Kornimate/medical-research-clean huggingface dataset:
sequentially administered cpt-11 and mitomycin c in patients with advanced esophageal and stomach cancer

Conditions: Esophageal Cancer; Esophagus Cancer; Cancer of Stomach; Stomach Cancer

Summary: to determine the most efficacious of two combination regimens of sequential cpt-11 and mmc in patients with advanced and previously untreated esophageal and ge junction adenocarcinomas.

rationale: previous studies suggest that both irinotecan and mytomycin c when administered alone have some efficacy against stomach cancer. based on laboratory testing, researchers hypothesized that mytomycin c may enhance the efficacy of irinotecan through an enzyme called topoisomerase i. in addition, because mytomycin c has severe side effects, combining these chemotherapy agents together may allow for lower dosages resulting in greater efficacy and reduced side effects. a recent study indicates that the combination of these drugs has promising anti-tumor activity against esophageal and stomach cancers. the current study builds on previous research to explore the most effective schedule for administering these drugs together. purpose: this study is evaluating the combination of irinotecan and mytomycin c on two different treatment schedules in patients with advanced esophageal and stomach cancers. characteristics of different genes will also be measured, along with genetic and molecular changes by comparing test results from the beginning and end of the study. treatment: patients in this study will receive irinotecan and mytomycin c in one of two treatment schedules. both drugs will be administered in patients through an intravenous infusion. a computer will randomly assign patients to a treatment group. group one will receive mytomycin c on day 1 and irinotecan on days 2 and 9. group two will receive mytomycin c on days 1 and 8 and irinotecan on days 2 and 9. after day 9, patients in both groups will not be given any study drugs for almost three weeks to complete a four week cycle. several tests and exams will be given throughout the study to closely monitor patients. patients will continue receiving the study drugs until they experience disease growth or unacceptable side effects.

Eligibility criteria:
inclusion criteria: * must have pathologically confirmed \& measurable advanced esophageal or gastroesophageal junction adenocarcinoma * no prior chemotherapy * prior radiation allowed if \<=20% of bone marrow was irradiated * target lesions must not be in radiation field.

Keywords: advanced
radiation exposure using laser guided fluoroscopy in various orthopaedic procedures

Conditions: Fractures

Summary: introduction: the orthopaedic surgeon is frequently exposed to ionizing radiation, especially during intraoperative fluoroscopy. it is expected that using a laser guided fluoroscopy technique, which should improve accuracy of radiography, should also reduce the amount of time of exposure to radiation. finally, the literature appears controversial in this matter with no clear conclusions that could be drawn from such. hypothesis: the test hypothesis is that the use of the laser-aiming device for fluoroscopy in several orthopaedic procedures will reduce the exposure of the patient and the surgeon to the damaging effects of radiation. the null hypothesis then states that there will be no difference in exposure to radiation between the group using the laser device and the group not using the apparatus. methods: a prospective randomized controlled trial will be performed in which patients undergoing fluoroscopy will be randomly allocated to two groups. one group will undergo imaging with use of the device throughout the procedure and the other group will undergo radiation without the laser guided device. number and time of exposure will be recorded for each procedure. it is of the utmost importance that the complexity of the procedures remains relatively similar. it is believed that a good measure of complexity is the surgical time. therefore, any procedures that are statistically similar from a set mean (p \> 0.05) would be included into the study. it is also important that one or two surgeons with similar expertise and years of experience perform the surgeries to avoid confounding factors. it is expected that throughout the duration of the study (8 weeks) 50-100 cases would be reported which would produce statistically significant results. the results will be analyzed by calculating confidence intervals and differences between means of continuous data and significance levels by the student's t test. statistical significance will be set to p \< 0.05. risks and benefits: this study involves minimal risk. the use of the laser guide will not increase or introduce any risks other than the associated inherent surgical risks. the risks usually associated with this type of studies concern breach of confidentiality. to reduce this risk, research numbers will be assigned to subjects' data collected during the procedure, whose personal information will be found in another password-protected database. this study will help the investigators to investigate a technique that may help reduce the amount of time that a patient is exposed to radiation.


