Kornimate/medical-research-clean huggingface dataset:
a multi-center protocol for obtaining and storing human samples for immediate or future microbial, immune, or host-microbe scientific study

Conditions: Infections

Summary: the intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies. this clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device.

the samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions. the samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. the studies can examine microbes or the host's response to microbes by examining the nucleic acids (e.g. 16s dna, mrna), proteins, or other metabolites.

Eligibility criteria:
inclusion criteria: 1. the subject must be 18 years of age or older 2. the subject must be mentally competent as determined by the investigator, or have a legally authorized representative. exclusion criteria: 1. the subject may not be currently incarcerated. 2. the subject may not be knowingly pregnant. 3. the subject may not be institutionalized. 4. the subject may not be an employee or student of the investigator or sponsor.

Keywords: wound debridement removed orthopedic implants removed catheters or shunts excised tonsils, amputated tissue sputum stool other excretions.
the medipsa clinical trial

Conditions: Psoriatic Arthritis

Summary: the main purpose of this study is to validate the positive effect of "omnibiotic stress repair" on patients with active psoriatic arthritis.

this is a single center, double blind (patients and investigators), placebo controlled randomized trial. consecutive patients with psoriatic arthritis (psa) in moderate disease activity (psoriatic arthritis disease activity score: pasdas \>3.2 - \<5.4) on a stable treatment (no immunomodulatory treatment change in the last 3 months) with biological (bdmards) and/or synthetic disease modifying anti-rheumatic drugs (sdmards) and/or glucocorticoids will be included in the study. clinical assessment will be scheduled at baseline, 12 weeks and 24 weeks.

Eligibility criteria:
inclusion criteria: 1. male or female patient ≥18 years and \<90 years of age 2. psa according to caspar criteria 3. moda defined by a pasdas \>3.2 - \<5.4 4. stable immunomodulatory therapy for the last 12 weeks before baseline (no change in bdmard/sdmard/glucocorticoid treatment) 5. written informed consent exclusion criteria: 1. history of bariatric surgery 2. prior use of probiotics in the last 24 weeks 3. use of probiotics, other than the study product, during the study period. 4. antibiotic therapy within the last 4 weeks before inclusion 5. inflammatory bowel disease 6. recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure 7. recent (less than 12 weeks) stroke 8. known malignancy 9. inability of the patient to follow the treatment protocol 10. pregnancy

Keywords: psoriatic arthritis probiotics microbiome
evaluation of the addition of an interdental cleaning device to manual brushing on gingival health

Conditions: Gingivitis

Summary: this study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.


Eligibility criteria:
inclusion criteria: * between 25 and 70 years of age * able to provide written informed consent prior to participation * agree to not participate in any other oral/dental products clinical study for the study duration * good general health and be a non-smoker * a minimum of 50% bleeding on probing sites * a minimum pre-brushing plaque score of 0.6 * a minimum of 1.75 gingivitis score have no probing depths greater than 5 mm * a minimum of 20 teeth (not including 3rd molars) * no partial dentures, orthodontic brackets, wires or other appliances * agree to refrain from the use of any non-study dental device or oral care product for the study duration * agree to return for the scheduled visits and follow study procedures * agree to delay dental prophylaxis until study completion * have a minimum pre-brushing plaque score of 0.6 * have a minimum of 1.75 gingivitis score exclusion criteria: * probing depth greater than 5 mm * systemic disease (ex. diabetes, autoimmune disease) * advanced periodontitis * taking medication that can influence gingival health such as seizure meds, calcium channel blockers, cyclosporine, anticoagulants * orthodontic appliances or removable partial dentures * pregnant at time of study * use of antibiotics within 6 months of study
french language validation of questionnaires for the evaluation of problematic screen use.

Conditions: Smartphone Addiction

Summary: the main objective of this research is to linguistically validate the smartphone addiction scale, nomophobia questionnaire, the problematic use of mobile phones scale, smartphone addiction proneness scale, digital addiction scale for children, gaming motivation scale and problematic media use measure in french so that they are conceptually equivalent to their original version.


