Kornimate/medical-research-clean huggingface dataset:
tocilizumab versus baricitinib in patients with severe covid-19

Conditions: COVID-19

Summary: the aim of this study is to investigate whether baricitinib is non-inferior to tocilizumab in severe covid-19.

patients with covid-19 will be assigned to one of the two arms on 1:1 ratio based on the time point that pao2/fio2\<200 will be observed. patients aged 18 years or older with pao2/fio2 \<200 at any time during their hospitalization will be included in the analysis irrespective of values in inflammatory markers, such as crp and ferritin. exclusion criteria will be: age\<18 years, pregnancy, glomerular filtration rate\<30 and application of mechanical ventilation prior patients' transfer to our hospital. each patient or the patient's legally authorized representative provided written or witnessed oral informed consent. day 1 will be considered the first day that pao2/fio2\<200 will be identified. treatment with either tocilizumab or baricitinib will start from day 1. primary and secondary outcomes will be assessed in the days described below. this study aims to investigate whether baricitinib is non-inferior to tocilizumab in patients with severe covid-19. two hundred fifty one (n=251) patients will be enrolled based on the following assumptions: 1) hr θ 1, 2) hr θο 1.5, 3) overall probability of event (primary end point) 0.6 (based on previous records of our hospital), 4) power 80%, 5) type i error α 5%.

Eligibility criteria:
inclusion criteria: - covid-19, pao2/fio2\<200 exclusion criteria: - age\<18 years, pregnancy, glomerular filtration rate\<30, application of mechanical ventilation prior patients' transfer to our hospital

Keywords: covid-19 acute respiratory distress syndrome pao2/fio2 tocilizumab baricitinib
selective omission of axillary surgery in triple-negative and her2-positive breast cancer after nact

Conditions: Breast Cancer Female

Summary: neoadjuvant chemotherapy (nact) is standard treatment for many triple-negative (tnbc) and her2-positive breast cancer. study showed about half of the biopsy-proven axillary disease will be eradicated by nact and converted to ypn0 indicating the efficacy of systemic treatment in local disease control. according to current guidelines, all initial cn0 patients will undergo sentinel lymph node biopsy (slnb) after nact and further axillary dissection (alnd) if tumor residual is discovered after slnb. data suggest patients who underwent slnb have a significantly higher rate of disability in the early post-operative period compared to patients who did not and the avoidance of slnb might translate into a considerable reduction of physical and emotional distress. recent studies revealed the association between breast pcr and ypn0 status after nact. initially cn0 tnbc and her2-positive breast cancer patients who achieve pcr in breast after nact have a very low risk of positive lymph node residual and are very unlikely to benefit from further axillary surgery including slnb. the investigators designed a clinical trial to test the hypothesis that selective omission of axillary surgery in distinct responders after nact will not deteriorate survival. in the planned trial, axillary surgery will be completely eliminated for initially cn0 tnbc and her2-positive breast cancer patients who achieve pcr in breast after nact determined by lumpectomy. the trial is designed as a prospective, single-center, single-arm study with a limited number of patients (n=136). patients will be recruited in china over a period of 36 months. our results, together with other ongoing studies in other parts of the world with a similar design, might give practice-changing results and spare the time and the costs of a randomized comparison.


Eligibility criteria:
inclusion criteria: * written informed consent * core biopsy confirmed unicentric primary invasive triple-negative or her2-positive breast cancer. multifocal or multicentric tumors allowed only if breast-conserving surgery is deemed feasible. * at least 18 years of age * initial tumor stage ct1c-t3n0m0 prior to nact. cn0 stage established by clinical examination and ultrasonography * in cases with suspicious lymph node, a negative core biopsy or fine needle aspiration (fna) biopsy of the sonographically suspected lymph node is required * standard nact with evident radiologic response * planned breast-conserving surgery with postoperative external whole-breast irradiation exclusion criteria: * history of previous malignancy * histologically proven n1 patients, patients with distant metastasis (m1) * pregnant or lactating patients * inflammatory breast cancer * radiologically non-responsive after nact * mastectomy planned after nact * planned intraoperative radiotherapy (e.g. intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques * written informed consent not obtained
retrospective chart review of treataprost added to antibiotic treatment in patients with chronic prostatitis

