Kornimate/medical-research-clean huggingface dataset:
type 2 diabetes mellitus as catalyst for alzheimer's disease

Conditions: Alzheimer´s Disease; Diabetes Mellitus Type 2

Summary: in recent years, it has been observed that the type 2 diabetic patients (dm-2) have an increased risk of developing dementia, both vascular and alzheimer's disease (ad). the term mild cognitive impairment (mci) describes a transition state between normal cognitive function and dementia. the annual rate of conversion to dementia in mci patients is around 15% in the general population, regardless of the presence or absence of diabetes. at present it is not possible to identify which patients with mci are most likely to progress to ad. on this basis, the main objective of this study is to evaluate whether the presence of diabetes and or the presence of its related genes favors the conversion of mci to ad.

in recent years, it has been observed that the type 2 diabetic patients (dm-2) have an increased risk of developing dementia, both vascular and alzheimer's disease (ad). the term mild cognitive impairment (mci) describes a transition state between normal cognitive function and dementia. the annual rate of conversion to dementia in mci patients is around 15% in the general population, ie regardless of the presence or absence of diabetes. at present it is not possible to identify which patients with mci are most likely to progress to ad. on this basis, the main objective of this study is to evaluate whether the presence of diabetes favors the conversion of mci to ad. we propose a case-control study comparing a group of 110 diabetic patients and a group of 110 non-diabetic patients with mci matched by age, sex and cardiovascular risk factors. the main objective is the conversion to ad between the groups and if dm-2 is an independent risk factor. the secondary objective is to investigate whether genetic mechanisms related both to ad and dm-2 are associated with the increased risk of ad in diabetic patients. we will analyze 10 genes simultaneously associated with an increased risk of diabetes and / or its complications and ad.

Eligibility criteria:
inclusion criteria: * diagnosis of mci using the nbace neuropsychological tests battery. * age \>65 years. * at least two years follow-up. * 110 subjects with type 2 diabetes * 110 subjects without diabetes * written informed consent. exclusion criteria: * patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale fazekas (escor˃2)

Keywords: the risk of progession patients
patient education with or without physical training or mindfulness and medical yoga in established spinal osteoporosis

Conditions: Osteoporosis; Vertebral Fracture

Summary: in the present feasibility and pilot study we aim to investigate the effect and safety of patient education with or without additional physical training or mindfulness/medical yoga in patients with manifest spinal osteoporosis (at least one vertebral fracture). the study includes a 10-week intervention period with once weekly theory education with or without additional physical training or mindfulness/medical yoga (randomized groups). furthermore, a proceeding observation period of 10 weeks as well as a 1-year follow up post-intervention observation are included in the study design.

the sol-study (school of osteoporosis in linköping) is a feasibility and pilot study on patient education in manifest spinal osteoporosis. the study design is interventional with patients randomized to one of three different interventions, i.e. 1. theory only (t group) 2. theory and physical exercise (tph-group) 3. theory and mindfulness/medical yoga (tmmy-group) the intervention period is 10 weeks, including 1 hour theory session/week (same for all groups) and for tph- and tmmy-groups a one hour group training session is scheduled before the theory session. inclusion criteria are: 1) manifest spinal osteoporosis (diagnosed osteoporosis and \> 1 vertebral fracture \[vf\]); 2) \> 3 months had passed since the most recent vf; and 3) age over 60 years. clinical testing and questionnaire evaluation are performed at three timepoints; 1) baseline (t1), i.e. before intervention; 2) post-observation (t2) i.e. after a passive observation time of 4 months); and 3) post-intervention (t3) i.e. after the interventions. a one year follow up post-intervention is performed by questionnaire evaluation.

Eligibility criteria:
inclusion criteria: * diagnosed with established spinal osteoporosis (at least one vertebral fracture and osteoporosis) * \>3 months had passed since the most recent vf * age ≥60 years * physical ability to walk without an indoor walker exclusion criteria: * inability to understand the swedish language or difficulty following the research protocol or dementia

Keywords: patient education yoga mindfulness physical training
optilume™ bph catheter system for treatment of men experiencing symptomatic bph

Conditions: Benign Prostatic Hyperplasia

Summary: apex is a prospective multi-site registry of real-world experience with the optilume™ bph catheter system for treatment of men experiencing symptomatic bph.


