Kornimate/medical-research-clean huggingface dataset:
study of bevacizumab combined with capecitabine and either oxaliplatin or irinotecan as first course of treatment for patients with colorectal cancer that has spread beyond the colon

Conditions: Colorectal Neoplasms

Summary: bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. without new blood vessels, the growth of a tumor is slowed. chemotherapy works to kill cancer cells directly. this study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (capox) and capecitabine with irinotecan (capiri). given the data documenting the improved efficacy for 5-fu based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum) * evidence of adequate organ function (such as liver, kidneys, etc.) exclusion criteria: * diagnosis of anal cancer * patients who are candidates for surgery * patients who have received previous treatments * pregnant or lactating women * history of chronic disease(s) or other serious medical conditions

Keywords: nsabp bevacizumab capecitabine oxaliplatin irinotecan rectal cancer colon cancer colorectal cancer
trial of kuvan in lesch-nyhan disease

Conditions: Behavioral Manifestations of Lesch-Nyhan Disease

Summary: to assess the possibility that treatment with kuvan (a form of tetrahydrobiopterin) will lessen the abnormal behavior and/or neurology commonly found in lesch-nyhan disease (lnd); to assess biochemical changes as measured in blood and urine.

lesch-nyhan disease (lnd) is an x-linked disorder of purine metabolism which results from mutation in the gene for the enzyme hypoxanthineguanine phosphoribosyltransferase (hprt); patients have hyperuricemia, gout, urinary tract calculi, and nephropathy which are effectively treated with allopurinol. there is also a syndrome of dystonia, chorea and athetosis, as well as involuntary self mutilative biting and aggression toward their caretakers, for which there is no treatment. kuvan™ is a form of tetrahydrobiopterin (bh4), and is approved to help lower the blood levels of phenylalanine in people who have phenylketonuria (pku). lnd patients have been found to have decreased bh4 in the spinal fluid and brain; bh4 is a precursor of dopamine, which has an effect on behavior. in an earlier study dr nyhan found that treatment of lnd with 5-hydroxytryptophan and carbidopa abolished the self-injurious behavior but was uniformly transient. this is a single site open-label protocol for eight subjects age 4 years and older with lesch-nyhan disease documented by deficiency of hprt. the study involves three study visits to san diego and one study visit done locally. the first visit will last 13 days, the following visits are single day visits at week 4 and week 8, and the local study visit is a brief outpatient visit at week 6. physical and neurological exams, videotaping of the patient's interactions with the study staff, and blood and urine collection for laboratory analyses will be performed at each san diego visit. a family member or caregiver will be asked to complete a short assessment form and report any illness or medication changes. in addition, the study staff will have weekly telephone contact with the family to discuss any behavioral changes or study drug issues. if the patient's self injurious behavior becomes worse after starting kuvan the drug will be discontinued and the patient will be followed until the behavior returns to baseline.

Eligibility criteria:
inclusion criteria: 1. ages 4 years and older 2. must have documented evidence of hprt deficiency. 3. be on a stable treatment regimen for 30 days or more 4. willing and able to travel to san diego for the study visits 5. have a local neurologist or physician familiar with the patient or experienced in managing behavioral/neuromuscular disorders and willing to assist with study procedures and adverse events if necessary exclusion criteria: 1. concurrent enrollment in an investigational drug study 2. currently taking levodopa 3. elevated liver enzymes 4. renal or liver impairment or disease 5. inability to comply with required study procedures

Keywords: lesch-nyhan disease self-mutilating behavior
lymphocytic subsets and cytokine production with h. pylori infection

Conditions: Duodenal Ulcer; Gastric Ulcer; Dyspepsia

Summary: the aims of this study are 1) to determine the cytokines produced by both th1 and th2 subsets in gastric antral biopsy specimens from taiwanese patients before and after anti h. pylori therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in h. pylori-associated gastritis and to define possible contributing immune mechanisms responsible for the chronicity of the disease and its associated lesions.

helicobacter pylori, a gram-negative spiral bacterium, has been first isolated from a patient with chronic active gastritis since 1982. recent studies strongly suggest that chronic infection with h. pylori is tightly associated with chronic gastritis, peptic ulcer, and gastric carcinoma. however, only a minority of infected people develop signs and symptoms of gastric pathology. thus, both host and microbial factors may lead to different outcomes of infection. in spite of high prevalence in general population and increasing clinical attention has been paid on this infection, the knowledge of pathogenic mechanism of h. pylori infection is still limited and little is known about the role of host immune response in the pathogenesis of disease.the aims of this study are 1) to determine the cytokines produced by both th1 and th2 subsets in gastric antral biopsy specimens from taiwanese patients before and after anti h. pylori therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in h. pylori-associated gastritis and to define possible contributing immune mechanisms responsible for the chronicity of the disease and its associated lesions.

Eligibility criteria:
inclusion criteria: * h. pylori infection exclusion criteria: * none

Keywords: h. pylori、immune response、lymphocytic subsets、cytokine
sodium bicarbonate for prevention of contrast-induced nephropathy

Conditions: Renal Failure

Summary: the purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.


