Kornimate/medical-research-clean huggingface dataset:
botulinum toxin a associated costs in the treatment of upper limb spasticity post stroke

Conditions: Upper Limb Spasticity Post-Stroke

Summary: this study aims to estimate the costs of botulinum toxin a utilization in standard practice for the treatment of upper limb spasticity post-stroke in portugal. it will consider the three most used locally available brands of botulinum toxin a which show similar efficacy and safety profiles thus making it relevant to understand if choosing between one or another brand can depend directly on economic factors. the study will estimate direct and indirect drug-associated costs as determinant variables for the price of each drug and the standard drug dose used in clinical practice.

a comparison will be performed between direct costs associated with each therapeutic strategy and cost analysis assuming that quality of life values may be different between patients treated with each treatment.

Eligibility criteria:
inclusion criteria: * patients diagnosed with post-stroke upper limb spasticity * patients currently being treated with dysport®, botox® or xeomin® * patients stabilized from a therapeutic point of view - with no switches of treatment in at least the 2 last administrations * patients who gave their written informed consent to participate. exclusion criteria: * not applicable.
surgical versus functional treatment for acute ruptures of the lateral ligament complex of the ankle in young males - a randomized controlled trial with a mean of 14 years follow-up

Conditions: Ankle Injury

Summary: the aim of this prospective randomized controlled trial was to compare the effectiveness of surgical and conservative treatment in acute lateral ligament injury of ankle. the more detailed aims were to assess the function, physical activity level, re-injuries, objective stability and radiographic changes seen by magnetic resonance imaging in patients randomized to surgery or to functional treatment after a mean of 14 years follow-up.


Eligibility criteria:
inclusion criteria: * the inclusion criteria included positive stress radiographs (in all cases) and arthrography 15 (5 cases) proven fibulotalar anterior (fta) and fibulocalcanear (fc) ligament injury. * the positive findings for a lateral ligament injury included a clinically unstable ankle and a radiological talar tilt \>6 degrees or ads \>5 mm compared with the uninjured opposite ankle. exclusion criteria: * the exclusion criteria for the study were diabetes, inflammatory arthritis, previous severe trauma, pre-existing instability of joints. * in addition, patients were excluded from our study if they had previously undergone surgery of the ankle region.

Keywords: rct, intervention, surgery, lateral ligament injury of the ankle return to pre-injury level
mri biomarkers in as predictor of clinical endpoints in pediatric autoimmune liver disease

Conditions: Autoimmune Liver Disease; Autoimmune Hepatitis; Primary Sclerosing Cholangitis

Summary: autoimmune liver diseases (aild), which include primary sclerosing cholangitis (psc) and autoimmune hepatitis (aih) are a common etiological factor for chronic liver disease among adolescents. this is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset aild. this study will involve collection of mri-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. there is a strong possibility that mri quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. to investigate predictivity of mri based biomarkers, summary measures of mrcp/mrel from baseline, year 1 and year 2, e.g. change rate, maximum, and average will be calculated as predictors for year 10 clinical outcomes. the same predictors will also be used to model native liver survival in a proportional hazard regression. findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.


Eligibility criteria:
inclusion criteria: 1. age 6-23 years old. 2. established clinical diagnosis of aih or psc. exclusion criteria: 1. history of liver transplantation. 2. chronic hepatitis b or untreated hepatitis c virus infection. 3. pregnancy. 4. absolute contraindication for mri (e.g. pacemaker, metallic implants, claustrophobia). 5. diagnosis of cystic fibrosis or biliary atresia 6. diagnosis of cardiac hepatopathy. 7. diagnosis of wilson's disease, alpha-1 antitrypsin deficiency, or glycogen storage disease. 8. skin conditions which could be aggravated by mrel (i.e. epidermolysis bullosa).
a study to investigate the efficacy and safety of atezolizumab (tecentriq) in previously-treated patients with advanced thymic carcinoma

Conditions: Carcinoma, Thymic

Summary: this is a phase ii, open-label, single-arm, multicenter study of the efficacy and safety of atezolizumab treatment in participants with advanced thymic carcinoma who failed prior systemic therapy.


