Kornimate/medical-research-clean huggingface dataset:
cohort study to determine the antitumor activity of new car-macrophages in breast cancer patients' derived organoids

Conditions: Breast Cancer

Summary: cell-based immune therapy using modified macrophages is a promising therapeutic approach in breast cancer. the objective of this cohort study is to collect tumor samples to develop patients' derived organoids to test the antitumor activity of newly developed car-macrophages. other biological samples will be collected such as blood to analyze the host inflammatory status.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or more * histologically confirmed breast cancer at any stage * requiring surgery or tumor biopsy as standard of care * any or no systemic treatment * signed informaed consent * health insurance coverage exclusion criteria: * opposed to biospecimen collection
tap vs. esp block for gynecological post operative pain

Conditions: Nerve Block; Pain, Postoperative

Summary: the goal of this double blind randomized controlled trial is to compare transversus abdominis plane block and erector spinae plane block in gynecological surgery patients. the main questions it aims to answer are: * what are the numerical post-operative pain scores in these two groups? * is there any significant difference in the numerical post-operative pain scores between subjects who underwent tap block and subjects who underwent esp block? * what are the differences in the time needed for additional morphine in these two groups? * is there any significant differences in the time needed for additional morphine between subjects who underwent tap block and subjects who underwent esp block?


Eligibility criteria:
inclusion criteria: * subjects with gynecological surgery techniques with a median incision include: hysterectomy, myomectomy, salpingectomy, ovarectomy and ovarian cystectomy. * subjects with physical status based on the american society of anesthesiologists (asa) in categories i-ii * subjects who are willing to sign informed consent form. exclusion criteria: * the patient has a history of allergies to local anesthetic drugs used for tap blockade or esp blockade and is allergic to morphine. * patients who have skin infections at the injection site. * patients with a history of chronic pain, namely a history of pain for more than 1 month obtained from history taking. * patients with a history of chronic pain treatment obtained from history taking. * patients with impaired kidney function (ureum \>39 mg/dl; creatinine \>1.3 mg/dl) and liver (sgot \>37 u/l; sgpt \>59 u/l), myopathy, coagulopathy obtained from the results of supporting examinations, heart rhythm disorders obtained from the results of an ekg examination and neurological disorders in the form of hypesthesia or paraesthesia obtained from the results of a physical examination in the form of a sensory examination. * the patient is pregnant as determined by history taking. * patients who are illiterate as obtained from history taking. * the patient was uncooperative during examination.

Keywords: transversus abdominis plane block erector spinae plane block postoperative pain gynecological surgery
effect of protein and prebiotic fiber intake on adiposity in overweight and obese adults

Conditions: Obesity

Summary: the metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. the current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. dietary patterns and/or ingredients that curb hunger and reduce energy intake are critically needed. we hypothesize that inclusion of protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity adults.

the main objective of our study is to assess the effects of protein and prebiotic fiber intake on changes in adiposity in an overweight and obese adult population. primary objective - to determine the effect of 12 week protein (10 g/day) or prebiotic fiber (16 g/day) intake on changes in body composition, chiefly body fat. secondary objective - to measure changes in appetite following 12 weeks of protein (10 g/day) or prebiotic fiber (16 g/day) intake. other outcomes includes changes in quality of life ratings and gut microbiota.

Eligibility criteria:
inclusion criteria: * males and females * age 18 - 70 years * bmi 25 - 38 kg/m-2 * stable body weight for at least 3 months prior to the study exclusion criteria: * type 1 diabetes * clinically significant cardiovascular, liver or pancreas disease * major gastrointestinal surgeries * pregnant or lactating * concomitant use of any weight loss medication, diet or exercise regime * antibiotic use in the preceding 3 months to enrollment * weight loss \> 3 kg within preceding 3 months to enrollment * use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements

Keywords: weight loss appetite overweight obesity dietary fiber dietary protein
a study to determine the patient preference between zosano pharma parathyroid hormone (zp-pth) patch and forteo pen

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this study is to determine which of two delivery methods of parathyroid hormone (pth) is preferred by patients after 14 days of use for each.

the purpose of this study is to determine which of two delivery methods of pth is preferred by patients after 14 days of use for each. patient preference will be determined by means of patient questionnaires at the end of each treatment period and a final questionnaire after both treatment periods are complete. adverse events will also be collected.

