Kornimate/medical-research-clean huggingface dataset:
platelet function assay with flow imaging on imagestream cytometer

Conditions: Platelet Disorder; Heparin-induced Thrombocytopenia; Platelet Activation; Platelet Aggregation

Summary: platelets are essential blood elements to maintain hemostasis. quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia \[hit\]) troubles. diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. these platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. the investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the imagestream cytometer. the use of this cytometer offers an innovative approach. this study is a monocentric prospective and non-interventional study. the investigators will analyze patient samples with the imagestream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. this new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.


Eligibility criteria:
inclusion criteria: * male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or hit exclusion criteria: * minor patients * patients who have opposed the use of their personal data for research work.

Keywords: platelet disorder heparin-induced thrombocytopenia imagestream cytometer platelet activation platelet aggregation
health smart (stress management and relaxation training) to improve vaccine immune response

Conditions: Psychological Stress

Summary: the proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (cbsm) group intervention on immune response to vaccine and distress among women at elevated risk for breast cancer. hypothesis 1: women who participate in the cbsm intervention will have a larger primary and secondary antibody response to vaccines compared to women in the comparison group. hypothesis 2: women who participate in a 10-week cbsm group intervention will report lower levels of distress immediately after and 6 months after the intervention compared to women in the comparison group.

chronic stress can impair immune function, including immune response to vaccines. this has important implications for cancer control and prevention because tumor vaccines are emerging as tools for cancer treatment and prevention, and the cohort that would benefit from the vaccines is likely to be stressed. women at elevated risk for breast cancer experience significant levels of distress that have been associated with immune function decrements. interventions to treat distress-related immune decrements among these women are needed because these women will be among the first candidates for breast cancer vaccines. in theory, stress-management interventions should improve immune function and response to vaccines, but the findings to date are mixed, in part because most intervention studies have been done with medical patients who by nature have immune confounds. thus, it is unknown how stress management interventions affect immune function in stressed but otherwise healthy people, such as women at elevated risk for breast cancer. comparison: women will be randomly assigned to a 10-week structured, cbsm intervention or a wait-list comparison group with delay participation in the intervention. the comparison group will be offered the full cbsm intervention after all assessment time points have been completed.

Eligibility criteria:
inclusion criteria: * female, age 18-60 years * family history of breast cancer * fluent in english * working phone * working address * plan to live in the area for one year exclusion criteria: * prior cancer diagnosis (except non-melanoma skin cancer) * current major depressive episode * history of bipolar disorder or schizophrenia * history of autoimmune disease * history of hepatitis a or ha vaccination * current infectious disease * use of immune modulating drugs

Keywords: immune response to vaccines stress management breast cancer
study of a rapid triadic communication intention elicitation intervention to improve supportive oncology care delivery

Conditions: Vulvar Cancer; Ovarian Cancer; Uterine Cancer; Vaginal Cancer

Summary: the purpose of this study is to help test an idea designed to foster more supportive talk between providers (doctors or nurse practitioners), patients, and caregivers during an outpatient oncology appointment. a caregiver is the person the patient identifies is primarily involved in their healthcare. this study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.

this pilot study focuses on an intervention (freelisting) designed to elicit supportive oncology communication intentions among the patient-caregiver-provider triad prior to an outpatient oncology encounter. the goal is to shape communication behaviors during the encounter to improve outcomes of the encounter.

Eligibility criteria:
inclusion criteria: * patients will: 1. be adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease), 2. not be receiving specialty palliative care or hospice, 3. read/speak english, and 4. be able to provide written informed consent. * caregivers will: 1. identify as the individual who is primarily involved in the patient's care, 2. be able to attend the oncology encounter, 3. read/speak english, and 4. be able to provide written informed consent. * providers will: 1. specialize in gynecologic oncology, and 2. provide outpatient care at iusccc gynecologic oncology clinic. exclusion criteria: patients and/or caregivers will be excluded if either one or both demonstrate: 1. cognitive impairment, or 2. speech/hearing difficulties precluding participation.
vertical and horizontal alveolar ridge augmentation using autogenous onlay blocks combined with guided bone regeneration using native collagen membrane in atrophic anterior maxilla.

