Kornimate/medical-research-clean huggingface dataset:
clinical study on the early bactericidal activity of sitafloxacin against mycobacterium abscessus disease

Conditions: Fluoroquinolone; Mycobacterium

Summary: this study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (eba) of sitafloxacin against mycobacterium abscessus disease. patients with mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. colony forming units (cfu) and time to positivity (ttp) in sputum cultures were analyzed and compared. by assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of mycobacterium abscessus disease.

this study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (eba) of sitafloxacin against mycobacterium abscessus disease. patients with mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. colony forming units (cfu) and time to positivity (ttp) in sputum cultures were analyzed and compared. by assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of mycobacterium abscessus disease. study medication: sitafloxacin 100mg qd for 14 days.

Eligibility criteria:
inclusion criteria: * (1) diagnosed or clinically diagnosed with mycobacterium abscessus pulmonary disease within 6 months prior to enrollment; (2) voluntarily participate in this study and sign the informed consent form; (3) agree to use contraception voluntarily. exclusion criteria: * (1) received glucocorticoids or immunosuppressants within 90 days prior to enrollment; (2) pregnant women or postpartum lactating women; (3) patients with evidence of fluoroquinolone resistance or allergy.

Keywords: mycobacterium abscessus sitafloxacin early bactericidal activity colony forming units time to positivity
docetaxel and radiation therapy in treating patients with stage ii or stage iii cancer of the larynx or hypopharynx

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. radiation therapy uses high-energy x-rays to kill tumor cells. giving docetaxel together with radiation therapy may kill more tumor cells. purpose: this phase ii trial is studying how well giving docetaxel together with radiation therapy works in treating patients with stage ii or stage iii cancer of the larynx or hypopharynx.

objectives: primary * determine the objective response of the primary tumor in patients with stage ii or iii squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy. secondary * determine the local relapse-free survival of patients treated with this regimen. * determine the larynx-preservation survival of patients treated with this regimen. * determine the overall survival of patients treated with this regimen. * determine the protocol completion rate in patients treated with this regimen. * determine the adverse effects of this regimen in these patients. outline: this is a multicenter study. patients receive docetaxel iv over 1 hour on days 1, 8, 15, 22, and 29 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33. projected accrual: a total of 25-50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the larynx or hypopharynx * stage ii or iii disease * solitary lymph node metastasis located in level ii-iii allowed * age 70 and over or meets 1 of the following criteria: * creatinine clearance 30-60 ml/min * history of platinum allergy * diagnosis of unstable angina * ineligible for systemic chemotherapy, including high-dose platinum-containing regimens patient characteristics: age * see disease characteristics performance status * ecog 0-2 life expectancy * not specified hematopoietic * wbc \> 3,000/mm\^3 * neutrophil count \> 1,500/mm\^3 * hemoglobin \> 10 g/dl * platelet count \> 100,000/mm\^3 hepatic * ast and alt ≤ 2.0 times upper limit of normal * bilirubin \< 2.0 mg/dl * no severe liver disease renal * see disease characteristics * creatinine clearance ≥ 30 ml/min * no severe renal disease pulmonary * no severe pulmonary disease other * no severe neurologic disease prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior systemic chemotherapy endocrine therapy * not specified radiotherapy * no prior radiotherapy surgery * no prior surgery

Keywords: stage ii squamous cell carcinoma of the hypopharynx stage ii squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the larynx
healthcare resource utilization in adults diagnosed with acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia (AML)

Summary: this was a non-interventional, retrospective registry study, utilizing electronic health record (ehr) data collected in the hospital district of helsinki and uusimaa (hus). real-world health care resource utilization (hcru) of aml patients was characterized.

adult patients (18 years or older) with the inclusion diagnosis, aml (icd-10 c92.0), between 1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion diagnosis) until the end of follow-up (30.6.2020), or death. this study did not involve any contacts to patients. the study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to 1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016.

Eligibility criteria:
inclusion criteria: * patients who are diagnosed with acute myeloid leukemia (icd-10 c92.0) during 1.1.2016-30.6.2020 * adult (18 years or older) at the time of first diagnosis * health registry data is available and accessible * resident in the hospital district hus at the time of index diagnosis exclusion criteria: - aml patients with no treatment information

Keywords: acute myeloid leukemia, midostaurin, healthcare resource utilization
change in penile length following bilateral nerve-sparing radical prostatectomy

Conditions: Prostate Cancer

Summary: some men complain of changes in the shape or dimensions of their penis after undergoing radical prostatectomy (removal of the prostate) for prostate cancer. changes in penile dimensions include shortening or decreased girth. changes in shape include a curvature or bending of the penis, and/or the appearance of indentation. these changes may be associated with formation of scar tissue involving the covering of the erection chambers, known as "plaque". the appearance of indurated plaque and a resultant curvature or indentation is a well described medical condition known as "peyronie's disease" and may occur in men who did or did not undergo radical prostatectomy. the purpose of this study is to evaluate these changes in penile shape and dimensions.


