Kornimate/medical-research-clean huggingface dataset:
development and validation of pelvi-fit app

Conditions: Urinary Incontinence

Summary: urinary incontinence (ui) is defined as involuntary urinary leakage or inability to control urine. various physiological changes during pregnancy, including collagen changes, hormonal changes, and increased uterine and fetal weight, contribute to the weakening of the pelvic floor muscles (pfms) during pregnancy. approximately, 42% of women experience their first ui during pregnancy, and up to 31% of parous women have ui. women with persistent ui after delivery may continue to experience ui for another 12 years. therefore, ui during pregnancy may be an essential risk factor for subsequent ui among women. this study will result in a product called pelvi-fit app that will help patients to self-treat their pelvic floor disorders in a way that is approved by medical experts. it will allow the patient to train their pelvic floor muscles independently who are not able to get medical assistance due to being in remote areas or any other reason.

literature suggests that ui is troublesome, affects women's quality of life physically, emotionally, spiritually, and financially. those who experience it may resort to various methods to deal with the problem, including using pads or incontinence diapers and avoiding social situations because of embarrassment. however, many women do not seek help despite having ui symptoms because of the perception of ui as embarrassment to initiate a discussion about ui with their health care provider. some are unaware of treatment availability, such as pfm training (pfmt), whereas others feel they should not disturb their health care provider as ui is a temporary issue. developing a positive attitude is essential to enable people to change their behavior successfully. the use of persuasive technology (pt) in mhealth apps may support attitude and behavior change in users to adopt pfmt as part of their lifestyle. the pre-final version of pevi-fit app will be made in this study. the control group will receive the validated content-based treatment protocol of ui in descriptive form and the experiment group will receive the same treatment of ui through pre-final version of the pelvi-fit app. the results of both groups will be recorded and compared to assess the effectiveness of using technological methods in the treatment of patients with urinary incontinence

Eligibility criteria:
inclusion criteria: * females of child-bearing age up to 65 years of age having urinary incontinence. * females having cognitive ability to use the pelvi-fit app, screened through mmse tool (average score \>25). exclusion criteria * patients of neurological conditions; sci, stroke. * not friendly to use mobile apps.
oestrogen treatment for covid-19 symptoms

Conditions: COVID-19

Summary: the aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed covid19.

it is known that (i) women are relatively protected from the impacts of other respiratory viruses, and that oestrogen may partly mediate this effect (ii) oestrogen protects rodents from sars-cov-1 related mortality (iii) women are relatively protected from developing or dying from severe covid-19 and (iv) postmenopausal women taking oestrogen replacement appear less likely to suffer covid19-related critical illness. these effects may be mediated through oestrogen-related immunomodulation. in addition, however, 17β estradiol reduces expression of ace2 (the receptor protein through which sars-cov-2 gains cellular entry) in tissues such as the kidney. as such, supplemental oestrogen may represent an effective therapy for covid19. we will randomise adult men and postmenopausal women with confirmed covid19 disease to receive 10 days of transdermal oestrogen (3mg/day). the primary endpoint will be evidence of disease progression, indicated by hospitalisation (mild cases) or need for mechanical ventilation or death within 28 days of randomisation for those hospiatlsied. secondary outcomes will include hospital mortality, duration of hospital admission, admission to icu/ hdu facility, icu/ hdu length of stay, need for renal replacement therapy, receipt and duration of invasive mechanical ventilation, cause-specific mortality and time to being fit for hospital discharge .

Eligibility criteria:
inclusion criteria: * acute covid-19 disease (pcr-confirmed or clinically diagnosed with high certainty) * adult males \> 18 years of age or * post-menopausal women (spontaneous amenorrhoea for \>12 months in the absence of any other cause) exclusion criteria: women: * taking oestrogen supplements or oestrogen receptor antagonists * with abnormal genital bleeding * with a history of breast cancer * with a history of endometrial or ovarian cancer * with untreated endometrial hyperplasia men: • taking hormone therapies (e.g. for prostate cancer) any subject: * failure to obtain consent * taking lamotrigine * with a thromboembolic disorder (e.g. protein c or protein s deficiency, antithrombin iii deficiency) * with pre-existing liver or renal disease * with known allergy to exogenous oestrogens * with a history of porphyria * with a history of thromboembolic event including deep vein thrombosis, thromboembolic stroke or pulmonary emboli * taking part in another interventional clinical trial

Keywords: covid-19 oestrogen
comparison bile duct brushings, cholangioscopy-directed biopsies and pediatric forceps biopsies in biliary strictures

Conditions: Cholangiocarcinoma; Stricture; Bile Duct

Summary: prospective, randomized, multi-center study. investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.