Eligibility criteria:
inclusion criteria: * patients with fractures requiring surgery with fluoroscopic assistance exclusion criteria: * patients with fractures treated without surgery

Keywords: fracture fixation fluoroscopy laser radiation
effects of hmos on faecal microbiota, gastrointestinal symptoms, mucosal immunity and barrier function in ibs patients

Conditions: Irritable Bowel Syndrome (IBS)

Summary: the study is a randomised, placebo-controlled, double-blind parallel study in ibs patients. a total of 60 adult patients diagnosed with ibs-c, -d or -a/m according to rome iv criteria will be included. the participants will be randomized into one of three groups consuming either hmo (two groups) or placebo (one group). the primary objective of the study is to establish the effect of hmos on the faecal microbiota in ibs patients. secondary objectives are to assess the effect on gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and depression.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. age between 18 and 75 years at visit 2 3. fulfills definition of ibs-d, ibs-c or ibs-a/m according to rome iv criteria 4. have a global ibs-sss score of \>174 during the 2 weeks run-in period 5. read, speak and understand swedish 6. ability and willingness to understand and comply with the study procedures exclusion criteria: 1. participation in a clinical intervention trial one month prior to screening visit and throughout the study. 2. any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular * lactose intolerance * coeliac disease 3. other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator. 4. severe psychiatric disease and/or psychological disturbance, as judged by the investigator. 5. use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. the excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as proviva, actimel, activia, wellness, and verum. 6. consumption of antibiotic drugs one month prior to screening and throughout the study. antibiotic use within the last three months prior to screening will be registered. 7. consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) two weeks prior to screening and throughout the study. specifically excluded drugs are opioids, nsaids on a weekly basis, regular use of laxatives and anti-diarrhoeal drugs, any drugs indicated for ibs symptoms. 8. diagnosed with and treated for ibs for more than 10 years 9. pregnant or lactating or wish to become pregnant during the period of the study. 10. lack of suitability for participation in the study for any reason as judged by the investigator.
pmcf study on the safety and performance of cespace 3d

Conditions: Degenerative Instability; Spondylolisthesis; Post-discectomy Syndrome; Post-traumatic Instabilities

Summary: prospective, pure data collection of all cespace 3d patients in selected centers (not interventional, multicenter)


Eligibility criteria:
inclusion criteria: * patient is minimum 18 years old * written informed consent for the documentation of clinical and radiological results * patient's indication according to ifu * patient is not pregnant exclusion criteria: • patient is not willing or able to participate at the follow-up examination

Keywords: cervical vertebrae; spondylolisthesis; treatment outcome; interbody fusion
clinical efficacy of ustekinumab in crohn's disease

Conditions: Crohn's Disease

Summary: clinical efficacy of ustekinumab in crohn's disease: an observational study with retrospective and prospective components.


Eligibility criteria:
inclusion criteria: * patients aged 18 years and older; * patients who were first prescribed ustekinumab between january 1 and december 31, 2024 * patients who provided written informed consent to participate in the study exclusion criteria: * contraindications to the use of the drug ustekinumab per the current instructions: * clinically significant active infection (active tuberculosis, active viral hepatitis); * pregnancy and lactation; * a history of clinically significant, in the opinion of the investigator, psychiatric disorders that may interfere with the study procedures and compliance with the drug regimen; * ulcerative colitis; * malignant gastrointestinal diseases in history or at the time of inclusion in the study; * decompensated chronic diseases of the liver, kidneys, cardiovascular system, systemic vasculitis, diabetes mellitus; * abuse of alcohol or psychoactive drugs within 1 year before the start of this study (as reported by the patient); * participation in an interventional clinical trial.
risk factors of cat scratch colon developing.

Conditions: Mucosal Erosion

Summary: this study was designed to: estimate the incidence of cat scratch colon in the investigators environment; explore the diseases associated to its development; identify the factors related to its development; and assess its clinical repercussions.

all of the ambulatory colonoscopies performed at the investigators university hospital from september 2007 were prospectively included in the study. data recorded for each patient included: age, sex, disease background, reason for the examination, hematological data and the endoscopic diagnosis. every patient presenting csc lesions had colon biopsies taken. these were studied by a single anatomic pathologist specializing in gastrointestinal pathologies. the characteristics (age, sex, disease background, indication for surgery, age at the time of surgery, time elapsed since surgery, hematological data and pathoanatomical study of the colon biopsies) of diversion colitis patients with and without csc lesions will bi compared.

Eligibility criteria:
inclusion criteria: * all of the ambulatory colonoscopies performed at our university hospita exclusion criteria: * patients thats refused.