Eligibility criteria:
inclusion criteria: * histological confirmation of thymic carcinoma by the central pathology laboratory * advanced disease not amenable to curative treatment * at least 1 prior line of chemotherapy * progression of disease must be documented prior to study entry * measurable disease, as defined by response evaluation criteria for solid tumors, version 1.1 (recist v1.1) * availability of a representative tumor specimen that is suitable for biomarkers research via central testing * ecog performance status 0 or1 * life expectancy \> 3 months * adequate hematologic and end-organ function within 14 days prior to the first study treatment * for patients receiving therapeutic anticoagulation: stable anticoagulant regimen * for women of childbearing potential: agreement to remain abstinent or use contraception exclusion criteria: * disease which is amenable to radical treatment with surgery or radiation or a combination of treatments. * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * history of leptomeningeal disease * uncontrolled tumor-related pain * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * uncontrolled or symptomatic hypercalcemia * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * active tuberculosis * significant cardiovascular disease within 3 months prior to initiation of study treatment unstable arrhythmia, or unstable angina. * prior treatment with chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered from adverse events due to a previously administered agent. * additional malignancy that is progressing or requires active treatment. exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
effectiveness of vitamin d in primary dysmenorrhoea

Conditions: Primary Dysmenorrhoea

Summary: vitamin d in the treatment of primary dysmenorrhoea. design:randomised controlled trial. setting:in a university hospital. population: 142 women aged 16-35 years. methods: patients were treated with 667 unit of vitamin d once a day, 200 unit of vitamin e once a day or 400 mg ibuprofen twice a day,2 days before the date of menstruation and continued through the first 3 days, for 2 months. main outcome measures: pain score. results: mean vas of vitamin d group was 4,91, was 6,54 in the vitamin e group and was 4,02 in the ibuprofen group conclusion:vitamin d and vitamin e are effective in relieving the pain,but the effect of vitamin d are more prominent

an excessive uterine production of prostaglandins is the pathogenic trigger of dysmenorrhoea. nonsteroidal anti-inflammatory drugs (nsaids) are the currently accepted drugs for the management of this disorder. the capacity for synthesizing vitamin d and the presence of vitamin d receptor in human cycling endometrium have also been demonstrated. because vitamin d reduces the synthesis of prostaglandins, a beneficial effect of vitamin d for the uterus is possible.vitamin e inhibits the release of arachidonic acid and the conversion of arachidonic acid to prostaglandin via an action on the enzymes phospholipase a2 and cyclooxygenase.

Eligibility criteria:
inclusion criteria: 1. women had regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 7 days; 2. women had to be in good health and taking no medications including calcium, magnesium, vitamin d and oral contraceptives. 3. women had not a previous history of gynaecological disease, and a normal pelvic examination were eligible. exclusion criteria: 1) previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted

Keywords: vitamin d
the effects of synbiotic on cardiovascular and bone metabolism markers in transplanted kidney patients

Conditions: Transplanted Kidney

Summary: the aim of this double-blind randomized clinical trial is to determine the effects of synbiotic supplement on cardiovascular disease risk factors and bone metabolism markers and depression, in transplanted kidney patients on chronic post-kidney transplant phase diet.this study is a double-blind, randomized controlled clinical trial with two parallel groups. 44 patients will be randomly assigned into synbiotic and control group. transplanted kidney patients referring to the hospital clinics will be invited to participate. after assessing the entrance criteria, 7 cc blood samples are taken. the food recall is completed. supplements are given to patients for 10-12 weeks. serum concentrations of malondialdehyde; high sensitivity c-reactive protein; soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; osteoprotegerin; receptor activator of nuclear factor kappa-β ligand; n-telopeptide; intact parathyroid hormone; triglyceride; total cholesterol; high-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; blood nitrogen urea; creatinine; and also systolic blood pressure; diastolic blood pressure; weight; body mass index; waist circumference; hip circumference; and questionnaires including quality of depression.


Eligibility criteria:
inclusion criteria: * : more than one year has passed since the last kidney transplant * having serum creatinine less than 2.5 mg/dl in the last three months * being in the age range of 18-75 years * bmi\<35 kg/m2 exclusion criteria: * receiving synbiotic supplement
sleep timing and insulin resistance in adolescents with obesity

Conditions: Obesity

Summary: this study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. the investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions.