Eligibility criteria:
inclusion criteria: 1. patients treated with the optilume bph catheter system in accordance with the instructions for use (ifu). exclusion criteria: 1. unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure 2. presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate 3. confirmed or suspected malignancy of prostate or bladder. 4. active urinary tract infection (uti) 5. anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the optilume bph catheter system

Keywords: bph drug coated balloon dcb prostate luts optilume
helicobacter pylori first-line treatment containing tetracycline in patients allergic to penicillin

Conditions: Helicobacter Pylori Infection

Summary: the purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of helicobacter pylori infection in patients allergic to penicillin.

helicobacter pylori(h.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. strongly evidence supports that h.pylori eradication is an effective approach to reduce the incidence of those pathologies.however,helicobacter pylori eradication is a challenge in patients allergic to penicillin. therefore, the investigators aim to assess and compare the effectiveness of levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of helicobacter pylori infection in patients allergic to penicillin.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with h. pylori infection. * patients allergic to penicillin. exclusion criteria: * patients with previous h. pylori eradication therapy. * patients treated with histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks. * patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer. * patients with known or suspected allergy to study medications. * currently pregnant or lactating. * inability to provide informed consent

Keywords: helicobacter pylori eradication allergic penicillin tetracycline
impact of covid-19 infection and confinement on diabetic ulcer management and amputation risk

Conditions: Diabetic Subjects With Hospital Stays

Summary: in the context of the covid-19 pandemic, a number of factors, including the lockdown that was imposed to limit the spread of infection, the fear of being contaminated during hospital consultations and the difficulty in accessing general practitioners may have led to delays in the referral of patients to facilities specialized in the management of diabetic ulcers. since the beginning of the coronavirus pandemic and during the first lockdown, we observed a clear decrease in hospitalizations and consultations for diabetic ulcers. patients who had regular follow-up for the management of their diabetic ulcers cancelled their scheduled appointments for fear of being contaminated in the hospital. it is feared that the current epidemic context has favored the delay of referral of patients with diabetic ulcers to specialized facilities, with consequences on the prognosis of these patients and the risk of lower limb amputation. in this context, this project aims to evaluate the impact of confinement on emergency hospitalizations for foot wounds and the effects on the risk of amputation during the lockdown and the three months following the end of the lockdown. our hypothesis is that the lockdown led to a decrease in hospitalizations for foot wounds, resulting in a delay in the management of these patients, and potentially leading to an increase in the number of amputations in the three months following the end of the lockdown. in parallel, we will also study the impact of confinement on deferrable hospitalizations (glycemic imbalance, assessment of diabetic complications...) or theoretically non-deferrable (diabetic comas, ketoacidosis, diagnosis of type 1 diabetes, acute coronary syndrome, stroke...) of diabetes mellitus. this will allow us to evaluate whether our findings relative to diabetic ulcers could be extended to other complications of diabetes.


Eligibility criteria:
inclusion criteria: diabetic subjects with hospital stays in france, 2017 to 2020. exclusion criteria: absence of diabetes
investigation of cognitive function before and after induced ventricular fibrillation in electrophysiological (ep) study

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Summary: in this study, changes in electroencephalogram (eeg) and the hemodynamic state during ventricular fibrillation or induced ventricular tachycardia are investigated.

patients with a high risk of malignant tachyarrhythmia are routinely investigated by programmed electrophysiological study (eps). to investigate the hemodynamic effects of ventricular arrhythmia to cerebral circulation an eeg and transcranial ultrasound are conducted simultaneously during the eps. before and after the eps a neuropsychological test and an investigation of a specific blood sample (neuron specific enolase, nse) is done.

Eligibility criteria:
inclusion criteria: * age \> 18 years * positive agreement * eps for primary and secondary prophylaxis of a malignant ventricular tachyarrhythmia: * primary prophylaxis: brugada syndrome, long qt syndrome, cardiomyopathy, short qt syndrome * secondary prophylaxis: multicenter automatic defibrillator implantation trial (madit) criteria, syncope, documented ventricular tachycardia exclusion criteria: * severe neurological deficit * cardiopulmonary resuscitation

Keywords: cerebral circulation
skin sensitisation (modified draize-95 test)

Conditions: Skin Sensitisation

Summary: skin sensitization test (modified draize-95) to support a low dermatitis potential claim for a powder free polychloroprene surgical gloves, sterile. to evaluate whether residual chemical additives at a level on the gloves that may induce type iv allergy to the unsensitized general user population when using polychloroprene based surgical gloves

1. to evaluate whether residual chemical additives at a level that may induce type iv allergy in the unsensitized general user population are present in a finished polychloroprene rubber containing medical device, powder free polychloroprene surgical gloves, sterile. (cr-sg-140-af-wh) 2. to meet requirements for claim: this product demonstrated reduced potential for sensitizing users to chemical additives as described in guidance for industry and fda staff- medical glove guidance manual. supporting test data: a negative skin sensitization test (modified draize-95 test) on a minimum of 200 non-sensitized human subjects.