Eligibility criteria:
inclusion criteria: * males, age 21 years or older (no maximum age limit) * ability and willingness to give informed consent * clinically localized prostate cancer * open, laparoscopic or robotic-assisted radical prostatectomy * must be sexually active (penetrative or non-penetrative sexual encounters, either with a partner or self-stimulation) exclusion criteria: * preoperative / postoperative pelvic radiation therapy * preoperative / postoperative hormonal treatment * preoperative peyronie's disease * preoperative presence of a penile implant

Keywords: prostate erectile function peyronie's plaque 08-135
benefits of exchanging a double lumen tube to a proseal laryngeal mask or a single lumen tube after a thoracic surgery

Conditions: Cough; Laryngospasm; Apnea; Desaturation; Voice Hoarseness

Summary: the purpose of this study is to determine whether exchange of the double lumen tube before emergence with a laryngeal mask airway (proseal) or a tracheal tube will reduce cough at emergence.

intubation with a double lumen tube is often the preferred method to ensure isolation of the lung and proper exposition of the surgical site during thoracoscopies and thoracostomies. unfortunately, because of the length and diameter of the double lumen tube, it is known to cause more irritation in the upper airways thereby inducing cough at emergence. in turn, cough has been associated with numerous multisystemic complications. severe respiratory complications include laryngospasm or upper airway obstruction, desaturation, vocal cord injury, tracheal and bronchial ruptures. the purpose of this study is to determine whether exchange of the double lumen tube before emergence with a laryngeal mask airway (proseal) or a tracheal tube will reduce cough at emergence.

Eligibility criteria:
inclusion criteria: * 18-75 year old undergoing elective thoracic surgery * intubation with double lumen tube required * patients in category asa 1, 2, 3 exclusion criteria: * difficult intubation anticipated * presence of gastro-esophageal reflux * patients considered with a full stomach * body mass index \>30 * presence of nasogastric tube when exchange should be done * patients undergoing oesophagogastrectomy * allergy to any medication used in the study

Keywords: exchanging double lumen tube with laryngeal mask proseal exchange double lumen tube with tracheal tube exchange double lumen tube before emergence decrease cough thoracoscopy and postoperative respiratory complications thoracostomy and postoperative respiratory complications postoperative cough postoperative respiratory complications laryngeal mask and postoperative respiratory complications
study of cb-839 (telaglenastat) in combination with talazoparib in patients with solid tumors

Conditions: Solid Tumor; Clear Cell Renal Cell Carcinoma; TNBC - Triple-Negative Breast Cancer; Colorectal Cancer; CRC; RCC; ccRCC

Summary: this is a phase 1b/2 study to determine the recommended phase 2 dose (rp2d), safety and tolerability, pharmacokinetics (pk) and clinical activity of the glutaminase inhibitor cb-839 with the poly adenosine diphosphate ribose polymerase (parp) inhibitor talazoparib in participants with advanced/metastatic solid tumors.


Eligibility criteria:
inclusion criteria: (part 1) -documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to standard therapies of proven clinical benefit. (part 2) meets 1 of the 3 defined cohorts: * cohort 1: documented incurable/locally advanced or metastatic ccrcc * cohort 2: documented incurable/locally advanced or metastatic defined as er, pr negative (\<1%) and her2 negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization \[fish\] negative) * cohort 3: incurable/locally advanced or metastatic crc for both parts 1 \& 2: * recovery to baseline or ≤ grade 1 common terminology criteria for adverse events (ctcae) v.5.0 from toxicities related to the prior therapy * adequate renal, hepatic, and hematological function * per response evaluation criteria in solid tumours (recist) v1.1 evaluable disease (part 1) or measurable disease (part 2) * ability to provide written consent in accordance with federal, local and institutional guidelines * eastern cooperative oncology group (ecog) performance status of 0-1 exclusion criteria for both parts 1 \& 2: * prior treatment with cb-839 or a parp inhibitor * unable to received oral medications * active and/or untreated central nervous system metastasis. patients with treated brain metastases must have (1) documented radiographic stability of at least 4 weeks duration demonstrated on baseline central nervous system (cns) imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment. * major surgery within 28 days prior to first dose of study drug * receipt of any anticancer therapy within the following windows: small molecule tyrosine kinase inhibitor therapy (including investigational) within the prior 2 weeks or 5 half-lives prior to c1d1, whichever is longer; any type of anti-cancer antibody or cytotoxic chemotherapy within 4 weeks prior to c1d1; radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to c1d1; patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.