Eligibility criteria:
inclusion criteria: * high school students between the ages of 15-19 * bmi \> 90th percentile * tanner stage 2 or greater exclusion criteria: * any medications that affect insulin resistance or sleep (e.g., metformin, hormonal contraception, stimulants, atypical antipsychotics) * regular use of melatonin or sleep aids * a prior diagnosis of obstructive sleep apnea, diabetes (hba1c \> 6.5), liver disease other than non-alcoholic fatty liver disease, pregnancy or breastfeeding * iq \< 70 or severe mental illness that may impact sleep (e.g., schizophrenia, psychotic episodes) * not enrolled in a traditional high school academic program (e.g., home school students) * night shift employment * travel across more than 2 time zones in the month prior to the study
lateral prostate capsule sparing versus non nerve sparing robot-assisted radical cystectomy-orthotopic ileal neobladder for bladder cancer in the male

Conditions: Bladder Cancer

Summary: to compare the perioperative, functional, and oncologic outcomes between non nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

this study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. the patients will be distributed into two comparable groups according to surgical procedures: non nerve sparing group and lateral prostate capsule sparing group. patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility criteria:
inclusion criteria: 1. male patients aged 18 or older. 2. patients those who are diagnosed with urothelial carcinoma. 3. patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by mri and serum t-psa\<2.5ng/ml. 4. patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder. 5. patients those who are able to cooperate and complete the follow-up. 6. patients those who volunteer to participate in this study and sign the informed consens. exclusion criteria: 1. patients thsoe who are diagnosed distant metastasis before surgery. 2. patients those who are diagnosed with other malignancies. 3. patients those who had received pelvic radiotherapy or major pelvic operation.
investigation of a novel silicone dressing to maximize the outcomes of scar revision procedures (improve)

Conditions: Hypertrophic

Summary: neodyne has developed an investigational dressing for post-operative incision care. neodyne is conducting this research to study whether the investigational dressing, called the neodyne dressing, can minimize scar formation in a simple manner.

it is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. it is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.

Eligibility criteria:
inclusion criteria: * the scar to be revised is: * at least 12 months old * linear and suitable for revision by excision and direct closure * appropriate size and location for neodyne dressing * the subject: * age \> 18 and \< 65 years old exclusion criteria: * subjects with a skin disorder that is chronic or currently active. * subjects who are involved in ongoing litigation in connection with the scar to be revised. * subjects with a history of collagen vascular disease * subjects diagnosed with scleroderma * subject who currently smokes * subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives * subjects with oozing, dehiscence, non-closed/healed incisions at time of first application. * subjects with inability to maintain adequate care of incision.

Keywords: scar incision wound healing scarring scar revision
a study of yzj-4729 tartrate injection for the treatment of pain after orthopedic surgery

Conditions: Pain

Summary: the primary objective is to evaluate the analgesic efficacy and safety of iv yzj-4729 tartrate injection in patients with acute postoperative pain following orthopedic surgery


Eligibility criteria:
inclusion criteria: 1. be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent 2. bmi≥18.0 kg/m2 and ≤28.0 kg/m2 3. asa i to ii 4. experiences a pain intensity rating of moderate to severe acute pain following orthopedic surgery, with a pain intensity score of ≥4 on a numeric rating scale (nrs) within 4 hours post-surgery exclusion criteria: 1. opioid allergy 2. nervous system diseases (e.g. epilepsy) 3. psychiatric disorders (e.g. depression) 4. history of difficult airways 5. random blood glucose ≥11.1 mmol/l 6. subjects with systolic blood pressure \>160 mmhg and/or diastolic blood pressure \>100 mmhg or systolic blood pressure \< 90 mmhg 7. abnormal pulse oxygen saturation (spo2 \<92 %) 8. abnormal liver function or renal function 9. used agents that could affect the analgesic response 10. used agents that could affect drug metabolism 11. has previously participated in another yzj-4729 clinical study
transanal versus laparoscopic total mesorectal excision for rectal cancer

Conditions: Rectal Cancer

Summary: this study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (tatme) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（latme）.

colorectal cancer (crc) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. at present，surgical treatments is the main means to cure crc. total mesorectal excision (tme) is the gold standard for rectal cancer surgery. transanal total mesorectal excision (tatme) was recently developed to overcome technical difficulties associated with latme and open tme. most reports are retrospective studies. more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for tatme for mid and low rectal cancer.this is a single-center, open-label, non-inferiority, randomized controlled trial. a total of 120 eligible patients will be randomly assigned to tatme group and latme group at a 1:1 ratio. it will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of tatme compared with latme for mid and low rectal cancer.