Eligibility criteria:
inclusion criteria: * serum creatinine \> 1.1 mg/dl * glomerular filtration rate (gfr) \< 50 ml/min exclusion criteria: * age \< 18 years * use of radiographic contrast media during the last 21 days * history of dialysis * cardiac insufficiency class iii-iv * emergency procedures

Keywords: contras-induced nephropathy
light-ct in the diagnosis of breast tumor and lymph node

Conditions: Breast Neoplasms

Summary: intraoperative pathological diagnosis such as frozen section and imprint cytology is not routinely recommended in clinical practice because of time and accuracy concerns. full-field optical coherence tomography (ff-oct) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (dci) added the viability information of cells/tissue, which could be more important in cancer diagnosis. this study was to evaluate the feasibility and diagnostic value of ff-oct and dci in breast lesions and lymph node specimens during breast cancer surgery. we evaluated normal breast tissue, benign breast lesions, breast cancer and axillary lymph node specimens resected from patients undergoing breast surgery.

light-ct, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. in this study, fresh breast tissue, fat, benign breast lesions, breast cancer and axillary lymph node specimens are collected to assess the usefulness of light-ct. during the in vitro examination, both ff-oct and dci images are obtained and stored. imaging analysis would be performed in traditional imaging analysis like manner and an artificial intelligence aided approach as well. in this study, breast and lymph node specimens would be collected and imaged both through light imaging and conventional pathological analysis.

Eligibility criteria:
inclusion criteria: * patients planning to undergoing breast surgery/surgical lymph node staging. * specimen could be obtained. exclusion criteria: * prior open biopsy

Keywords: breast neoplasms optical coherence tomogram sentinel lymph node dynamic cell imaging
bridge occlusion balloon in lead extraction procedure

Conditions: C.Surgical Procedure; Cardiac; Cardiac Dysrhythmia; Disorder of Pacing Function

Summary: to evaluate the use of an occlusion balloon (bridge™ occlusion balloon, spectranetics) within the superior vena cava in lead extraction patients.

this study will evaluate the use of an occlusion balloon (bridge™ occlusion balloon, spectranetics) within the superior vena cava in lead extraction patients. this will be performed in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. the study will focus on the effect of the bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy. understanding these factors will help build a more robust clinical workflow with the goal of better patient outcomes in the case of an superior vena cava injury. the images and data generated during this study can help in dissemination of the practical use knowledge to fellow lead extractors. at the time of the protocol registration, the timeframe 12 months was entered, this was actually the anticipated length of the study at registration. the timeframe was corrected to 33 minutes (average time) at the time of results entry.

Eligibility criteria:
inclusion criteria: * subject age more than 18 years * lead extraction patients exclusion criteria: lead extraction patients with: * superior vena cava occlusion or stenosis. * significant vegetation. * hemodynamic instability. * class iv heart failure * creatinine \> 2.0mg/dl * patients \> 85 years old

Keywords: lead extraction superior vena cava tear pacemaker/defibrillator lead extraction
detection of chromosomal aberrations in non-small cell lung cancer (nsclc) using fluorescent in situ hybridization (fish) (alk test)

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of the study is the identification of chromosomal aberrations in non-small cell lung cancer (nsclc) . the imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying alk fish stained lung samples.

the alk break apart fish test detects chromosomal aberrations via fluorescence in situ hybridization (fish) in formalin-fixed paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tissue specimens. the fda approved alk kit is designed to detect rearrangements involving the alk gene (2p23). results from the alk kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for the pathologist in the identification of patients eligible for treatment with xalkori® (crizotinib).

Eligibility criteria:
inclusion criteria: * well stained slides with bright fish signals exclusion criteria: * very old slides that were already bleached

Keywords: non-small cell lung cancer (nsclc) alk probe fish chromosomal aberrations
circulating and imaging biomarkers to improve lung cancer management and early detection

Conditions: Lung Cancer

Summary: validation of biomolecular markers in the circulation and radiomic features are the focus of this project.the aim is to assess the role of molecular and cellular biomarkers (exosomes antigens, circulating tumor cells - ctcs, panel of mutations in circulating free dna) and radiomic signature, as complementary to assist early detection of lung cancer by ldct.


Eligibility criteria:
inclusion criteria: * age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%). * smoker or former smoker former smokers must have ceased smoking within the 15 years prior to enrollment in the study. * absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss. exclusion criteria: * previous diagnosis of lung cancer. * positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor). * performing a chest ct scan in the last 18 months. * severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.

