Kornimate/medical-research-clean huggingface dataset:
a phase 1 dose escalation study of zg006 in patients with small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this is a multi-center, open-label, phase 1 clinical study of zg006 in the us for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. during the dose escalation stage, a standard "3+3" design will be used to assess the mtd/ recommended dose for the subsequent studies.


Eligibility criteria:
inclusion criteria: * small cell lung cancer (sclc), who failed or intolerant to available standard treatments; * tissue sample positive for dll3 expression; * life expectancy ≥ 3 months; * eastern cooperative oncology group (ecog) performance status of 0 or 1; * female and male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug. exclusion criteria: * patients having received any of the following treatments: * chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry; * systemic immunosuppressive medications, such as corticosteroid (doses \&gt; 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry; * use of any vaccines against viral infections (covid-19, influenza, varicella, etc.) within 4 weeks of study entry; * patients received any blood transfusion, epo, g-csf, albumin infusion and renal replacement therapy within 14 days prior to study entry; * a history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment; * active infection (such as acute bacterial infection, tuberculosis, active hepatitis b/c, active syphilis, or active human immunodeficiency virus infection); * known allergy to other mabs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins; * a female who is pregnant or nursing; * patients were deemed unsuitable for participating in the study by the investigator for any reason.
immunohistochemical & immunoblot analysis of nis (na+/i-symporter) in archival & frozen tissue sample

Conditions: Breast Cancer; Stomach Neoplasms; Salivary Gland Neoplasms; Thyroid Cancer

Summary: the goal of this study is to study nis expression in benign and malignant breast and thyroid samples using archival formalin-fixed paraffin-embedded tissue sections.

the objective of the study is to further understanding of proteins that occur in both normal cells and tumor cells and to learn more about certain diseases and potential alternative treatments for these diseases.

Eligibility criteria:
inclusion criteria: 1. patient must be over the age of 18. 2. patients must have benign and malignant breast and thyroid cancer. 3. patient mus sign consent form. exclusion criteria: 1. no children will be allowed.
technology assisted rehabilitation for upper limb function in myotonic dystrophy type 1

Conditions: Myotonic Dystrophy Type 1 (DM1)

Summary: myotonic dystrophy type 1 (dm1) is a genetic multisystem disease causing muscle weakness and myotonia. as a result, upper limb function might become impaired. there are little research regarding rehabilitation and exercise for upper limb function in dm1. it is known from research on lower limb function in dm1 and other muscular dystrophies, that there are possibilities to improve function also in these deteriorating diseases. in this single subject experimental design study, 6-10 adults with dm1, who are at an inpatient rehabilitation center, will get intensive, but personally adapted senso- and robot assisted rehabilitation for arm- and hand function with tyromotion amadeo and armeo senso. these devices have previously been used in rehabilitation research for other neurological conditions. the participants will be followed up, and evaluated at a weekly basis, using video consultations. fine motor skill dexterity test (9hpt) and the nut and bolt test will be used, and active range of motion (rom) and muscle strenght and movement of upper limb will be measured. furthermore, patient reported outcome measures (proms) on hand impairment and myotonia will be used, all with purpose to evaluate upper limb function.


Eligibility criteria:
inclusion criteria: * granted rehabilitation at vikersund rehabilitation center genetical confirmed myotonic dystrophy diagnosis mirs score between 2-5 exclusion criteria: * mirs score on 1 reduced cognitive function and unable to participate in technological rehabilitation and digital evaluation
efficacy and safety study of deferasirox in patients with non-transfusion dependent thalassemia

Conditions: Non-transfusion Dependent Thalassemia

Summary: assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. provided further assessment of the long-term efficacy and safety of deferasirox in ntdt patients with iron overload (lic ≥ 5 mg fe/g liver dw and sf ≥ 300 ng/ml) for up to 260 weeks.


