). several retrospective and prospective studies including ours have demonstrated that bf conditioning regimen has a lower nrm compared with bucy conditioning regimen, while the relapse and survival are similar in patients undergoing bf and bucy conditioning regimens. based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of g-csf+dac+bucy and g-csf+dac+bf conditioning regimens in raeb-1, reab-2 and aml secondary to mds undergoing allo-hsct.

Eligibility criteria:
inclusion criteria: * raeb-1, reab-2 and aml secondary to mds undergoing allo-hsct * 14-65 years exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)
neutrophil-lymphocyte and platelet-lymphocyte ratios and their relations to vascular comlications and glycemic control in patients with type 2 diabetes attending the diabetes center of assiut university hospitals

Conditions: Vascular Complication, Diabetic

Summary: evaluate plr and nlr and their assiotation to vascular complications and glycemic control in type 2 dm

vascular complications of dm result from various disorders including metabolic, cellular, and blood disturbances. excessive production of pro-inflammatory adipokines from adipose tissue, resulting in low-grade chronic inflammation, causing insulin resistance (ir) and type 2 dm \[3\]. hematological changes affecting the red blood cells (rbcs), white blood cells (wbcs), platelet function, and the coagulation factors are detected to be associated with dm . it is important to add that, high wbc count, one of the chief components of inflammatory process, sharing to atheroscle-rosis development and cardiovascular diseases (cvd) . lately, the neutrophil-to-lymphocyte (n/l) and the platelet-to-lymphocyte (p/l) ratios, were offered as markers of inflammation in cardiac diseases, neoplasms and diabetes-related complications . moreover, high leucocyte counts have been used as diagnostic and prognostic markers in vascular complication of diabetes

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (t2dm) patients with good glycemic control and have hba1c \<7and ages ranging from ≥18 old. and poor glycemic control and have hba1c ≥7 and ages rang from ≥ 18 years old exclusion criteria: * patients with, type 1 diabetes mellitus 1. idiopathic thrombocytopenic purpura, 2. liver cell failure 3. myeloproliferative neoplasm 4. patients on anticoagulant drugs , anti platelet drugs or on steroids were excluded from the study

Keywords: neutrophils to lymhocyte ratio and platelets to lymhocyte ratio
enhanced implementation of low back pain guidelines in general practice

Conditions: Low Back Pain

Summary: the aim of this study is to evaluate whether an enhanced strategy of implementation of the new guideline will lower the number of patients getting referred to secondary care spine centres compared to a normal implementation strategy.

introduction: there is a need for more knowledge on how to introduce new guidelines effectively in general practice. a new low back pain treatment guideline is implemented in denmark. this guideline demands that patients with low back pain who have not improved after eight weeks of primary care treatment should be referred to a secondary care spine centre. methods: this is a cluster randomized trial. one hundred general practices define clusters and are randomly allocated to enhanced or usual implementation of the new guideline. the practices are all situated in the north denmark region and count two hundred general practitioners (gps). general practices in the control group will receive normal implementation of the new guideline, which include newsletters and briefings. in contrast the intervention group will receive an enhanced implementation strategy, adding visits from a consultant, two different stratification tools and feedback on guideline compliance. the two stratification tools: the start back screening tool (start) and a "social and occupational screening" tool (sos). the two screening tools subgroups patients and aids the clinicians in their choice of treatment. discussion: to evaluate how change in behaviour may improve guideline adherence and patient treatment we plan two ph.d. studies in relation to this study; one focusing on the clinical and an one on the economic aspects of the study. in addition a qualitative study is planned for patients refered to specialists in social medicine.

Eligibility criteria:
inclusion criteria: * provider number in the north denmark region (practice level) * icpc coded: l02, l03, l84, and l86 (patient level) * age 18-65 years (patient level) exclusion criteria: * no signed written consent form (practice level) * earlier participation in project testing (practice level) * already included (patient level) * patients with "red flags"/signs of serious pathology (patient level) * pregnancy (patient level) * insufficient danish language skills (patient level)

Keywords: general practice low back pain guideline health plan implementation referral and consultation
concentration of ofloxacin into the aqueous humour of patients with dry eye disease

Conditions: Dry Eye Disease

Summary: after topical installation of one drop of 0.3% commercially available ofloxacin (oxatrex®) four times at intervals of 15min in catarract patients with dry eye disease, aqueous humour samples will be collected intraoperatively, one hour after the last installation. concentration of ofloxacin in aqueous humour will be measured by hplc-ms/ms.

