Kornimate/medical-research-clean huggingface dataset:
effects of blueberry on gut microbiota and metabolic syndrome

Conditions: Gut Microbiota; Metabolic Syndrome

Summary: there is growing evidence that nutritional intervention with dietary polyphenols can positively modulate the gut microbiota to improve cardiometabolic health. whether the beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to their potential impact on the gut microbiota and intestinal integrity remains speculative at this time. moreover, the mechanisms of action underlying health benefits associated to blueberry consumption are still unknown. the investigators are thus proposing to combine the study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity of highbush blueberries can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.


Eligibility criteria:
inclusion criteria: * men and premenopause women in good health * caucasians * at least one of the following : bmi between 25 and 40 kg/m2 or waist circumference ≥ 80 cm for women and ≥ 94 cm for men * at least one of the following : tg ≥ 1.35 mmol/l or fasting insulinemia ≥ 42 pmol/l exclusion criteria: * metabolic disorders (hypertension, diabetes, hypercholesterolemia) * regular use of medication affecting study parameters * use of natural health product in the last 3 months * use of antibiotics in the last 3 months * nicotine users * allergy or intolerance for blueberries * blueberry taste aversion * more than 2 alcohol drinks par day * particular dietary habits (vegetarism, gluten-free diet, cetogenic diet...) * weight change of more than 5% in the last 3 months * surgery in the last 3 months or planed during the study

Keywords: blueberry diet
post market clinical study - evolution® esophageal stent systems, europe: fully and partially covered

Conditions: Esophageal Diseases

Summary: the aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed evolution® esophageal stent system (partially- and fully covered).

cook evolution® esophageal stent post-market data collection study a retrospective observational, multi-center, chart review study will be performed. data specific to cook evolution® esophageal stent placement procedures from all consecutive patients who underwent stent placement with any of the stents at the participating sites between 1st january 2015 and 31st december 2020 (index period) will be collected. research on the commercially available cook evolution® esophageal stents is being conducted to comply with the new medical device regulation, eu 2017/745, to assess the device for its continued safety and performance. to do this, cook research incorporated is working with participating hospitals to collect pseudonymized (coded) personal health data. this study is in the interest of public health; to learn more about the necessary data processing, please visit the webpage below. https://www.cookresearchinc.com/extranet/pdf/2054-55_data_protection_notice.pdf spanish: https://www.cookresearchinc.com/extranet/pdf/2054-55_data_protection_notice_esp.pdf

Eligibility criteria:
inclusion criteria: 1: patient has had at least one of the following stents implanted between 1st january 2018 and 31st december 2020\*: * evolution® esophageal stent system-partially covered * evolution® esophageal stent system-fully covered * evolution® esophageal stent system-fully covered exclusion criteria: 1: deceased retrospective patient who has set post-mortem instruction against processing of his/her health data 2. patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to sign not willing to sign an informed consent, if it is required by the local ec committee. there may be local exemptions where consent is not a requirement or non-objection letters may replace informed consent processes.

Keywords: unresectable esophageal malignancies benign strictures tracheoesophageal fistulas esophageal stents
long-term safety and tolerability of bms-820836 in the treatment of patients with treatment resistant major depression

Conditions: Depression

Summary: the purpose of this study it to evaluate the long-term safety and tolerability of bms-820836 in patients with depression.


Eligibility criteria:
inclusion criteria: * men and women of age 18-65 years (argentina the minimum age will be 24 years of age) * patients randomized in parent study who complete cn162-006 and cn162-007 who consent to enter the rollover study. * patient not randomized in parent study that meet inadequate response criteria exclusion criteria: * patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam. * patients with a cardiovascular system organ class adverse event(s) occurring in parent study (cn162-006 or cn162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study \[including but not limited to left bundle branch block, or prolonged qt interval corrected (qtc)\]. * in addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ecg) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.
staging system in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: recently two staging systems have been proposed for amyotrophic lateral sclerosis (als), based on clinical milestones the king's college clinical staging system (1) and als milano-torino staging (als-mitos) (2). further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression. general objective : to validate the two previously proposed staging system and to test the interest of considering neurofilament biomarkers in these systems. specific objectives: 1) to validate the two classification systems in an independent cohort of patients with als followed-up in the als expert center of limoges (france) 2) to assess the interest of nf biomarkers to predict neurological decline