Conditions: Anterior Maxilla With Deficient Ridge Height and/or Width

Summary: many different techniques exist for effective vertical bone augmentation, such as the use of particulate bone grafts and bone graft substitutes, barrier membranes for guided bone regeneration (gbr), autogenous and allogenic block grafts, and the application of distraction osteogenesis. harvesting of autogenous block grafts is associated with greater morbidity compared with the less invasive procedure of using autogenous particles harvested through bone scrapers. on the other hand, particulate grafts always require a space-maintaining barrier, or their physical properties would not allow three-dimensional bone regeneration as those of block grafts do.

an autogenous ring block is harvested from the chin area by trephine bur and the autogenous bone chips will be collected with a bone scraper, then a specially manufactured machine titanium tenting screw is used to fasten the ring block to the alveolar ridge. two or three ring blocks is screwed according to the defect. then resorbable collagen membrane is fixed to the alveolar ridge instead of the titanium-reinforced e-ptfe and equally autogenous and xenograft bone particles is packed around the screw to fill the defect area completely. extreme care is taken to avoid autogenous particles drifting distally toward the area of the block. the barrier membrane was then closed over the block and particulate graft and fixed by bone tacks. then periosteal releasing incision is done to allow tension free adaption of the mucoperisteal flap.

Eligibility criteria:
inclusion criteria: * patients with partially edentulous in the anterior area of the maxilla, with a residual ridge that allowed insertion of ≤11.5 mm length implants. * both sexes. * no intraoral soft and hard tissue pathology * no systemic condition that contraindicate implant placement. exclusion criteria: * pathology. * heavy smokers more than 20 cigarettes per day. * patients with systemic disease that may affect normal healing. * psychiatric problems * disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site * immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
a new prognostic stratification-based safety and efficacy study of ruxolitinib in myelofibrosis

Conditions: Myelofibrosis

Summary: this is a multi-center, prospective, single-arm study to assess safety and efficacy of ruxolitinib in myelofibrosis (mf) based on a new prognostic stratification.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥18 years with a diagnosis of primary or secondary mf by world health organization and international working group for myeloproliferative neoplasms research and treat- ment (iwg-mrt) criteria; 2. received ruxolitinib treatment for ≥3 months. exclusion criteria: 1. malignant tumors with other progression or myelofibrosis secondary to other diseases; 2. exclude myelofibrosis patients after splenectomy; 3. patients with poor compliance with case follow-up or lost to follow-up.
effectiveness of music therapy on sleep disorders

Conditions: Sleep Disorder; Chronic Insomnia

Summary: the purpose of this study is to determine whether listening to music before falling asleep can improve sleep quality in patients with sleep disorders.

sleep is a key factor in a person's health, and we actually spend one third of our lives sleeping. the latest figures show a prevalence of insomnia in 20-30% of french adults. sleep disorders are a growing public health concern. treatment for insomnia is often some form of drugs; however, the side effects of these treatments (sedatives, hypnotics or anti-anxiety medications) are significant. non drug-treatments like music therapy are growing in popularity. the objective of this study is to demonstrate the effectiveness of musical interventions on sleep disorders in general population. it is a prospective, multicentered, double-blind, randomized comparative intervention study, comparing 3 parallel patient groups. patients included in this study will be selected by their physicians according to the severity of their disorders. enrollment period will last for 2 months and the study will last 3 months. the primary outcome (score on pittsburgh sleep quality index, psqi) is a discrete quantitative variable. the statistical tests used will concern the comparison of the average deltas of each group by using analysis of variance (anova). the selected alpha risk, or type 1 error, is 5%. the results expected in this study are a significant decrease in pittsburgh scale scores in the music intervention group. the decrease in pittsburgh scale scores should be compared to the results from this study: qun wang and al; the effects of music intervention on sleep quality in community-dwelling elderly, the journal of alternative and complementary medicine, 2016. in this 3-month study, the average change compared to the baseline is 6.44 in the musical intervention group and 3.28 in the control group. the pooled standard deviation is estimated to be 3.53. musical intervention is non-invasive, so it's a low-risk therapeutic tool for general practice that may be useful in the management of sleep disorders. its effectiveness, if demonstrated, could lead to new recommendations for the treatment of sleep disorders, and reduce the use of medication such as sedatives and hypnotics.

Eligibility criteria:
inclusion criteria: * adults over 18 years old * speaking french, * with sleep complaints at least 3 times a week for more than 3 months, * or with a sleep medications at least 3 times a week for more than 3 months, * and an isi score (insomnia severity index) greater than 14 exclusion criteria: * age \< 18 years old. * patients with severe cognitive disorders or comprehension disorders deemed incompatible with the study protocol by the physician. * patients with severe hearing loss, not using hearing aids. * patients who do not own a music distribution device (smartphone, tablet, laptop, hifi system...). * patients without internet access.