patients will be categorized into three groups, according to ded severity. group i comprises of subjects without ded, group ii of patients are evaluated as non-severe ded, and group iii consists of patients suffering from severe ded. the day before cataract surgery will be performed patient examination, during standard cataract preoperative evaluation. briefly, symptom-based assessment will be delivered by scoring the ocular surface disease index (osdi) questionnaire, and evaluation of ocular surface damage will be performed by corneal fluorescein staining using the oxford scale. before surgery, patients will be assigned to receive one drop of commercially available topical ofloxacin solution 0.3% at monodoses without preservatives (oxatrex, zwitter pharmaceuticals, greece) four times at fifteen minutes intervals starting 2 hours before surgery. the eye drops will be applied in the middle of the inferior lower fornix. patients who miss any of the 4 doses will be excluded from the study. aqueous humor will be collected after 1 hour of the last administration, intraoperatively, at the beginning of cataract surgery. a paracentesis track will be made with a 15ᵒ superblade, a 30g cannula, connected to a tuberculin syringe, will be inserted into the a/c and approximately 50 μl of aqueous humor will be withdrawn. aqh samples will be collected in an eppendorf tube. all samples will kept frozen at -20ᵒc. ofloxacin concentrations will be determined by hplc-ms/ms. ded severity, symptoms (ocular surface disease index) and signs (corneal staining using the oxford score) will be correlated to ofloxacin's concentration in the aqh.

Eligibility criteria:
inclusion criteria: * cataract surgery * willing to participate exclusion criteria: * presence of exfoliation material within the anterior segment of the eye * pigment dispersion syndrome * anterior chamber angle \< 20ᵒ * other ocular pathology than cataract * abnormal eyelid function * diabetes mellitus, renal or hepatic failure * chronic topical ocular treatment * systematic antibiotic treatment * allergy to fluoroquinolone antibiotics * contact lens use

Keywords: inflammation dry eye disease therapeutics topical application aqueous humour
a community health worker intervention to address adverse pregnancy outcomes

Conditions: Preeclampsia Postpartum; Adverse Pregnancy Outcomes

Summary: united states maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. the research proposed focuses on adapting and expanding a perinatal community health worker intervention for black postpartum patients with preeclampsia (pe) and other adverse pregnancy outcomes (apos). investigators will partner with a community-based organization that trains and deploys community health workers. investigators will test an intervention for urban and rural black postpartum patients with apos to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. this pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.

the investigators will adapt a current perinatal community health worker intervention, lead by a leading community health worker organization, connection health, to the unique needs of black postpartum patients with preeclampsia and other adverse pregnancy outcomes. the investigators will conduct a pilot trial to assess the feasibility and acceptability of the intervention. the hypothesis is that it is possible to randomize eligible patients to the feasibility trial, and the intervention will be acceptable to participants. the investigators will randomize black postpartum patients with preeclampsia or other adverse pregnancy outcomes to either 1) usual care - cardiovascular disease-prevention education before discharge, or 2) intervention - cardiovascular disease prevention education before discharge plus an adapted connection health community health worker intervention. following the completion of this project, the investigators intend to conduct a larger postpartum community health worker intervention trial in patients with preeclampsia or other adverse pregnancy outcomes powered to detect a difference in clinically meaningful outcomes, as informed by our existing community advisory board.

Eligibility criteria:
inclusion criteria: * self identifies as black * between 16-56 years old * experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant * planning to deliver at uab hospital * speaks and writes in english exclusion criteria: * declines randomization * speaks or writes in languages other than english * currently incarcerated * previously enrolled in p3oppy

Keywords: community health workers adverse pregnancy outcomes preeclampsia
evaluation of the pharmacokinetics and safety of vx-548 in participants with renal impairment

Conditions: Pain

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk), safety, and tolerability of vx-548 and its metabolite in participants with severe or moderate renal impairment and healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * cohorts 1 and 3: participants with severe or moderate renal impairment * body mass index (bmi) of greater than or equal to (\>=)18.0 to less than (\<) 40.0 kilogram per square meter (kg/m\^2) * stable renal function as pre-defined in the protocol * cohorts 2 and 4: matched healthy participants * healthy participants will be matched to cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and bmi (±15%) key exclusion criteria: * cohorts 1 and 3: participants with severe or moderate renal impairment * hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dl) at screening * cohorts 2 and 4: matched healthy participants * prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis * all cohorts: * history of febrile or acute illness that has not fully resolved by 14 days before study drug dosing. * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
systems analysis and improvement approach for the hypertension care cascade

Conditions: HIV/AIDS; Hypertension

Summary: as undiagnosed and untreated hypertension is one of the largest drivers of cardiovascular disease in sub-saharan africa approaches are needed to optimize the hypertension care cascade. the hiv treatment platform in low and middle income countries provides a robust, scalable foundation to address other chronic care priorities, such as hypertension. this proposal will evaluate an evidence-based intervention designed to improve chronic care services (the systems analysis and improvement approach (saia)) for hypertension detection and management in people living with hiv, and will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource-limited countries.