amyotrophic lateral sclerosis (als) is a rare, fatal neurodegenerative disease of the human motor system. recently two new staging systems have been proposed for als, based on clinical milestones related also to the spreading pattern of the disease (1,2). furthermore, biomarker development is still an essential component of future therapeutic development in als. thus, it is also important to acknowledge the value of biomarker research in supporting or revealing fundamental pathophysiological mechanisms in als. the proposed staging systems: have been recently tested in two independent cohorts (3,4) with results that were not fully consistent (ii) did not considered the potential value of biomarkers.

Eligibility criteria:
inclusion criteria: * als cases recruited for retrospectively (between) 2007 to 2016 for the retrospective cohort * als cases recruited for prospectively by the als expert center of limoges for one year. exclusion criteria: * previous neurosurgical operations * a recent history of neurotrauma * peripheral neuropathies * als/frontotemporal dementia (als/ftd)

Keywords: amyotrophic lateral sclerosis als staging biomarker
wemr with clinical decision support for diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: the goal of this project to begin using a wound research database with clinical decision support features at winthrop university hospital. a research database is an electronic computer system that is used to collect patient information. clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. the investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients diagnosed with diabetic foot ulcers and ultimately lower the risk of death and illness caused by these wounds. in order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. the investigators will be using the data collected in this study for future research and publication. data will be reviewed to answer questions important to diabetic foot ulcer healing and for the purpose of developing the clinical decision support alert system. after providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months. participants will be expected to return to winthrop university hospital for wound follow-up on a regular basis, or as determined by the principal investigator.


Eligibility criteria:
inclusion criteria: * age ≥ 21 * diabetes type i, or type ii * must have a break in the skin on the plantar aspect of foot, \> 0.5cm2 * willing and able to provide written informed consent exclusion criteria: * none

Keywords: diabetes wounds wound healing diabetic foot ulcer dfu clinical decision support
study of oral lbh589 in adult patients with refractory cutaneous t-cell lymphoma

Conditions: Cutaneous T-Cell Lymphoma

Summary: this study will evaluate the safety and efficacy of lbh489b in adult patients with refractory cutaneous t-cell lymphoma.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to any screening procedures 2. age ≥ 18 years old 3. patients with biopsy-confirmed stages ib-iva mycosis fungoides or sézary syndrome. patients with ss who have bone marrow involvement are also eligible. 4. patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. systemic regimens include oral bexarotene, puva, photophoresis, oral corticosteroids, total skin electron bean therapy, chemotherapy such as methotrexate, and interferon. topical steroids alone are not considered as a treatment regimen. 5. patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen. 6. patients will be accrued to one of two groups: patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment. exclusion criteria: 1. prior treatment with an hdac inhibitor. 2. patients with visceral disease including cns involvement (i.e. stage ivb ctcl). note; patients with ss who have bone marrow involvement are eligible. 3. impaired cardiac function 4. concomitant use of drugs with a risk of causing torsades de pointes 5. patients who have received chemotherapy or any investigational drug or undergone major surgery \< 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy 6. less than 3 months since prior electron beam therapy 7. female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control 8. uncontrolled hypertension 9. concomitant use of any anti-cancer therapy or radiation therapy. low potency topical steroid use is permitted. topical bexarotene use is prohibited during the trial 10. concomitant use of cyp3a4/5 inhibitors. 11. patients with unresolved diarrhea \> ctcae grade 1 12. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral lbh589 13. other concurrent severe and/or uncontrolled medical conditions 14. patients who would need to receive valproic acid for any reason during the study or ≤ 5 days prior to starting study drug. other protocol-defined inclusion/exclusion criteria may apply

Keywords: cutaneous t-cell lymphoma, adults mycosis fungoides sézary syndrome ctcl
transversus abdominis plane block versus local anesthetic infiltration for pain control in the abdominal surgery

