Kornimate/medical-research-clean huggingface dataset:
assessment of direct biomarkers of aspirin action to develop a precision chemoprevention therapy of colorectal cancer

Conditions: Colorectal Cancer

Summary: acetylsalicylic acid (asa) seems the ideal colorectal cancer (crc) chemoprevention agent. several ongoing trials are testing the effect of asa as co-therapy in crc. the mechanisms of action, the appropriate dose and the ideal target population are unknown. the investigators have demonstrated that doses of 100 mg of asa induce direct and partial but persistent acetylation of the cyclooxygenase (cox) isoenzyme cox-1 in the normal colorectal mucosa. the primary objective is to perform a study of aspirin by using a proteomic assay for comparing platelet cox-1 and crc mucosal cox-1 after different doses of asa. secondary objectives are: the measurement of prostaglandin e2 (pge2) and phosphorylated s6 protein (p-s6) levels in crc mucosa, the assessment of indirect biomarker of aspirin action (serum thromboxane b2 (txb2) and urinary levels of 11-dehydro-txb2 (tx-m)), the evaluation of systemic biomarkers of inflammatory/tumorigenic cox-2 by assessing urinary levels of major metabolite of pge2 (pge-m). methods: phase ii randomized clinical trial in 60 patients with newly diagnosed crc in 3 groups of 20 patients receiving 100 or 300 mg/day, or 100 mg/12 hours of enteric-coated asa for 3±1 weeks, prior to definitive treatment by surgery. main outcome: acetylation of cox-1 and cox-2. eicosanoid levels in target organs. expected results: evidence for the current uncertainty about the mechanisms of action and the dose required to obtain the best chemopreventive effect with asa in crc. confirm acetylation of cox as a key biomarker of efficacy with asa.


Eligibility criteria:
inclusion criteria: * age ≥ 18 \< 80 years old * recent diagnosis (\< 48h) of rectum or colon cancer, established by endoscopy and later confirmed by anatomo-pathologic study * normal coagulation values and biochemical vales without clinically significant deviations that, at the discretion of the investigator, may interfere with the study procedures exclusion criteria: * allergy to asa or to any other nsaid. * rectal cancer requiring neoadjuvant treatment within the two weeks following the beginning of asa treatment. * previous use of asa, nsaids, antiplatelet agents, corticosteroids or misoprostol within the 15 days prior to diagnosis and/or anticipation of need for treatment with any of these drugs during the study period. history of peptic ulcer disease or active peptic ulcer or any other gastrointestinal disease that may be considered a contraindication to the use of asa, without the concomitant use of proton pump inhibitors. * diagnosis of bleeding disorders. * diagnosis of cancer (excluding non-melanoma skin cancer) within the previous 3 years. * conditions supposing serious comorbidity, excluding diabetes, and including respiratory, cardiac, hepatic and renal diseases. * active smoking. * pregnancy or breastfeeding. * history of drug or alcohol abuse.
maternal exercise and antenatal anxiety

Conditions: Anxiety

Summary: this is a randomized controlled trial study. we evaluate effectiveness of maternal exercise on anxiety during normal pregnancy compared to those who receive antenatal care regularly. we plan to recruit 220 healthy pregnant women over the age of 18 in shenzhen and to use a standard maternal exercise from korea as intervention.


Eligibility criteria:
inclusion criteria: * pregnant women who are over 18 years old and confirmed to be pregnant in shenzhen dapeng new district. exclusion criteria: * 1.pregnant women who have accepted maternal exercise training (at least twice a week in last month);2.pregnant women who have orthopedics, cardiovascular or mental diseases; 3.pregnant women who have or had any condition as follows:miscarriage more than two times,premature delivery,placenta previa,fetal dysplasia, low weight before pregnancy (bmi \<17.5),polycyesis,preeclampsia,premature rupture of membranes,uterine growth retardation,cervical/ligation,repeated vaginal bleeding,anemia or diabetes; 4.the gestational age is less than 12 weeks or more than 16 weeks;5.received psychotherapy or psychotropic medication within 6 months before the study;6.can not participate in regular inspections.