Keywords: tumor metabolism glutaminase inhibitor cb-839 telaglenastat talazoparib parp inhibitor dna damage dna repair homologous recombination deficiency hrd brca 1 brca 2
serum-derived bovine immunoglobulin /protein isolate (sbi) 5.0 g bid on nutritional status in subjects with ibs-d

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Summary: to evaluate the safety and effectiveness of oral nutritional therapy serum-derived bovine immunoglobulin (sbi) on nutritional status, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with ibs-d.

this is an open label study evaluating the impact of sbi 5.0 g twice daily on 1. nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio), 2. intestinal permeability (in vivo) and 3. mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines status in patients with ibs-d. plasma, duodenal and stool samples will be collected. fifteen eligible subjects will be enrolled to receive sbi for 8 weeks (sbi 5.0g bid for 8 weeks). intestinal permeability will be measured in vivo by two sugar urine excretion(s) after oral ingestion. biopsies from the distal second or third portion of the duodenum will be obtained endoscopically, to measure mrna expression of tight junction proteins and markers of immune function,

Eligibility criteria:
inclusion criteria: 1. age 18-65y 2. male or non-pregnant female 3. ibs by rome iii criteria with predominant symptom of diarrhea 4. baseline 14 day diary showing average of 2 days per week with \>3 bowel movements per day exclusion criteria: 1. intake of medications that interfere with the study 2. antibiotic within prior 2 weeks and throughout study 3. prior abdominal surgery except appendectomy 4. active gastrointestinal diagnosis other than ibs 5. history of allergy or intolerance to beef or to any ingredient in the investigational product 6. uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment 7. use of tobacco products within the past six months or nonsteroidal antiinflammatory drugs or aspirin within the past week (since they all may affect intestinal permeability) 8. bleeding disorders or medications that increase risk of bleeding from mucosal biopsies. 9. for two days prior to studies, patients are instructed to avoid ingestion of artificial sweeteners such as splenda trademark (tm) (sucralose), nutrasweet tm (aspartame), foods containing lactulose or mannitol.

Keywords: diarrhea irritable bowel syndrome
clearance of nrl972 in patients with cirrhosis and in healthy volunteers

Conditions: Hepatic Cirrhosis

Summary: a study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (nrl972)


Eligibility criteria:
inclusion criteria: subjects meeting the following conditions will be eligible for enrolment: general - all subjects 1. males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception) 2. caucasian 3. bmi: between 19 and 34 kg.m-2 4. bw: between 45 and 110 kg 5. willing and able to provide informed consent healthy volunteers (group n) 6. age: 18 - 40 years (inclusive) and \> 60 years 7. assessed as healthy based on the pre-study examination hepatic cirrhosis 8. age: 18 - 75 years 9. stable compensated liver cirrhosis (cryptogenic, posthepatic, alcoholic) with histo-logical or macroscopic (e.g. laparascopy, biopsy, ultrasound sonography or other adequate imaging techniques) confirmation exclusion criteria: subjects of any of the following categories will be excluded from enrolment: general - all subjects 1. previous participation in the trial 2. participant in any other trial during the last 90 days 3. donation of blood during the last 60 days or a history of blood loss exceeding 300 ml within the last 3 months 4. history of any clinically relevant allergy 5. presence of acute or chronic infection 6. uncontrolled diabetes mellitus 7. resting systolic blood pressure \> 160 or \ 95 or \< 50 mmhg 8. clinically relevant ecg-abnormalities, prolonged qtc with \> 450 msec in males and \> 460 msec in females in particular 9. positive hiv test 10. positive alcohol or urine drug test on recruitment 11. daily use of \> 30 gr alcohol 12. smoking more than 15 cigarettes/day or equivalent of other tobacco products 13. use of prohibited medication 14. suspicion or evidence that the subject is not trustworthy and reliable 15. suspicion or evidence that the subject is not able to make a free consent or to under-stand the information in this regard general - all females 16. positive pregnancy test 17. lactating 18. not using appropriate contraception in premenopausal women all healthy subjects 19. presence or history of any relevant comorbidity 20. presence of any relevant abnormality in the laboratory safety tests, especially low hemoglobin, increased liver enzymes, reduced serum creatinine 21. positive serology for hbsag, anti hbc and anti hcv 22. history of alcohol and/or drug abuse patients with hepatic disease 23. biliary liver cirrhosis 24. liver impairment due to space-occupying processes (e.g. carcinoma) 25. state after liver transplantation or patient scheduled for liver transplantation
stratification of patients with chronic liver disease using multi spectral ct

