Kornimate/medical-research-clean huggingface dataset:
evaluation of the severity of cardiovascular autonomic neuropathy in type 1 diabetic patients with osas

Conditions: Sleep Apnea, Obstructive; Diabetes Mellitus, Type 1

Summary: the links between obstructive sleep apnea syndrome (osas) and type 1 diabetes (t1d) are poorly studied. this study proposes to evaluate the severity of cardiovascular autonomic neuropathy (can) related to t1d in case of associated osas. this issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed can in t1d patients.

cardiovascular autonomic neuropathy (can) is a common complication of type 1 diabetes (t1d) and is associated with increased cardiovascular risk. otherwise, some studies have found a high frequence of obstructive sleep apnea syndrome (osas) in t1d. cardiac autonomic modulations are deeply altered in osas. the combination of t1d and osas could therefore increase the severity of can and worsen the cardiovascular prognosis. the most common method used to explore can is the study of heart rate variability (hrv). hrv is a practical, non-invasive and reproducible measure of autonomic nervous system function. hrv abnormalities are a predictor of hypertension and increased mortality in t1d. th investigators therefore propose to explore the severity of nac in case of osas associated with t1d, and the hypothesis is that cardiovascular damage is increased in the presence of these two pathologies. the patients included in this study will be patients with type 1 diabetes diagnosed for more than 5 years. after overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of hrv, cardiovascular autonomic reflex test (ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using sudoscan. the severity of can will be evaluated in t1d patients with moderate to severe osas (apnea hypopnea index (iah) ≥15 / hour) compared to t1d patients with iah \<15 / hour. furthermore, glycemic holter will describe the links between glycemic variability, sleep architecture and can. biological oxidative stress assays will improve physiopathological knowledge between t1d, osas and can. finally, a 24-hour monitoring of blood pressure will be performed. an ancillary study is planned to evaluate the evolution of markers of the autonomic nervous system after three months of treatment with cpap in 15 patients with severe osas (ahi ≥30 / hour) having previously participated in the main study. fifteen patients with iah \<30 / hour will also be reassessed at three months to assess the intra-individual variability of the hrv.

Eligibility criteria:
inclusion criteria: * type 1 diabetes patients with a diabetes duration of at least 5 years * age between 18 and 60 years old. exclusion criteria: * osas treated with cpap * chronic alcoholism * neuromuscular disease * drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker * pregant woman

Keywords: sleep apnea, obstructive diabetes
motivational and cognitive intervention for college drinkers

Conditions: Alcohol Consumption; Anxiety; Depression

Summary: in the proposed project the investigators will develop and test a novel brief intervention targeting college students who drink heavily to cope with anxiety and depression, a behavior that increases risk for the development of alcohol dependence.


Eligibility criteria:
inclusion criteria: - 1. at least 1 heavy drinking episode (4 or more drinks for women; 5 or more drinks for men). 2. sub-clinical anxiety or depression 3. occasional to frequent drinking related problems exclusion criteria: * 1. clinical axis i diagnosis 2. current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations

Keywords: alcohol consumption social anxiety depression brief intervention motivational interviewing cognitive behavioral therapy sub-clinical social anxiety sub-clinical depression
effect of nmes as an add-on to exercise program in degenerative meniscus tears

Conditions: Degenerative Disease; Meniscus Tear; Knee Pain Swelling

Summary: this randomized-controlled trial aims to investigate the effect of nmes as an add-on to an exercise program in patients with degenerative meniscus tears.

to investigate the efficacy of nmes as an add-on to an exercise program, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: group 1 (nmes with exercise) and group 2 (exercise). interventions will be applied for 16 sessions (twice a week for 8 weeks). the patients will be assessed at baseline and at the end of the 8-week intervention. the pain during activity, at rest, and at night will be assessed with the visual analog scale (vas). active range of motion will be assessed with a digital goniometer. isometric muscle strength will be measured with a handheld dynamometer. the functional status and symptoms will be evaluated by the knee injury and osteoarthritis outcome score (koos) and lysholm knee scoring scale. health-related quality of life will be assessed with the short form-12 (sf-12).