Eligibility criteria:
inclusion criteria: * inclusion criteria for the sas, nmp-q, saps questionnaires * university students over 18 years of age inclusion criteria for the gams questionnaire * university students over 18 years of age * video game players (at least one video game session in the past two weeks) inclusion criteria for the pump and dasc questionnaires * adolescents (12-17 years old) inclusion criteria for the pmum-sf questionnaire * parents of adolescents (this can be parents of adolescents who answered the previous questions) * adolescents must have access to at least one screen: smartphone, computer, television, etc (even that of a parent) exclusion criteria: * difficulties in understanding the french language * cognitive disorders * subject under guardianship or subject deprived of liberty * opposition to participation in the study
management of antithrombotic therapy in patients with atrial fibrillation or developing atrial fibrillation during hospitalization for pci

Conditions: Acute Coronary Syndrome; Atrial Fibrillation

Summary: acs are a potent risk factor for af, with new onset af occurring in up to 1 in every 5 patients hospitalized with an acs. despite its relatively frequent occurrence and the many etiologic factors involved in its pathogenetic condition, the frequency and prognostic significance of af complicating acs remain unclear

there are limited data available, particularly from a representative population-based perspective describing recent pharmacological and non-pharmacological management and clinical event rates associated with af complicating acs in the era of novel treatment strategies (in both af and acs) and high coronary reperfusion rates. this registry will assess the current in-hospital management and clinical events at 6 months of consecutive patients admitted in italian cardiology intensive care units (ccus) for an acs treated invasively with pci and stent implantation who present af at admission or during hospital stay, before or after stent implantation .

Eligibility criteria:
inclusion criteria: * all consecutive acs patients treated with pci with stent implantation who present af at admission or during hospital stay, before or after stent implantation. exclusion criteria: * patients admitted with a diagnosis of acs at the time of enrolment but not confirmed during hospitalization * acs treated medically or with pci but without stent implantation * patients not giving informed consent

Keywords: acute coronary syndrome atrial fibrillation percutaneous coronary intervention
peri tonsillar infiltration of ketamine or bupivacaine for post tonsillectomy analgesia

Conditions: Post Operative Pain

Summary: comparison between the analgesic effect of local infiltration of either bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia


Eligibility criteria:
inclusion criteria * 3-20 years old patients * elective tonsillectomy or adenotonsillectomy with or without ventilation tube application. exclusion criteria * allergy to bupivacaine or ketamine * coagulopathy * endocrine, neuropsychiatric or cardiopulmonary dysfunction * increase intracranial pressure (icp) * psychiatric illness, history of seizure, patients under chronic analgesic treatment * history of peritonsillar abscess, tonsillar malignancy.

Keywords: ketamine bupivacaine tonsillectomy analgesia
the efficacy and safety of oral oxcarbazepine 300-1200 mg/day as adjuvant therapy in the treatment of bipolar disorder i or ii this study is not being conducted in the united states.

Conditions: Bipolar Disorder

Summary: bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. this study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type i or ii.


Eligibility criteria:
inclusion criteria: * history of bipolar disorder type i or ii exclusion criteria: * other serious medical conditions * treatment with antiepileptic medications other protocol-defined inclusion/exclusion criteria may apply.

Keywords: oxcarbazepine, bipolar disorder
effects of prednisolone and infliximab on the regulation of urea synthesis in active inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (ibd). the investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process. the purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and crohn's disease.


Eligibility criteria:
inclusion criteria: * moderate to severe active inflammatory bowel disease exclusion criteria: * viral or bacterial infections * other chronical inflammatory diseases * cancer * other catabolic diseases * treatment with prednisolone or infliximab within the last 8 weeks

Keywords: inflammation urea synthesis catabolism nitrogen balance
evaluation of symptom-specific goal achievement

Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: lower urinary tract symptoms (luts) secondary to benign prostatic hyperplasia (bph) consists of a constellation of symptoms (including voiding, storage, and post-micturition). the impact of the luts on patients' health-related quality of life is substantial and multifaceted. thus, the therapies aimed at treating bph are concerned primarily with improving patients' symptoms, thereby improving quality of life. when multiple symptoms are present, the level of bother associated with individual symptoms varies and patients prioritize their treatment goals for symptom relief. a measure that addresses patients' most bothersome symptoms (mbs) and evaluation of symptom-specific goal achievements may lead to improved outcomes and patient satisfaction to the treatment. the objectives of this study were (1) to assess patient-reported mbs and symptom-specific goal achievements (pga) with medical treatment in bph patients, and (2) to identify factors that influence or have relation to the pga.


