Kornimate/medical-research-clean huggingface dataset:
pulsed low dose rate radiation therapy for gastric cancer patients with peritoneal metastasis

Conditions: Radiotherapy; Radiotherapy Side Effect; Stomach Neoplasms

Summary: this phase ii trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis.

this phase ii trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis. radiation therapy uses pulsed low dose rate high energy x rays to kill tumor cells and make less side effects than conventional 3-dimensional conformal radiation therapy. palliative radiation therapy may help gastric cancer patients with peritoneal metastasis live more comfortably.

Eligibility criteria:
inclusion criteria: * patients must have histologically-confirmed gastric adenocarcinoma * patients must have metastasis tumor located within peritoneal cavity * tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician * patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist * patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, or other therapies * patients must have measurable disease per response evaluation criteria in solid tumor (recist) 1.1 in the irradiated field * women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed * eastern cooperative oncology group (ecog) performance status determined to be between 0 and 3 * absolute neutrophil count (anc) \>=1,000/ul * platelets (plt) \>=75,000/ul * subjects must sign a written informed consent and health insurance probability and accountability act (hipaa) consent prior to performance of study-specific procedures of assessments and must be willing to comply with treatment and follow-up exclusion criteria: * patients who have had chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study * a history of ataxia telangiectasia or other documented history of radiation hypersensitivity * scleroderma or active connective tissue disease * active inflammatory bowel disease * serious, active infections requiring treatment with intravenous (iv) antibiotics * uncontrolled intercurrent illness including, but not limited to, or psychiatric illness/social situations that would limit compliance with study requirements
rapid test to detect staphylococcus aureus in blood and wound infections

Conditions: Staphylococcus Aureus; Staphylococcal Skin Infections; Bacteremia

Summary: the purpose of this study is to determine whether the cepheid genexpert system accurately detects methicillin-resistant and -susceptible staphylococcus aureus in blood cultures and wound swabs.

staphylococcus aureus (sa) remains a major pathogen for human beings, causing infections of skin, soft tissue, bone, and other organs. bacteremia due to this organism is common, and often occurs in association with medical interventions such as intravenous lines and implantable devices. with the increase in methicillin-resistant s. aureus (mrsa), there has been increasing dependence upon vancomycin, a drug that is inferior to the beta-lactams in its activity against methicillin-susceptible s. aureus (mssa). if the microbiology laboratory had the ability to identify s. aureus (sa) and its drug susceptibility within hours rather than days, focused therapy would be possible earlier in the course of illness. clinicians would be able to discontinue antibiotics when sa is not present, to discontinue other broad-spectrum antibiotics when sa is present, or to replace empiric vancomycin with nafcillin when mssa is identified. the genexpert system (cepheid) uses real-time pcr to detect genes that encode staphylococcus aureus protein a (spa), the staphylococcal cassette chromosome (scc) and methicillin resistance (meca). all blood cultures with gram stain revealing gram positive cocci in clusters will be tested by pcr the day they became positive. wound swabs submitted for routine bacteriologic culture will be tested within 48 hr of collection. results will be compared with those of standard bacteriologic culture. in addition, discrepancies between the genexpert and wound culture results will be reviewed in the medical record to ascertain whether antibiotic use at the time of specimen collection is associated with false positive results in which the wound culture yields no s. aureus but pcr detects staphylococcal dna components. in the second phase of the study, pcr results for wound swabs and blood cultures will be reported to physicians immediately upon completion of the reaction. the clinical impact of early identification of s. aureus will be determined by comparing antibiotic treatment and clinical outcome of patients for whom early identification was available with those of patients for whom conventional bacteriological culture was the sole diagnostic test.

Eligibility criteria:
inclusion criteria: * positive blood culture with gram stain revealing gram positive cocci in clusters * all wound swabs submitted to the microbiology lab for standard bacteriologic culture may be included. exclusion criteria: * blood cultures that became positive more than 24 hours previously * wound swabs for which over 48 hours have passed from the time of collection

Keywords: polymerase chain reaction
european registry of transcatheter repair for tricuspid regurgitation

Conditions: Tricuspid Regurgitation; Valvular Heart Disease; Heart Failure

Summary: to investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.

background and rationale: tricuspid regurgitation (tr) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. surcial treatment of tr is associated with high procedural and in-hospital mortality. due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. transcatheter tricuspid valve (tv) repair and replacement techniques (ttvt) now offer a new treatment perspective for these patients. the eurotr registry aims at optimizing patient selection prior to ttvt and thus treatment quality by collecting respective data in a real-world setting. objectives: to investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.

