Kornimate/medical-research-clean huggingface dataset:
randomized study comparing tamoxifen vs. tamoxifen + aminoglutethimide in postmenopausal receptor-positive patients

Conditions: Early-stage Breast Cancer

Summary: primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.


Eligibility criteria:
inclusion criteria: * postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer * hormone receptor-positive status * more than 6 histologically examined lymph nodes * laboratory parameters 1. hematopoiesis: \> 3500/µl leucocytes, \> 100,000/µl thrombocytes 2. renal function: creatinin \< 1.5mg% 3. hepatic function: got \< 2.5 x unl 4. bilirubin: \< 1.5mg % 5. metabolic parameters: na, ca, k in normal range, normal level of blood sugar * concluded healing process following surgery * less than 4 weeks interval since surgery * informed consent exclusion criteria: * premenopausal patients, non-determinable menopausal status * previous radiotherapy, chemotherapy or endocrine treatment * generalized disease (as verified by lung x-ray, skeletal x-ray, liver ultrasound) * contraindications against tamoxifen or anastrozole * t4 tumors; carcinoma in situ * lacking compliance or understanding of disease * karnofsky index \< 3 * serious concomitant disease * septic complications, systemic infections or infectious local processes * bilateral ovariectomy or ovarian irradiation * second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)

Keywords: tamoxifen aminoglutethimide breast cancer
effects of gnrha on ovarian function against chemotherapy-induced-gonadotoxicity

Conditions: Breast Cancer

Summary: this prospective randomized controlled study is conducted to analyze the effect of goserelin on ovarian function in women with breast cancer in china.


Eligibility criteria:
inclusion criteria: * premenopausal women 18 to 49 years of age are eligible for enrollment * patients have operable stage i to iiia breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned. * eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment. * human chorionic gonadotropin negative by urine test before entering the group. * informed consent, understanding and compliance with the requirements of the study. * no significant chronic disease and any organ dysfunction. exclusion criteria: * exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization. * use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization. * patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded. * patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial. * patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable. * allergic to active or inactive excipients of gnrha is an exclusion criterion.

Keywords: gnrha ovarian function anti-mullerian hormone
prevention of growth retardation by early treatment with growth hormone (gh) in children with cja treated by corticosteroid therapy

Conditions: Endocrine System Diseases

Summary: * to evaluate the effect of increasing the growth hormone dose on the statural response * to assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of cja, or treated for 4 years after the diagnosis

this trial terminated on 10-jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. the decision to terminate was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * this study will be proposed to all patients previously included in study ctn 97-8129-016 exclusion criteria: * discontinuation of corticosteroid therapy for more than a year during study ctn 97-8129-016 * patients withdrawing from the study prematurely
local anesthetic injection into both angles of the rectus sheath incision

Conditions: Postoperative Cesarean Delivery Pain

Summary: local anesthetic will be injected into both angles of the rectus sheath incision in an attempt to block sensory nerves in this area that cause the sensation of pain from lscs wound.


Eligibility criteria:
inclusion criteria: * patients booked for lscs * primisection * singleton pregnancy exclusion criteria: * emergency cesarean section * bleeding tendency * hypersensitivity to local anesthetic
a study to evaluate the safety of augment™ bone graft

Conditions: Defect of Articular Cartilage

Summary: is augment bone graft plus allograft safe to use for the treatment of osteochondral defects of the knee?

subjects will be 18 to 40 years with an osteochondral defects of the knee.they will be candidates for allograft and augment bone graft will be added to the procedure. the safety of augment bone graft plus allograft for osteochondral defects of the knee will be evaluated by type, frequency, severity and relatedness of adverse events to the device for a minimum of 24 weeks.magnetic resonance imaging will be performed at 1,12 and 42 weeks to evaluate device integrity and surgical treatment of osteochondral defects. computed tomography will be done at week 1 and week 24 to determine the healing status of the osteochondral defect.

