Kornimate/medical-research-clean huggingface dataset:
hetrombopag for lower-risk mds with thrombocytopenia: a prospective，open-label, single-arm study.

Conditions: Myelodysplastic Syndromes

Summary: the is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in lower-risk mds patients with thrombocytopenia.

the is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in patients with very low, low, or intermediate risk myelodysplastic syndromes(mds) according to the revised international prognostic scoring system (ipss-r) with thrombocytopenia. the primary endpoint was proportion of patients achieving platelet response at week 24.

Eligibility criteria:
inclusion criteria: * 18 years or older； * confirmed diagnosis of mds based on 2016 who (world health organization) and classification with very low, low or intermediate (score ≤ 3.5) risk according to the revised international prognostic scoring system (ipss-r). * platelets \< 30 x 10\^9/l or platelets \< 50 x 10\^9/l with active bleeding at screening. * eastern cooperative oncology group (ecog) performance score ≤ 2； * ability to understand information material and written informed consent. exclusion criteria: * severe active bleeding/infection or any other uncontrolled severe condition; * history of treatment with thrombopoietin receptor agonists (eltrombopag, avatrombopag, romiplostim, etc.) or recombinant human thrombopoietin with 1 month prior; * patients with known active hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) at screening（if hepatitis b surface antigen or hepatitis b core antibody are positive, hbv-dna testing are needed. if positive, it suggests a viral replication and subjects will be excluded. if hepatitis c antibody are positive, hcv-rna testing are needed. if positive, it suggests a viral replication and subjects will be excluded）; * alanine aminotransferase (alt) and aspartate aminotransferase (ast) \>2.5 x upper limit of normal (uln), total bilirubin \>2.5 x uln, creatinine \>1.5 x uln; * history of portal hypertension or cirrhosis； * history of any types of solid tumors within 5 years prior, whether the tumors has been treated, metastasized or relapsed (except basal cell carcinoma); * history of congestive heart failure requiring medical management, cardiac arrhythmias, peripheral arteriovenous thrombosis within 1 years prior, or myocardial infarction or cerebral infarction within 3 months prior; * ecog performance score ≥ 3; * female subjects who are pregnant or breastfeeding, or subjects who are planning pregnancy within 6 months; * women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation; * participated in other clinical trials within 3 months prior; * any condition which, in the investigator's opinion, deems the subject an unsuitable candidate to receive study drug.

Keywords: hetrombopag thrombocytopenia myelodysplastic syndromes
pilot: mind over matter: healthy bowels, healthy bladder

Conditions: Urinary Incontinence; Fecal Incontinence; Accidental Bowel Leakage

Summary: the study is to pilot-test an innovative, combined urinary/bowel continence workshop in two wisconsin communities. between 8-15 women with incontinence will be enrolled in each of the two pilot communities and will complete three 90-minute workshop sessions over a 6 week period.

the pilot study will use mixed methods to compare pre- and post-workshop data about urinary and bowel incontinence symptoms and care-seeking from workshop participants as well as information about workshop acceptability from workshop participants and community partners. the study is expected to last 6 months from initial irb approval through data analysis and workshop revision. this research will provide preliminary data for a larger test of this workshop in four diverse wisconsin communities, followed by a randomized, controlled trial and subsequent dissemination research study.

Eligibility criteria:
inclusion criteria: * qualifying symptoms in 3 months prior to enrollment exclusion criteria: * receiving new treatment for qualifying symptoms in 3 months prior to enrollment
screening and therapeutic monitoring of multiple myeloma by maldi-tof ms analysis

Conditions: Monoclonal Gammopathies; Multiple Myeloma; M-protein

Summary: to provide a comprehensive maldi-tof mass spectrometry method for detecting, characterizing, and quantifying m-protein, and to track m-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.

m-protein is a serum biomarker directly related to clonal plasma cell load in multiple myeloma (mm) patients and can be used as a diagnostic marker to make out disease and a quantitative marker to track disease progression and response to treatment. identification, typing and quantification of m-proteins are useful for initial diagnosis of disease, risk stratification and monitoring of response to treatment. although the determination of m-protein can be used as an auxiliary diagnosis of multiple myeloma, the early diagnosis and risk assessment of mm still lack convenient and effective tools for large-scale screening. in recent years, the use of matter-assisted laser desorption/ionization time-of-flight mass spectrometry (maldi-tof ms) for proteomic analysis of complex biological mixtures has attracted extensive attention, and has become one of the most promising methods for the detection of m proteins. in this study, we screened the population by maldi mass spectrometry in order to detect low level circulating m-protein by a faster and more sensitive method.

