Kornimate/medical-research-clean huggingface dataset:
phase 2 study of kh903 in patients with advanced gastric or gastroesophageal junction adenocarcinoma as second-line therapy

Conditions: Gastric Cancer; Gastroesophageal Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of the study drug known as kh903 in participants with gastric and gastroesophageal cance


Eligibility criteria:
inclusion criteria: * 1.prior to any detailed procedures of this study, subjects are able to understand, voluntarily participate in and sign the informed consent approved by the ethics committee. * 2.age ≥ 18 years. * 3.histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma . * 4.have at least 1 measurable lesion based on response evaluation criteria in solid tumors (recist), version 1.1. * 5.have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum or/and fluoropyrimidine doublet for unresectable or metastatic disease.second line chemotherapy is suitable for paclitaxel. * 6.laboratory test values must meet the following criteria. anc ≥1.5×109/l, platelets ≥ 100×109/l, hemoglobin≥9g/dl. blood creatinine ≤ 1.5 ×uln or creatinine clearance ≥ 50 ml/min/m2. total bilirubin ≤ 1.5× uln(≤ 3 x uln if gilbert disease), ast and alt ≤ 2.5× uln (≤ 5×uln if hepatic metastasis). inr ≤ 1.5× uln, aptt ≤ 1.5× uln. dipstick proteinuria \<2+ or 24 hour proteinuria \<1g . * 7.good performance status eastern cooperative oncology group (ecog) performance status (ps) 0 to 1. * 8.life expectancy of ≥ 3 months. exclusion criteria: * 1.histologically confirmed squamous cell carcinoma or undifferentiated gastric cancer. * 2.patients with disease progression within 6 months after previous adjuvant or neoadjuvant chemotherapy with paclitaxel, or patients with recurrent or metastatic gastric adenocarcinoma or gej adenocarcinoma treated with paclitaxel. * 3. gi perforation and/or fistulae in the 6 months preceding randomization. * 4.deep-vein thrombosis, pulmonary embolism (pe), or any other episode of uncontrolled thromboembolism in the 6 months preceding randomization. * 5.any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) * 6.uncontrolled hypertension (≥150/100 mm hg ) despite properly observed antihypertensive therapy. * 7.known brain metastasis. * 8.known allergy to paclitaxel or kh903. * 9.serious concurrent infection or medical illness. * 10.active hepatitis b virus or active hepatitis c virus (hcv) infection at screening. * 11.any condition which results in an undue risk for the patient during the trial participation according to the investigator.
physiological biomarkers of cancer treatment related fatigue in women with breast cancer.

Conditions: Breast; Cancer

Summary: physiological biomarkers of cancer treatment related fatigue in women with breast cancer.

as above.

Eligibility criteria:
inclusion criteria: * newly diagnosed early stage breast cancer. exclusion criteria: * not specified.
clinical, biological and histological pulmonary and renal damage associated with the sars-cov-2 syndrome in patients admitted in icu

Conditions: Acute Respiratory Distress Syndrome

Summary: renal damage in patients hospitalized for ards in the icu can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries. the researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe covid19 infections in ards: clinical, biological and histological (by performing post-mortem biopsies). translated with www.deepl.com/translator (free version)


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * diagnosed covid-19 by rt pcr * hospitalized in intensive care for management of complications related to covid-19 from march 1, 2020 to april 20, 2020 * patient not having expressed his or her opposition, after information, to the re-use of his or her data for the purposes of this research. exclusion criteria: - subject who expressed opposition to participating in the study

Keywords: ards covid-19 sars-cov-2 inflammatory cytokine sepsis icu tbular necrosis ischemia pulmonary damage renal damage kidney damage
an observational study of case managed versus non-case managed initiation of hemodialysis

Conditions: Chronic Kidney Disease

Summary: the purpose of the study is to compare the 90 day and 12 month composite end point of death (all-cause mortality) and hospitalization in incident hemodialysis patients randomized to receive support from a dedicated case manager (intervention group) versus those not receiving support from a dedicated case manager (control group).

this is multicenter, prospective, observational, and randomized (the study drug is assigned by chance), 1-year study, in academic and community-based nephrology clinical practices that will examine the impact of a facility nurse case manager. in this study a group of patients guideline- based, algorithm- driven approach to hemodialysis initiation with targets (as per canadian society of nephrology and/or international guidelines) will be used with facility nurse case manager and in control group same approach will be used without facility nurse case manager. patients will be treated with any approved erythropoiesis stimulating agent for the correction of anemia, according to guidance in the current approved product monographs. all treatments will be prescribed by the physician according to actual clinical practice or standard of care for chronic kidney disease. the entire study duration for each participant will be approximately 12 months.