Eligibility criteria:
inclusion criteria: * postmenopausal with prior diagnosis of osteoporosis exclusion criteria: * significant health issue * previous use of teriparatide * history of paget's disease
cbct vs opt on the oral health status at 12 months of patients hospitalized for infective endocarditis.

Conditions: Infective Endocarditis

Summary: 1. infective endocarditis (ie) is a rare and serious disease with high morbidity and mortality; 2. streptoccoci of oral origin are the second more frequent microorganisms responsible for ie; 3. oral infectious foci (oif) are underdetected using the current recommended clinical examination/orthopantomogram (opt) approach; 4. cone beam computed tomography (cbct) has a better sensitivity and sensibility to detect oif than opt; 5. to date, no study has been performed to assess the potential benefit of a clinical examination/cbct approach on the oral health status in ie patients. thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/cbct approach on the oral health status of patients hospitalized for ie and potentially to reduce ie new episodes.


Eligibility criteria:
inclusion criteria: 1. patients hospitalized for definite ie according to the 2015 esc classification, whatever the ie responsible microorganism; 2. patients with a stable clinical state compatible with the performance of an opt and a cbct during his/her initial hospitalization for acute ie management; 3. patients whose life expectancy is expected to be longer than 6 months; 4. patients who agree to visit the dental department of the hospital to carry out oif eradication or at his/her personal dentist; 5. patients over 18 years old; 6. patients affiliated to a social security or a health insurance scheme; 7. patients who have given informed consent to participate to the study. exclusion criteria: 1. opt or cbct already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization. 2. medical contraindications to perform opt or cbct imaging; 3. absence of microbiologic identification of the ie responsible microorganism; 4. pregnant or breastfeeding women; 5. patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).
clinical trial evaluating acutrak headless compression screw fixation of medial malleolus fractures

Conditions: Medial Malleolus Fractures

Summary: the purpose of this study is assess the safety and efficacy of acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. the investigators hope to learn the following objectives from this study 1. prospectively establish equivalence with respect to fracture union rate after acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 2. prospectively establish equivalence with respect patient reported outcome measurement information system (promis) scores after acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 3. prospectively establish superiority with respect to hardware related pain after acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 4. prospectively establish superiority with respect to the hardware removal rate after acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. patients scheduled for open reduction and internal fixation for medial malleolus fracture by using acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or acutrak headless compression screws. at the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. after operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the promis and visual analogue pain scale (vas) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation


Eligibility criteria:
inclusion criteria: * ankle fractures that undergo open reduction internal fixation of the medial malleolus exclusion criteria: * tibial plafond (pilon) fractures * medial malleolar osteotomies to access the talus, perform an ankle fusion, or deal with a pathologic lesion, osteonecrosis, or infection due to their diversity in diagnosis, management, and weight bearing status * patients with prior surgical treatment of the ankle for fracture, deformity, infection, neoplasia, or other pathologic process on the ipsilateral extremity * patients that are non-weight bearing on one or both lower extremities prior to sustaining their ankle injury

Keywords: medial malleolus fractures headless screws headed screws
study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of mbx-2982 administered daily for 4 weeks as monotherapy in patients with type 2 diabetes

Conditions: Diabetes

Summary: to define the relative efficacy, safety and tolerability profiles of oral daily mbx-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-tzd, non-injectable).

approximately 100 patients will be randomized in this study, 20 to each of of the three mbx-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. patients will be taking 3 tablets and 1 capsule daily. this sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with mbx-2982, assuming a drop-out rate of 20% and a common sd of 25%.