Eligibility criteria:
inclusion criteria: * prior magnetic resonance imaging (mri) evaluation or mri on screening. * subjects with grade iii osteochondral defect (ocd) of femoral condyle. * subjects with ocd \> 1 cm.squared. * independent and ambulatory pts. * subjects from 18 to 40 years of age. * subject with a stable knee joint and similar stability on the opposite knee. * subject has knee x-ray with \< 15 degrees of valgus and \< 5 degrees varus. * no deformity from previous fractures of tibia or fibula. * bmi \< 35. * subject has an american association of anaesthetists physical status classification of 1 or 2. * subject must present with pain \> 3.0 cm according to the visual analogue score. * subject has exhausted non operative treatment. exclusion: * allergy to yeast derived products. * index knee has had cartilage repair in the last six months. * subjects with osteoarthritis,inflammatory arthritis, rheumatoid arthritis and avascular necrosis of index knee. * subject has contralateral knee complications which would interfere with rehabilitation * subject has implanted metallic devices that would prevent magnetic resonance imaging (mri). * subject has claustrophobia that would prevent mri. * subject has had a malignancy or is being treated for a malignancy. * subject is physically or mentally compromised that would interfere with compliance. * subject is a prisoner or transient. * subject has a recent history (12 months) of alcohol abuse. * subject is pregnant, able to become pregnant but not practising birth control. * subject has an infection in the operative area. * subject has scheduled surgery on the contralateral knee over the course of the study. * subject requires another procedure in the index knee. * subject has had steroid therapy in the past six months. * subject is taking prescription pain medication for another indication other than the index knee. * subject is using nicotine in any form.
effectiveness for interventions to minimize surgical site infections

Conditions: Infections

Summary: the purpose of this study is to evaluate two different simple and inexpensive extra treatments during colorectal surgeries to see if this will reduce the rate of post operative infections

the population for inclusion for this study will be drawn from the patients undergoing elective transabdominal colorectal surgery. this population was chosen due to its inherently high rate of superficial-incisional infection.colorectal procedures stand out as a particularly highrisk surgery with respect to ssi. several studies have reported rates of infection of 25% or more making colorectal surgeries an excellent opportunity for testing new strategies to reduce ssi. this pilot project seeks to preliminarily evaluate two new strategies that are inexpensive and could be readily incorporated into current practice. the strategies are pressurized irrigation of the superficial surgical wound (above the fascia) and subcutaneous injection of gentamicin into the surgical wound prior to initial skin incision. comparison will be made between prospectively enrolled patients and historic controls.the hypothesis to be tested is that these interventions will significantly reduce superficial incisional infection rates compared with historic control.

Eligibility criteria:
inclusion criteria: * va patients getting transabdominal,elective colorectal procedures * willing and capable of giving self informed consent exclusion criteria: * patients unable to give informed consent * emergency colorectal procedures * transanal procedures * patients who have contaminated or dirty wounds that would preclude attempts at skin closure at the conclusion of the procedure * patients undergoing appendectomy * patients undergoing intraabdominal procedures not including surgical resection of the colon or rectum (ie.procedures involving small bowel , stomach) * patients with pre/op creatinine clearance less than 20ml/min * patients with known allergy or hypersensitivity to gentamicin * patients that have received gentamicin within 2 weeks of potential study date

Keywords: colorectal surgery
the implication of plasma ctdna methylation haplotypes in detecting colorectal cancer and adenomas

Conditions: Colorectal Cancer; Adenoma

Summary: this is a multicenter, clinical study. this study is to evaluate the sensitivity of plasma ctdna methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

colorectal cancer (crc) is the third most common cancer worldwide, the second deadliest cancer in the united states. dna methylation is a commonly used biomarker for non-invasive crc detection in plasma. the low sensitivity of blood-based tests is due to several limitations of detecting ctdna in early-stage cancer. we developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. this previously established colorectal tumor-specific plasma ctdna methylation markers (diagnostic model established by next-generation sequencing of gene loci methylation) had a high sensitivity in crc patients and a high specificity in healthy individuals in a large retrospective sample study. this prospective, multicenter, clinical study is to further evaluate the sensitivity of plasma ctdna methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

Eligibility criteria:
inclusion criteria: healthy individuals: * written informed consent must be obtained from healthy individuals to comply with the requirements of the study. * healthy individuals who received colonoscopy. patients with colorectal cancer or adenomas: * male or female ≥ 18 years of age on the day of signing informed consent. * patients need to receive surgical resection or endoscopic resection. * patients must have histologically confirmed stage i-iv colorectal cancer or adenomas * patients must have a performance status of ≤1 on the ecog performance scale. * written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study. exclusion criteria: * patients received adjuvant treatment prior to the surgical resection. * patients received blood transfusion two weeks before or during the surgical resection. * patients with unresected advanced colorectal adenoma. * patients who are positive for human immunodeficiency virus (hiv), hepatitis b or hepatitis c. * patients who are pregnant. * patients who are alcoholic or drug abusers. * patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.