Eligibility criteria:
inclusion criteria: * the test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days. * age of the test subjects ranged from 18 to 65 years. * efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the us exclusion criteria: * the test subjects with any visible skin disease that might be confused with skin reactions caused by the test material. * the test subjects with any indication of existing type i allergy to natural rubber proteins. * the test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing. * test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure). * all subjects who are pregnant or become pregnant during the study. * all lactating women,
evaluation of correlations between radiologic features and pathologic subtypes of ggo luad via wms (ectop-1011)

Conditions: Adenocarcinoma of Lung

Summary: this study is one of the eastern cooperative thoracic oncology projects (ectop-1011). it aims to evaluate the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma via whole-mount section.

the pathological lepidic growth pattern was believed to relate to the ground-glass component, whereas invasive adenocarcinoma patterns relate to the solid component. however, the solid components might be fibrosis rather tumor; and previous studies demonstrated the ground-glass components might be invasive lesions. therefore, it is of considerable significance to establish the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma.

Eligibility criteria:
inclusion criteria: * ground glass opacity featured lung nodule diagnosed by thin-section computed tomography(tsct) * pre-operation clinical ia stage * pulmonary lobectomy or segmentectomy * provision of informed consent exclusion criteria: * postoperative diagnosis of non-adenocarcinoma or mucinous adenocarcinoma * the surgical specimens fail to satisfy requirement of inflation and formalin fixation

Keywords: ground glass opacity
e-cadherin and integrin alpha v beta 1 in vitiligo

Conditions: Vitiligo

Summary: the purpose of this clinical trial is to study the effect of narrow band uvb on e-cadherin and integrin alpha v beta 1 as representatives of adhesion molecules in non-segmental vitiligo in a trial to verify a novel proposed mechanism of narrow band uvb. additionally, specific melanocyte marker (melan a) will be done to settle the localization of adhesion molecules in relation to melanocytes.


Eligibility criteria:
inclusion criteria: * all clinically diagnosed cases of non-segmental vitiligo . * patients with vida +1 or more (new/expanding lesions active in time period of 6-12 months ago) will be included in the trial. activity of vitiligo will be evaluated through vitiligo disease activity (vida) score. exclusion criteria: * patients who have stable disease at the time of study i.e. no progression of existing disease or appearance of new lesions in the last six months. * patients receiving treatment for vitiligo 3 months prior to the study. * patients with contraindications for phototherapy. * patients with current/history of any systemic and/or dermatological diseases affecting the immune system as autoimmune diseases and malignancy.
c15:0 supplementation in young adults at risk for metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this study will determine changes in plasma c15:0 levels in young adults with bmi ≥ 25 in response to 12 weeks of daily oral c15:0 supplementation.

metabolic syndrome is a disturbance in how the body processes both carbohydrates and fats. this condition has become common in children and young adults, especially in association with excess body fat. people with metabolic syndrome are at increased risk for type 2 diabetes, cardiovascular disease, and nonalcoholic fatty liver disease (nafld). diet is believed to play an important role in both developing and treating metabolic syndrome. studies have shown that low dietary intake of a type of fats known as odd chain fatty acids is associated with a higher risk for each of the metabolic syndrome associated conditions of diabetes, heart disease, and liver disease. supplementation with one specific odd chain fatty acid known as c15:0 has shown to decrease the effects of metabolic syndrome in both cellular and animal models. in people, the epidemiology of consumption of c15:0 in the diet is consistent with this belief. however, clinical trials have yet to be done with supplemental c15:0. this study is a pilot study of c15:0 supplementation in a group of young adults at risk for metabolic syndrome. the study will determine how well supplementation with c15:0 daily for 12 weeks is able to raise levels of c15:0 in the blood when compared to placebo. the study will also look for signs that increasing blood levels of c15:0 leads to changes in physiology.

Eligibility criteria:
inclusion criteria: * age 18 through 25 years * body mass index ≥ 25 kg/m2 exclusion criteria: * reported habitual dietary intake of c15:0 that consistently exceeds 250 mg per day * significant alcohol consumption (average consumption \>1 drink/day for females, \>2 drink/day for males or episodes of binge drinking \>5 drinks/day) * inability to swallow capsules * type 1 or type 2 diabetes * liver cirrhosis * pregnancy * body weight greater than 125 kg at screening * ldl-cholesterol \> 160 mg/dl * triglycerides \> 500 mg/dl * hemoglobin \< 10.0 gm/dl * current omega 3 fatty acid supplement usage * current use of statin medications * any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study * patients who are currently enrolled in a clinical trial or who received an investigational study drug within 180 days of screening. * subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator. * failure to give informed consent
pancreatic cancer initial detection via liquid biopsy