Eligibility criteria:
inclusion criteria: non-transfusion dependent congenital or chronic anemia inclusive of beta-thalassemia intermedia, hbe beta-thalassemia or alpha-thalassemia intermedia (hbh disease)/ liver iron concentration \>/= 5 mg fe/g dw serum ferritin \>/= 300 ng/ml exclusion criteria: hbs-beta thalassemia, anticipated regular transfusion program during the study, blood transfusion 6 months prior to study start, significant proteinuria, creatinine clearance \ uln, alt \>5 x uln, active hepatitis b or c, cirrhosis pediatrics only: a patient's weight of at least 20 kg is required to allow dosing of 5 mg/kg with one tablet of 125 mg

Keywords: non-transfusion dependent thalassemia ntdt deferasirox icl670 lic liver iron concentration
a study of the safety and pharmacokinetics of sar245408 tablets in patients with solid tumors or lymphoma

Conditions: Neoplasm Malignant

Summary: primary objective: - to assess the safety, tolerability and plasma pharmacokinetics (pk) of sar245408 given once daily as a tablet formulation of polymorph e in subjects with solid tumors or lymphoma.

screening: 1 to 28 days study treatment period: two 28-day cycles (56 days) end-of-treatment visit: no later than 7 days after the last study drug administration subjects not eligible for treatment continuation after cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration subjects eligible for treatment continuation after cycle 2 will be offered the opportunity to enroll in the treatment-extension study ted12414. total duration of study participation for each patient: 58 to 118 days.

Eligibility criteria:
inclusion criteria : * solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma (including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which standard therapies are no longer effective or there are no therapies known to prolong survival or patient cannot tolerate or has contra-indication for a standard therapy and there is no alternative therapies. * male or female patient \> or = 18 years old. * weight \> or = 40 kg. * eastern cooperative oncology group performance status \< or = 1. * adequate white blood cells, platelets, and haemoglobin. * adequate liver and kidney functions. * fasting plasma glucose \< 8.9 mmol/l. * sexually active patients using adequate contraception. * women of child-bearing potential with negative pregnancy test. exclusion criteria: * lymphoma involving the gastrointestinal tract. * prior treatment with cytotoxic chemotherapy (including investigational agents) or biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or nitrosoureas or mitomycin c within 6 weeks, before the first dose of study drug. * prior treatment with a small-molecule kinase inhibitor (including investigational agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever is longer, before the first dose of study drug. * any other investigational therapy within 4 weeks before the first dose of study drug. * intolerance to prior treatment with a pi3k inhibitor. * prior anticancer hormonal therapy within 2 weeks before the first dose of study drug. * prior radiation therapy within 2 weeks before the first dose of study drug. * uncontrolled brain metastases or primary brain tumor. * hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (hiv) infection. * positive serologies for hepatitis b surface antigen (hbsag) or anti-hepatitis c virus (anti-hcv) antibodies. * patient is pregnant or breastfeeding. * history of gastrointestinal surgery, or presence of gastrointestinal abnormality or disease, that may affect the pharmacokinetics of study drug. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of allopurinol on left ventricular function in children with dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: the aim of this study is to detect effect of allopurinol supplementation in pediatric patients with dilated cardiomyopathy.

dcm as a serious cardiac disorder in which structural or functional abnormalities of the heart muscle can lead to substantial morbidity and mortality owing to complications such as heart failure and arrhythmia among patients with heart failure (hf), elevated serum uric acid levels and increased oxidative stress have been associated with increased mortality, implicating xanthine oxidase as a possible therapeutic target xanthine oxidase (xo), a superoxide-generating enzyme, is up regulated in animals (6,7) and in humans with heart failure. acute administration of the xo inhibitor allopurinol improves the mechanical efficiency of the failing heart ), whereas oxygen consumption paradoxically decreases. direct xo inhibition in cardiac muscle leads to increased force generation by the myofilaments at any given level of activator calcium(10). allopurinol, an inhibitor of xanthine oxidase, may be a novel therapeutic agent for hf. allopurinol reduces uric acid levels, prevents acute gout, and acts as an anti oxidant, which could be beneficial among hf patients(5)

Eligibility criteria:
inclusion criteria: 1 - children (1-16) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy, who attend pediatric cardiology unit 2-children attend to pediatric cardiology out patient clinic in assiut university children hospital 3-children with no allergic reaction from allopurinol exclusion criteria: 1. children with impaired left ventricular systolic function due to other causes like congenital heart diseases 2. children with acquired heart diseases 3. patients with allergic reaction or contra indicated from allopurinol
the role of noncontrast computed tomography markers in predicting the clinical outcome of cerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: the goal of this observational study is to to investigate the ability of noncontrast computed tomography to predict clinical prognosis in intracerebral hemorrhage. the main question it aims to answer is:how to judge the prognosis of patients with cerebral hemorrhage by ct image reading at admission.