Conditions: Chronic Liver Disease; HepatoCellular Carcinoma; Liver Fibrosis

Summary: the purpose of this study is to evaluate the feasibility to stratify liver fibrosis in patients with chronic liver disease through non-invasive, spectral ct.

this is a retrospective study, in which a fda approved imaging device (spectral ct scanner) currently used for several clinical applications will be evaluated for feasibility of studying chronic liver disease (this application has not yet been validated). tomographic imaging has assumed a fundamental role in patients with chronic liver disease (cld) to screen patients for hepatocellular carcinoma (hcc), and, is increasingly being explored as a noninvasive alternative for characterizing liver fibrosis. the overarching goal of this study is to improve noninvasive characterization of liver fibrosis through spectral ct. hypothesis: concentration of iodine-based contrast agent in the liver parenchyma during the delayed phase, as measured with spectral ct imaging, increases monotonically with ishak fibrosis score obtained from liver biopsy. this hypothesis is supported by the literature and our preliminary data, described in the references section (lamb et al. 2015). we will evaluate multiphase spectral ct images consisting of the arterial phase, 2-minute delayed phase, and 5-minute delayed phase. fibrosis will be assessed on both delayed phase images, where it is assumed that any remaining contrast agent, in the liver, is due to the presence of fibrosis. this type of multiphase protocol can still be used to image cld patients with spectral ct for hcc detection and, thus, will not interfere with liver lesion workup and evaluation.

Eligibility criteria:
inclusion criteria: * adult patient with chronic liver disease undergoing ct scan for/suspicion of hepatocellular carcinoma. * patients should be scheduled for/or should have obtained a multiphasic mri of the liver. exclusion criteria: * patients \< 18 years old. * history of allergy to intravenous contrast. * patients at risk for contrast-induced-nephropathy, * pregnant patients.

Keywords: liver disease multi spectral ct
effect of ursolic acid of loquat extract on function of muscle

Conditions: Sarcopenia

Summary: this randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of ursolic acid of loquat extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of loquat extract per day or a placebo for 12 weeks.

this randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of ursolic acid of loquat extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of loquat extract per day or a placebo for 12 weeks. change over time in muscle fuction was evaluated by four outcomes: assessment of appendicular skeletal mass using dexa (dual energy x-ray absorptiometry); quadriceps muscle power by biodex; hand grib power; and short physical performance battery, sppb.

Eligibility criteria:
inclusion criteria: * bmi 18.5-30kg/m2 exclusion criteria: * \> serum creatinine 1.2mg/dl * \> ast or alt 60iu/l * dm patients
cd7 car-t for patients with r/r cd7+ t-all/t-lbl

Conditions: Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Hematologic Diseases

Summary: this is a single-arm, open-label, single-center, phase i study. the primary objective is to evaluate the safety of cd7 car-t therapy for patients with cd7-positive relapsed or refractory t-all/lbl, and to evaluate the pharmacokinetics of cd7 car-t in patients.


Eligibility criteria:
inclusion criteria: 1. age 3-70 2. diagnosis of r/r t-all/lbl. 3. cd7 positive expression 4. bone marrow lymphoblasts ≥5% by morphologic evaluation at screening 5. creatinine clearance (as estimated by cockcroft gault) ≥ 60 ml/min, serum alanine aminotransferase(alt)/aspartate aminotransferase(ast) \< 3×upper limit of normal, total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl 6. left ventricular ejection fraction ≥ 50% . 7. baseline oxygen saturation ≥ 92% on room air. 8. ecog performance status of 0 to 2. 9. the estimated survival time is more than 3 months. 10. subjects or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: 1. sujects with concomitant genetic syndromes associated with bone marrow failure states. 2. sujects with some cardiac conditions will be excluded. 3. history of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. 4. history of malignancy other than non-melanoma skin cancer or carcinoma. 5. primary immune deficiency. 6. presence of uncontrolled infections. 7. sujects with some anticancer therapy before car-t infusion will be excluded. 8. active uncontrolled acute infections. 9. known history of infection with human immunodeficiency virus (hiv); active or latent hepatitis b, hepatitis c and syphilis. 10. subjects who are receiving systemic steroid therapy prior to screening. 11. subjects with acute graft-versus-host disease (gvhd) 12. having received live/attenuated vaccine within 4 weeks prior to screening. 13. history of allergy to any component of the cell therapy product. 14. pregnant or breastfeeding women 15. any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.