Eligibility criteria:
inclusion criteria: 1. all patients with obstructive jaundice, and imaging (ct or mri) suggestive of biliary stricture, without obvious pancreatic mass 2. all patients with obstructive jaundice, and index ercp suggestive of biliary stricture, without obvious pancreatic mass 3. all patients with obstructive jaundice, and prior ercp suggestive of biliary stricture 4. expected patient survival of at least 90 days 5. high likelihood of patient follow-up 6. patient is able to give a written informed consent 7. patient is willing and able to comply with the study procedures exclusion criteria: 1. patients with imaging suggestive of pancreatic tumor 2. children \< 18 years of age 3. pregnant women 4. patients with impaired decision-making 5. healthy volunteers 6. primary sclerosing cholangitis (psc) 7. patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation 8. patients with any contraindication to endoscopic procedure 9. participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit 10. patients unable to provide informed consent
acetaminophen to prevent ischemic oxidative reperfusion injury during percutaneous coronary intervention for acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to test the hypothesis that acetaminophen will reduce lipid peroxidation and isoprostane formation during reperfusion after percutaneous revascularization for acute myocardial infarction.


Eligibility criteria:
inclusion criteria: - patients presenting with stemi exclusion criteria: * duration of symptoms \> 12 hours * suspected lm or proximal lad occlusion (based on ekg interpretation) * hemodynamic instability * acetaminophen use in prior 24 hours * use of dipyridamole, or aggrenox, a formulation of aspirin and extended-release dipyridamole, within 48 hours * current use of the following medications: phenytoin, valproic acid, phenobarbital, topiramate, rifampin, carbamazepine, cyclophosphamide, ritonavir, efavirenz, st. john's wort * chronic heavy alcohol use * chronic liver disease (other than non-alcoholic fatty liver infiltration) * severe valvular heart disease * stroke in the past 60 days * active major bleeding * major surgery in the past 30 days * ongoing treatment for active malignancy * life expectancy less than 12 months as determined by the patient's attending physician * pregnancy * asthma or severe copd * active wheezing on presentation * allergy or prior adverse reaction to adenosine

Keywords: myocardial infarction percutaneous coronary intervention acetaminophen lipid peroxidation
efficacy and safety of aeb071 versus tacrolimus in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation

Conditions: Kidney Transplantation

Summary: efficacy and safety of aeb071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.


Eligibility criteria:
inclusion: * male and female patients of any race 18 years or older * adult recipients of kidney transplant from a deceased or living donor * recipients of a functioning kidney within 24 hours post transplant exclusion: * need for medication prohibited by the protocol * patients or donors infected with hepatitis b,c or hiv * patients with a history of cancer within last 5 years * patients with history of significant cardiac disorder * patients of high-risk immunological status other protocol-defined inclusion/exclusion criteria may apply.

Keywords: kidney transplantation rejection aeb071 tacrolimus mycophenolic basiliximab immunosuppression
a comparison of epivir plus crixivan combined with zerit or retrovir in hiv-infected patients who have never taken anti-hiv drugs

Conditions: HIV Infections

Summary: to evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

100 patients will be randomized to receive zerit (stavudine) + epivir (lamivudine) + crixivan (indinavir) and 100 patients will be randomized to receive retrovir (zidovudine) + epivir (lamivudine) + crixivan (indinavir). patients will be treated for 48 weeks.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4 cell count of 200 - 700 cells/mm3. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: aids defining condition within 1 month of study entry. prior medication: excluded: patients with any history of antiretroviral therapy treatment.