Eligibility criteria:
inclusion criteria: * being aged between 40 and 65 years * having the degenerative meniscus tear in at least one knee * having body mass index in the range of 18-30 kg/m2 * feeling the pain that lasts for at least 2 months * having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the mri results * having the ability to read and write turkish exclusion criteria: * having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear * participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks * have received steroid injections in the last 6 months * accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis * presence of any systemic disorder that may affect assessment parameters * failure to cooperate with assessments
a clinical simulation study of a test material on the anterior nares

Conditions: Colonization, Asymptomatic

Summary: the objective of this study is simulate the clinical use of a test material within a 24h window. efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. staphylococcus aureus, escherichia coli, etc).


Eligibility criteria:
inclusion criteria: 1. subject is male or female between 18 to 55 years of age; 2. subject has normal nasal passage; 3. subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis). 4. subject is willing to have materials applied and follow the protocol; 5. subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application. 6. subject agrees to refrain from getting the application site wet and scrubbing or washing the test area with soap or applying powders, lotions or personal care products to the area during the course of the study; 7. subject agrees not to introduce any new cosmetic or toiletry products during the study; 8. subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits; 9. subject is willing to participate in all study evaluations; 10. subject is in generally good health; 11. subject understands and is willing to sign an informed consent form exclusion criteria: 1. female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control; 2. subject has a chronic nasal disease (e.g sinusitis, rhinitis); 3. subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile; 4. subject reports a history of allergies to antiseptics; 5. subject is currently taking certain medications which, in the opinion of the principal investigator, may interfere with the study; 6. subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
platelet rich plasma on osteoarthritis of knee

Conditions: Knee Osteoarthritis

Summary: although few studies have showed beneficial effect of platelet rich plasma (prp) for osteoarthritis of knee (oa knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with oa knees. we assess the analgesic effect and the extent of improved muscle strength and balance after prp in patients with oa knee.

patients with bilateral oa knee will be enrolled and randomized into intervention and control knee. one dose of prp is applied in the intervention knee and normal saline in control side. outcome measurements included visual analog scale (vas)、lequesne's severity index、western ontario and mcmaster universities osteoarthritis index (womac)、balance test (biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).

Eligibility criteria:
inclusion criteria: 1. age between 35 to 75 y/o. 2. alert consciousness 3. symptom of knee osteoarthritis persist at least 6 months and stage i or ii scored by ahlbäck grading system 4. the pain score measured by vas at least 4 points exclusion criteria: 1. has received hyaluronic acid or steroid injection within 6 monts 2. has received nsaids or steroid within one week 3. tumor or metastasis surrounding the knee joint 4. has received total knee replacement, major surgery in knee, rheumatoid arthritis 5. patient who cant tolerance the balance or muscle strength test.

Keywords: platelet rich plasma osteoarthritis of knee balance strength
autoimmune gastrointestinal dysmotility: symptoms, pathogenesis and treatment

Conditions: Dysmotility Syndrome; Autoimmunity

Summary: autoimmune gastrointestinal dysmotility syndromes are poorly understood, and often difficult to treat because the underlying pathogenesis is unclear. refractory symptoms result in an impaired quality of life. the presence of positive serum autoantibodies to peripheral nervous system gangliosides and glycoproteins is suggestive of a possible mechanism. immunomodulator treatments have shown benefit in case reports and case series but standardized data for treatment response is lacking. therefore, our primary aims are to further characterize this syndrome in terms of symptoms, laboratory testing, pathology, and assess treatment response of immunomodulator therapy. our research plan involves identifying this subset of patients with autoimmune gastrointestinal dysmotility and dysautonomia, and studying them as they are managed by their gastroenterologists.the study team will administer symptom-based questionnaires in a systematic manner to assess the clinical trajectory of this population and treatment response. the investigators will also analyze laboratory values (antibody titers, tilt testing, inflammatory markers) and study pathology specimens (enteric and skin biopsies) obtained from this cohort to gain a deeper understanding of the pathogenesis of their disease.