Keywords: colorectal cancer adenomas ctdna methylation haplotypes
birkebeiner ii study

Conditions: Atrial Fibrillation

Summary: prolonged endurance exercise is associated with an elevated risk of atrial fibrillation (af). the mechanisms governing this increased risk remains elusive. this study aim to detail the specific traits of elderly subjects with af conducting endurance training by comparing elderly participators in the birkebeiner cross country ski race(an indicator of prolonged endurance exercise practice) with and without af to a not-so-trained control group.

in recent years endurance sports with high intensity and participation in competition have been increasingly popular among middle aged and older people. the birkebeiner studies are investigations of elderly non-professional athletes (65 years or older at enrollment in 2009/10) participating in the birkebeiner cross-country ski race. it consists of birkebeiner aging study, bias and the birkebeiner atrial fibrillation, (baf-study). the baf-study investigated the association between prolonged endurance sport practice and the risk of af by comparing the cohort of veteran cross-country skiers to a control population drawn from the health and environment study in oslo (helmilo 2009). the main findings of the birkebeiner study so far have been that participation in the birkebeiner cross-country ski race (an indicator of prolonged endurance exercise practice) is associated with an elevated risk of atrial fibrillation (af) among men ≥ 65 years, and that this risk correlates with the cumulated amount of endurance-training. similar findings were seen amongst female athletes. this increased risk of af was shown independent of other known significant comorbidities (such as hypertension and diabetes), indicating that endurance-training at this level itself is an independent risk factor. regular physical exercise is an important factor when it comes to successful ageing. however, dose-relationship of physical exercise in a longer perspective is poorly studied. atrial fibrillation is associated with increased risk of stroke, heart failure, dementia and death. the mechanisms governing the increased risk of af in elderly subjects undergoing endurance-training remains elusive. this study aim to detail the specific traits of elderly subjects with af conducting endurance-training in comparison with trained and not-so-trained control groups. thus, generating knowledge that can form the basis for better prevention and treatment of af in this group.

Eligibility criteria:
inclusion criteria: * already included in the birkebeiner studies or "health and environment study in oslo" (helmilo) * born 1960 and earlier exclusion criteria: * born before 1935. * earlier heart valve surgery. * mi (mitral insufficiency)≥ grade 3 * ejection fraction (ef) \<35%
efficacy of dun ye guan xin ning tablet in patients with stable angina pectoris

Conditions: Coronary Heart Disease

Summary: this registry is designed to investigate factors affecting the efficacy of dun ye guan xin ning tablet on patients with stable angina. the potential hypothesis is that dun ye guan xin ning has a better effect on different subgroup patients with certain characteristics.

a total of 1000 eligible patients enrolled from 20 centers will take standard medications of care for stable angina plus dun ye guan xin ning tablet for 6 months. symptoms, questionnaires (saq, psqi, and angina pectoris quantitative table of chinese medicine symptoms scale), lipid, fasting glucose, homocysteine, ekg, blood pressure and other physical examination will be collected at baseline and follow-up. among them, 200 patients will measure and inflammation biomarkers and endothelial function for further evaluation.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 75 years. 2. documented stable angina pectoris. 3. during a period of time (more than 3 months), the duration, severity and the threshold of angina is relatively stable. 4. patients with at least one of the following events: ① patients who have done pci or cabg for more than half a year; ② coronary cta angiography or coronary angiography showed at least one major coronary artery stenosis ≥ 50%. symptom occurs at least once per month. 5. medications remain stable within 1 month before the enrollment. 6. patients have the ability to understand the study, and can cooperate with researchers to carry out the test. 7. signed inform consent. exclusion criteria: 1. patents with coronary heart disease acute coronary syndrome during the last 6 months. 2. patients with aortic stenosis, hypertrophic cardiomyopathy and other diseases leading to angina. 3. patients have other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastroesophageal reflux caused by chest pain. 4. patients combined with severe cardiopulmonary insufficiency (nyha grade iii ord iv), pulmonary insufficiency graded reference copd clinical severity of lung function grade iii (fev1 / fvc \<70%, 30% 1 / fvc% of predicted value \<50%) and grade iv), severe arrhythmia (eg. iii degree atrioventricular block) 5. patients combined with liver, kidney, hematopoietic system and other serious primary disease patients (tbil ≥ 1.5uln, ast ≥ 2uln, alt ≥ 2uln, serum creatinine ≥ 1.5uln, hb \<9mg/dl). 6. patients with cognitive, intellectual, or mental disorders. 7. those who can not take oral medication. 8. allergy to any component of this product. 9. patients received the trial medication within 28 days prior to the first treatment of this product. 10. lactating or pregnant women. 11. patients who are unwilling or unable to contraceptive in the reproductive period. 12. poor medication compliance. 13. other circumstances that the investigator considers unsuitable for inclusion.