Eligibility criteria:
inclusion criteria:(1) inclusion criteria for cases: serum samples from related people diagnosed with multiple myeloma were included in maldi-tof-ms analysis by serum protein electrophoresis (spep), serum immunofixation electrophoresis (ife), ig isotype detection and other methods. (2) inclusion criteria of the controls were as follows: individuals in good health without obvious disease and with normal physical examination report; avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex. - exclusion criteria: samples with incomplete sample information and untraceable source; samples whose sample volume is insufficient for testing; samples that do not meet the requirements for sample collection and storage -

Keywords: m-protein
diagnosis of hepatic tumors in cirrhosis: prospective validation of the noninvasive diagnostic criteria for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. all the patients who receive hepatomy in our department 2. diagnose as hcc 3. diagnosis of hcc is confirmed by noninvasive criteria for hcc as used by the american association for the study of the liver guidelines 4. no history of previous treatments 5. no pathological diagnosis before treatment

Keywords: sensitivity specificity positive rate negative rate
safety and tolerability of cilofexor in participants with primary sclerosing cholangitis (psc) and compensated cirrhosis

Conditions: Primary Sclerosing Cholangitis; Compensated Cirrhosis

Summary: the primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (cilo) in participants with primary sclerosing cholangitis (psc) and compensated cirrhosis.


Eligibility criteria:
key inclusion criteria: * diagnosis psc based on cholangiogram (magnetic resonance cholangiopancreatography \[mrcp\], endoscopic retrograde cholangiopancreatography \[ercp\], or percutaneous transhepatic cholangiogram \[ptc\]) or liver biopsy * individuals have evidence of cirrhosis based on historical liver biopsy, abdominal imaging \[magnetic resonance imaging (mri), computed tomography (ct), or ultrasound\], or a screening fibroscan®, enhanced liver fibrosis (elf)™, or fibrotest®. * individual has the following laboratory parameters at the screening visit, as determined by the central laboratory: * estimated glomerular filtration rate (egfr) \> 60 milliliter/minute (ml/min), as calculated by the cockcroft-gault equation * alanine aminotransferase (alt) ≤ 5 x upper limit of the normal (uln) * total 2 milligram/deciliter (mg/dl), unless the individual is known to have gilbert's syndrome or hemolytic anemia * international normalized ratio (inr) ≤ 1.4, unless due to therapeutic anticoagulation * platelet count ≥ 75,000/microliter (μl). individuals with evidence of high-risk esophageal or gastric varices in the opinion of the investigator are excluded * negative anti-mitochondrial antibody key exclusion criteria: * current or prior history of any of the following * decompensated liver disease, including ascites, hepatic encephalopathy (he), or variceal hemorrhage * liver transplantation * cholangiocarcinoma or hepatocellular carcinoma (hcc). * model for end-stage liver disease (meld) score \> 12 at screening, unless due to an alternate etiology such as therapeutic anticoagulation * child-pugh (cp) score \> 6 at screening, unless due to an alternative etiology such as gilbert's syndrome or therapeutic anticoagulation * current moderate to severely active inflammatory bowel disease (ibd) (including ulcerative colitis, crohn's disease, and indeterminate colitis). * note: individuals with ibd who currently have an external ostomy bag and/or proctocolectomy are not subject to this exclusion criterion and need not undergo ibd symptom severity assessment. note: other protocol defined inclusion/exclusion criteria may apply.
induction chemotherapy, chemoradiotherapy and surgery in locally advanced gastric cancer patients

Conditions: Gastric Cancer; Adenocarcinoma; Effects of Chemotherapy; Surgery; Gastrointestinal Neoplasms

Summary: the aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.

patients with locally advanced gastric cancer (t3-4 and/or n+) are included. initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. the neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 gy). surgery is scheduled 4 to 6 weeks after the end of crt. pathological response is graded according to the becker criteria. statistical analysis is performed ibm spss v20. estimate whether r0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (nlr) and platelet lymphocyte ratio (plr)