Eligibility criteria:
inclusion criteria: * males and females, aged\>15 * evidence of enteric dysmotility with documented abnormality on objective testing which may include high resolution esophageal manometry, gastric emptying scintigraphy, smartpill wireless motility capsule, sitz marker studies, antroduodenal manometry or anorectal manometry. * english proficiency and literacy sufficient to sign consent form and fill out questionnaires. * previous mayo paraneoplastic panel testing. * referring gastroenterologist has recommended intravenous immunoglobulin (ivig) therapy. exclusion criteria: * non-autoimmune causes of enteric dysmotility (diabetes, adrenal insufficiency, parkinson's, thyroid, electrolytes, drugs, malignancy). * pregnancy as documented in epic with serum or urine human chorionic gonadotropin (hcg) testing * if participants believe that they are pregnant, they will need to notify a study physician who will order a serum or urine hcg test for pregnancy within epic and remove them from the study if the test results come back positive. * previous treatment with ivig.
use of resorbable prosthetic mesh "ante rectus" as prevention of parastomal hernia.

Conditions: Parastomal Hernia

Summary: the aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

several surgical scenarios include colon diversion as part of their management. among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, inflammatory bowel disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. parastomal hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by computer tomography. although parastomal hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' quality of life. several surgical options are available for parastomal hernia repair, many of them supporting the use of mesh to strengthen the fascia. however, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia. the aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

Eligibility criteria:
inclusion criteria: * age \> 18 years * endo colostomy * informed consent exclusion criteria: * age \< 18 years; * life expectancy \< 24 months (as estimated by the operating surgeon) * pregnancy * immunosuppressant therapy within 2 weeks before surgery
duloxetine versus placebo in the prevention of recurrence of major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.


Eligibility criteria:
inclusion criteria: * patient must be at least 18 years old. * patient must be diagnosed with depression and have had previous episodes of depression. * patient must sign informed consent. exclusion criteria: * female and pregnant or breastfeeding. * history of bipolar disorder, schizophrenia, or other psychotic disorders. * suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization. * have been treated with a medication called monoamine oxidase inhibitor (maoi) within 14 days of the start of the study, or potential need to use a maoi within 5 days of finishing the study. * have taken an antidepressant called fluoxetine within 30 days of the start of the study.
ach04 to assess the safety and tolerability in healthy adults subjects

Conditions: Diarrhea

Summary: this study intends to provide information on the safety and tolerability of repeated oral doses of ach04. a phase i, single-center, first in human, open-label, dose escalation study of ach04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.


Eligibility criteria:
inclusion criteria: * subjects will be healthy males subjects between 18 and 50 years of age; * subjects must be in good healthy as determined by a medical history, physical examination and clinical laboratory evaluations; * subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the stdy restrictions. exclusion criteria: * subjects with hypersensitivity known to psidium guajava l. or history of serious adverse events; * subjects who have a significant history of alcoholism or drug/chemical abuse; * subjects who have body mass index \ 30; * subjects who have received any medications that is known to have a toxic potential well defined in large organs within the past 3 months prior the study start; * subjets who doesn´t agree to use, for the duration of the study, a barrier contraceptive; * subjects who were hospitalized for any reason in the six week prior the study start; * subjects who, in the opinion of the investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol; * subjects who are participating in a clinical trial or have participated in a clinical study involving administration of an investigational drug, within one year; * subjects who are relatives of employees from the sponsor and the site, respectively; * subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the investigator; * any finding of clinical observation (anamnesis and physical evaluation), laboratory abnormality, who in the investigator opinion, may jeopardize the subjects or interfere with the study goals.

Keywords: safety tolerability rising multiple doses ach04 adult male
liraglutide and beta-cell repair (libra) study

Conditions: Type 2 Diabetes

Summary: type 2 diabetes mellitus (t2dm) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). we propose a double-blind, randomized controlled study comparing the effect of liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with t2dm. this study may demonstrate an important beta-cell protective capacity of liraglutide.

in this study, patients with type 2 diabetes who meet randomization criteria will be randomized to either liraglutide or placebo, with serial assessment of beta-cell function over 48 weeks follow-up. the hypothesis under study is whether liraglutide can preserve beta-cell function.