Keywords: drug therapy, combination zidovudine stavudine hiv protease inhibitors cd4 lymphocyte count lamivudine indinavir reverse transcriptase inhibitors anti-hiv agents viral load
application of autologous adipose stromal vascular fraction in the treatment of premature ovarian insufficiency

Conditions: Premature Ovarian Insufficiency

Summary: a single-center, prospective, randomised controlled clinical trial (1:1 treatment ratio), designed to investigate the efficacy and safety of autologous svf in improving the pregnancy outcome of infertile patients with poi.

a single-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with poi based on the inclusion and exclusion criteria from peking university third hospital. eligible participants will be randomized to two groups at a ratio of 1:1- svf protocol, and conventional protocol.the participation in this study will be approximately 2 years with a total of 6 visits and 3 follow-up phone calls.

Eligibility criteria:
inclusion criteria: * women aged ≥20 and ≤39 years who have childbearing requirements. * cessation of menstruation or oligomenorrhea for at least 4 months * serum level of basal follicle stimulating hormone (fsh) \>25 u/l at least 2 times (during the second to fourth day of the menstrual cycle or during amenorrhea; the interval between the two tests is 4 weeks) * serum level of anti-mullerian hormone (amh) ≤1.1 ng/ml * women with intact uterus and bilateral adnexa. * voluntary participation and informed consent obtained. exclusion criteria: * women with autoimmune diseases. * women with abnormal and uncontrolled thyroid function. * women with tumors in bilateral adnexa that are not clearly benign or malignant. * women with a history of malignant tumors, radiation therapy or chemotherapy. * women with a history of venous thrombosis or pulmonary embolism during the screening period. * women with severe illnesses that are not suitable for pregnancy, such as diseases of the circulatory system, urinary system, digestive system, endocrine system, respiratory system, immune system, mental or neurological system, etc. * women who continuously used systemic glucocorticoids or other immunosuppressants for≥3 weeks within 6 months before administration and women who used systemic glucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressants within 3 days before administration. * women who are allergic to the active ingredients or excipients of test drugs. * women with a family history of severe genetic diseases or gynecologic malignancies.

Keywords: female fertility premature ovarian insufficiency adipose stromal vascular fraction
reasons of transfer in emergency units of patients in end of life situation.

Conditions: End of Life; Palliative Care

Summary: this qualitative study aimed to describe and understand the factors leading to the admission in emergency unit of patients coming from their home, in an end of life situation. this study was conducted in the university hospital of besançon, france. semi-structured interviews were conducted with general practitioners and family members in order to understand the factors leading, from their points of view, to the admission in emergency unit whereas this hospitalization wasn't necessary.


Eligibility criteria:
inclusion criteria: * for patients : * aged of 18 yo or more * admitted in the emergency unit of the university hospital of besançon * who died within the 3 days following their admission in the emergency unit * who died of a chronic disease in terminal phase * for whom therapeutic goals were only focused on comfort * living at their home or at their family's home before their transfer in emergency unit * accompanied by at least one main carer (family member or friend) and one general practitioner during the last weeks before death * for main carers : * family members or friends of the patient * who were the main carers of the patient during his/her last weeks * speaking easily in french * who agreed for being interviewed and whom psychic and emotional state is compatible with a interview * living within 80km from besançon * for general practitioners : * who were the main medical actor for the patient during his/her last weeks * who agreed for being interviewed * working within 80km from besançon exclusion criteria: * for patients : * patients who expressed a wish to not die at home * patients who died because of any other medical event than predictable death following the terminal phase of a chronic disease * minors * for main carers and general practitioners : * refusal to participate to the interviews

Keywords: qualitative study, end of life, ethics, palliative care
breath testing for breast and colon cancer diagnosis- nanose study

Conditions: Breast Cancer; Colon Cancer

Summary: the concept of breath testing for various diseases has been around since ancient greece. it has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. this study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.

cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome p- 450 mixed oxidase enzymes (cyp). both processes affect the abundance of volatile organic compounds (vocs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by cyp. in the technion labs, a new system for breath samples diagnosis, is being developed. the system is based on nanoparticles technology. the current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals. men and women coming for colonoscopy or breast biopsy will be recruited for the study. breath samples will be taken from all volunteers before the medical test. subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control. the research goal is to test the nanose system ability to discriminate between healthy and sick.

Eligibility criteria:
inclusion criteria: * men and women attending rambam medical center for either breast biopsy or colonoscopy. * suspicious finding on breast imaging requiring a biopsy. * complaints indicating the possibility of colon cancer: blood in stool, weight loss, constipation, anemia, family history of colon cancer. exclusion criteria: * other known active malignancy. * history of malignant disease and treatments.