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes of at least 3 months duration * treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other glp-1 analogs, pioglitazone or rosiglitazone) * hba1c 7.0-8.5% (inclusive) at screening * bmi ≥ 26 kg/m2 for patients recruited from u.s or georgia or ≥ 22 kg/m2 for patients recruited from india exclusion criteria: * any history of type 1 diabetes or diabetic ketoacidosis * history of major upper gi surgery * evidence or history of clinically significant gi illness including dyspepsia, pud, nausea, diarrhea, malabsorption, etc. * history of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable) * weight loss \> 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or otc) within 30 days of screening
the glucosamine-study: the effect of glucosamine in treatment of chronic low back pain

Conditions: Low Back Pain

Summary: low back pain (lbp) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (oa) changes is a significant cause of pain and disability. some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (gs). the oa process in the lumbar spine is most likely to oa processes in knees and hips, hence gs could have comparable symptomatic and structural effect on lumbar oa. study hypothesis: no difference in treatment effect exists between oral intake of gs- or placebo-capsules for patients' with chronic low back pain measured with roland morris disability questionnaire.


Eligibility criteria:
inclusion criteria: * low back pain for more than 6 months * patient older than 25 years old * mri findings comparable with lumbar degenerative/osteoarthritic changes. exclusion criteria: * spinal stenosis with neurological deficits * spinal prolapse with neurological deficits * rheumatoid arthritis, psoriatic arthritis, * old lumbar fractures * chronic pain syndromes (e.g. fibromyalgia) * psychosocial status not suitable for participation * pregnancy * breastfeeding * allergic to shellfish

Keywords: chronic low back pain
comparison of a new formulation of insulin glargine with lantus in patients with type 1 diabetes mellitus on basal plus mealtime insulin

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: * to compare the glucose control during treatment with a new formulation of insulin glargine and lantus in adult participants with type 1 diabetes mellitus secondary objectives: * to compare a new formulation of insulin glargine and lantus given in the morning or in the evening * to compare the incidence and frequency of hypoglycemic episodes * to assess the safety and tolerability of the new formulation of insulin glargine

* up to 4-week screening period; * 16-week open-label comparative efficacy and safety treatment period; * 4-week post-treatment safety follow-up period.

Eligibility criteria:
inclusion criteria : * participants with type 1 diabetes mellitus exclusion criteria: * hba1c greater than (\>) 9% (at screening) * participants receiving \>0.5 u/kg body weight basal insulin in the last 30 days prior to screening visit * participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit * less than 1 year on any basal plus mealtime insulin * participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit * use of an insulin pump in the last 6 months before screening visit; * any contraindication to use of insulin glargine as defined in the national product label * not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening * hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization * initiation of any glucose-lowering agents in the last 3 months before screening visit * weight change of greater than equal to (\>=) 5 kg during the last 3 months prior to screening visit * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require laser, surgical treatment or injectable drugs during the study period the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
snu ibd cohort study : searching for characterization of high risk populations for developing inflammatory bowel disease

Conditions: Inflammatory Bowel Disease (IBD)

Summary: the goal of this observational study is to investigate characteristics of individuals at high risk for developing inflammatory bowel disease (ibd) in order to identify risk factors associated with its incidence. the main question it aims to answer is: what are the risk factors for developing inflammatory bowel disease? researchers will compare groups at high risk for ibd to healthy populations and to patients already diagnosed with ibd. participants will * undergo assessments of general demographic and clinical characteristics. * be monitored for symptoms using questionnaires administered at regular intervals. * have blood tests and stool examinations performed. in cases where participants undergo colonoscopy for routine clinical indications, gut biopsies will also be performed.

recruitment announcements for participants who are first-degree relatives with patients of ibd will be posted on the bulletin board of the patient community, the outpatient bulletin board, and in the consultation room. for patients with confirmed anti-saccharomyces cerevisiae antibody (asca) positivity or those diagnosed with autoimmune diseases, recruitment will be conducted from among outpatients who meet the criteria. detailed explanations about the study will be provided, and consent to participate will be obtained prior to recruitment. blood and stools will be used for genomic and proteomic, metabolomic analysis. 16s rrna gene sequencing and whole genome shotgun sequencing will be done for microbiome analysis. biopsy specimen will be used for proteomic analysis. adverse events related with blood sampling will be monitored in outpatient clinic.