Eligibility criteria:
inclusion criteria: * patients who initiated hemodialysis and expected to be on hemodialysis for at least 1 year * patients initiating hemodialysis requiring treatment (erythropoiesis stimulating agent or red blood cell transfusion) to correct the anemia of chronic kidney disease who are receiving erythropoiesis stimulating agent treatment at study entry or patients who do not require erythropoiesis stimulating agent therapy (hb within or above target range) * life expectancy should be more than 12 months exclusion criteria: * patients contraindicated to receive erythropoiesis stimulating agent therapy (including but not limited to patients who develop pure red cell aplasia following treatment with any erythropoiesis stimulating agent ) * patients entering the study on any other agent to increase red blood cell mass (such as androgen therapy, or investigational agents, or other non-approved erythropoiesis stimulating agent) * patients unwilling or unable to receive erythropoiesis stimulating agent therapy to correct the anemia of chronic kidney disease * patients with uncontrolled hypertension * patients who for any reason cannot receive adequate antithrombotic treatment

Keywords: chronic kidney disease hemodialysis eprex aranesp esa anemia
bone intake proteins and muscle mass deficiency in proximal femur fractures

Conditions: Femoral Neck Fractures; Pertrochanteric Fracture; Bone Resorption; Bone Loss; Muscle Loss; Muscle Damage

Summary: the aim of this clinical trial is to compare serum concentration of bone intake proteins \[ sex hormone-binding globulin (shbg), cross linked c-telopeptide of type i collagen (ctx-i)\] and muscle atrophy marker \[creatine kinase (ck-mb)\] between patients after the fracture of proximal femur and their age corresponding counterpart without the fracture. the main question it aims to answer is: • is the higher concentration of bone intake proteins and muscle atrophy marker a predictive factor of proximal femur fracture? the part of participants (group 1) will be hospitalized at the department of orthopaedics and rehabilitation and will undergo a surgical treatment (open reduction of the fracture). the rest (group 2) will be admitted to the department of internal medicine. participants of both groups will have the blood sample test taken, to evaluate and compare the serum concentration of shbg, ctx-i and ck-mb proteins.


Eligibility criteria:
inclusion criteria: * age over 65 * proximal femur fracture (group 1) exclusion criteria: * neoplasmatic history in the anamnesis, * prevalent fracture * mental illness * immune disease affecting protein balance

Keywords: proximal femur fracture femoral neck fracture pertrochanteric fracture bone intake proteins bone resorption bone loss muscle damage muscle loss
thumb carpometacarpal joint denervation versus trapeziectomy

Conditions: Thumb Osteoarthritis

Summary: this is a prospective study tracking the outcomes of patients who undergo either of two treatments for thumb carpo-metacarpal joint arthritis: trapeziectomy with ligament reconstruction (lrti) or denervation.

a total of 100 patients with carpo-metacarpal (cmc) arthritis will be enrolled in the study. the design of the study is a prospective non-blinded, non-randomized control study. enrollment will occur at the time of initial clinic visit. all patients presenting with cmc arthritis and deemed appropriate for surgery will be considered for screened for inclusion. as a part of routine workup for cmc arthritis patients receive a hand xray. specific attendings will perform their preferred technique for cmc arthritis: two perform denervation of the cmc joint, and two perform trapeziectomy with ligament reconstruction tendon-interposition (lrti) only per their normal clinical practice. pre-operative and peri-operative care will be unchanged from standard patient care. both procedures are outpatient procedures, usually performed under regional anesthesia and patients go home the same day. patients are discharged with a standard thumb spica splint which is removed on their first clinic appointment which is generally post-operative day 7. patients enrolled in the study will have additional follow up at the 3, 6, 12 and 24 month time points. at the 3, 6, 12 and 24 month time points patients will be asked to come to clinic for evaluation with 1) a standard hand questionnaire the michigan hand questionnaire, 2) lateral pinch strength, grip strength and range of motion testing, 3) kapandji score, 4) visual analog pain scale. each visit will take approximately 15 minutes. patients who are unable to follow up in clinic will be given a phone questionnaire with the michigan hand questionnaire, visual analog pain scale and opiate usage. there is no monetary compensation for participation in the study.