Keywords: breath test colon cancer breast cancer
phase 1 study of gc1130a in pediatric patients with sanfilippo syndrome type a (mps iiia)

Conditions: Sanfilippo Syndrome Type A

Summary: the purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of recombinant human heparan n-sulfatase (rhhns, gc1130a) administered via intracerebroventricular access device in pediatric patients with sanfilippo syndrome type a (mps iiia).


Eligibility criteria:
inclusion criteria: * participants with documented mps iiia diagnosis * participants aged ≥ 24 months and ≤ 72 months exclusion criteria: * participants with significant non-mps iiia related central nervous system impairment * participants with previous complication from intraventricular drug administration * participants with contraindications for mri scans and for neurosurgery * participants that received treatment with any investigational drug or a device intended as a treatment for mps iiia within 30 days or 5 half-lives prior to the study * participants that received a hematopoietic stem cell or bone marrow transplant or received gene therapy

Keywords: mucopolysaccharidosis type iii subtype a mps iiia
efficacy of da-5204 on gastroesophageal reflux disease

Conditions: Esophageal Disease

Summary: this is a single-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy of da-5204 and proton pump inhibitor combination therapy compared with proton pump inhibitor alone therapy in patients with gastroesophageal reflux disease.

gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus causes troublesome symptoms, such as heartburn and acid regurgitation. proton pump inhibitors, as acid suppressor, are the agents recommended as the first-line treatment for gastroesophageal reflux disease. however, approximately 20-30% of patients have insufficient effect on this therapy alone. da-5204 is a medicine based on artemisia asiatica 95% ethanol extract. da-5204 has been administered to treat gastritis and gastric ulcers with antioxidative and cytoprotective actions on gastric mucosal damage. therefore, we expect da-5204 to be effective in reflux esophagitis (esophageal mucosal injury).

Eligibility criteria:
inclusion criteria: * age is over 20 years old, under 75 years old, men or women * patients diagnosed with erosive esophagitis by gastroscopy * signed the informed consent forms exclusion criteria: * patients who is impossible to receive gastroscopy * patients with esophageal stricture, esophageal varix, barrett's esophagus, peptic ulcer or gastrointestinal bleeding * patients administered with prokinetics, h2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks * patients with surgery related to gastroesophageal * patients with zollinger-ellison syndrome * patients with any kind of malignant tumor * patients administered with anti-thrombotic drugs * patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease * patients with neuropsychiatric disorder, alcoholism, or drug abuse * patients taking other investigational drugs or participating in other clinical studies in 4 weeks. * women either pregnant or breast feeding

Keywords: gastroesophageal reflux esophagitis, peptic
perceived stress among icu medical staff during covid-19 crisis

Conditions: Coronavirus; Nurse's Role; Professional Stress

Summary: the objective of this study is to compare psychological distress and needs of nurses in icu before and during coronavirus pandemic.

well-being of caregivers and stress management in intensive care units are essential keys to an adequate quality of care, especially during the anxious context of coronavirus pandemic. taking care of numerous patients, the increasing work and mental charges, facing death, the need of material and changes in work organization are all elements that can influence stress among medical workers. considering real causes of stress and what are the needs of the medical team is fundamental for developing concrete actions to ease the workloads. a few studies were conducted in china on psychological distress of medical staff during covid-19. according to these few studies about psychological distress in icu, investigators think that stress scores during covid-19 could be increased among nurses during pandemic. the second hypothesis is that causes of stress would be not so different from normal care but could be amplified by the actual situation. one point to take into consideration is that most of the studies were conducted in china and medical policy and hospital organization are different in belgium. the objective of the study is to compare psychological distress and needs of nurses in icu before and during coronavirus pandemic.

Eligibility criteria:
inclusion criteria: * adults \> 18 years old * working in icu for at least november 2019 * working in icu regularly since march 2020 * medical and paramedical professionals * working in direct contact with covid patients exclusion criteria: * medical professionals from others departments * internship students * external volunteers for covid * non front-line nurses

Keywords: coronavirus covid-19 pandemia professional stress burnout nursing intensive care units (icu) infection work organization