Keywords: cat scratch colon. mucosal tears. mucosal erosion. colonoscopy.
early mobilization in cardiac surgery

Conditions: Nursing Caries; Ambulation Difficulty

Summary: this study was planned to determine the mobilization process and factors affecting this process in patients who underwent open heart surgery and were admitted to the cardiovascular surgery intensive care unit.

mobilization; it is defined as "standing up, walking, being able to move and walking around, especially after the operation, when the patient stands up and walks around". postoperative mobilization is a basic human need and one of the basic principles of nursing care. in the postoperative period, with the delay of mobilization, the patient's insulin resistance increases, muscle weakness and muscle mass loss occur, problems in pulmonary functions are experienced and the risk of thromboembolism increases. surgery of patients admitted to cardiovascular icus after open heart surgery close monitoring afterwards, maintenance of cardio-respiratory functions, healing is supported. during care in the intensive care unit preparation of materials that may be needed by the patient, general condition of the patient and vital information monitoring symptoms, performing breathing exercises, evaluating pain and management, monitoring fluid-electrolyte balance, monitoring hemodynamic parameters, surgical wound dressing, getting the patient up as soon as possible and in bed increasing mobility. in this process, while the mobilization process of the patients is planned, the patient's the general condition and tolerance regarding mobilization should be evaluated. patient's general depending on the suitability of the condition, turning in bed, foot-leg exercises, deep breathing and gradual mobilization, such as cough exercises, sitting in bed, standing up, and walking inform the patient and the patient's family about the methods, plan the mobilization process, the patient should be evaluated before, during and after mobilization. early postoperative mobilization is an important component of nursing care. early mobilization of patients after open heart surgery, although the recommendations to increase the mobility are getting stronger, the mobilization levels of the patients are still not at the desired level. although studies examining the early mobilization process of patients after open heart surgery have been conducted so far, findings regarding the clinical factors affecting this process are very limited.

Eligibility criteria:
inclusion criteria: * being over 18 years old * staying in the cardiovascular intensive care unit for 24 hours or more exclusion criteria: * being diagnosed with a psychiatric disorder * do not have active bleeding * do not have arrhythmia * reporting pain intensity of 4 or above on the visual analog scale
assessment of factors that affected respiratory parameters in mucopolysaccharidoses patients

Conditions: Mucopolysaccharidoses

Summary: respiratory system affects in mucopolysaccharidosis (mps) disease. respiratory system symptoms are seen in almost every mps patients and respiratory failure is one of the most common causes of death in this population. the aim of the study was to evaluate respiratory muscle strength and endurance, cough effectiveness and functional capacity in mps patients and to defined the factors that affected the respiratory problem in this.

this study was participated mps patients. patients' pulmonary function test, functional capacity, respiratory muscle strength and endurance, peak cough flow was assessed and recorded. pulmonary function test was assessed with spirometry, functional capacity was evaluated with 3-minute step test and six minute walk test (mwt). respiratory muscle strength was evaluated mouth pressure measurement (mip- maximal inspiratory pressure and mep- maximal expiratory pressure) and sniff nasal inspiratory pressure (snip). respiratory muscle endurance was assessed powerbreathe. and cough effectiveness was evaluated peak cough flow.

Eligibility criteria:
inclusion criteria: * people who diagnosed mucopolysaccharidoses disease in hacettepe university. * cooperation exclusion criteria: * patients who were not walking ability.

Keywords: respiratory muscles exercise test
study to gather information about the use of healthcare services and the way the disease is cared for in canadian patients with prostate gland cancer which spread throughout the body

Conditions: Prostate Cancer

Summary: study to gather information about the optimal placement of ra-223 in the order of different treatments in terms of the effect on patients and in terms of the use of healthcare services for the treatment of canadian patients with prostate gland cancer which spread to other parts of the body. in order to collect this information real world data from prostate gland cancer patients from four canadian administrative databases will be analyzed. data collected from patients treated with their 2nd line of life-prolonging therapy for non-metastatic castration resistant prostate cancer (mcrpc) initiated from 01 jan 2012 to 31 dec 2017. for patients included in the study, all available data from the beginning for their record until death, lost to follow-up or database cut-off will be included. the index date is the date of initiation of the 2nd line life-prolonging therapy for mcrpc.


Eligibility criteria:
inclusion criteria: * use of at least 2 lines of life-prolonging mcrpc therapy * the 2nd line of life-prolonging therapy was initiated between 01-jan-2012 to 31-dec-2017 exclusion criteria: - no formal exclusion criteria will be applied in order to capture real world use of ra-223

Keywords: metastatic castrate resistant prostate cancer mcrpc
randomized study of the safety and effectiveness of the tearcare system for the signs and symptoms of dry eye disease

Conditions: Dry Eye Syndromes

Summary: in this study, the tearcare system will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. the objective is to demonstrate that the tearcare system is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage. note: all sites have been selected for this study.