Eligibility criteria:
inclusion criteria: * patients treated with one of the following transcatheter devices for tv repair or replacement: pascal, triclip, tricvalve, evoque, lux-valve * age ≥ 18 years

Keywords: tricuspid regurgitation teer edge-to-edge repair
effect of post isometric relaxation versus myofascial release therapy in the management of non specific neck pain

Conditions: Neck Pain

Summary: non-specific neck pain (ns-np) is the most prevailing musculoskeletal disorder (msk) which has large socio-economic burden worldwide. it is associated with poor posture and neck strain which may lead to pain and restricted mobility. post isometric relaxation a form of muscle energy technique, that works on the principles of restoring biomechanics, reducing the movement restriction and pain. myofascial release therapy will improve muscle immobility and pain by improving blood circulation lymphatic drainage and relaxing the contracted muscles. the aim of this study is to determine the effect of post-isometric relaxation versus myofascial release therapy on pain, range of motion, disability and quality of life in the management of non-specific neck pain.

a randomized control trial will be conducted at ipmr (institute of physical medicine and rehabilitation) on 60 patients with non-specific neck pain with age group between 25-40 years. initial screening of the patients will be carried out by referring physiatrist. patients who fulfils inclusion criteria will be randomly allocated to either group by computer generated random sampling after taking written informed consent. all the patients will be evaluated using visual analogue scale for pain, neck disability index for functional status and disability, universal goniometer for cervical range of motion and who bref for quality of life on 1st and 6th sessions. group 1 will receive post isometric relaxation for upper trapezius and levator scapulae along with cryotherapy and strengthening exercises . group 2 will receive myofascial release therapy for upper trapezius and levator scapulae muscles along with cryotherapy and strengthening exercises. data will be analyzed using the spss version 21. baseline reading will be taken for further comparison at the end of treatment. baseline variables are pain, rom, functional disability and qol. for within group analysis, paired sample t test will be used. for intergroup independent sample t test will be used. p value less than 0.05 will be set as threshold to detect statistical significance.

Eligibility criteria:
inclusion criteria: 1. non-specific neck pain for 2-6 weeks. 2. unilateral neck pain 3. patients' age group between 25 - 40. 4. on vas scale pain intensity \>4. exclusion criteria: 1. cervicogenic headache. 2. tumor of cervical spine. 3. whiplash injury. 4. cervical fractures 5. normal rom of cervical spine.

Keywords: non specific neck pain post isometric relaxation muscle energy techniques myofascial release therapy
an observational study to describe in routine clinical practice the treatment patterns of usage of biological dmards in ra patients.

Conditions: Rheumatoid Arthritis

Summary: this observational study will describe the treatment patterns of usage of biological dmards in routine clinical practice and the demographics and ra disease characteristics in patients suffering from rheumatoid arthritis. patients will be recruited and examined the same day when recruited. there will be no follow up visit or treatment period only one visit in this study.


Eligibility criteria:
inclusion criteria: * patients at least 18 years of age. * patients with a diagnosis of ra according to the revised acr criteria. * patients receiving treatment of launched biological dmards. exclusion criteria: * patients who received biological dmards due to clinical trials or biologics not launched. * patients who are considered not appropriate for study due to other reasons at physicians' discretion.
minimally invasive soft channel brain haemorrhage evacuation for acute basal ganglia haemorrhage--small hemorrhage evacuation (miracle-s)

Conditions: Intracerebral Hemorrhage

Summary: the objective of this study is to determine whether minimally invasive soft channel brain hemorrhage evacuation (scmis), compared to usual care, leads to superior functional recovery as measured by utility-weighted modified rankin scale (uw-mrs) scores at 6 months in patients with basal ganglia intracerebral hemorrhage (ich) of 20 ≤ volume ≤ 30 ml.