Keywords: stable angina pectoris dun ye guan xin ning
adiponectin gene and coronary artery disease

Conditions: Coronary Artery Disease

Summary: genetic studies of coronary artery disease, restenosis after angioplasty or stenting, focusing on renin-angiotensin system genes and adiponectin gene, and their interactions.


Eligibility criteria:
inclusion criteria: * patients receiving angiography exclusion criteria: * patients receiving angioplasty and reluctant for the study
a study of tar-200 in participants with muscle-invasive urothelial carcinoma of the bladder who are ineligible for or refuse cisplatin-based chemotherapy and who are unfit for radical cystectomy

Conditions: Urinary Bladder Neoplasms

Summary: the purpose of this study is to evaluate both the safety and tolerability of up to 4 dosing cycles of tar-200 for 21 days per dosing cycle in the induction period.


Eligibility criteria:
inclusion criteria: * histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder * participant must have been as fully resected as possible per the physician's judgment * participants must be deemed unfit for rc due to comorbid conditions with a risk of mortality * participants must refuse or be deemed ineligible for cisplatin-based chemotherapy * participant must refuse or not be eligible for radiotherapy exclusion criteria: * other active malignancies * presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of tar-200 * pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed) * evidence of bladder perforation during diagnostic cystoscopy * concurrent clinically significant infections as determined by the treating investigator
nicotinamide mmononucleotide in patients undergoing cabg surgery

Conditions: Coronary Artery Bypass Graft

Summary: the investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective coronary artery bypass grafting (cabg) surgery to investigate the effects of oral nicotinamide mononucleotide (nmn) administration on myocardial nad+ concentrations and on postoperative markers of myocardial and kidney injury.

this is a phase 2a, randomized, double-blind, parallel-group, placebo-controlled clinical trial in adult patients undergoing elective coronary artery bypass grafting (cabg) surgery. a total of 90 patients will be randomized 1:1:1 to placebo or to one of two dosing regimens of nmn seven days prior to surgery as follows: arm a: nmn 1,000 mg po twice daily, administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively arm b: nmn 1,000 mg po twice daily, administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively arm c: placebo po twice daily, administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively there are two major study aims: aim 1: test the effect of oral nmn administration on myocardial nad+ concentration. aim 2: test the effect of oral nmn administration on postoperative myocardial and kidney injury parameters.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. scheduled to undergo elective isolated cabg surgery with cardiopulmonary bypass (cpb) 3. at increased risk of postoperative complications based on ≥1 of the following: 1. age ≥65 years 2. egfr \<45 ml/min/1.73m2 3. documented history of congestive heart failure or left ventricular ejection fraction (lvef) ≤40% within 6 months before surgery 4. diabetes mellitus and urine albumin-to-creatinine ratio \>30 mg/g creatinine 5. peripheral arterial disease 6. anemia, defined as hemoglobin \<10 g/dl 7. prior cardiac surgery exclusion criteria: 1. any of the following laboratory abnormalities at the time of screening: 1. alt \>3-fold the upper limit of normal 2. egfr \<30 ml/min/1.73m2 or eskd on dialysis 3. hemoglobin \<8 g/dl 2. history of gastric bypass or malabsorption 3. active alcohol or illicit substance use in the prior 6 months 4. participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter 5. pregnant or breast-feeding 6. unwillingness to use contraception while taking study drug and for 8 weeks after the last dose for women of reproductive age or non-sterilized male participants who are sexually active with a female partner of childbearing potential 7. current use of niacin \>100 mg/day or nmn, nicotinamide, or nicotinamide riboside at any dose 8. conflict with other research studies 9. any condition which, in the judgement of the investigator, might increase the risk to the participant

Keywords: coronary artery bypass graft cardiac surgery cardiopulmonary bypass nicotinamide nmn acute kidney injury