Keywords: music therapy white noise sleeping medicine psychotropics
ketek in cap / aecb in ambulatory adult patients

Conditions: Community Acquired Pneumonia (CAP); Acute Exacerbation of Chronic Bronchitis (AECB)

Summary: to determine the clinical effectiveness of telithromycin in the treatment of either cap or aecb in a large population of ambulatory adult patients in a community-based setting.


Eligibility criteria:
inclusion criteria: male or female subjects greater than or equal to 18 years who fulfill the clinical diagnostic criteria for outpatient treatment of one of the two following community acquired respiratory tract infections (cartis): * cap: a new pulmonary infiltrate confirmed by chest x-ray and at least 3 of the following signs or symptoms of infection: fever greater than or equal to 38c, cough, chest pain, sputum production, rales, dyspnea, malaise and/or headache; or * ecb: documented medical history of chronic bronchitis in subjects over the age of 40 and presenting an fev1 \<80% of the predicted value in the last 36 months and at least 2 of the following clinical symptoms: increased sputum purulence, increased dyspnea and/or increased sputum production. exclusion criteria: * subjects with a confirmed cardiogenic syncope, ventricular tachyarrythmia or torsades de pointes while taking a medicinal product with qt- prolonging potential, such as a macrolide or quinolone antibiotic, or other non-antibiotic suspected of prolonging the qt interval; * pregnancy or lactation; * hypersensitivity to macrolides; * concomitant treatment with terfenadine, ergot alkaloid derivatives, astemizole or pimozide; * myasthenia gravis; * antibiotic treatment in the 30 days prior to study entry; * treatment with any investigational product in the 30 days prior to study entry and/or a previous participation in this study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effects of biofunctional orange juice on cardiometabolic risk markers

Conditions: Overweight and Obesity; Prediabetes; Hypertension; Dyslipidemias

Summary: the effects of orange juice enriched with vitamin d3 and encapsulated probiotics (lacticaseibacillus casei shirota and lacticaseibacillus rhamnosus gg) compared to conventional orange juice on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease.

this randomized, double-blind, controlled clinical trial aims to evaluate the effects of the consumption of orange juice enriched with vitamin d3 and encapsulated probiotics (lacticaseibacillus casei shirota and lacticaseibacillus rhamnosus gg) compared to conventional orange juice in 50 high cardiometabolic risk volunteers. the participants must be overweight/obese with either prediabetes, and/or hypertension, and/or hyperlipidemia, and will be divided and randomly assigned into 2 groups of 25 individuals each. participants will consume 250 ml of either orange juice enriched with vitamin d3 and encapsulated probiotics (lacticaseibacillus casei shirota and lacticaseibacillus rhamnosus gg) or conventional orange juice daily for 8 weeks as an addition to their usual dietary intake. participants will be asked to maintain their usual physical activity during the intervention period. at the beginning of the study and at 8 weeks, blood samples will be collected after 12 hours of fasting. two-hour oral glucose tolerance test (ogtt) will be performed using a continuous glucose monitoring system at the beginning and at 8 weeks. anthropometric measurements will be performed at the beginning and every week for 8 weeks. basal metabolic rate (bmr) and central aortic blood pressure will be measured at the beginning, 4 weeks, and 8 weeks of intervention. fecal samples will be collected and analyzed to study gut microbiome compositob at the intervention's beginning and at 8 weeks.

Eligibility criteria:
inclusion criteria: * body mass index \>= 25 kg/m2 * prediabetes \[fasting blood glucose \> 100 mg/dl\], or/and * hypertension \[systolic blood pressure (sbp) \> 130 mmhg or diastolic blood pressure (dbp) \> 80 mmhg\], or/and * hyperlipidemia \[total cholesterol \> 200 mg/dl, and/or ldl-c \> 100 mg/dl, and/or triglycerides \> 150 mg/dl\] exclusion criteria: * severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver diseases, endocrine conditions) * medication that affects glycemia such as metformin, glucocorticoids, thiazide diuretics * gastrointestinal disorders * pregnancy * lactation * alcohol abuse * drug dependency * body weight lowering medications and/or history of bariatric surgery * depression and other psychiatric diseases * cancer * probiotic, prebiotic, and vitamin d supplemental intake

Keywords: orange juice vitamin d3 probiotics cardiometabolic risk factors
nursing consultation in out-patient clinics for patients with inflammatory rheumatic disease

Conditions: Arthritis

Summary: evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.

this study is part of a national multicenter study (nor-dmard) that aims to measure the longterm safety and effectiveness of disease modifying therapies in inflammatory arthropathies. the nor-dmard study is a comparative, phase iv, longitudinal, observational study. all patients starting a dmard regime are enrolled. patients from two clinics (different parts of norway) will be randomised to receive follow-up care from either a clinical nurse or a rheumatologist. the primary outcome measure is patient satisfaction measured by leeds satisfaction questionnaire. the secondary outcome is effectiveness measured by coping (cors),health related quality of life (sf-36) and disease activity (mhaq, das-28).

