Kornimate/medical-research-clean huggingface dataset:
an exploratory study of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer (crc)

Conditions: Colorectal Cancer

Summary: this is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. the progression-free-survival (pfs) will be evaluated as the primary endpoints.


Eligibility criteria:
inclusion criteria: 1. has fully understood and voluntarily signed an written informed consent and agreed to follow the research plan treatment and visiting plan; 2. aged \>=18 years, \<= 85 years; 3. histologically confirmed initial unresectable colorectal cancer; 4. eastern cooperative oncology group (ecog) performance status 0-1; 5. expected survival period ≥ 3 months; 6. at least one measurable lesion, according to recist 1.1; 7. the main function is normal. exclusion criteria: 1. known hypersensitivity to any of the study drugs or excipients; 2. hypertension that is not controlled by the drug; 3. international normalized ratio (inr) \> 1.5 or partially activated prothrombin time (aptt) \> 1.5 × uln; 4. wbc count \< 3000 /mm\^3; 5. platlet count \< 50000 /mm\^3; 6. poorly controlled diabetes before enrollment; 7. clinically significant electrolyte abnormalities judged by researchers; 8. patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment; 9. cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure, new york heart association (nyha) grade \> 2; ventricular arrhythmia requiring drug treatment; lvef (left ventricular ejection fraction) \< 50%; 10. active infection or serious infection that is not controlled by drug; 11. history of clinically significant hepatic disease (alt and/or ast \>5 times the upper normal limit); 12. women who are pregnant or lactating; 13. urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g; 14. have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
magnesium sulfate and neuroendocrine hormone

Conditions: Arthropathy of Knee; Magnesium Sulfate; Cortisol; Dehydroepiandrosterone

Summary: total knee arthroplasty is a procedure that relieves pain in patients with severe symptomatic osteoarthritis, but it can be associated with postoperative pain, which hinders recovery. in the previous study, we reported evidence of increased pain in patients undergoing staged total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) as a result of the surgical injury to the first operated knee. magnesium sulfate is an effective analgesic adjuvant for postoperative pain. its analgesic property seems to be associated with the regulation of calcium influx into the cells, or antagonism of n-methyl-d-aspartate receptors in the central nervous system. additionally, magnesium is known to have an anti-inflammatory effect. inflammatory state may accompany with pain via peripheral or central sensitization. recently, we reported that magnesium sulfate effectively attenuates not only postoperative pain but also increased pain intensity without serious adverse effects in the bilateral staged total knee arthroplasty. however, the exact mechanism regarding these effects of magnesium sulfate remains unclear. in the present study, we will investigate the analgesic mechanism of magnesium sulfate via analysis of endocrine neurosteroid levels in patients undergoing bilateral staged total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients who undergo staged bilateral total knee arthroplasty * spinal anesthesia * american society of anesthesiologists physical status 1 and 2 exclusion criteria: * patients who undergo unilateral total knee arthroplasty * general anesthesia * musculoskeletal disease * hypermagnesemia * atrioventricular block * previous history of administration of calcium channel blockers
a study of maribavir in adults with kidney failure who have a cytomegalovirus (cmv) infection after transplantation

Conditions: Cytomegalovirus (CMV); Kidney Disease; Kidney Failure

Summary: the main aim of this study is to assess the safety profile of maribavir when treating refractory cytomegalovirus (cmv) infection after transplantation in adults with kidneys that are no longer functioning on their own (also called end-stage renal disease or esrd) or have severe chronic kidney disease requiring artificial filtering of the kidney (dialysis) or the blood (hemodialysis). in this study, already existing data will be collected from the participant's medical records. the study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.