Eligibility criteria:
inclusion criteria: * 18 years \< age \< 80 years * body mass index (bmi) \<30 kg/m2 * tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection) * pathological rectal carcinoma * clinically diagnosed ct1-3n0-2 m0 lesions according to the 7th edition of ajcc cancer staging manual with or without neoadjuvant therapeutic history * tumor size of 5 cm or less * ecog score is 0-1 * asa score is ⅰ-ⅲ * informed consent exclusion criteria: * requiring a mile's procedure * fecal incontinence * history of inflammatory bowel disease * pregnant woman or lactating woman * severe mental disease * intolerance of surgery for severe comorbidities * previous abdominal surgery * emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer * requirement of simultaneous surgery for other disease

Keywords: tatme rectal cancer laparoscopic surgery
effects of delayed enteral nutrition on inflammatory responses and immune function competence in critically ill patients with prolonged fasting

Conditions: Severe Acute Pancreatitis Patients; Duodenal Fistula; Inflammatory Intestinal Obstruction

Summary: different studies suggest that early enteral nutrition (een) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (en) is detrimental and if it may have effects on inflammatory responses and immune function.


Eligibility criteria:
inclusion criteria: * having a fasting time of more than 14 days * american society of anesthesiologists (asa) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy. exclusion criteria: * chronic renal failure (peritoneal or hemodialysis or creatinine \> 2.5 mg/dl) * history of chronic obstructive pulmonary disease * hepatic dysfunction or cirrhosis or a bilirubin value \> 3 mg/dl * metabolic diseases,severe anemia * blood coagulation dysfunction * pregnancy lactation * history of psychiatric illness * patients underwent immunosuppressive therapy
a multicenter, open-label, non-inferiority randomized controlled trial of postoperative vte prevention in chinese patients after colorectal cancer surgery

Conditions: Colorectal Surgery; VTE (Venous Thromboembolism)

Summary: research objective 1. optimize vte prevention management after crc surgery. 2. improve the prevention and treatment level of vte in current perioperative patients. 3. reduce the social burden of vte related diseases. participants will: 1. start low molecular weight heparin prophylaxis within 24 hours post-surgery. 2. the prophylactic regimen for the experimental group lasted 14 days, while the control group received it for 28 days. low molecular weight heparin is given subcutaneously at a dose of 0.3ml once daily. 3. atients underwent lower limb color doppler ultrasound on postoperative days 7 ± 2, 14 ± 3, and 28 ± 5, which included screening for thrombosis in the proximal deep veins (femoral, popliteal), distal deep veins (posterior tibial, fibular, and muscular veins), and their perforating branches.


Eligibility criteria:
inclusion criteria: * age\&gt;18 years old; diagnosed with colorectal cancer and undergoing curative, palliative, or other limited surgeries (laparoscopic or open surgery), with an estimated surgery time of\&gt;45 minutes; expected postoperative survival\&gt;6 months; expected caprini score of ≥ 5 on the first day after surgery; the patient agrees to the research plan and signs an informed consent form. exclusion criteria: * renal dysfunction (crcl\&lt;30 ml/min) or liver dysfunction (alt\&gt;3 times the upper limit of normal); known allergies to lmwh, anesthetics, or contrast agents; there is a systemic bleeding disorder or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis within 6 months, cerebral hemorrhage, or a history of neurosurgical surgery; known brain metastases, endocarditis, or previous heparin induced thrombocytopenia; vte occurred within 3 months before surgery; use heparin or oral anticoagulant therapy within 5 days before surgery; pregnant or lactating women; pregnant or lactating women; any conditions that researcher determines the subject not suitable for anticoagulant therapy.
safety and efficacy of folfox6 + cetuximab versus folfiri +cetuximab in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: in patients with metastatic colorectal cancer the following treatments first-line folfiri+cetuximab first-line folfox6 + cetuximab will be concerning efficacy and safety. the trial compares folfiri + cetuximab and folfox6 + cetuximab concerning efficacy and safety as first

the multicenter randomized phase ii study will enroll a target of approximately 150 first-line patients with metastatic crc. egfr expression is not required for study entry, however, the egfr status will be measured retrospectively. patients are randomized to arm a or arm b. arm a: folfox 6 in combination with cetuximab arm b: folfiri in combination with cetuximab. both efficacy and safety data will be collected. the investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Eligibility criteria:
inclusion criteria: * diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * metastatic colorectal carcinoma not suitable for curative-intent resection * availability of tumor sample (or able and willing to provide tumor sample) for egfr assessment * presence of at least one lesion measurable unidimensional by ct scan or mri (target lesion(s) must not lie within an irradiated area) * ecog performance status of \< 2 at study entry exclusion criteria: * brain metastasis (known or suspected) * previous chemotherapy for metastatic crc or adjuvant therapy with oxaliplatin or irinotecan. adjuvant therapy with 5 fu or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months * surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry * cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * any investigational agent(s) within 4 weeks prior to entry * previous exposure to egfr-pathway targeting therapy

Keywords: metastatic colorectal cancer folfox 6 folfiri