Eligibility criteria:
inclusion criteria: * males ≥50 years with luts secondary to bph * moderate to severe luts : ipss ≥ 8 * an enlarged prostate : trus ≥25 ml * decreased peak flow rate : qmax ≤15ml/s (volume voided ≥ 120 ml) * having signed the informed consent to participate in the study. exclusion criteria: * post voided residual urine ≥ 200ml * patients performing catheterization * urinary tract infection patients * patients taking 5 alpha reductase inhibitor * known hypersensitivity to alfuzosin * history of postural hypotension or syncope * hypertension patients treated with other alpha1-blockers * patients newly taking anticholinergic medication within 1 month * hepatic insufficiency (ast/alt ≥ 2 times of normal range) * renal insufficiency (s-cr ≥ 2mg/dl) * unstable angina pectoris * uninvestigated hematuria * serum psa ≥ 4 ng/ml (biopsy proven no cancer patients can be included) * interstitial cystitis patients * severe concomitant condition threatening life. * patient who is unable to make voiding diary * bladder or prostate cancer patients * patients receiving prostate or bladder surgery

Keywords: patient-reported most bothersome symptom patient-reported symptom-specific goal achievement medical treatment
tumor-infiltrating lymphocytes and low-dose interleukin-2 therapy following cyclophosphamide and fludarabine in patients with melanoma

Conditions: Metastatic, Stage III or Stage IV, Melanoma

Summary: this is a phase ii clinical study for patients with metastatic (the cancer has spread to other parts of the body) melanoma. patients will receive an infusion (given by vein) of autologous tumor infiltrating lymphocytes (tils). tils are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down. prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the tils. after cell infusion, patients will receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. this study will see how useful this regimen is in treating metastatic melanoma.


Eligibility criteria:
inclusion criteria (eligibility for til evaluation): * must have measurable, unresectable stage iii or stage iv melanoma * suitable tumor for collection * if tumor is suitable for collection, patient must be suitable for surgery * patient must be 18 years of age or older * performance status of ecog 0 or 1 * life expectancy \> 5 months from date of consent of til evaluation * willing to be tested for transmissible diseases * for patients with a history of allergy to penicillin, gentamycin, streptomycin, or anti-fungals, the ability to generate tils will be confirmed with the cell manufacturing laboratory inclusion criteria (eligibility for treatment): * signed and dated the informed consent * no brain metastases or stable brain metastases for 3 months following definitive treatment. * life expectancy \> 3 months from the date of consent for tils treatment * tils are suitable for use as determined by laboratory * more than 30 days since any prior systemic therapy at the time of the cell infusion, or more than six weeks since prior nitrosurea therapy. for patients with prior ipilimumab therapy, at least six weeks must elapse between the last ipilimumab dose and the start of study treatment. all side effects from previous treatment must have recovered to an acceptable grade level. * adequate organ function * must have positive ebv titres * women of child-bearing potential must have a negative pregnancy test. patients of both genders must be willing to practice birth control during treatment and for 6 months post completion of il-2 treatment. exclusion criteria: * requiring systemic steroid therapy * hiv positive * with active hepatitis b or hepatitis c, syphilis, or htlv * must not have any active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, uncontrolled psychiatric disorders, or other conditions that may affect following study procedures. * have no active underlying cardiac illnesses defined by positive stress test, lvef\<40% or ongoing life-threatening arrhythmias * abnormal lung function test

Keywords: measurable unresectable stage iii stage iv metastatic melanoma tumor-infiltrating lymphocytes low-dose interleukin-2 cyclophosphamide fludarabine
the development of a covid19 oral vaccine consisting of bacillus subtilis spores

Conditions: COVID-19 Pneumonia

Summary: this is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered bacillus subtilis which express and display spike protein of the sars-cov2 on the spore coat.

bacillus subtilis is regarded as safe organism by the food and drug administration and it is presented in most food sources. preliminary experiments have shown that the genetically engineered bacillus subtilis can express and display receptor binding domain of spike protein of the sars-cov2 on its spore coat, thus successfully induce the secretion of cytokines of human cells in vitro. previous experiments also successfully demonstrated that a increased detection of neutralizing igg and igm levels in mice after oral administrated with the bacillus subtilis. this suggests that the transgenic spores of bacillus subtilis have successfully activated the immune system, producing high-affinity neutralizing antibodies and memory b cells. furthermore, no adverse effects were shown in all the mices. the engineered bacillus subtilis will be further studied in a human trials through oral administration to test its safety and the immune effect resulted in human bodys.