Eligibility criteria:
inclusion criteria: * diagnosed with dry eye disease * signs and symptoms of dry eye disease * best corrected visual acuity 20/100 or better * willing and able to comply with study procedures * willing and able to provide consent exclusion criteria: * active ocular infection or inflammation * history of eyelid, conjunctiva or corneal surgery within the past year. * recent office-based dry eye treatment, punctal occlusion or punctal plug placement * contact lens wearer * significant ocular surface or eyelid abnormalities, recent ocular trauma * certain corneal surface abnormalities * use of medications for treatment of dry eye or medications that cause dry eye * systemic disease that results in dry eye
safety and immunogenicity study of a dengue virus dna vaccine

Conditions: Dengue

Summary: the purpose of this study is to exame the safety of a dna vaccine against dengue-1.

dengue is a desease that affects 100 million people throughout the world mainly in tropical countries in the south pacific, asia, the caribbean, and africa. the disease often presents with high fever, severe headache, and joint/muscle pain that usually goes away on its own, but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. humans catch this disease by being bitten by mosquitoes that have been infected with dengue virus. scientists at the naval medical research center have been working on vaccines to prevent dengue disease. this vaccine, referred to as d1me, is an experimental dna vaccine that contains genes from the dengue-1 virus. the purpose of this study is to test the safety of a new experimental vaccine against dengue and to see if the vaccine can stimulate the immune system.

Eligibility criteria:
inclusion criteria: * available to participate for the duration of the study (approximately 12 months) * completion and review of knowledge assement quiz exclusion criteria: * pregnant (by history or as ascertained by pregnancy test) or lactating female * female who intends to become pregnant during the study * plan to have elective surgery during the study period * hiv infection * known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed) * history of splenectomy * administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination * evidence of active (acute or chronic) hepatitis b or c infection * autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease * acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening * clinical or laboratory evidence of significant anemia * history of flavivirus infection or previous receipt of flavivirus vaccine * positive serology for flaviviruses (all four dengue virus serotypes, japanese encephalitis, yellow fever virus, and west nile virus), hiv-1, hepatitis b surface antigen, or anti-hepatitis c virus antibodies prior to enrollment * use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period. * previous history of allergic or anaphylactic reaction to any vaccine * planned travel to areas with endemic dengue during the study period * any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol

Keywords: dengue dna vaccine
use of stealth liposomal doxorubicin hcl ( dox-sl ) in the treatment of moderate to severe aids-related kaposi's sarcoma.

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to provide stealth liposomal doxorubicin hydrochloride ( dox-sl ) as a therapy for kaposi's sarcoma patients who have no remaining treatment options other than dox-sl or patients who have been participating in another dox-sl protocol and for whom continuation in dox-sl is medically indicated. also, to evaluate the safety and efficacy of dox-sl in patients with kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

patients receive dox-sl every 3 weeks for up to 20 cycles.

Eligibility criteria:
inclusion criteria patients must have: * aids-related kaposi's sarcoma that requires systemic chemotherapy. * either a medical indication for continuation of dox-sl following treatment on another dox-sl protocol, or no remaining treatment options other than dox-sl. prior medication: allowed: * prior anthracyclines. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * cardiac ejection fraction \< 50 percent or clinically significant cardiac disease. * eligibility for a liposomal technology comparative protocol. concurrent medication: excluded: * other cytotoxic chemotherapy. patients with the following prior condition are excluded: history of idiosyncratic or allergic reaction to anthracyclines. prior medication: excluded: * chemotherapy within the past 3 weeks.

Keywords: sarcoma, kaposi liposomes doxorubicin acquired immunodeficiency syndrome drug carriers
safety and immunogenicity of zoster vaccine (zostavax™) made with an alternative manufacturing process (amp) (v211-042 am1)

Conditions: Herpes Zoster; Shingles

Summary: this study will determine whether zostavax™ made with an alternative manufacturing process \[zostavax™ (amp)\] is well tolerated and immunogenic, and has a comparable immune response to zostavax™.


Eligibility criteria:
inclusion criteria: * no fever on day of vaccination * history of varicella or residence in a vzv-endemic area for ≥30 years * females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control exclusion criteria: * history of hypersensitivity reaction to any vaccine component * prior receipt of any varicella or zoster vaccine * prior history of herpes zoster * have recently had another vaccination * pregnant or breastfeeding * use of immunosuppressive therapy * known or suspected immune dysfunction * concomitant antiviral therapy