Keywords: anxiety pregnancy exercise
a study to evaluate the efficacy and safety of shr8008 vs. fluconazole in subjects with recurrent vulvovaginal candidiasis

Conditions: Recurrent Vulvovaginal Candidiasis

Summary: the purpose of this study is to evaluate the efficacy and safety of shr8008 capsule in subjects with recurrent vulvovaginal candidiasis


Eligibility criteria:
inclusion criteria: 1. females, ≥18 and ≤75 years old. 2. have a history of rvvc at screening. 3. suitable for oral therapy and able to swallow capsules intact. 4. subjects of childbearing potential must use highly effective contraceptive measures throughout the study. 5. willing to sign the informed consent form to participate in this study. exclusion criteria: 1. presence of concomitant vulvovaginitis caused by other pathogens. 2. have a history of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ascus)" as indicated by pap test or other tests reported within 1 year before screening (not applicable to subjects with a history of total hysterectomy). 3. any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination. 4. moderate to severe hepatic and/or renal disorders. 5. significant laboratory abnormality at screening. 6. qtc interval greater than 470 ms or other clinically significant ecg abnormality at screening. 7. have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, cyp3a4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization. 8. have received any estrogen replacement therapy or vaginal topical products. 9. have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization; 10. have planned surgery or other medical procedures that may impact compliance with the protocol; 11. known history of hypersensitivity or intolerance to azole antifungal drugs. 12. history of narcotic or drug abuse or alcoholism, or any other medical, psychiatric or social condition that in the investigator's opinion could preclude compliance with the protocol. 13. women who are pregnant or lactating, or planning to become pregnant during the study period. 14. have received vt-1161 study medication in a previous study or received any investigational medicinal product (imp) in a clinical study within 5 half-lives of that imp prior to screening (if the half-life is unknown, 60 days prior to screening); 15. other conditions unsuitable for participation in the study.
clinical study on the safety of safil® mesh

Conditions: Abdominal Wall Defect; Ventral Hernia; Abdominal Hernia; Fascial Hernia

Summary: observational, retrospective, multi-center clinical study on the safety of safil® mesh in patients undergoing reinforcement of soft tissues after abdominal wall surgery or other fascial defects

the study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with safil® mesh after abdominal wall surgery or other fascial defects between the period january 2019 - november 2020

Eligibility criteria:
inclusion criteria: * patients operated between january 2019 - november 2020 for abdominal wall surgery or other fascial defects and received safil® mesh exclusion criteria: * no exclusion criteria have been set.

Keywords: reinforcement of soft tissues hernioplasty mesh repair
combined treatment of platelet-rich plasma (prp) and low-intensity extracorporeal shockwave therapy (li-eswt) on erectile dysfunction (ed)

Conditions: Erectile Dysfunction

Summary: the purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

according to statistics from the taiwan society of andrology, 18 to 25 years old male population in taiwan having erectile dysfunction (ed) trouble is as high as 5 to 10 percent. at the same time, statistics from the taiwan sexual dysfunction counseling training committee show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction. erectile dysfunction is the most common sexual dysfunction in men and is believed to be related to nerve or blood vessel damage, and often significantly affects the patients' quality of life. prp is the abbreviation of "platelet-rich plasma". it can release growth factors and cytokines in the body to further promote tissue repair. the results of pre-clinical and clinical trials show that prp can promote the repair of cavernous tissue, protect erection function of nerve, and stimulate the regeneration of nerve. low-intensity extracorporeal shockwave therapy (li-eswt) is a non-invasive treatment. under this treatment, it will help body producing angiogenesis-related proteins, stimulating the formation of small blood vessels, generating new blood vessels at the site to be treated, and increasing the perfusion flow of local tissues. li-eswt has been clinically shown to have a significant effect on erectile dysfunction. the purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

Eligibility criteria:
inclusion criteria: * impotence for more than three months * international index of erectile function, (iief) less than 21( including 21) * erectile hardness score, (ehs) less than 3( including 3) * age over 30 years old exclusion criteria: * hypogonadism * bleeding tendency * could not cooperate with the treatment * aids, syphilis and condyloma victim * received radical prostatectomy * prostate cancer or pelvis malignant tumor victim * gonad dysfunction * penis deformities * penile prosthesis implantation * psychiatric disease victim * neural disease ( multiple myeloma , brain atrophy, etc) * pacemaker implantation * not suitable join this trial judged by investigator * alcohol or drug abuse

Keywords: erectile dysfunction platelet-rich plasma low-intensity extracorporeal shockwave therapy
exercise training in patients with persistent or permanent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the main purpose of this project is to evaluate the effects of high-intensity interval training (hiit) compared to moderate-intensity continuous exercise training (mice) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.

recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. recent standards for the provision of cardiac rehabilitation of ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. the main purpose of this project is to evaluate the effects of high-intensity interval training (hiit) compared to moderate-intensity continuous exercise training (mice) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.

Eligibility criteria:
inclusion criteria: 1. persistent or permanent atrial fibrillation; 2. rate controlled with a resting ventricular rate of equal to or less than 100 bpm; 3. able to perform a symptom-limited exercise test; 4. at least 40 years of age (i.e. participants must be 40 years or older); exclusion criteria: 1. currently participating in routine exercise training (more than two times per week); 2. unstable angina; 3. diagnosed severe mitral or aortic stenosis; 4. diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction; 5. pregnant, lactating or planning to become pregnant during the study period; 6. unable to provide written, informed consent, or 7. unwilling or unable to return for follow up at week 12.