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the stomach * age ≥18 years old * performance status- eastern cooperative oncology group (ecog) 0-1 * body mass index ≥ 18 * no prior chemotherapy or chemoradiotherapy * tnm stage of t3-t4 and/or positive regional lymph nodes (n+) by endoscopic ultrasound or computed tomography (ct) * no evidence of metastasis (m0) * adequate hematological, liver and renal functions (alt and ast≤2.5 unl, total bilirubin ≤1.5 unl, and serum creatinine ≤1.5 unl) exclusion criteria: * patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated * patients with evidence of severe or uncontrolled systemic disease * medically unfit for chemotherapy * tumors involving the esophageal junction, comprising siewert i to iii

Keywords: radiotherapy neoadjuvant therapy induction chemotherapy concurrent chemoradiotherapy preoperative factors dynamic factors prognostic factor
investigation of the suburothelial myofibroblast network and of smooth muscle function and control in the human urinary outflow tract

Conditions: Incontinence, Overactive Bladder, Stress Urinary Incontinence

Summary: the aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. to further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.


Eligibility criteria:
inclusion criteria: tissue will be collected from the operation theatre only after having obtained the patient´s consent and in strictest accordance with histopathological requirements, i.e. after assessment of resection margins. it might be necessary to retrieve the tissue from the pathologist after first pathological assessment is completed. tissue will be placed in tyrode´s solution, gassed with 95 % o2 and 5 % co2, for functional and rt-pcr or western blot experiments, or in oct (optimal cutting temperature) compound, snap-frozen in liquid nitrogen, and stored in a -80°c freezer until cutting for immunohistochemical experiments. exclusion criteria: none.
single dose enteral tranexamic acid in critically ill patients

Conditions: Shock; Sepsis; Hypotension; Critical Illness

Summary: the premise of this study is that enteral tranexamic acid will help to maintain small bowel integrity, which is often compromised by critical illness due to inadequate cardiovascular perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease morbidity in critically ill patients.

the primary objective of this study is to provide preliminary efficacy and safety data on the enteral administration of a one-time dose of tranexamic acid to critically ill patients for the reduction of morbidity at 28 days after enrollment in the study. secondary objectives of this study are to determine the efficacy of administration of enteral tranexamic acid in reducing intensive care unit (icu) and hospital length-of-stay, as well and mortality and morbidity at 6 months.

Eligibility criteria:
inclusion criteria: * critically ill patients admitted to icu within 48 hours of onset of illness * patients with feeding tubes (e.g., orogastric, nasogastric, peg, etc.) exclusion criteria: * primary admitting diagnosis of cancer * primary admitting diagnosis of acute congestive heart failure * primary admitting diagnosis of chronic obstructive pulmonary disease (copd) * primary admitting diagnosis of acute myocardial infarction or unstable cardiac arrythmia * primary admitting diagnosis of amyotrophic lateral sclerosis (als) or other non-infectious disease * primary admitting diagnosis of post-operative neurosurgical procedure * known hypersensitivity to tranexamic acid * acquired disturbances of color vision * hematuria cause by disease of the renal parenchyma * active thromboembolic disease such as deep venous thrombosis or pulmonary embolism * patients with known clotting disorders or other known bleeding disorders * recent (within 3 months) or active cerebrovascular bleed * pregnancy * inability to take study medicine (i.e., ileus with \> 500ml stomach residuals, npo status) * patients excluded at the discretion of the treating physician

Keywords: sepsis shock placebo controlled double blinded interventional
impact of nebivolol on central aortic pressure

Conditions: Central Aortic Pressure

Summary: a randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease.


Eligibility criteria:
inclusion criteria: * subjects with history of hypertension * subjects who have received metoprolol for a minimum of 3 months exclusion criteria: * patients who have had an acute myocardial infarction, coronary revascularization or who have been hospitalized for heart failure or cardiac arrhythmia in the past 6 months

Keywords: nebivolol metoprolol central aortic pressure hypertension
randomized controlled trial assessing the effect of dexamethasone on postoperative function after distal radius fixation

Conditions: Distal Radius Fracture

Summary: the study is designed to assess the use of intraoperative dexamethasone on postoperative analgesia and stiffness after open reduction and internal fixation of distal radius fractures. the idea is that the dexamethasone will aid in reducing postoperative swelling which will then improve pain control as well as overall function.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * willingness to comply with study procedures and * male or female greater than 18 years old * american society of anesthesia class i/ii/iii * ability to take oral medicine in order to assess opioid regimen postop * distal radius open reduction and internal fixation surgery with single incision and volar plate * ability to consent for and receive a preoperative upper extremity nerve block by anesthesia exclusion criteria: * chronic opioid users * prescriptions for selective-serotonin reuptake inhibitors, gabapentin, duloxetine within 3 days of surgery * history of diabetes and a1c \> 8 * systemic glucocorticoids within 1 month of study enrollment * inability to take ibuprofen or acetaminophen due to allergy or condition * history of hepatitis * pregnancy or lactation * allergic to opioids * known allergic reactions to components of iv dexamethasone
ct screening for lung cancer in high risk patients: the russian study.