Conditions: Pancreatic Cancer; IPMN, Pancreatic; Individuals at Risk; Chronic Pancreatitis

Summary: the overall rationale of pancaid is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. with a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. for the entire series of these studies, the following groups are planned: 1) histologically proven early-stage pancreatic cancer (e.g. t1a/b and t2 carcinomas \[n0m0\]); 2) intraductal papillary mucinous neoplasia (ipmn) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct ipmn; 4) individuals at risk (iar) with and without ipmn, with and without known hereditary cancer gene (e.g. brca2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 py), with newly onset diabetes mellitus (nodm).


Eligibility criteria:
inclusion criteria: * suspicion of or elevated risk for pancreatic ductal adenocarcinoma (pdac); intraductal papillary mucinous neoplasias (ipmn); individuals at risk (iar) for pancreatic cancer exclusion criteria: * other malignant condition

Keywords: diabetes mellitus smoking
a multi-site study of the zyga glyder facet restoration device in subjects with lumbar facet pain syndrome - duet

Conditions: Facet Joint Pain

Summary: a non-randomized, multi-site feasibility study to evaluate the safety of the glyder device in subjects with a history of lumbar facet joint disease (l2 to the sacrum) and successful neural ablation in which the facet joint is confirmed as the source of pain.


Eligibility criteria:
key inclusion criteria: 1. confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy (neural ablation) within 18 months prior to enrollment 2. facet pain is limited to one to two levels from l2 to the sacrum and pain is bilateral 3. two diagnostic injections (mbbs) both resulting in 80% relief to confirm back pain is facetogenic 4. vas back pain of ≥ 60 mm on a 100 mm scale, and vas back pain is greater than or equal to the highest vas leg pain score 5. odi ≥ 20 points 6. at least six (6) months of non-operative conservative management (analgesic therapy for a minimum of 2 weeks and a minimum of 4 weeks of nsaid therapy; supervised exercise and/or physical therapy program-minimum of 12 sessions) 7. at least 22 years of age and skeletally mature key exclusion criteria: 1. pain is from a spinal structure other than facet joints (i.e., disc, hip and si joint pain are excluded) 2. osteoporosis or severe osteopenia 3. lumbar fusion 4. symptomatic spinal stenosis requiring surgical intervention 5. prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device 6. disc herniation requiring surgical intervention 7. the subject has a body mass index (bmi) of greater than 35 8. planned elective surgery within 12 months

Keywords: facet joint facet joint pain facet joint disease lumbar pain back pain
efficacy of almonds added to chronic statin therapy

Conditions: Hyperlipidemia

Summary: the purpose of the study is to evaluate the effects of 100-110 grams of almonds (about ¾ cupful) daily on the lipoprotein profile when given to patients on a statin drug. the study will compare the effects on the lipoprotein profile to patients who eat almonds and those patients not eating almonds.

the primary objectives of this study are to determine the changes in the lipid profile \[ldl-c, hdl-c, triglycerides, total cholesterol\], ldl-c particle size, and the emerging risk factor lp(a) when 100-110 g of almonds daily are added to statin therapy. also, all subjects will receive step i dietary counseling.

Eligibility criteria:
inclusion criteria: * stable on current statin regimen for at least 8 weeks with plans to continue on the same dose while participating in the study * male or non-pregnant female - women are eligible if they are surgically sterile or postmenopausal not using hormone replacement therapy (hrt) or using a stable, consistent does of hrt with intentions to continue therapy throughout the course of the study. females of childbearing potential are eligible if using an effective form or contraception and intention to continue use through the study * mentally competent to understand study * speak and read english * able to maintain current medication regimen throughout study duration exclusion criteria: * ldl-c levels \<70mg/dl * currently taking lipid-lowering agents other than statins including niacin, bile-acid sequestrants, ezetimibe, fibrates, high-dose omega-3 fish oils (\>1500mg of combined epa/dha daily) and policosanol * adherence to specialized diet regimes, i.e., multiple food allergies or nut allergy, vegetarian, macrobiotic, fad or popular diets, taking diet pills, etc. * already consuming nuts more than twice a week * active liver disease or a history of liver disease * chronic disease involving, hepatic, renal or coronary artery disease * currently taking systemic steroidal drugs * dependence on alcohol (\> 10 drinks per week) or illicit drugs * participation in any other clinical trial within the last 30 days * engages in moderate intensity exercise for \> 30 minutes each day * presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study