Eligibility criteria:
inclusion criteria: * adult men and women (\>18 years of age) no prior traumatic thumb injuries (fractures, dislocation) no concurrent thumb procedures scheduled eaton/littler stage 2-4 osteoarthritis9 minimal cmc joint subluxation on x-ray exclusion criteria: * traumatic thumb injury (fracture, dislocation) prior thumb surgery proximal to the interphalangeal joint. non-fluent english speaking planned concurrent procedures on the thumb eg ganglion removal, trigger thumb release
evolution of dyspnea after bariatric surgery in patient with obesity

Conditions: Obesity

Summary: obesity, defined as a body mass index greater than or equal to 30 kg/m2, represents a significant public health issue. dyspnea is a very common and crippling symptom in obesity. about 80% of people with obesity experience dyspnea in daily living. bariatric surgery has been demonstrated to be an excellent treatment for obesity by inducing significant weight loss. nevertheless, changes in dyspnea in daily living after bariatric surgery and the links between variations in dyspnea and lung function tests after bariatric surgery have not been previously investigated.

the objective of this study was to determine if bariatric surgery is associated with an improvement of dyspnea in daily living according to the mmrc scale in patients with obesity.

Eligibility criteria:
inclusion criteria: * obesity * scheduled bariatric surgery exclusion criteria: - age \< 18 years old

Keywords: obesity dyspnea bariatric surgery
lidocaine prilocaine spray in reducing pain during hysterosalpingography in women with primary infertility

Conditions: Infertility, Female

Summary: we aim to assess the safety and efficacy of cervical lidocaine prilocaine spray in reducing pain during hysterosalpingography in women with primary infertility

we aim to assess the safety and efficacy of cervical lidocaine prilocaine spray in reducing pain during hysterosalpingography in women with primary infertility.

Eligibility criteria:
inclusion criteria: * women aged 18-45 years. diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for hsg as part of infertility evaluation. exclusion criteria: * known allergy or hypersensitivity to lidocaine, prilocaine, or any components of the spray. * current pregnancy or suspicion of pregnancy. * active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months. * use of systemic analgesics, sedatives, or anesthetics within 24 hours prior to the procedure.
effect of transcranial direct-current stimulation therapy on primary chronic insomnia patients

Conditions: Primary Insomnia

Summary: to evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tdcs) in the patients with primary chronic insomnia .

* visit 1 * to fill in a questionnaire (clinical global impression, cgi; leeds sleep evaluation questionnaire, lseq; stanford sleepiness scale, sss; hospital anxiety and depression scale, hads; 36-item short form survey, sf-36) * eeg * visit 2-6 * tdcs stimulation (monday \~ friday) * anodal / cathodal / sham * to fill in a questionnaire (cgi, lseq, sss, hads) * analysis the results of sleep log and actigraphy * visit 7 : 1 week after treatment * to fill in a questionnaire (cgi, lseq, sss, hads) * analysis the results of sleep log and actigraphy * eeg * visit 8 : 1 month after treatment * to fill in a questionnaire (cgi, lseq, sss, hads, sf-36) * analysis the results of sleep log

Eligibility criteria:
inclusion criteria: * adult (older than 19 years) * primary insomnia * right handed * agree with participation of this study exclusion criteria: * diagnosed with epilepsy or history of seizure * change of antipsychotic drug within 1 month * under suspicion of sleep apnea or periodic limb movement disorder * mental retardation (iq \< 70) * pregnant woman
89zr-kn035 pet imaging in patients with advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: this is a single arm study by using 89zr-labeled kn035 (89zr-kn035) pet imaging to evaluate the biodistribution and target lesion uptake of 89zr-kn035 in patients with pd-l1 positive advanced solid tumors.

the overall purpose of the study is to evaluate the biodistribution and target lesion uptake of 89zr-kn035 in patients with pd-l1 positive advanced solid tumors by using pet imaging. safety will be observed after 89zr-kn035 injection, and radiation dosimetry of 89zr-kn035 will be calculated.