Eligibility criteria:
* inclusion criteria: 1. adults (18 - 80 years) ; 2. the clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging; 3. onset within 48 hours, and surgery can be initiated within 48 hours; 4. basal ganglia hemorrhage, with a bleeding volume of 20 ≤ volume ≤ 30 ml; 5. reduced level of consciousness (gcs 9-14); 6. pre-stroke mrs score≤1 points; 7. systolic blood pressure \<140 mmhg before randomisation; 8. informed consent obtain accordingly to local regulations. * exclusion criteria: 1. definite evidence the ich is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or neurointerventional surgery. 2. a high likelihood that the patient will not adhere to the study treatment and follow-up regimen. 3. platelet count \ 1.4.
safety and efficacy of levomilnacipran er (f2695 sr) in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran er versus placebo in the treatment of outpatients with major depressive disorder


Eligibility criteria:
inclusion criteria: * men and women, 18-80 years old * currently meet the dsm-iv-tr criteria for major depressive disorder * the patient's current depressive episode must be at least 4 weeks in duration exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control. * patients with a history of meeting dsm-iv-tr criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder. * patients who are considered a suicide risk

Keywords: depression major depressive disorder
postoperative analgesia by epidural vs iv ketamine concurrent with caudal anesthesia in pediatric orthopedic surgery

Conditions: Analgesia

Summary: preemptive analgesia can improve postoperative pain management. ketamine may prevent central sensitization during surgery and result in preemptive analgesia. the purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of n-methyl-d-aspartate (nmda) receptor in neuroplasticity.

after receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 s(+)-ketamine. all patients will receive caudal block anesthesia with marcaine. cardiovascular monitoring will be assessed during operation. follow up will continue for 24 hours after caudal block. duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. data will be analyzed statistically by chi square, t test and nonparametric tests.

Eligibility criteria:
inclusion criteria: * children aged \< = 12 years * children scheduled for elective orthopedic surgery with caudal block * asa score \< = 3 exclusion criteria: * contraindication for caudal block such as vertebral defect or infection at the site of block * disagreement of parents * patient's age \> 12 years * asa score \> = 4

Keywords: epidural intravenous ketamine analgesia caudal pediatric regional local anesthetics
study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

bruton's tyrosine kinase (btk) is an enzyme that is present in hematopoietic cells other than t cells and is necessary for downstream signal transduction from various hematopoietic receptors including the b cell receptor as well as some fc, chemokine, and adhesion receptors, and is crucial for both b cell development and osteoclastogenesis. although down-regulated in normal plasma cells, btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. ibrutinib is a potent and specific inhibitor of btk currently in phase 2 and 3 clinical trials. the current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

Eligibility criteria:
inclusion criteria: * subjects with relapsed/refractory mm who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen. * measurable disease defined by at least one of the following: 1. serum monoclonal protein (spep) ≥1 g/dl. 2. urine monoclonal protein (upep) ≥200 mg by 24 hour urine. * adequate hematologic, hepatic, and renal function * ecog performance status of ≤ 2 exclusion criteria: * subject must not have primary refractory disease * plasma cell leukemia, primary amyloidosis or poems syndrome * unable to swallow capsules or disease significantly affecting gastrointestinal function * requires treatment with strong cyp3a inhibitors * women who are pregnant or breast feeding.

Keywords: multiple myeloma bruton's tyrosine kinase pci-32765 pomalidomide dexamethasone relapsed refractory multiple myeloma ibrutinib
database of patients undergoing cardiac computed tomographic angiography at william beaumont hospital (ct database)

Conditions: Acute Coronary Syndrome; Chest Pain

Summary: the purpose of the study is to establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all william beaumont hospital (wbh) patients undergoing cardiac computed tomographic angiography (ccta) testing for clinical or scientific reasons.

the principal goal of his project is to enable the study investigators to organize wbh research activity in the field of ccta by concentrating data from all the patients who allow use of their data in one organized, audited and securely stored database. it will allow the ability to collect retrospective and prospective data from a number of different clinical systems and securely maintain patient medical record numbers for the reference on future projects as well as identification of patients with multiple studies and multiple follow-ups.

Eligibility criteria:
inclusion criteria: * all retrospective patients who under went a cta and were granted a waiver of consent * all prospective patients cta patients who gave informed consent. exclusion criteria: * non cta patients * patients who refused participation.