Conditions: Quality of Life; Infection, Bacterial; PSA; Prostatitis

Summary: multicenter, retrospectivecohort study in patients with chronic prostatitis, chronic bacterial prostatitis (category ii) and chronic pelvic pain syndrome (category iiia, iiib) and 140 patients without other significant comorbidities will be participated. the aim of the study is to collect post-treatment data to evaluate inflammation, infection status and quality of life with standard antibiotic therapy with nsaid and added treataprost effect.

this study will be conducted in patients with confirmed chronic prostatitis and the datas of these patients will be recorded. in real clinical practice, the data of patients who received treataprost in addition to antibiotic therapy with nsaids will be recorded. this is a non-invasive retrospective cohort study. the primary endpoint of this study is: * to determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with chronic prostatitis, chronic bacterial prostatitis (category ii) and chronic pelvic pain syndrome (category iiia, iiib) * treataprost added to standard antibiotic therapy and nsaid in clinical practice, chronic prostatitis, chronic in patients with bacterial prostatitis (category ii) and chronic pelvic pain syndrome (category iiia, iiib) understanding treatment patterns the secondary endpoint of this study is: * the aim of the study will to evaluated gather detailed information about the effect on quality of life of treataprost given with standard antibiotic therapy and nsaid. * it will be collected gather detailed information the infection status after post treatment treataprost given with standard antibiotic therapy and nsaid

Eligibility criteria:
inclusion criteria: * patients must be ≥ 18 years old and male. * the participant must be willing and competent to give written informed consent. if the subject is unable to consent on his behalf, a legally acceptable representative (ie, acceptable to the international council for harmonization \[ich\] and local law as appropriate) must give informed consent on his behalf. * chronic prostatitis, chronic bacterial prostatitis (category ii) and chronic pelvic pain syndrome (category iiia, iiib) diagnosed with standard antibiotic therapy with nsaid and antibiotic therapy with nsaid together with treataprost patients exclusion criteria: * in patients with chronic prostatitis, chronic bacterial prostatitis (category ii) and chronic pelvic pain syndrome (category iiia, iiib) not receiving any treatment * for chronic prostatitis, chronic bacterial prostatitis (category ii) and chronic pelvic pain syndrome (category iiia, iiib) taking an herbal preparation other than treataprost in addition to standard antibiotic therapy and nsaid * patients who have participated in any clinical trial and received an investigational product * patients who did not give written informed consent
a study to evaluate the efficacy and safety of vb-201 in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by modified mayo score, modified baron score, ibdq, calprotectin and other assessments.


Eligibility criteria:
inclusion criteria: * male or female, ≥18 years of age, who has a diagnosis of active uc for at least 6 months prior to screening * a rectal/colonic biopsy obtained previously and consistent with a diagnosis of uc * endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of uc within 2 weeks prior to randomization * endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of uc within 2 weeks prior to randomization * active uc despite previous treatment with at least one 5-asa compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy exclusion criteria: * diagnosis of indeterminate colitis, crohn's disease, or clinical findings suggestive of crohn's disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis) * subject whose symptoms are likely caused by factors other than inflammatory uc, including infection or irritable bowel syndrome (ibs) * history of dysplasia on colonic biopsy * subject with ≥ 8 year history of pancolitis or ≥ 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year * subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years * subject who has had any prior surgical resection of any part of the colon excluding the appendix * previous treatment with any biologic product including investigational biologic products within 1 year prior to baseline visit * the subject is taking systemic corticosteroids, azathioprine/6-mercaptopurine/methotrexate, immunosuppressants, oral 5-asa compounds unless they have been on a stable dose of sufficient duration prior to baseline. if recently discontinued the subject must have had a wash-out periods of sufficient duration prior to baseline * rectally administered corticosteroids or 5-asa, antibiotics for the treatment of uc and probiotics within 14 days of the baseline visit and throughout the study * the subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or clostridium difficile toxin at the screening visit * presence of, or history of cancer, with the exception of skin cancer
hcv post-exposure prophylaxis for health care workers

Conditions: Hepatitis C

Summary: this is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis c virus from needlestick injury with hollow-bore needles.

the goal of this study is to assess the safety and tolerability of the use of sofosbuvir-velpatasvir in the setting of post-exposure prophylaxis among health care workers exposed to hcv from needlestick injury with hollow-bore needles

Eligibility criteria:
inclusion criteria: * healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are hcv positive * healthcare worker must be hcv ab- exclusion criteria: * hcv ab positive * hcv ab negative and hcv rna greater than 1000 iu/ml * active malignancy * positive urine pregnancy test

Keywords: hcv needlestick
an open-label, long-term study of gfb-887 in patients with glomerular kidney diseases