Eligibility criteria:
inclusion criteria: * men and women between the ages of 30 and 75 years inclusive * physician-diagnosed type 2 diabetes of \</= 7 years duration * negative for anti-gad antibodies * on 0-2 oral anti-diabetic medications * a1c at screening between 5.5% and 9.0% inclusive, if on oral anti-diabetic medications, or between 6.0% and 10.0% inclusive, if not on oral anti-diabetic medications exclusion criteria: * use of insulin, glp-1 agonist, or dipeptidyl peptidase-4 (dpp-4) inhibitor * type 1 diabetes or secondary forms of diabetes * major illness with life expectancy \< 5 years * involvement in another study requiring drug therapy * hypersensitivity to insulin, liraglutide, or metformin * renal dysfunction * hepatic dysfunction * history of pancreatitis * family or personal history of multiple endocrine neoplasia type 2 (men-2) or familial medullary thyroid carcinoma * personal history of non-familial medullary thyroid carcinoma * malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer) * excessive alcohol consumption * unwillingness to undergo multiple daily insulin injection therapy * unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy * congestive heart failure * pregnancy

Keywords: beta-cell function glp-1 analogue diabetes
study of donated amnion, fetal placental membrane, as skin substitute for burn patients

Conditions: Wounds

Summary: is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious. will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair.


Eligibility criteria:
inclusion criteria: * women * pregnant, delivery expected within the month exclusion criteria: * known history of hepatitis, hiv, or active transmissable diseases

Keywords: burns wound healing amnion
evaluation of nets in patients with solid cancers associated with a high risk of venous thromboembolic events

Conditions: Pancreatic Cancer; Gastric Cancer; Colorectal Cancer

Summary: venous thromboembolic events (etvs) are the second leading cause of death (9.2% of causes of death) in cancer patients after tumor progression (1). indeed, cancer is associated with a 4 to 7-fold risk of etv during chemotherapy (2). this complication is observed in 20% of cancer patients (3), and is sometimes an inaugural manifestation of cancer. this risk is particularly increased during the first 3 months after cancer diagnosis (4). a biomarker correlated with the occurrence of etvs would make it possible to target patients at high risk of thrombosis who could benefit from primary thromboprophylaxis, thus avoiding the complications, particularly haemorrhagic, and the additional costs associated with the long-term diagnostic and therapeutic management of etvs. the investigator has implemented in the laboratory an innovative approach to the detection and quantification of circulating nets by flow cytometry (fcm) allowing the routine determination of nets. therefore the investigator propose to assess nets by cmf in a cohort of cancer patients with a very high risk of etvs (pancreatic cancer, gastric cancer and colon cancer).

the nets will be detected and quantified by cmf on the remaining edta tube collected to perform the blood count (nfs), using the method in place in the laboratory, adapted from the method initially described by gavillet et al. the analyses will be carried out on a fortessa lsr cytometer (becton dickinson), the antibodies used are specific to net components: citrullinated h3 anti-histone in indirect labelling coupled apc, pe myeloperoxidase and hoescht 34580 as dna marker. the level will be measured in nets/µl of whole blood as a function of the white blood cell count (sysmex xn-3000). in parallel, other parameters associated with etv risk will be evaluated: nfs on sysmex-xn plc, d-dimers, fviii and mp. the assays of pm, d-dimers and fviii will be performed specifically as part of the project, the other parameters will be measured as part of routine patient management and will not result in any additional constraints or costs. biomarker assays will be performed at the time of cancer diagnosis on the edta and citrate tubes collected for nfs and tp/tca respectively as part of routine care.

Eligibility criteria:
inclusion criteria: * male or female over 18 years of age (≥18), * patient with pancreatic, gastric or colorectal cancer, * patient with a high risk of etv, * patient on the first line of treatment or relapsing after a period of complete remission, * patient affiliated to a social security system or cmu. exclusion criteria: * patient who has had an etv in the 3 months prior to inclusion, * patient with a life expectancy of less than 3 months, * patient with an anticoagulation placement, * known pregnant or breastfeeding woman, * patient under guardianship or curatorship.