Eligibility criteria:
inclusion criteria * adults more than and equal to (≥) 18 years of age at index date * diagnosis of esrd or severe chronic renal disease prior to the index date * if esrd: participant diagnosed with esrd confirmed by an estimated glomerular filtration rate (egfr) less than (\<) 15 milliliter per minute (ml/min) * if severe chronic renal disease: participant diagnosed with severe chronic renal disease requiring peritoneal dialysis or hemodialysis; participant has an egfr of 15 to \<30 ml/min at index * participant has undergone solid organ transplant (sot) or hematopoietic stem cell transplantation (hsct) before index date * participant was diagnosed with refractory (with or without resistance) cmv during the latest post-transplant period * participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir * informed consent provided (where required by local regulations) before data collection commences exclusion criteria there are no exclusion criteria for this study

Keywords: drug therapy
the use of aeriseal ® in the management of collateral ventilation positive copd patients undergoing elvr utilizing endobronchial valves.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves ebv in managing patients with copd who are collateral ventilation (cv) positive. this study has two arms; arm 1 is for cv positive participants who will receive the lung sealant and ebv; arm 2 is the cv negative group who will only receive ebv as the standard management.


Eligibility criteria:
inclusion criteria: * i. 18-85 years of age * ii. forced expiratory volume in 1second (fev1) 20 - 50% * iii. residual volume (rv) \> 175% * iv. 6 min walk test \> 150 m * v. completed a course of pulmonary rehabilitation * vi. stratx assessment - left upper lobe as the most appropriate lobe to target for elvr * vii. this study will be investigating heterogenous emphysema only. minimum of 15% differential in emphysema destruction scores at -950 hu exclusion criteria: * i. acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment * ii. acute respiratory tract infections * iii. significant bronchiectasis, * iv. co-existing interstitial lung diseases, pneumothorax, * v. known active malignancy * vi. pregnancy.
a multicentre observational study to evaluate clinical outcomes of the g7 acetabular system

Conditions: Noninflammatory Degenerative Joint Disease; Rheumatoid Arthritis

Summary: the primary purpose of this study is to evaluate the clinical and radiographic performance of the g7 acetabular cup system.

the primary purpose of this study is to evaluate the clinical and radiographic performance of the g7 acetabular cup system in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.

Eligibility criteria:
inclusion criteria: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis * correction of functional deformity * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * revision procedures where other treatment or devices have failed * 18 years of age or older * subjects willing to return for follow-up evaluations exclusion criteria: * infection, sepsis and osteomyelitis * subjects unable to cooperate with and complete the study * neurological conditions affecting movement * pregnancy

Keywords: joint osteoarthritis avascular necrosis
obstetrics and periodontal therapy (opt) study

Conditions: Periodontitis; Infant, Premature

Summary: the purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).

eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. volunteers will be recruited from hennepin county medical center (mn), the jackson medical mall (ms), the university of kentucky, and harlem (ny) hospital. the incidence of preterm birth is higher at these sites than the national average. subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. all subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. all women will also receive essential dental care to restore caries and treat abscessed teeth. the primary birth outcome is gestational age at birth and the secondary outcome is birthweight. maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. the study will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measure.

Eligibility criteria:
inclusion * be pregnant in the first 13-16 weeks of gestation as determined by menstrual history and obstetrical ultrasound * be at least 16 years of age * have at least 20 natural teeth, * have bleeding on probing (bop) on at least 35% of all tooth sites * have 4 or more teeth with pockets greater than or equal to 4 mm and attachment loss greater than or equal to 2 mm exclusion * are unable to provide informed consent or are unable to cooperate with the study protocol. * may be placed at medical risk as a result of participation (i.e. subjects with hematologic disease or other disorders tha preclude routine non-surgical periodontal therapy). * have multiple fetuses as diagnosed by ultrasound. * require antibiotic prophylaxis for periodontal procedures * require greater than 3 essential dental care visits because of extensive decay and/or broken teeth and are likely to have less than 20 natural teeth following essential dental care
transcutaneous oxygen pressure of the injured ankle as predictor of postoperative cutaneous pain

Conditions: Ankle Injuries

Summary: this monocentric prospective observational pilot study aims to investigate if the measurement of tcpo2 can be used as a predictor of postoperative cutaneous pain in patients with ankle surgery.

this prospective observational study aims to determine the limit of tcpo2 predictive of postoperative cutaneous pain in patients with ankle trauma. a tcpo2 measurement will be performed preoperatively at the patient's arrival in the emergency room, then every day after the operation for 3 days and finally at the follow-up visits at 3 and 6 weeks. the cutaneous pain is evaluated by a psas self-questionnaire (completed by the patient) and an osas questionnaire (completed by the surgeon). these grids evaluate the tolerance and cicatricial quality in the medium and long term by the operator and the patient.

Eligibility criteria:
inclusion criteria: * patients with surgery of ankle trauma exclusion criteria: * patient who does not agree to participate * patient unable to express agreement (ex: unconscious) * minor patient * major patient under tutorship or curatorship
association of vitamin d binding protein polymorphisms with response to hcv therapy

Conditions: Chronic Hepatitis C

Summary: introduction: vitamin d binding protein (vdbp) is a potential modulator of immune response and is associated with clinical progression of many diseases. our aim is to assess influence of baseline 25-hydroxyvitamin d levels and vdbp single nucleotide polymorphisms (snps), rs4588 (c\>a) and rs7041 (g\>t), on baseline clinical parameters and response to interferon based therapy in chronic hepatitis c patients in egypt. methodology: genotyping will be performed by rflp (restriction fragment length polymorphism) in treatment naïve hepatitis c patients and healthy controls. vitamin d levels will be assessed by elisa. hcv rna quantification will be performed by pcr to assess therapy outcome.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 60 years, fasting blood sugar less than 115 mg/dl or 20% upper normal limit (140 mg/dl), hba1c ≤ 7.5% in diabetic patients, normal serum creatinine, normal thyroid stimulating hormone level, negative hepatitis b surface antigen, hemoglobin ≥ 12g/dl for male or ≥ 11g/dl for female, total leukocytes ≥ 3,500/mm3, anc ≥ 1500/mm3, platelets ≥ 100,000/mm3, presence of hcv rna by pcr and elevated liver enzymes within the preceding 6 months for patients with f1 fibrosis stage. exclusion criteria: * hypersensitivity to interferon or ribavirin, decompensated liver cirrhosis (presence of ascites, esophageal varices or hepatic encephalopathy), hepatocellular carcinoma, body mass index\>35 kg/m2 and vitamin d supplementation.

Keywords: vdbp single nucleotide polymorphisms (snps) interferon based therapy egypt
bayer oa knee pain pilot

Conditions: Osteoarthritis, Knee

Summary: the objective of this study is to investigate if mri can be used to evaluated effect of knee artery embolization for knee osteoarthritis. participants be evaluated in clinic, obtain a knee mri, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. a second mri is obtained 6 months after embolization. participants will keep a record of their pain level and treatment and answer questionnaires at each visit. in addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.


Eligibility criteria:
inclusion criteria: 1. age 25 to 90 2. symptomatic osteoarthritis of one or both knees, with kellgren-lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis 3. one or more months of non-surgical therapy for knee pain such as joint injections, oral nsaids, or opioid analgesia 4. subjects able to provide informed consent. as this is a study of pain, patients must be able to consent for themselves. 5. patients without contraindication to mri imaging with gadolinium-based contrast. exclusion criteria: 1. anaphylaxis to gadolinium or iodinated contrast media 2. impaired renal function with gfr \<30ml/min 3. severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies) 4. active septic arthritis of the symptomatic knee within 2 months of screening 5. malignancy of the involved knee 6. rheumatoid arthritis or gout 7. prior knee surgery 8. hemarthrosis 9. females who are pregnant or plan to become pregnant during the study. all participants able to become pregnant will be administered a urine pregnancy test.
a study of biological effects of a polyphenol supplement

Conditions: Healthy Aging

Summary: a randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the investigational product "dailycolors™" (dc) on age-related pathways in adults. the aim of this study is to measure the effects of acute treatment with dc on key pathways relevant to healthy ageing using blood biomarkers. based on power calculations a sample size of 20, is sufficient to detect an effect size of 0.46 at a power \> 90%. to account for dropout the investigators will include 26 subjects in total.

aims: the aim of this study is to measure the effects of acute treatment with dc on key pathways relevant to healthy ageing using blood biomarkers. hypotheses: there will be preliminary evidence that the ip has positive clinical effects on biologically relevant pathways related to healthy aging of brain and muscle including blood markers of inflammation, oxidative stress markers, and trophic factors. design: a randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the investigational product (dailycolors™) on age-related pathways in adults. participants will receive dailycolors™ or placebo for a week, then one week wash-out, and then placebo/dailycolors™ for a week, in random order. in addition, participants will be invited to participate in an open-label extension study for 3 months.

Eligibility criteria:
inclusion criteria: * male or female, (nb equal number of male and female participants) * age between 55 and 80 * body mass index (bmi) over 25 (since this group is expected to have a some degree of inflammation and other metabolic changes and more likely to respond to the supplement) * willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits * provided voluntary, written, informed consent to participate in the study. exclusion criteria: * alcohol or drug abuse in past year * subject has a known allergy to the test material's active or inactive ingredients * subjects with unstable, life-threatening medical conditions * use of polyphenol or phytochemical supplements * use of dietary supplements last month, except from cod liver oil or other vitamin d supplements * vegetarians and vegans * clinically significant abnormal laboratory results at screening * participation in a clinical research trial within 30 days prior to randomization * individuals with dementia and/or who are unable to give informed consent * individuals with unusual high intake of fruit, berries, vegetable and/ or coffee intake, \> 5 portions of fruit, berries and/or vegetables per day or \> 5 cups of coffee per day * any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
comparing perioperative outcomes in pain control

Conditions: Post-operative Pain

Summary: this project consists of a randomized controlled study design. study candidates will include all patients 18 years or older, who were evaluated at ucsd and found to have an orthopaedic injury requiring surgery. patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. data on opioid usage, pain control, and functional status will be collected for each participant. after 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.


Eligibility criteria:
inclusion criteria: * orthopaedic injury requiring surgery * evaluation and treatment at ucsd * age 18years or older * ability to understand the content of the patient information/informed consent form * signed and dated institutional review board (irb) approved written informed consent exclusion criteria: * polytrauma * any not medically managed severe systemic disease * their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other. * the patient prefers one type of pain management protocol and is not willing to be randomized. * recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control * pregnancy or women planning to conceive within the subject participation period (1 year) o pregnancy will be self-reported and no test will be performed to test for it. * prisoner * participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.
efficacy and safety study of total flavonoids of propolis dropping pill to treat angina pectoris

Conditions: Stable Angina Pectoris

Summary: the purpose of this study is to confirm the efficacy and safety of total flavonoids of propolis dropping pill to treat angina pectoris, evaluated by total exercise time of treadmill exercise test.


Eligibility criteria:
inclusion criteria: * class i, class ii and class iii stable angina pectoris, angina attack more than 3 times one week; * qi deficiency and blood stasis syndrome of traditional chinese medicine; * in resting electrocardiogram, st-segment deviation≥0.05mv and/or t-wave inversion≥0.2mv in the leads r-wave is predominant during non-attack period, or st-segment deviation≥0.1mv and/or t-wave inversion≥0.2mv in the leads r-wave is predominant during angina attack; * total exercise time of treadmill exercise test≥3 minutes.the discontinuance standard should be reached. and the difference of total exercise time between before and after run in period should ≤15%; * other confirmed diagnostic evidence of coronary heart disease, such as definite history of old myocardial infarction, or incomplete revascularization one year after coronary intervention therapy(residual luminal stenosis≥50%), or coronary angiography evidence(at least single vessel disease and luminal stenosis≥50%), or nuclein examination evidence, or computer tomography angiography evidence; * signed the informed consent form. exclusion criteria: * chest pain caused by acute myocardial infarction(ami), class iv/serious angina pectoris, psychosis, serious neurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, gallbladder- heart syndrome, gastroesophageal reflux, hiatus hernia, aortic dissection, aortic valve disease; * not well controlled hypertension(systolic pressure≥160mmhg，diastolic pressure≥100mmhg), serious cardiopulmonary insufficiency, serious arrhythmia(rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc); * serious diseases of heart, lung, liver, kidney and blood; * allergic constitution or allergic to the components of total flavonoids of propolis dropping pill; * women during pregnancy or lactation; * received any major operation within 4 weeks; * have been in other clinical trials within 30 days; * using but can not withdraw anti-angina medicine as long acting nitrates; * not well controlled hyperglycemia; * not fit for this trial judged by investigator.

Keywords: chest stuffiness of tcm qi deficiency and blood stasis of tcm