Eligibility criteria:
inclusion criteria: 1. age≥18 years 2. had completed a ct examination within 24 h of disease onset; 3. had a hemorrhage that was located in the brain parenchyma, including the basal ganglia, thalamus,brain lobes, brainstem, and cerebellum. exclusion criteria: 1. had secondary ich caused by brain trauma,cerebrovascular malformations, aneurysms, and tumors; 2. had ischemic cerebral infarction hemorrhagic transformation; 3. had undergone surgical treatment (e.g.hematoma removal or puncture drainage) before the ct examination; 4. had images of poor quality that could notbe accurately evaluated; 5. had a hematoma withborders that could not be delineated, thus precluding delineation of the region of interest (roi).

Keywords: ich
artificial intelligence in computed tomography for quantifying lung changes of bronchiectasis patients

Conditions: Bronchiectasis

Summary: bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.the incidence and prevalence of bronchiectasis have assumed continuously grows in global. chest computed tomography (ct) remains the imaging standard for demonstrating cystic fibrosis (cf) airway structural disease in vivo. however, visual scoring systems as an outcome measure are time consuming, require training and lack high reproducibility. our objective was to validate a fully automated artificial intelligence (ai)-driven scoring system of cf lung disease severity.


Eligibility criteria:
inclusion criteria: * patients diagnosed with bronchiectasis (according to the chinese consensus, patient's previous chest ct examination must show bronchiectasis) exclusion criteria: * patients with ct data and medical records missing

Keywords: bronchiectasis machine learning artificial intelligence
clinical significance of retinal emboli during diagnostic and therapeutic cardiac catheterization

Conditions: Cardiac Catheterization; Retina; Embolism

Summary: retinal emboli is a common phenomenon in cardiac catheterization. in this study the investigators evaluate the incidence of retinal emboli post diagnostic and therapeutic cardiac catheterization over 300 patients. the incidence was 6.3% and had no clinical sequel on visual acuity and visual field.

background and purpose cardiac catheterization may cause retinal embolization, a risk factor for cerebrovascular emboli and stroke. we describe the incidence of clinically silent and apparent retinal emboli following diagnostic and interventional coronary catheterization and associated risk factors. methods three hundred selected patients attending a tertiary referral center for diagnostic and therapeutic cardiac catheterization were studied. direct retinal examination and examination of the visual field and acuity were done before and after catheterization by a retinal specialist.

Eligibility criteria:
inclusion criteria: * every patient with diagnostic and therapeutic cardiac catheterization exclusion criteria: * patient refusal to follow up ophthalmology * abscence of coronary disease in angiogram * abnormal retinal angiogram prior to study

Keywords: catheter coronary artery disease embolus stroke retinal emboli
rasi for preventing postoperative recurrence of stage ii/iii colon cancer

Conditions: Colon Cancer (Stage II &Amp;Amp; III)

Summary: the goal of this retrospective cohort study is to learn about the long-term effects of renin-angiotensin system inhibitors (rasi) in preventing patients with hypertension and stage ii/iii colon cancer from recurrence and metastases after radical resection. the main question it aims to answer is: does rasi improve the 3-year disease-free survival of patients with hypertension and stage ii/iii colon cancer after surgery? participants with hypertension and already having radical resection of stage ii/iii colon cancer will be followed up for 3 years.

previous studies have shown that renin-angiotensin system inhibitors (rasi) may reduce postoperative recurrence and metastases of colorectal cancer. however, the relevant clinical evidences were low level and controversial. this study retrospectively collect patients with hypertension and stage ii/iii colon cancer after radical resection, and compare the patients with vs. without rasi in terms of long-term oncological outcomes, to study the inhibitory effect of rasi on recurrence and metastasis.

Eligibility criteria:
inclusion criteria: 1. inferior tumor edge \> 15 cm from anal verge; 2. received radical resection of primary tumor; 3. pathological proved stage ii or stage iii adenocarcinoma; 4. no evidence of distant metastases at time of surgery (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, ct, mri, pet-ct, intraoperative exploration, etc; 5. combined with hypertension at time of surgery; 6. no other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri; 7. informed consent. exclusion criteria: 1. emergency surgery for acute intestinal obstruction, bleeding, perforation, etc; 2. multiple primary colorectal cancer; 3. hereditary colorectal cancer (familial adenomatosis polyposis, lynch syndrome, etc.); 4. co-existent inflammatory bowel disease; 5. pregnancy or lactation; 6. received any of preoperative anti-cancer treatment.