Conditions: Lung Cancer

Summary: this prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in russian federation using low-dose ct scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking.

low dose computer tomography (ldct) showed promising results in recently published studied. lung cancer screening programs with fluorography introduced in ussr in 70s-80s showed shift to earlier stages with no data on mortality. no other studies or programs on lung cancer screening were introduced in russia since then. the purpose of this study is to assess the feasibility of establishing a lung cancer screening program in russian federation using ldct scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. this cohort prospective study is planned to enroll at least 500 current or former smokers. patients will be screened by ldct scan at baseline with recommendation to perform follow-up in case of any positive result. for nodes more than 10 mm full clinical examination is recommended. for nodes 3-9.9 mm follow-up scans in 1, 3 or 6 months is recommended. for nodes smaller than 3 mm and negative results annual ldct is recommended. patient with positive results will be followed until final clinical diagnosis. secondary outcomes include: * lung cancer diagnoses * lung cancer and overall mortality * quality of life assessment * complications of diagnostic and surgical procedures following a positive result. * comparison of independent radiological evaluation of scans.

Eligibility criteria:
inclusion criteria: * age 50-75 years * 30 or more pack-years of cigarette smoking history * former smokers: quit smoking within the previous 10 years * ability to tolerate ct procedure * signed informed consent exclusion criteria: * any cancer other than nonmelanoma skin cancer or carcinoma in situ in the 5 years prior to eligibility assessment * severe uncontrolled heart, vascular, respiratory or endocrine pathology. * life-expectancy less than 1 year * history of lung cancer * history of lung surgery. * acute respiratory disease * hemoptysis. * weight loss more than 10 kg in the 12 months prior to eligibility assessment * participation in other cancer clinical trial * chest ct examination in the 12 months prior to eligibility assessment.

Keywords: lung cancer screening low dose computed tomography
feeding malnourished children different types of fatty acids to promote neurocognitive development

Conditions: Severe Acute Malnutrition

Summary: an appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. in young children recovering from severe acute malnutrition (sam), excess omega-6 intake depletes omega-3 fatty acid status. this research will evaluate how novel ready-to-use therapeutic foods (rutf) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in malawi recovering from sam, yielding new knowledge that also has implications for development of well-nourished children.


Eligibility criteria:
inclusion criteria: * 6-59 months * an acceptable appetite defined by the ability to consume 30 grams rutf within 20 minutes * mid upper arm circumference \<11.5 cm, weight-for-height z-score \< -3, or bilateral pitting edema on the dorsum of the feet exclusion criteria: * participation in any other ongoing study or supplementary feeding program * children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy

Keywords: malnutrition micronutrients polyunsaturated fatty acids ready-to-use therapeutic foods omega-3 fatty acids peanuts
study of allogeneic adipose-derived mesenchymal stem cells to treat post covid-19 "long haul" pulmonary compromise

Conditions: Covid19

Summary: this is a phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of covi-msc in treating post covid-19 "long haul" pulmonary compromise.

this is a phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of covi-msc in treating post covid-19 "long haul" pulmonary compromise. covi-msc will be administered intravenously on day 0, day 2, and day 4.

Eligibility criteria:
inclusion criteria: * has had prior laboratory-confirmed sars-cov-2 infection as determined by an approved polymerase chain reaction (pcr) or an approved antigen test of any specimen * has had a recent (within a week) negative sars-cov-2 test (an approved pcr or antigen test) * has had at least moderate or severe post-covid-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-covid-19 status * willing to follow contraception guidelines exclusion criteria: * clinically improving pulmonary status over the month prior to screening * undergone a previous stem cell infusion unrelated to this trial * pregnant or breast feeding or planning for either during the study * suspected uncontrolled active bacterial, fungal, viral, or other infection * any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study * history of a splenectomy, lung transplant or lung lobectomy * concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Keywords: covid19 long haul post-acute covid