Eligibility criteria:
inclusion criteria: * first-degree relatives of inflammatory bowel disease patients * patients who are diagnosed with autoimmune diseases * patients with functional gastrointestinal disorders who are asca-positive exclusion criteria: * patients with symptoms such as a 10% weight loss within 3 months, abdominal pain, hematochezia, or diarrhea will undergo colonoscopy, and those diagnosed with inflammatory bowel disease will be excluded. * treatment history of diabetes mellitus, irritable bowel syndrome, or colon cancer.

Keywords: crohn disease ulcerative colitis psoriasis ankylosing spondylitis
safety and immunogenicity study of an inactivated vaccine against hand, foot and mouth disease caused by enterovirus 71

Conditions: Hand, Foot and Mouth Disease

Summary: the purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (hfmd) caused by enterovirus 71 (ev71).

hand, foot and mouth disease (hfmd) caused by enterovirus 71 (ev71) can be severely debilitating for some children with a risk of paralysis and death. the most susceptible age group is the 1 to 5 year olds, and the disease is spread via the oral-fecal route. currently, there is no antiviral therapy nor there is a vaccine available to prevent hfmd. in this study, an inactivated vaccine (inv21) based on the ev71 antigen will be evaluated in terms of safety and immune response that is generated after two doses of the vaccine are given to healthy adults. safety assessments include the frequency and severity of systemic adverse events as well as local reactions. immune response will be assessed by measurement of ev71 neutralizing antibody levels at specified time points throughout the study.

Eligibility criteria:
inclusion criteria: * male or female aged 21 to 45 years, inclusive, at time of screening * in good health as determined by medical history and physical examination. * normal clinical safety laboratory examinations. * body mass index (bmi) in the range 19-28 kg/m2. * documented negative serology for hiv, hepatitis c antibody, and hepatitis b surface antigen. * females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination. * willing and able to give written informed consent to participate. * willing and able to communicate with the investigator and understand the requirements of the study. * low levels of ev71 neutralizing antibody. exclusion criteria: * any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent * clinically significant hematological (including bleeding disorders), renal, hepatic, pulmonary (including asthma), central nervous system (including epilepsy, seizures, convulsions, or chronic migraines), cardiovascular, or gastrointestinal disorders, according to investigator's judgment. * ongoing rash or other dermatologic disease. * abnormal ecg as assessed by the investigator. * history of diabetes mellitus. * hypersensitivity to any vaccine. * history of severe hfmd with cns involvement. * receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study. * history of thymic pathology, thymectomy, myasthenia or any immunodeficiency. * history of recurring migraines or on prescription medication for treatment of recurring headaches or migraines. * positive urine test for drugs of abuse. * females who are pregnant or lactating

Keywords: hfmd ev71 enterovirus inv21 encephalitis
osteosarcoma and ewing sarcoma treatment response assessment with functional mri imaging in children and young adults

Conditions: Ewing Sarcoma; Osteosarcoma

Summary: the purpose of the study was to investigate whether functional mri imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. all patients will be scanned before, during and after chemotherapy. the findings on mri will be correlated with histological finding after surgery. second purpose : to define apparent diffusion coefficient value of the bone sarcoma. third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.


Eligibility criteria:
inclusion criteria: * ewing or osteosarcoma, proven by biopsy and histopathology * all patients are treated by chemotherapy defined by euramos and euro-ewing protocol exclusion criteria: * patients under the age of 6 years old * patients with contra-indication for mr exam (pace-maker...) * patients with renal insufficiency * claustrophobia

Keywords: diffusion weighted mri patient outcome assessment treatment response histopathology