Keywords: biomarkers circulating tumor cells screening computer tomography (ct scan)
xiidra vs. xiidra + dextenza treatment for dry eye disease

Conditions: Dry Eye Syndromes

Summary: to evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

this prospective study will use a fellow-eye design for 20 participants, 40 eyes. all eyes will receive bilateral xiidra. the most symptomatic eye will be selected to receive dextenza® insertion on the day xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). if there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. the study group will consist of 20 eyes receiving dextenza® insertion. the control group will consist of 20 eyes receiving sham punctum dilation. thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. this fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

Eligibility criteria:
inclusion criteria: a patient's study eye must meet the following criteria to be eligible for inclusion in the study: * 18 years of age or older * signs and symptoms of ded * consent to treat with topical immunomodulator * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: a patient who meets any of the following criteria will be excluded from the study: * patients under the age of 18. * pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * active infectious systemic disease * active infectious ocular or extraocular disease * altered nasolacrimal flow of either acquired, induced, or congenital origin * hypersensitivity to dexamethasone * patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit * patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including nsaids) * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
impact of virtual reality physiotherapy on multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the goal of this clinical trial is to learn if virtual reality combined with conventional physiotherapy intervention works to treat moderate to severe multiple sclerosis persons. the main questions it aims to answer are: * does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in motor aspects of patients with multiple sclerosis? * does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in cognitive aspects of patients with multiple sclerosis researchers will compare a virtual reality-based program along with conventional physiotherapy with a placebo virtual reality to see if virtual reality improve motor and cognitive aspects of multiple sclerosis. participants will: * visit the clinic twice a week for 10 weeks to receive a 1-hour session of virtual reality and conventional physiotherapy. * be assessed using various scales and questionnaires at three different times: at the start of the study, at the end of the treatment, and 4 weeks after the study ends.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple sclerosis based on mcdonald criteria, with an evolution time of more than two years. * all patients with multiple sclerosis are included according to the kurtzke multiple sclerosis disability status scale (edss) (annex ii) with a score greater than or equal to 6.5 (need of two types of support to walk -two canes, walker...- about 20 meters without resting). * stable medical treatment for at least six months prior to intervention. * absence of cognitive impairment, with ability to understand instructions and to obtain a score equal to or greater than 24 on the minimental test. exclusion criteria: * diagnosis of another neurological disease or musculoskeletal disorder other than ms. * diagnosis of any cardiovascular, respiratory or metabolic disease, or other conditions that may interfere with this study. * to have suffered an exacerbation or hospitalization in the last 3 months before starting the assessment protocol, nor during the therapeutic intervention process. * to have received a course of steroids, intravenously or orally, 6 months prior to the start of the assessment protocol and within the intervention period of the study duration. * visual disturbances not corrected by ocular devices.

Keywords: multiple sclerosis virtual reality
a 24-month clinical evaluation of different bulk-fill restorative resins in class ii restorations

Conditions: Dental Caries

Summary: the aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in class ii restorations over a period of 24 months.

the objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in class ii restorations. forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. a total of 120 class ii cavities will be restored using tetric evoceram bulk fill (n=40), surefil sdr flow + ceram x mono (n=40), and everx posterior + g-aenial posterior (n=40) with their respective adhesives according to the manufacturers' instructions. all restorations will be placed by one operator. the restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified usphs criteria by one examiner. the restoration groups for each category will be compared using pearson's chi-square test, while cochran's q test will be used to compare the changes across different time points within each restorative material (p\<0.05).

Eligibility criteria:
inclusion criteria: * patients who accept to participate and sign the informed consent * patients who have at least three similar-sized approximal primary caries lesions in premolar and molar teeth. * the teeth to be restored had a normal occlusal relationship with natural dentition and had adjacent tooth contact and had a normal response to a vitality test with no periapical pathology exclusion criteria: * patients who don't accept to participate and sign the informed consent * patients who have a history of adverse reaction to the test materials * patients who are pregnant or lactating, have fewer than 20 teeth * patients who have poor oral hygiene, have severe or chronic periodontal disease, have heavy bruxism

Keywords: bulk-fill restorative resins, dental caries
study to characterize rate of ureagenesis in patients with ornithine transcarbamylase (otc) deficiency

Conditions: Ornithine Transcarbamylase Deficiency

Summary: the objectives of the study are to characterize urea production rates in patients with otc, characterize the association of rate of ureagenesis and disease severity in otc patients, characterize the association of rate of ureagenesis and executive and verbal function and characterize the association of rate of ureagenesis and patient-reported functional status.

study dtx301-cl102 is a noninterventional, observational study to characterize the rate of ureagenesis and to assess neurocognition and functional status in the spectrum of otc deficiency and their association with biochemical characteristics. \[1-13c\]sodium acetate will be administered orally as a tracer to measure the rate of ureagenesis.

Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent. * for symptomatic patients: * confirmed clinical diagnosis of otc deficiency and enzymatic, biochemical, or molecular testing. * documented history of ≥ 1 symptomatic hyperammonemic episode with ammonia level ≥ 100 μmol/l * patients on ongoing daily ammonia scavenger therapy must be at a stable dose(s) for ≥ 4 weeks prior to visit 1 (baseline) * for asymptomatic patients: confirmed diagnosis of otc deficiency by family history and documented by molecular testing. * willing and able to comply with the study procedures and requirements, including clinic visits, blood and urine collections, questionnaires, and cognitive assessments. key exclusion criteria: * liver transplant, including hepatocyte cell therapy/transplant. * history of liver disease * significant hepatic inflammation or cirrhosis * participation in another investigational medicine study within 3 months of screening * participation (current or previous) in another gene transfer study * pregnant or nursing other protocol specific criteria may apply

Keywords: otc otc deficiency neonatal late onset asymptomatic carrier