Eligibility criteria:
inclusion criteria (main): 1. patients voluntarily signed informed consent; 2. age 18-75, male or female; 3. patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology; 4. patients with biopsy-proven pd-l1 positive; 5. ecog score ≤ 0\~1; life expectancy of at least 3 months; 6. women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects. exclusion criteria(main): 1. currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. if participating in a non-interventional clinical trial, it is not be excluded. 2. patients with systemic or locally severe infections (ctcae ≥ 2); 3. patients with allergies or allergies to any component of the imaging agent or antibody; 4. patients who cannot undergo pet/ct imaging; 5. intolerance of intravenous administration, as well as difficulties in venous blood collection (if having the medical history of fainting during acupuncture, and blood phobia); 6. symptomatic congestive heart failure (nyha class ii-iv) or symptomatic or poorly controlled arrhythmia; 7. patients have significant qt/qtc interval prolongation during the screening period; 8. received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose; 9. patents have not recovered to ctcae grade 0 or 1 from the adverse events due to cancer therapeutics administered; 10. previously received cd137 agonist or immune checkpoint blocking therapy; 11. patients with diabetes who have a fasting blood glucose greater than 10 mmol/l; 12. hiv antibody positive, active hepatitis b/c, and tb positive; 13. patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol); 14. patients with symptomatic ascites, pleural effusion, or hydropericardium; 15. pregnant or lactating women, or planning to become pregnant or have children during this trial.

Keywords: 89zr pd-l1 kn035 pet
the ablate-by-law study

Conditions: Atrial Fibrillation

Summary: of all the determinants of lesion creation during atrial fibrillation (af) ablation, left atrial wall thickness (lawt), as measured with multi-detector cardiac tomography (mdct) is one key element that has been evaluated in some retrospective analyses but is not yet used per protocol to modulate the radiofrequency delivery. adapting ablation index (ai) to lawt would be very useful in standardising the ablation procedure with parameters fitted to every patient, enabling the development of a personalized approach that will both: i) increase efficacy by performing transmural lesions to prevent the formation of conduction gaps in the initial lesion set, and ii) increase safety by preventing excessive rf delivery on thin wall areas related to procedural complications, such as cardiac perforation or atrio-esophageal fistula. the investigators sought to evaluate the feasibility, safety, efficacy and reproducibility of guiding af ablation procedures with the integrated mdct-derived lawt information.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * indication for paroxysmal atrial fibrillation ablation. * signed informed consent. exclusion criteria: * age \< 18 years. * pregnancy. * previous af ablation procedure (redo).

Keywords: atrial fibrillation catheter-based ablation radiofrequency ablation pulmonary vein isolation left atrial wall thickness multidetector cardiac tomography
a 12 month core study to assess the efficacy and safety of ranibizumab (intravitreal injections) in patients with visual impairment due to diabetic macular edema and a 24 month open-label extension study

Conditions: Diabetic Macular Edema

Summary: crfb002d2301: the core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema. crfb002d2301e1: a 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.


Eligibility criteria:
inclusion criteria: * visual acuity impairment * diabetic macular edema in at least one eye * type 1 or type 2 diabetes mellitus * medication for the diabetes treatment must be stable for the last 3 months exclusion criteria: * patients with uncontrolled systemic or ocular diseases * laser photocoagulation in the study eye for the last 3 months * any history of any intraocular surgery in the study eye within the past 3 months * blood pressure \> 160/100 mmhg extension inclusion criteria: -completion of the core study

Keywords: dme diabetic macula edema ranibizumab restore
efficacy assessment and monitoring of subcutaneous infliximab levels.

Conditions: Inflammatory Bowel Diseases

Summary: retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored. treatment is prior to and independent of the patient's participation in the study and is governed by clinical judgment criteria and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice. patients are older than 14 years who suffer from inflammatory bowel disease and who receive remsima as routine treatment. the source of information will be the patient's medical history.

Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease. * over 14 years old. * receive remsin as a treatment for his disease. and always this treatment that the patient is going to receive is governed by the criteria of clinical judgment and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice. exclusion criteria: * patients with inflammatory bowel disease under 14 years of age. * or older than this age with inflammatory bowel disease who do not attend the established check-ups