Keywords: atrial fibrillation exercise
evaluation of cognitive function in a suicidal crisis

Conditions: Suicide

Summary: the aftermath of suicide is devastating, being the cause of 800 000 deaths every year worldwide. in france, suicide still causes about 10 000 deaths per year and the number of suicide attempts (sa) is estimated between 170 000 and 200 000 per year (invs). it is often thought that a suicidal crisis is only related to depression, as it actually is a far more complex phenomenon. a suicidal crisis can occur on various grounds like psychiatric disorders but also contextual events or somatic diseases and it has been hypothesized that suicidal ideas or inclinations could have a common and independent cognitive origin


Eligibility criteria:
inclusion criteria: * normal or corrected vision * having understood the information not and having signed the form of consent * being hospitalized for suicidal ideas (score with inclusion at the level of beck \> 3) or after a suicide attempt of less than one week. exclusion criteria: * pregnant woman and/or nursing * diagnosed irrational pathology * known proven intellectual deficiency * patient whose physical or mental status does not allow to pass the tests of the study * being under supervision or trusteeship or private of freedom or in emergency

Keywords: cognitive functions moca test
inflammatory biomarkers in saliva at depression

Conditions: Gingivitis; Depression; Inflammation; Inflammatory Response

Summary: the goal of this observational study is to evaluate the inflammatory saliva biomarkers in depression and gingivitis. the main question will be ; will there be an increase at salivary biomarkers with depression patients and is it associated with gingivitis?

background: the neuroimmune regulation disorder in depression patients causes the progression of inflammatory periodontal disease. the present study was to evaluate the periodontal health status and the levels of triggering receptor expressed on myeloid cells 1 (trem-1), peptidoglycan recognition protein 1 (pglyrp1) and interleukin-1 beta (il-1β) in individuals diagnosed with depression and to compare these findings with those of systemically healthy individuals. methods: forty-two depression patients were classified in two groups: depression with gingivitis (dg) and depression with periodontally healthy (dph) patients. additionally, 23 systemically and periodontally healthy (sph) individuals were enrolled to the study. periodontal parameters were recorded. saliva samples were collected and salivary levels of trem-1, pglyrp1, il-1β were measured using enzyme-linked immunosorbent assay (elisa) kits. depression regardless of periodontal status.

Eligibility criteria:
inclusion criteria: * patients who were moderate in severity according to the test result, who had not started drug therapy yet and who had not received antidepressant medication in the last 12 months exclusion criteria: patients with * psychotic disorders * autism spectrum disorders * other anxiety disorders * bipolar disorder * mental any organic mental disorder and * smokers, substance users
paravertebral block for percutaneous nephrolithotomy

Conditions: Post Operative Pain

Summary: this study will compare post-operative pain levels in patients who receive paravertebral block prior to percutaneous nephrolithotomy (pcnl) surgery versus those who do not receive the block. we hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.

the strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (eswl), ureteroscopy, open surgery and percutaneous nephrolithotomy (pcnl). pcnl in an inpatient procedure performed in two steps. step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. this step is typically performed by interventional radiologists under conscious sedation. step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. the minimally invasive approach of pcnl is well accepted to be as effective as open procedures for stone removal with less morbidity. post-operative pain management remains challenging and can lead to extended hospital stays. this randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.

Eligibility criteria:
inclusion criteria: * consent to undergo percutaneous nephrolithotomy * between the ages of 18 and 75 * able to consent, fill out study documents, and complete all study procedures and follow-up visits exclusion criteria: * will have bilateral percutaneous nephrolithotomy * have an infection at the site of the proposed block * have anatomy that prevents ability to perform block * have a coagulopathy which may increase their chances of bleeding from the block * have a known allergy to local anesthetics * are unable to fill out the vas scale due to physical or mental conditions * are unable to use a patient controlled analgesia (pca) device due to physical or mental conditions * are pregnant

Keywords: percutaneous nephrolithotomy paravertebral block bupivacaine
hyper-personalized medicine using patient derived xenografts (pdxovo) for metastatic solid tumors

Conditions: Kidney Neoplasm; Carcinoma, Renal Cell; Metastatic Solid Tumor

Summary: the investigators will use novel pdx (patient-derived xenograft) technology to form xenografts using material from metastatic solid tumor patients. xenografts will be treated with a panel of drugs to determine which agent(s) yield the greatest anti-tumor effect on the xenograft.