Eligibility criteria:
inclusion criteria: * healthy * age over 25 years * the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); * participant vaccinated with sinovac over 4 months * anti-sars cov 2 neutralizing antibody is negative in serum. exclusion criteria: * pregnant women * history of covid-19 infection or showing covid-19 infection symptoms * having had contact to people with known covid-19 infection in the last 14 days * having fever (\> 37.4oc in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. * positive real time rt-pcr covid-19 test. * persons with autoimmune diseases * allergic diathesis or any clinically significant allergic disease (i.e. asthma) * any condition that might impair the immune response * recent or current immunosuppressive medication * any other vaccine application 30 days before the first dose

Keywords: covid-19 vaccine reaction bacillus subtilis
a study of suizenji in patients with unresectable pancreatic cancer

Conditions: Unresectable Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of standard chemotherapy with or without a novel high intensity focused ultrasound system (code: suizenji) in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy.


Eligibility criteria:
inclusion criteria: * ages 20 years and over. * unresectable pancreatic cancer (including metastatic pancreatic cancer) who are refractory or intolerant to first-line chemotherapy. any first-line chemotherapy is acceptable. * target treatment tumor is located in the pancreas, and the target tumor can be visualized with ultrasound echography and can also be treated by high-intensity focused ultrasound. * has primary tumor site of measurable lesion according to recist guidelines version 1.1 * ecog performance status of 0 to 2. exclusion criteria: * active multiple cancers that require treatment. * suspected gastrointestinal invasion of the primary tumor based on ct scan. * obstructive jaundice. however, patients who have a bile duct stent placed for obstructive jaundice by the time of allocation may be enrolled. * child-pugh classification b or c liver failure due to liver metastases. * tumor embolization in the veins surrounding the pancreas. * cystic component within the pancreatic cancer. * peritoneal dissemination. * pleural effusion or ascites with poorly controlled * contraindications to the use of secondary chemotherapy used in this study.

Keywords: unresectable pancreatic cancer suizenji high intensity focused ultrasound hifu
the effect of acute exogenous oral ketone supplementation on immune cells function and immune cells histone β-hydroxybutyrylation

Conditions: Ketosis, Metabolic; Immune Functions; Histone Deacetylase (HDAC) Activity

Summary: to conduct a single-arm pilot study to determine how acute ingestion of an exogenous ketone monoester supplement alters the histone lysine β-hydroxybutyrylation and immune function in healthy human monocytes and lymphocytes.


Eligibility criteria:
inclusion criteria: * over the age of 19 * able to fast overnight exclusion criteria: * being a competitive endurance athlete. * following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regularly consuming ketogenic supplements. * being unable to travel to and from the university * being pregnant. * having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease * being unable to read or communicate in english.

Keywords: ketone supplement exogenous ketones immune function β-hydroxybutyrylation beta-hydroxybutyrate
amifostine in treating patients with advanced myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: rationale: amifostine may be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome. purpose: phase ii trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome.

objectives: i. determine the overall hematologic response rate to amifostine in patients with advanced myelodysplastic syndrome. ii. determine the toxic effects of amifostine in these patients. outline: this is an open label study. patients receive intravenous amifostine over 15 minutes three times a week. patients failing to respond by 8 weeks undergo dose escalation. nonresponding patients are removed from the study by 12 weeks. therapy is continued for up to six months in responding patients. patients are observed for duration of response upon therapy discontinuation. patients who relapse will have therapy resumed at the previous dose. patients will be followed until death. projected accrual: a maximum of 36 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven advanced myelodysplastic syndrome (mds), including: refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation mds with at least bicytopenia no chronic myelomonocytic leukemia no acute leukemia patient characteristics: age: 17 and over performance status: ecog 0-2 life expectancy: greater than 6 months hematopoietic: hemoglobin less than 8.5 g/dl absolute granulocyte count less than 1,000 g/dl platelet count less than 70,000/mm3 hepatic: no major hepatic problems renal: no major renal problems cardiovascular: no major cardiac disease other: prior transfusion of blood products is allowed not pregnant fertile patients must use effective contraception prior concurrent therapy: biologic therapy: prior cytokine therapy is allowed chemotherapy: no prior chemotherapy endocrine therapy: prior steroid therapy is allowed radiotherapy: not specified surgery: not specified other: prior leucovorin calcium and pyridoxine allowed

Keywords: refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation