Kornimate/medical-research-clean huggingface dataset:
negative pressure therapy in preventing infection after surgery in patients with colon, rectal, pancreatic, or peritoneal surface cancer

Conditions: Colon Cancer; Pancreatic Cancer; Perioperative/Postoperative Complications; Primary Peritoneal Cavity Cancer; Rectal Cancer

Summary: the purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. in this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. in this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing

primary objectives: i. to determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive standard sterile dressing (ssd) over their closed laparotomy incision at the conclusion of their surgery. arm ii: patients receive negative pressure therapy (npt) dressing over their closed laparotomy incision at the conclusion of their surgery. after completion of study treatment, patients are followed up at 30 days.

Eligibility criteria:
inclusion criteria: * surgical resection for a colorectal, pancreatic, or peritoneal surface malignancy * the scheduled procedure will be performed via midline laparotomy * the planned procedure is a clean-contaminated (class ii) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections) * ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative) exclusion criteria: * emergent cases will not be included in the study * pregnant patients will not be included in the study as pregnancy is a relative contraindication for these types of surgical procedures * clean (class i), contaminated (class iii) and dirty (class iv) procedures will likewise be excluded * patients on chronic immunosuppressive medications, including steroids, within the past three months * patients with a history of skin allergy to iodine or adhesive drapes * the planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study
pk/pd of vitamin d3 in adults with cf

Conditions: Vitamin D Deficiency; Cystic Fibrosis

Summary: despite the extensive literature on adverse clinical outcomes associated with vitamin d deficiency, there are currently no proven treatment strategy that effectively achieves and maintains optimal serum vitamin d status in cystic fibrosis (cf) patients. for the treatment of vitamin d deficiency, cf foundation currently recommends 2,000 iu daily. however, because achieving adequate serum 25(oh)d levels is a challenge in cf, higher doses of vitamin d may be necessary to reach and maintain vitamin d sufficiency. poor oral bioavailability of ergocalciferol has been demonstrated in cf patients, which may potentially also be an issue with cholecalciferol. in order to optimize the treatment of vitamin d deficiency in cf, the kinetic disposition must be well understood. however, there are very few data currently available describing the kinetics of both vitamin d and 25-hydroxyvitamin d, and to the investigator's knowledge, no studies have yet characterized the pharmacokinetic disposition of vitamin d and its metabolites in cystic fibrosis. addressing this issue is crucial in effectively and safely correcting vitamin d deficiency in cf.

clinically stable cf patients with a history of pancreatic insufficiency (n=6) and matching non-cf subjects (n=6) will be recruited in this study. all subjects will be pre-screened for 25(oh)d status to include those with 25(oh)d levels below 30 ng/ml. the subjects will receive a single oral dose (300,000 - 600,000 iu) of vitamin d3, and the dose will be based on study participant's baseline 25-hydroxyvitamin d3 level. for cf patients, the dose will be administered with food and pancreatic enzyme supplement. this dose was chosen as previous studies in pediatric cf patients demonstrated that a large single dose of up to 600,000 iu vitamin d3 raised and maintained sufficient 25(oh)d concentrations without any signs of adverse events.

Eligibility criteria:
inclusion criteria: * for cf, diagnosis of cf based on positive sweat chloride or known cf mutation * for cf, patients with pancreatic insufficiency * age ≥ 18 years * serum 25(oh)d concentrations below 30 ng/ml (75 nmol/l) exclusion criteria: * pregnancy * history of lung transplant, * severe anemia (hemoglobin concentration \< 7 g/dl), * liver disease (ast/alt \> 3x uln), kidney disease (gfr ≤ 40 ml/min), or granulomatous conditions * patients taking steroids, cholesterol-lowering drug (cholestyramine), weight-loss drugs (orlistat) , statins, anti-tuberculosis drugs (rifampin and isoniazid), phenobarbital, phenytoin, carbamazepine, immunosuppressants (cyclosporine, tacrolimus)

Keywords: pharmacokinetics pharmacodynamics
effect of early gait training on knee cartilage degeneration after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injuries; Cartilage Degeneration

Summary: a randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after aclr surgery.the relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation.

in this randomized controlled clinical study, patients with primary unilateral acl rupture were included. in addition to standardized rehabilitation training content, gait training intervention under weight loss was added to the subjects in the early postoperative period. the control group only received standardized rehabilitation training. based on motion testing and dynamic analysis, the influence of early postoperative gait training on postoperative gait biomechanical characteristics was explored. and the influence of early cartilage health status; based on functional mri, the effects of early postoperative gait training on biochemical parameters of knee tibiofemoral and patellofemoral cartilage were investigated.

Eligibility criteria:
inclusion criteria: 1. patients with acl rupture were diagnosed by mri; 2. unilateral acl rupture for the first time should be performed in our hospital (department of sports medicine, peking university third hospital)the art of reconstruction; 3. normal bmi range: 18.5-23.9 kg/m2; 4. within 6 months from the trauma; 5. the affected knee joint has passed the acute stage, no obvious redness, pain,inflammation, and limited joint motion,basically restore joint motion. exclusion criteria: 1. bmi\<18.5 kg/m2 or bmi≥24 kg/m2); 2. there is a history of contralateral lower limb musculoskeletal system injury and surgery; 3. acl injury time \> 6 months; 4. outerbridge damage rating ⅲ and ⅳ; 5. patients with meniscal tears who are expected to undergo meniscal suture surgery at the time of aclr surgery; 6. serious injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament; 7. there is metabolic syndrome (obesity, dyslipidemia, diabetes, etc.), which will involve articular cartilage epidemic diseases, serious cardiovascular and cerebrovascular diseases, etc.; 8. those who do not want to accept this treatment

Keywords: anterior cruciate ligament injuries gait training cartilage biochemical characteristics anterior cruciate ligament reconstruction
efficacy and safety of insulin lispro biphasic 25 compared to humalog® mix 25 in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus

Summary: the study is designed to approve non-inferior efficacy and safety of insulin lispro biphasic 25 ("geropharm") compared to humalog® mix 25 in type 2 diabetes mellitus patients.


Eligibility criteria:
inclusion criteria: * signed written consent * clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening * glycosylated hemoglobin (hba1c) level of 7.6 to 12.0 % at screening (both values inclusive) * body mass index (bmi) of 18.0 to 35 kg/m2 at screening (both values inclusive) * stable doses oads for at least 3 months prior to treatment of experimental drug * female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion exclusion criteria: * acute inflammation disease for 3 weeks prior to screening * deviation of the laboratory results conducted during the screening: hemoglobin value \ 2 folds as high as maximal normal value; serum bilirubin value \> 1.5 folds as high as maximal normal value * history of hematological disorders that can affect the reliability of hba1c estimation (hemoglobinopathies, hemolytic anemia, etc.) * serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.) * contraindication to the use of insulin lispro biphasic 25 * insulin resistance over 1.5 u/kg insulin pro day * presence of insulin antibodies in the blood at the screening ˃10 u/ml * use of 3 or more oral antidiabetic drugs (oad) * presence of severe diabetes complications * history or presence of uncontrolled diabetes mellitus for 6 months prior to screening * deviation of vital signs, which can influence to results * history of administration of glucocorticoids for 1 year prior to screening * history of autoimmune disease, except controlled autoimmune thyroid disease * pregnant and breast-feeding women * history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, or history of significant allergic drug reactions * administration of any immunosuppressive drugs (cyclosporinum, methotrexatum) * incomplete recovery after surgery procedure

Keywords: diabetes mellitus, type 2 lispro biphasic insulin
evaluating validity of clinical criteria for requesting chest x-rays in trauma patients

Conditions: Chest Trauma

Summary: the purpose of this study is to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.

at present, a chest x-ray is obtained from all trauma patients having suspicion to chest trauma. the indications for such radiographs are not well defined. this results in a large number of unnecessary chest radiographs being obtained. our goal was to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.

Eligibility criteria:
inclusion criteria: * every patient with blunt trauma to chest exclusion criteria: * nothing

Keywords: cxray
a randomized, placebo-controlled, double blind trial to investigate whether vitamin k2 can influence arterial calcification in patients with type 2 diabetes

Conditions: Arterial Calcification; Diabetes Mellitus Type 2

Summary: arterial calcification is an independent predictor of coronary events associated with a 3-4 fold increased risk of cardiovascular events. currently, no effective intervention exists to reduce arterial calcification. however, recent studies showed that vitamin k may reduce ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification. the primary objective is to determine if mk-7 supplementation leads to stabilization or attenuation of ongoing calcium deposition in the femoral artery as quantified by 18f-naf pet/ct imaging in patients with type 2 diabetes and arterial disease.


Eligibility criteria:
inclusion criteria: * middle aged men and women, ≥ 40 years. * diagnosed with type 2 diabetes. * presence of arterial diseases, based on an ankle brachial index (abi) \<0.9 and/or diagnosed with arterial diseases by physician. * abi\<0.9 * written informed consent. exclusion criteria: * subjects participate in another intervention research or study using imaging. * contra-indication for undergoing18f-naf pet/ct scan (claustrophobia, pregnancy, breastfeeding). * subject underwent amputation of the lower extremities (above the knee). * using vitamin k antagonists. * known coagulation problems (history of venous thrombo embolism). * using vitamin supplements that contain vitamin k, or unwilling to stop two weeks before randomisation. * a mean vitamin k2 intake ≥120 microgram/day measured with a questionnaire. * natto or goose liver consumers. * low kidney function (egfr\<30).
5-mthf supplementation for treatment of type 1 diabetes patients

Conditions: Type 1 Diabetes Mellitus

Summary: this study aims to evaluate the improvement of autoimmune status in patients with type 1 diabetes (t1d) through supplementation with 5-methyltetrahydrofolate, and to explore the safety and efficacy of this treatment. the research seeks to provide new methods for the treatment of t1d and offer innovative ideas for enhancing the quality of life of t1d patients.


Eligibility criteria:
inclusion criteria: 1. diagnosed with t1d based on the world health organization (who) classification criteria for disease diagnosis. 2. aged 13-65 years, regardless of gender. 3. duration of t1d ≤ 5 years. 4. retained residual islet function, defined as fasting c-peptide \> 0.1 nmol/l \[0.30 ng/ml\] or postprandial 2-hour c-peptide \> 0.2 nmol/l \[0.60 ng/ml\]. 5. determined by the investigator to be capable and willing to: perform self-monitoring of blood glucose (smbg); complete patient logs as required; receive diabetes education; and comply with the study treatment and visit schedule as per the protocol. 6) signed informed consent form, with parental/guardian consent and signature required for pediatric/adolescent participants. exclusion criteria: 1. serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range. 2. currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state. 3. women who are breastfeeding, pregnant, or planning to become pregnant during the trial. 4. received immunosuppressive or immunomodulatory therapy within the past year. 5. comorbid with other autoimmune diseases, such as systemic lupus erythematosus. 6. severe liver, kidney, gastrointestinal, hematologic, cerebral, or circulatory system diseases. 7. psychiatric or neurological disorders leading to non-cooperation, non-adherence to medication, substance abuse, or other related issues. 8. malignancy. 9. recent surgery or significant stress. 10. known hypersensitivity or allergic reaction to 5-methyltetrahydrofolate or its excipients. 11. investigator's judgment of significant evidence of severe, active, or uncontrolled endocrine or autoimmune abnormalities. 12. currently participating in another clinical trial.
visual and refractive outcomes after implantation of aspheric iols with different dioptric increments and manufacturing

Conditions: Cataract

Summary: this study compares two intraocular lenses, the softec hd and the tecnis z9002, used to replace the natural crystalline lens after cataract extraction. the variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.


Eligibility criteria:
inclusion criteria: * operable cataracts in both eyes * require intraocular lenses (iols) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes * \</=1 diopter (d) of regular astigmatism in both eyes exclusion criteria: * intraocular surgery or laser treatment prior to cataract surgery * severe dry eye * presence of ocular infection * uncontrolled intraocular pressure (iop) or glaucoma preventing a postoperative best corrected visual acuity (bcva) of 20/25 snellen or better * retinal or macular pathology preventing a postoperative bcva of 20/25 snellen or better * history of retinal detachment * corneal decompensation * history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) * clinically significant corneal endothelial dystrophy (e.g., fuchs' dystrophy) * amblyopia preventing a postoperative bcva of 20/25 snellen or better

Keywords: intraocular lens (iol) quarter diopter biaspheric
efficacy of biofeedback-assisted pelvic muscle floor training and electrical stimulation on women with stress urinary incontinence

Conditions: Stress Urinary Incontinence; Urethral Hypermobility; Intrinsic Sphincter Deficiency

Summary: the pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. this study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.

participant will be assigned randomly to biofeedback-assisted pelvic floor muscle training (pfmt) group and biofeedback-assisted pelvic floor muscle training (pfmt) combined with electrical stimulation group. each of the participant will receive the therapy for two months.the investigators expected that combination therapy will improve the compliance and severity of symptoms in women with stress urinary incontinence.

Eligibility criteria:
inclusion criteria: 1. overactivity bladder for more than 3 months 2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination 3. need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises exclusion criteria: 1. suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc. 2. kidney disease 3. liver disease 4. patients with cardiac rhythm devices. 5. insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises. 6. women during pregnancy. 7. maternity within six weeks after delivery
a study of prexasertib (ly2606368) with chemotherapy and radiation in participants with head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: the main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. the study has two parts (a and b). participants will only enroll in one part.

the primary purpose of parts a and b of this study is to determine a recommended dose level of prexasertib (an inhibitor of checkpoint kinase 1\[chk-1\]) in combination with cisplatin and radiation therapy (part a) or cetuximab and radiation therapy (part b) in participants with locally advanced head and neck cancer.

Eligibility criteria:
inclusion criteria: * must be able to comply with the treatment plan and follow-up schedule * must have diagnosis of head and neck squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), hypopharynx, or larynx * have adequate organ function * if participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for six months following the last dose of study drug * if the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding exclusion criteria: * must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment * must not have received any of the following prior therapies or treatments: systemic therapy for the study cancer, radiation therapy to the head and neck region, or curative-intent surgery in the head and neck region * have evidence of a distant metastatic disease * must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (hiv) or hepatitis a, b, or c * must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months * must not have a family history of long corrected qt interval (qtc) syndrome * must not have known allergic reaction against any of the components of the study treatment

Keywords: cancer
study evaluating etanercept in the treatment of subjects with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study will represent the sponsor's first controlled study of etanercept in chinese subjects with ankylosing spondytitis (as). this trial is designed to assess the safety and efficacy of etanercept compared to placebo in the treatment of patients with as.

multicenter, double-blind, randomized, parallel and placebo-controlled outpatient study. the study consists of 2 parts: part a is a 6-week double-blind treatment period and part b is a 6-week open-label treatment period. during part a of the study, subjects will be randomly assigned to 1 of 2 treatment regimens: 2 etanercept 25 mg or placebo once weekly, administered subcutaneously (sc). after the completion of part a, all subjects will receive 2 etanercept 25 mg once weekly. the use of placebo as a control in part a is necessary to allow a valid comparison and to provide a quantitative assessment of effect.

Eligibility criteria:
inclusion criteria: 1. must be of chinese ancestry and living in china. 2. diagnosis of as, as defined by modified new york criteria for ankylosing spondylitis. 3. active as at time of enrollment, defined by average of visual analog scale (vas) values for duration and intensity of morning stiffness 30 and two of the following: vas for patient global assessment 30; average of vas for nocturnal and total pain 30; basfi greater than or equal to 30 (all scores on a scale of 0 to 100). exclusion criteria: 1. complete ankylosis (fusion) of spine. 2. previous treatment with etanercept, antibody to tumor necrosis factor a (tnfa), or other tnfa inhibitors or other biologic agents. 3. use of disease modifying antirheumatic drugs (dmards) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.