the goal is to use pdxovos, which are chick embryos cultivated in an ex ovo fashion that will act as a xenograft host, for drug paneling. chick embryos as a pdx host model system offer multiple advantages, such as increased tumor take rates, rapid drug testing, a short evaluation timeframe, and an undeveloped adaptive immune system. collectively, these advantages allow for implantation of tumor xenografts, subsequent growth in vivo, subsequent drug challenge, and subsequent evaluation for anti-tumor effects. patients with metastatic forms of solid tumors will be enrolled regardless of subtype. metastases will be provided either via metastasectomy or needle core biopsy of metastatic deposits. spinal and intracranial metastases will be included. thoracentesis and paracentesis fluid samples yielding tumor tissue will also be included. tissue will be processed and briefly cultured in vitro. upon authentication and expansion to a suitable number of cells, xenografts will be formed in the chick embryo pre-clinical model. after implantation (2 days later), drug treatments will be applied topically to each xenograft's surface. drug treatments are: sunitinib, pazopanib, axitinib, temsirolimus, cabozantinib, gemcitabine (n\>18/treatment group). evaluation of xenografts for anti-tumor effects will be performed via ultrasound imaging (changes in tumor volume and tumor vascularity) and confirmed by histology (h\&e, tunel, cd31+ microvessel density). treatments will be compared to vehicle control (5% dmso in saline) treated xenografts. anova (2-way, p\<0.01, bon ferroni alpha corrected) analysis will be performed to identify treatments that lead to the greatest decrease in tumor volume and tumor vascularity (ultrasound imaging metrics). agents identified will not be used to intervene in clinical care. objective response rates with clinically chosen drug in each patient will be compared to the corresponding pdx drug panel results using kappa analysis.

Eligibility criteria:
patient eligibility: localized solid tumor inclusion criteria: i) age 18+ ii) localized solid tumor irrespective of subtype undergoing curative surgery iii) consent to provide tumor tissue for this research metastatic cancer inclusion criteria: i) age 18+ ii) metastatic cancer irrespective of subtype undergoing a needle biopsy or resection of lung, liver or brain as part of their routine clinical care. iii) metastatic cancer irrespective of disease site undergoing a thoracentesis or paracentesis as part of their routine clinical care. iv) measurable disease as per recist 1.1 criteria v) consent to provide tumor tissue for this research

Keywords: hyper-personalized medicine patient derived xenograft chick embryo
stress index to individualize mechanical ventilation in ards

Conditions: Acute Respiratory Distress Syndrome

Summary: acute respiratory distress syndrome (ards) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. lower-tidal volume ventilation has been largely accepted as a means of lung protective ventilation, but the mechanism for its effectiveness is not yet clear, and debate remains as to how best to choose positive end-expiratory pressure (peep). reduction in driving pressure (plateau pressure minus peep) has been suggested as a possible means to minimize ventilator-induced lung injury. this protocol aims to identify the range of safe paired-settings of peep and tidal volume, with selection guided by driving pressure and the stress index, a tool to recognize potential lung hyperinflation during mechanical ventilation.


Eligibility criteria:
inclusion criteria: * admitted to the intensive care unit * receiving invasive mechanical ventilation via endotracheal or tracheostomy tube * presence of ards by berlin criteria (acute onset bilateral pulmonary infiltrates incompletely explained by left heart failure together with a pao2/fio2 of \<300 or spo2/fio2 \<315) exclusion criteria: * inability to obtain surrogate consent * presence of specified comorbidities: 1. pregnancy 2. pre-existing severe chronic obstructive pulmonary disease, defined as fev1 documented \< 1l or baseline hypercapnia 3. cerebral edema 4. known intra-cranial abnormality 5. acute coronary syndrome * endotracheal or tracheostomy cuff leak * chest tube with persistent air leak * severe hemodynamic instability (defined as attending judgment that the patient is unable to safely tolerate ventilator manipulations) * presence of spontaneous respiratory activity as evidenced by examination of the ventilator waveform tracing * intrinsic peep of \> 5 cmh2o * assessment of study staff or patient's attending physician that the patient would not be a good study participant

Keywords: mechanical ventilation respiratory mechanics acute respiratory distress syndrome positive end-expiratory pressure tidal volume
risk factors for development of rapid cycling in bipolar disorder patients

Conditions: Bipolar Disorder

Summary: in this study we tried to elucidate the factors associated with the development of a rapid cycling course in bipolar disorder patients, in a prospective and longitudinal design, and the role of antidepressants. the identification of risk factors is extremely relevant from the clinical point of view. we hypothesized that rapid cycling bipolar disorder is associated with more chronicity, poor outcome, and more antidepressant prescription.


Eligibility criteria:
inclusion criteria: * bipolar i and ii disorder patients according to dsm-iv criteria exclusion criteria: * major medical comorbidities, voluntary drop-out from study

Keywords: rapid cycling