Eligibility criteria:
inclusion criteria: * patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.

Keywords: nurse practitioner rheumatology care outpatient clinic patient satisfaction
manuka honey nasal rinse study

Conditions: Rhinosinusitis

Summary: the purpose of this study is to evaluate whether high-volume nasal rinses with a manuka honey/saline mixture will improve symptom scores, nasal endoscopic findings and ct scan findings compared to nasal saline rinse without manuka honey in patients with chronic rhinosinusitis. manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in new zealand. it has been shown to have antibacterial activity against common bacteria that cause chronic sinusitis.

if the subject chooses to participate in the study, the subject will be asked to fill out a symptom questionnaire at the beginning of the study and at each follow-up visit. the subject will be randomly assigned (much like the flip of a coin) to one of two treatment arms in addition to the prescribed medical treatments: 1) nasal rinses twice daily with a saline solution (standard therapy) or 2) nasal rinses with a saline solution mixed with manuka honey (the experimental therapy.) subjects in the manuka honey/saline rinse arm will perform the experimental rinses twice daily for one month, and then will continue with saline rinses twice daily, with manuka honey added to the rinses only as needed. nasal rinsing of some kind will be continued through the entire study period.

Eligibility criteria:
inclusion criteria: * chronic rhinosinusitis * nasal polyposis stages 1-3 exclusion criteria: * nasal polyposis stage 4-5 * cystic fibrosis * immunocompromised patients * allergy to bees or honey

Keywords: chronic rhinosinusitis
bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) in hiv-1 infected patients with active illicit substance use

Conditions: HIV-1-infection

Summary: this study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) in hiv-1 infected patients who actively use illicit substances. the study will also evaluate retention in care and adherence to b/f/taf by self-report and pharmacokinetic analysis.

this is a single-center, single-arm, prospective, pilot study to evaluate the effectiveness and safety of b/f/taf in viremic hiv-1 infected treatment naive or experienced patients with active illicit substance use outside of nicotine, alcohol, and marijuana use.

Eligibility criteria:
inclusion criteria: * documented hiv-1 infection * treatment naive or experienced * self-reported illicit substance use or confirmed urine drug screen within past 6 months of any of the following: cocaine, heroin, methamphetamine, mdma, phencyclidine, ketamine, gamma hydroxybutyrate, cathiniones, or inappropriate prescription opiate, benzodiazepine or stimulant use (excluding nicotine, alcohol, marijuana for criteria) * hiv rna \>1000 copies/ml * creatinine clearance \> 30 ml/min (cockroft-gault) * alt and ast \< 5 times the upper limit of normal * willing and able to provide written informed consent exclusion criteria: * history of integrase or tenofovir related hiv resistance mutations * pregnancy * serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry

Keywords: substance use
long-term safety study of tak-438 in the maintenance treatment of healed erosive esophagitis

Conditions: Erosive Esophagitis

Summary: the purpose of this study is to determine the safety of long term use of tak-438, once daily (qd), for the maintenance treatment of healed erosive esophagitis.


Eligibility criteria:
inclusion criteria: 1. participants must have successfully completed the preceding phase 3 double-blind study (tak-438/cct-002: preceding study) and have endoscopically healed ee at week 2, 4, or 8 in the preceding study.\* \* "endoscopically healed ee" is defined as those participants who have endoscopically confirmed ee of grade o as defined by the los angeles (la) classification grading system. 2. outpatient (including inpatient for examination) exclusion criteria: 1. participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). however, participants with schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or barrett's esophagus are allowed to be included. 2. participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy) 3. participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to visit m-1 (initiation of study drug administration). however, participants with gastric or duodenal erosions are allowed to be included. 4. participants with a previous or current history of zollinger-ellison syndrome, or other gastric acid hypersecretion disorder

Keywords: drug therapy
clinical and laboratory predictors of respiratory morbidities in cp children

Conditions: Recurrent Respiratory Tract Infections

Summary: relationship between respiratory morbidities and cerebral palsy in children

identification of symptoms,signs,severity and outcomes of respiratory morbidities in children with cp

Eligibility criteria:
inclusion criteria: * children with cp from 1 month to 18 years exclusion criteria: * neonates with cp cp patients more than 18 years old