Conditions: Postoperative Pain

Summary: postoperative analgesia is an important part of the anesthetic care. according to the recent studies, multimodal analgesia can provide better analgesia \& patient satisfaction with fewer side effect. for example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (tap) block or local anesthetic (la) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery. for abdominal surgery, both local infiltration and tap block target on relieving somatic pain. local anesthetic wound infiltration is easy to perform with low risk. as the advancement of ultrasound technology, performing the tap block also becomes easier, safer and more accurate. but whether la infiltration or tap block is better for the multimodal analgesia regimen remains unclear. this study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. the investigators hypothesized that tap block may be more effective than la infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.


Eligibility criteria:
inclusion criteria: * adult (20\~65y/o) * american society of anesthesiologists (asa) physical status i\~ii * patients scheduled for regular abdominal surgery under general anesthesia exclusion criteria: * asa physical status ≥ 3 * allergy to morphine or local anesthetics * morphine tolerance * drug abuse or addiction * bleeding tendency

Keywords: transversus abdominis plane block local infiltration ropivacaine heart rate variability postoperative analgesia
syph-check syphilis antibody point of care (poc) test

Conditions: Screening for Syphilis Infections

Summary: the study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.

the overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (syph-check cassette format) for treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (std) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal rpr and a treponemal elisa or tppa test.

Eligibility criteria:
inclusion criteria: * men and women will be eligible who: 1. are 18 years of age or older; 2. routine "presumed uninfected" for screening visit, or show symptomatic signs of infection or are asymptomatic but are suspected of infection, and either/or have other std disease conditions and infections, will be identified. 3. pregnant women in the first and third trimester exclusion criteria: * are under 18 years of age * unwillingness to give consent

Keywords: syphilis
evaluate safety and efficacy of naftifine hydrochloride gel 2% and naftin® gel 2% in tinea pedis

Conditions: Tinea Pedis

Summary: to compare the efficacy and safety of the test formulation naftifine hydrochloride gel 2% to naftin® (naftifine hydrochloride) gel 2%

the purpose of this study is to compare the efficacy and safety of the test formulation naftifine hydrochloride gel 2% to naftin® (naftifine hydrochloride) gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating females 18 years of age or older. * the sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus. * clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot. * the presence of interdigital tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation. exclusion criteria: * females who are pregnant, lactating or planning to become pregnant during the study period. * use of antipruritics, including antihistamines within 72 hours prior to baseline visit. * use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit. * use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit. * use of oral terbinafine or itraconazole within 2 months prior to baseline visit. * use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit. * any known hypersensitivity to naftifine hydrochloride, or any component of the formulation. * confluent, diffuse moccasin-type tinea pedis of the entire plantar surface. * history of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place patient at undue risk by participation or could jeopardize the integrity of the study evaluations. * evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the investigator's evaluation of tinea pedis. * patients with a past history of dermatophyte infections with a lack of response to antifungal therapy.
high-flow nasal cannula therapy for stable chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is a prospective, randomized crossover study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy with the myairvo2® in stable copd patients with stage 2-4 of the global initiative for chronic obstructive lung disease (gold) and hypercapnia who require home oxygen therapy (hot). the total duration of subject participation will be 52 weeks, consisting of 12-week treatment period and 40-week continuation period. subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, arm a (week 1-6: the myairvo2® therapy plus hot, week 7-12: hot only) or arm b (week 1-6: hot only, week 7-12: the myairvo2® therapy plus hot). all subjects will receive nocturnal high-flow nasal cannula therapy with the myairvo2®, in addition to their current hot. after treatment period, the willing subjects can continue the myairvo2® therapy plus hot for week 13-52 regardless of treatment arm assignment. the end of the study is defined as the treatment period or continuation period end date of the last participant, whichever is later. subjects will primarily be assessed by the st. george's respiratory questionnaire for copd patients (sgrq-c) at week 0, 6, 12, 24 and 52.