Keywords: coronary artery disease chest pain ccta
booster study of spikogen covid-19 vaccine

Conditions: COVID-19

Summary: the purpose of the study is to assess the effectiveness of spikogen vaccine when used as a 3rd or 4th dose booster in adults who have been previously vaccinated with any covid-19 vaccine types, including mrna vaccine, adenoviral vector vaccines, recombinant protein vaccines, or inactivated virus vaccines.

currently in australia, mrna, adenoviral vector and recombinant protein vaccines have provisional approval for use as 3rd or 4th booster doses. this study will provide important data on the use of spikogen as an alternative recombinant protein booster vaccine. the study will provide data in ambulatory adults on the safety and effectiveness of spikogen vaccine when administered as a single intramuscular booster dose in those who previously vaccinated with mrna vaccine in comparison to those immunised with other covid-19 vaccine platforms.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * males or females 18 years of age or older * have previously had a primary course of covid-19 vaccine with the most recent dose no less than 3 months previously. * understand and are likely to comply with planned study procedures and be available for all study visits. exclusion criteria * allergy to spikogen vaccine or one of its components, e.g. polysorbate 80. * have received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial reporting period. * any serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Keywords: covid-19 vaccine adjuvant spikogen advax cpg55.2
prospective spine registry

Conditions: Sacroiliac; Fusion; Sacroiliac; Joint Diseases; Musculoskeletal Diseases; Spinal Disease; Spinal Stenosis; Spinal Instability; Fusion of Joint; Fusion of Spine; Spinal Fusion; Spine

Summary: this study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on rti's spine products.


Eligibility criteria:
inclusion criteria: 1. candidate for rti spine product. 2. willing and able to consent to the study. exclusion criteria: 1. patient who is, or is expected to be inaccessible for follow-up. 2. patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.). 3. other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent participation or otherwise render patient ineligible for the study.
biomarkers for gynecologic cancer

Conditions: Ovarian Cancer; Endometrial Cancer; Benign Gynecological Disease

Summary: a novel blood metabolic biomarker, aminoindextm (gynecological), was developed for gynecological cancers from over 400 japanese patient's plasma free amino acid profiles (pfaas) by a rapid and sensitive lc-ms (liquid chromatography - mass spectrometry), followed by multivariate statistical analyses. however, further studies to assess whether this biomarker demonstrates the same performance characteristics in non-japanese populations for cancer is yet to be determined.

"aminoindex technology" was developed based on high-throughput and absolute quantitative analysis method of amino acids and amines using uflc-ms, and creating a clinical database to search for amino acid patterns across different diseases including cancer. "aminoindex technology" can evaluate certain health conditions and the possibility of diseases by analyzing the balance of plasma amino acids. multicenter studies in japan were conducted to develop an blood based biomarker panel for cancer. this study wil be conducted to evaluate the performance of aminoindextm (gynecological) biomarker based on "aminoindex technology" for gynecological cancers in us populations. this will be done by analyzing plasma metabolites including amino acids, from endometrial and ovarian cancer patients, from patients with benign gynecological disease, and healthy subjects using liquid chromatography and mass spectrometry (lc-ms) and liquid chromatography - tandem mass spectrometry (lc-msms).

Eligibility criteria:
inclusion criteria: participants in this study will be patients with primary endometrial and ovarian cancer, benign gynecological diseases (such as uterine fibroids, endometriosis, dysplasia, and benign ovarian tumors), and healthy subjects that meet the following criteria: * age \> 20 years (no data is currently available on use of aminoindextm in patients under 20 years of age or over 80 years of age) * willing to follow fasting and clinic visit requirements * ability to understand and consent to participate in study. women of all races and ethnic groups are eligible for this trial. exclusion criteria: women will be excluded from study participation for the following reasons: * an inability to fast (no food or drink other than water) for 8 hours prior to the pre-surgery sample collection. * are known to be positive for hiv/hcv/hbv * pregnancy or breastfeeding (pregnant and breastfeeding women are excluded from this study because amino acid levels are known to differ in pregnancy). * currently receiving investigational agents. * history of any drug therapy or surgery for treatment of gynecological cancer * unable to come for the blood sample collection between 6:00 am and 12:00 noon * currently undergoing dialysis * congenital metabolic disease * the investigator considers individual to be ineligible based on prior medical history, histology or other findings