Eligibility criteria:
inclusion criteria: * (a1) frontline health workers / health facility managers currently working in outpatient, emergency or related (pharmacy, laboratory) services at one of the study clinics in manica and sofala provinces, mozambique; (a2) district health supervisors currently employed in a study district in manica and sofala provinces, mozambique regularly engaged in service provision or management of hiv-infected and/or hypertensive populations; and (a3) clinical experts currently working in mozambique in the clinical delivery of hiv and/or hypertension care and treatment or (b1) people living with hiv \>14 years old (b2) access hiv care and treatment services via outpatient/emergency services in study clinics. \>14 years is being used as the current ministry of health forms only use the age bounds of \ 14y and there is significant concern by the mozambican ministry of health to minimize additional data collection when not absolutely necessary. exclusion criteria: * (a1) not currently working as a frontline health worker/health facility manager at a participating study facility or (a2) not currently working as a district health supervisor in a participating district or (a3) not currently working in mozambique in the clinical delivery of hiv and/or hypertension care and treatment or (b1) hiv-negative or of unknown status or (b2) \<15 years old or age not recorded, (b3) or pregnant or postpartum.
efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination in participants with chronic genotype 1 hcv infection

Conditions: Chronic HCV Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * hcv rna ≥ 10\^4 iu/ml at screening * hcv treatment-naive, as defined as no prior exposure to any interferon (ifn) or other approved or experimental hcv-specific direct-acting antiviral agent; or hcv treatment-experienced with medical records that include sufficient detail of prior ifn-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse. * genotype 1 hcv at screening * hcv infection documented by anti-hcv antibody test, genotyping test, or liver biopsy key exclusion criteria: * pregnant or nursing female * chronic liver disease of a non-hcv etiology * current or prior history of any clinically-significant illness (other than hcv) * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) note: other protocol defined inclusion/ exclusion criteria may apply.
masitinib in combination with folfiri in third or fourth line of treatment of patients with metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: a prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with folfiri (irinotecan, 5-fluorouracil and folinic acid) versus best supportive care, in third or fourth line treatment of patients with metastatic colorectal cancer

the objective is to compare the efficacy and safety of masitinib in combination with folfiri (irinotecan, 5-fluorouracil and folinic acid) versus best supportive care in third or fourth line treatment of patients with metastatic colorectal cancer.

Eligibility criteria:
inclusion criteria: * patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum. * patient in third line or fourth line of treatment for metastatic colorectal cancer. * patient with measurable lesions according to recist criteria (version 1.1). * patient with ecog equal to or less than 2. * patient with adequate organ function * other inclusion criteria may also apply exclusion criteria: * prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib. * more than 3 prior chemotherapy regimens for metastatic colorectal cancer. * pregnant, intent to be pregnant, or nursing female patient * patient with any chronic inflammatory bowel disease * patient treated for a cancer other than colorectal cancer within five years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ. * other exclusion criteria may also apply
50 hz vs. 25 hz magnetic seizure therapy for schizophrenia

Conditions: Schizophrenia

Summary: this trial attempts to investigate whether the dosage (frequency) has an effect on the treatment efficacy and cognitive outcomes of magnetic seizure therapy (mst) among schizophrenia patients. half of the participants will be recruited to receive 25 hz mst, while the other half will be recruited to 50 hz mst.

magnetic seizure therapy (mst) is likely to be an alternative options to electroconvulsive therapy (ect).widespread stimulation of cortical and subcortical regions is inevitable for ect since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. in addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. as a consequence, mst are able to generate focus stimuli on superficial regions of the cortex while ect can't, which may give mst the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects. though high dose (frequency) mst is gaining popularity, there is no evidences supporting its superiority over low dose (frequency) mst either on efficacy, safety, or seizure quality.

Eligibility criteria:
inclusion criteria: 1. dsm-5 diagnosis of schizophrenia; 2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics; 3. the positive and negative syndrome scale (panss)\[20\] score ≥ 60; 4. informed consent in written form. exclusion criteria: 1. diagnosis of other mental disorders; 2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency; 3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants; 4. failure to respond to an adequate trial of ect lifetime; 5. are pregnant or intend to get pregnant during the study; 6. other conditions that investigators consider to be inappropriate to participate in this trial.

Keywords: magnetic seizure therapy schizophrenia controlled trial cognition