Keywords: renin-angiotensin system inhibitor colon cancer disease-free survival
safety and accuracy of alveoscopy in interstitial lung diseases

Conditions: Respiratory Tract Diseases

Summary: fibered confocal fluorescence microscopy (fcfm), also referred to as cell-vizio® (maunakea technologies, france) is a new technique that produces microscopic imaging in a living tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope. the system produces real-time imaging of endogenous fluorophores with a 5 µm lateral resolution and a field of view of 600 x 600 µm. fcfm is able to produce dynamic, high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in vivo during endoscopy (a procedure termed as alveoscopy). the hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases. the goals of this french phase ii trial are: * to evaluate the tolerance of the alveoscopy * to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects * to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases

the study will include 40 healthy smoker or non-smoker volunteers, 20 patients with normal chest ct scan and normal respiratory function tests, and 90 patients with focal or diffuse peripheral lung diseases. the alveoscopy will be performed under local anesthesia, in awake patients during a standard bronchoscopy. the alveoscopy will be performed on one side of the bronchial tree (left or right lung). two to ten separate bronchial areas will be explored in each patient, depending on the pathology, focal or diffuse, and the underlying respiratory function. a continuous monitoring of the oxygen saturation, blood pressure, ekg will be performed during the procedure. a chest x-ray will be performed after the procedure to eliminate a pneumothorax. the morphometric parameters of the alveolar microstructure and their variability will be studied according to the age, gender, lung area explored, smoking status in healthy volunteers and "normal ct scan" subjects, as well as in patients with peripheral lung diseases.

Eligibility criteria:
inclusion criteria: * healthy volunteers: normal chest x-rays and normal lung function tests * patients without parenchymal lung diseases: normal chest computed tomography (ct) scan, normal lung function tests, indication for a bronchoscopy * patients with parenchymal lung disease: indication for a bronchoscopy * written informed consent for the alveoscopy exclusion criteria: * bleeding disorders * pulmonary hypertension * contraindication for a bronchoscopy * known hypersensitivity to the fluorescent contrast agent (if required)

Keywords: bronchoscopy diagnostic imaging laser scanning confocal microscopy pulmonary alveoli healthy volunteers diffuse peripheral lung disease focal peripheral lung disease
retrospective evaluation of safety and efficacy of daptomycin used in patients with serious gram-positive infections

Conditions: Bacteremia; Endocarditis; Serious Gram-positive Infections

Summary: before daptomycin (cubicin ®) approved by the u.s. fda in 2003, there were large-scale clinical trials conducted that included more than 1,000 subjects and than daptomycin got complicated skin and soft tissue infections (csssi) indication. after 2004, daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood flow and endocardial infected patients. all subjects in daptomycin clinical trials are european and american race. it is necessary that collecting safety and efficacy data of daptomycin in taiwan race. i will intent to evaluate the safety and efficacy of daptomycin which were used in patients with serious gram-positive infections retrospectively. and the outcome could be a reference for daptomycin future using.


Eligibility criteria:
inclusion criteria: * hospitalized patients who were prescribed daptomycin from 1st january 2009 to 31st december 2010 for gram positive infections as deemed necessary by his/her treating physician. and patients received daptomycin therapy for at least 3 days. exclusion criteria: * patients received daptomycin therapy for over 3 days
non-invasive and invasive plaque characterisation

Conditions: Non ST Elevation Myocardial Infarction

Summary: the accuracy of coronary plaque characterization with multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without st-elevation.


Eligibility criteria:
inclusion criteria: * chest pain suggestive for myocardial ischemia for at least 30 minutes; - electrocardiogram (ecg) with st-segment shifts (st-segment depression \>1 mm in at least two contiguous leads or transient st-segment elevation \> 1mm with duration of \ 1.5 mm in at least three contiguous leads); - positive hs troponin t \> 14 ng/l or positive troponin t \<0.01 µg/l - clinical indication for invasive coronary angiography followed by pci of the ischemia-related target lesion; - informed consent. exclusion criteria: * persistent st-elevation of \>1 mm in 2 or more leads; - need for emergency invasive coronary angiography and percutaneous coronary intervention (pci); - need for emergency coronary artery bypass grafting; - presence of cardiogenic shock; - estimated glomerular filtration rate (egfr) \< 50 ml/min; - known allergy to iodine contrast agents; - cardiac rhythms other than sinus rhythm; - inability to lay supine; - inability tot sustain a breath-hold for 15 seconds; - inability to provide informed consent.

Keywords: non st elevation myocardial infarction optical coherence tomography intravascular ultrasound multi-slice computed tomography