Eligibility criteria:
inclusion criteria: 1. subjects with the global initiative for obstructive lung disease (gold) stage 2-4 copd 2. subjects who have received hot for at least 16 hours per day for at least 1 month at the time of informed consent 3. subjects with paco2 \ = 45 torr at the time of screening 4. subjects who have signed written informed consent to participate in this study exclusion criteria: 1. subjects with severe kidney, liver or cardiovascular disease 2. subjects with active malignant tumor 3. subjects with acute disease (i.e., acute myocardial infarction) 4. subjects with a history of obstructive sleep apnea syndrome 5. subjects with complications affecting efficacy endpoints and who are regarded by the investigator as inadequate for this study 6. subjects who had experienced copd exacerbation within the past 6 weeks prior to informed consent 7. subjects who have been receiving nocturnal noninvasive positive pressure ventilation (nppv) or had been received within the past 6 weeks prior to informed consent 8. subjects with a history of tracheotomy or severe pharyngeal nasal cavity surgery within the past 6 months 9. pregnant women 10. subjects with cognitive impairment or mental disorder and who are regarded by the investigator as inadequate to be evaluated in this study 11. subjects who are regarded by the investigator as being unable to operate the myairvo2 adequately at home 12. subjects who are participating or wil participate in the another clinical trial at the time of informed consent 13. any other cases who are regarded by the investigator as inadequate for enrollment

Keywords: myairvo2 high-flow nasal cannula therapy home oxygen therapy hot
advanced ultrasound methods in the assessment of carotid plaque instability

Conditions: Internal Carotid Artery Stenosis With Infarction

Summary: the primary aim of this project is to assess if advanced ultrasound methods such as smi (superb microvascular imaging) and swe (shear wave elastography) can identify intraplaque neovascularization and plaque tissue stiffness in carotid artery plaques and relate these results to ipsilateral cerebrovascular symptoms. the secondary aim of this project is to assess the level of agreement between the structural plaque characteristics assessed by advanced ultrasound examinations such as smi, swe, ceus (contrast enhanced ultrasound), gsm (plaque gray-scale-median) and carotid mri, metabolic activity of plaque assessed by 18f-fdg pet/ct with histology as the gold standard. findings from the methods mentioned above will be related to cerebrovascular symptoms, blood tests (cholesterol-tot, ldl, hdl, crp, leukocytes, glucose, hba1c) and other cardiovascular risk factors at inclusion and upon 1 year follow up.

the project will include 3 studies: study 1: analyse the correlation between smi assessed neovascularization and degree of stenosis in symptomatic patients with high-grade (\>50%) carotid stenosis versus asymptomatic patients with high-grade (\>50%) carotid stenosis. all patients upon inclusion will undergo: * clinical, neurological evaluation * blood tests * smi, ceus and swe ultrasound * carotid mri * pet (subgroup) * dw-mri * histological assessments after the removal of plaque at carotid endarterectomy (cea). study 2: smi and vascular events. asymptomatic patient's follow-up at 12 months: * clinical neurological evaluation * blood test * smi, ceus, swe ultrasound * carotid mri * pet (subgroup) study 3: this study will use the same patient pool described in study 1 undergoing the previously described procedural examinations upon inclusion and at one year follow up. quantification of stiffness/elasticity in the artery wall will be performed and compared to plaque echogenicity measured as gsm . these results will be correlated to histology of the carotid plaque after trombendarterectomy, risk markers in blood (lipids, hba1c, crp, leukocytes), other cardiovascular risk markers (hypertension, diabetes, nicotine) and cerebrovascular symptoms.

Eligibility criteria:
inclusion criteria: * atherosclerotic carotid stenosis \>50% with or without cerebrovascular symptoms. exclusion criteria: * malignancies * inflammatory disease
pharmacokinetics and safety of solithromycin capsules in adolescents

Conditions: Bacterial Infections

Summary: a study of the safety and pharmacokinetics of solithromycin capsules in adolescents


Eligibility criteria:
inclusion criteria: * 12 to 17 yo male or female with suspected or confirmed bacterial infection exclusion criteria: * bacterial meningitis * clinical significant concomitant medical condition