Conditions: Kidney Diseases; Glomerulosclerosis; Focal Segmental Nephrosis; Lipoid Urologic Disease; Glomerulonephritis; Nephritis; Nephrosis

Summary: this is an open-label phase 2 study evaluating the long term safety and tolerability of gfb-887 in patients with focal segmental glomerulosclerosis (fsgs), and treatment-resistant minimal change disease (tr-mcd)

participants will be enrolled from the ongoing gfb-887 multiple ascending dose trial. participants will be transitioned to a 200 mg qd dose level regardless of the dose received in the previous study although the data review team (drt) and medical monitor may elect to decrease or increase the dose to minimize adverse events or improve clinical efficacy. the drt may also elect to change dosing levels due to emerging data on gfb-887. participants will take gfb-887 once daily at home. a phone visit will be conducted at week 4 and at week 8 to assess safety and tolerability. participants will return to the clinic for follow up visits at weeks 12, 24, 36, 48, and every 24 weeks thereafter through approximately 3 years from the time of the participant's first dose to evaluate long-term safety and durability of response (for up to approximately 13 scheduled in-clinic visits).

Eligibility criteria:
inclusion criteria: * participants with fsgs/tr-mcd who have completed the treatment phase from an interventional clinical study with gfb-887. participants who were discontinued for rising proteinuria from a gfb-887 interventional study may be considered for enrollment following consultation with the medical monitor. * participants who enrolled in any other interventional study during the time between completion of the prior gfb-887 interventional study and this study may be considered for enrollment following consultation with the medical monitor. exclusion criteria: * participant is unable to take oral medications * participant has an unstable medical condition based on medical history, physical examination, laboratory tests, ecgs, vital signs or is otherwise unstable in the judgement of the investigator which would pose a risk to the participant or interfere with study evaluation, procedures, or completion * evidence of significant hypersensitivity, intolerance, or allergy to any component of investigational product gfb-887
a study to evaluate the long-term safety and efficacy of asp015k in subjects previously enrolled in a phase 2 asp015k rheumatoid arthritis study

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of asp015k in subjects with rheumatoid arthritis (ra) who have completed a preceding phase 2 asp015k ra study.

this study is comprised of a 104 week treatment period beginning on day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.

Eligibility criteria:
inclusion criteria: * subject completed the week 12 visit in one of the phase 2, asp015k rheumatoid arthritis studies within the previous 14 days. * male and female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation exclusion criteria: * subject has any condition considered by the principal investigator or medical monitor to preclude adequate evaluation of drug safety * subject is scheduled to receive any investigational drug other than asp015k during the course of the study * subject is scheduled to receive a prohibited medication * subject has a planned major surgery * subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding study * subject has out of range laboratory values within 14 days of the day 1 study dosing * absolute lymphocyte count (alc) \< 500/mm3 * creatine phosphokinase (cpk) \> 1.5 x upper limit of normal unless the level has been stable for at least 2 consecutive blood draws (at least 7 days apart), and subject does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps

Keywords: rheumatoid arthritis asp015k
nutrient levels alter transplant outcome

Conditions: Chronic Renal Disease

Summary: the purpose of this study is to look at lipid profiles of plasma and rbc and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3 fatty acids.


Eligibility criteria:
inclusion criteria: * renal transplant recipient * appropriate blood samples drawn and analyzed
determination of a threshold for mouth rinse induced discoloration of teeth

Conditions: Discoloration of Teeth

Summary: the purpose of this study is to daily monitor the discoloration of teeth when participants rinse with a mouth rinse and black tea and to determine the time point when unacceptable discoloration occurs.

tooth discoloration is a side effect of most mouth rinse solutions. it impairs the aesthetic appearance especially of the front teeth. the aim of this pilot study is to determine a time point when visible discoloration appears in the front teeth. therefore, participants of this study will rinse twice daily with chlorhexidine mouth rinse for 10 days. to elicit a more pronounced discoloration, participants will rinse with black tea right after the chlorhexidine rinse. discoloration will be measured daily by discoloration index, by spectrophotometry, and by the use of a digital photo.

Eligibility criteria:
inclusion criteria: * persons aged 18 to 30 years * written informed consent * healthy participants * participants who have no or mild gingivitis * participants who have all incisors and canines in the upper and lower jaw exclusion criteria: * participants who have severe general diseases * participants who have allergies against the ingredients of the mouthrinse * participants who are enrolled in another clinical study * participants who are not able to oversee the consequences of the study * female participants who are pregnant or breast feeding * participants who have impaired compliance * participants who have moderate or severe gingivitis * participants who have fillings in the incisors and canines * participants who smoke
efficacy testing of collagen drink on skin beauty and sleep aid

Conditions: Skin Condition; Sleep Disturbance

Summary: to assess collagen drink on skin condition and sleep quality improvement


Eligibility criteria:
inclusion criteria: * healthy adults aged above 20 years old exclusion criteria: * subject who is not willing to participate in this study. * patients with diseases of the skin, liver, kidney. * subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. * female who is pregnant or nursing * constant drug use * received facial laser therapy, chemical peeling or uv overexposure (\>3 hours everyday) in the past 4 weeks. * students taught by the pi
a double-blind rct of a single dose of hyaluronan in the treatment of osteoarthritis of the ankle

Conditions: Osteoarthritis

Summary: to compare the therapeutic effect of single intra-articular injection of hyaluronate with a single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.

this study is a randomized, prospective, double-blind (blinded observer) , saline solution-controlled, parallel experimental design. the study device is supartz (seikagaku corporation, tokyo, japan) a brand of sodium hyaluronate.

Eligibility criteria:
inclusion criteria: * to be eligible, subjects had to be at least 18 years old, not pregnant, and have pain and osteoarthritis of the ankle of at least stage 2 on the kellgren and lawrence scale. * their aofas score had to be 90 points or less out of a possible 100 points. * eligible subjects had to be willing to discontinue all pain medications and nsaids other than the rescue pain medications provided in the study. exclusion criteria: * persons with systemic inflammatory condition or infection of the ankle or nearby soft tissues, * an injection of steroid or surgery on the involved joint within 6 months, * local cellulitis, rash, skin condition * diabetic or neuropathic charcot arthropathy, * significant vascular insufficiency, * current treatment with anticoagulants, * lower extremity pain syndromes, sciatica, sprains, plantar fasciitis, * significant ankle instability or malalignment, * any known allergy to any of the components of either injection, known or suspected allergy to birds or bird products, * disabling degenerative joint disease of the ipsilateral hip, knee or foot were ineligible for the study.

Keywords: hyaluronate hyaluronic acid viscosupplementation
prevalence of mthfr polymorphisms in venous disease

Conditions: Varicose Veins; MTHFR; Venous Disease; Thrombosis

Summary: the etiologies of varicose veins and the progression to more serious forms of chronic venous disease and identification of appropriate diagnostic tests to better aid patient management by identifying individuals who may benefit from more aggressive treatment and/ or prophylactic measures.


Eligibility criteria:
inclusion criteria: * age 18 or over * no venous disease (n=30); or c2-c3 venous disease (n=30); or c4-c6 venous disease (n=30) exclusion criteria: * pregnancy * cancer * chronic obstructive pulmonary disease (copd) * any systemic inflammatory disease * any of the following within the previous 30 days: * trauma * any surgery * periods of prolonged inactivity
liver transplantation for non-resectable intrahepatic cholangiocarcinoma: a prospective exploratory trial (tesla trial)

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated..


Eligibility criteria:
inclusion criteria: * histologically verified diagnosis of intrahepatic cholangiocarcinoma (icca) * first time icca or liver only recurrence after previous liver resection for icca * disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction * no vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging * no signs of extrahepatic metastatic disease according to positron emission computed tomography (pet-ct) scan * patient must be accepted for transplantation before progressive disease on chemotherapy. * twelve months or more time span from the diagnosis of icca and date of being listed for liver transplantation * no signs of extrahepatic metastatic disease according to ct or magnetic resonance (mr) scan within 4 weeks prior to the faculty meeting at the transplant unit * at least 18 years of age * good performance status, eastern cooperative oncology group (ecog) 0 or 1 * signed informed consent and expected cooperation of the patients for the treatment and follow up * received at least 6 months of chemotherapy or locoregional therapy exclusion criteria: * major vascular involvement of the tumor * perforation of the visceral peritoneum * weight loss \>15% the last 6 months * patient bmi \> 30 * other malignancies, except curatively treated more than 5 years ago without relapse * known history of human immunodeficiency virus (hiv) infection * prior history of solid organ or bone marrow transplantation * substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * known hypersensitivity to rapamycin * prior extrahepatic metastatic disease * women who are pregnant or breast feeding * any reason why, in the opinion of the investigator, the patient should not participate