Kornimate/medical-research-clean huggingface dataset:
hdi versus chemotherapy as systemic adjuvant therapy for resected mucosal melanoma

Conditions: Melanoma

Summary: this is a a multicenter, randomized, controlled, phase iii trial comparing high-dose ifn-a2b with temozolomide plus cisplatin as systemic adjuvant therapy for resected mucosal melanoma.the study objective is to compare efficacy and safety of high-dose ifn-a2b and temozolomide-based chemotherapy as adjuvant therapy.

the patients who comply with the inclusion and exclusion criteria will be enrolled. the estimated recruiting duration is 36 months. patients with resected mucosal melanoma were randomized into two groups: hdi group (group a, treated with i.v. 15×10\^6u/m\^2/d ifn-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10\^6u ifn-a2b three times per week for 48 weeks), and chemotherapy group (group b, per os 200 mg/m\^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m\^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles). all patients will be followed for at least 2 years.

Eligibility criteria:
inclusion criteria: 1. age more than 18 years; 2. eastern cooperative oncology group (ecog) performance status of 0 or 1; 3. pathologically confirmed diagnosis of mucosal melanoma; 4. completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted); 5. no prior systemic adjuvant therapy or regional radiotherapy; 6. no evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (ct) of bone, and whole-body spiral ct or positron emission tomography-ct (pet-ct); 7. normal bone marrow function; and adequate liver and renal function \[including white blood cell (wbc) count \> 3,000/mm\^3;absolute neutrophil count \> 1,500/mm\^3; platelets \>100,000/mm\^3; serum creatinine less than two times of the upper limit of normal (uln); bilirubin less than 1.5 times of uln; aspartate aminotransferase (ast) and alanine aminotransferase (alt) less than 2.5 times of uln; international normalized ratio less than 1.5 times of uln; and partial thromboplastin time less than uln\]. exclusion criteria: 1. cutaneous melanoma or ocular melanoma or melanoma of unknown primary site; 2. incomplete resection or primary tumor unable to be resected; 3. a second cancer diagnosis; 4. definite medical history of cirrhoses of the liver or autoimmune diseases; 5. severe depression; and pregnant or lactating female.

Keywords: mucosal melanoma,adjuvant therapy,ifn-a2b,temozolomide
diagnostic imaging or observation in early equivocal appendicitis

Conditions: Appendicitis

Summary: the aim of the study is to evaluate whether patients with early equivocal appendicitis can be observed instead of immediate diagnostic imaging. half of the patients are randomly assigned to observation group, while the other half will undergo diagnostic imaging. the hypothesis is that resolving appendicitis is common in these patients. thus, in observation group there will be fewer patients with appendicitis diagnosis and observation reduces the use of diagnostic imaging and surgery.

for the study equivocal appendicitis is defined as clinical suspicion of appendicitis with adult appendicitis score between 11 and 15. the estimated prevalence of appendicitis in such patients is around 50%. diagnostic imaging is done using conditional computed tomography i.e. abdominal ultrasound first and computed tomography only after negative or inconclusive appendicitis after ultrasound. in observation group repeated clinical examination is done after 6-8 hours interval with repeated blood test for calculation of adult appendicitis score. patients with decreasing score value continue observation without imaging, whereas patients with the same score value or higher (but below 16) undergo diagnostic imaging as in other group. laparoscopy is done without imaging in patients with high score (16 or higher). antibiotics are not allowed, but prophylactic antibiotics during induction of anesthesia are allowed.

Eligibility criteria:
inclusion criteria: * clinical suspicion of acute appendicitis * equivocal appendicitis defined by adult appendicitis score: score ≥11 and ≤15. exclusion criteria: * c-reactive protein \>99 mg/l * time from symptom onset over 24 hours * pregnancy * antibiotics given within last 24 hours * suspicion of other disease than appendicitis, that would require immediate interventions such as surgery, diagnostic imaging or gynecologic consultation * missing written informed consent * patient randomized earlier to the study
comparison of closed-loop operation after morning meal with and without carbohydrate counting

Conditions: Type-1 Diabetes

Summary: closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosage based on the sensor's readings. a dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. the main goal of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (t1d) without a significant degradation in post-meal glucose control. each patient will be admitted twice to a clinical research facility. in one visit, patients will eat a morning meal accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. in the other visit, patients will eat the same meal but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. if post-meal glucose levels were indifferent between the two visits, then this would suggest that carbohydrate counting may not be necessary during closed-loop operation as the closed-loop system will give any remaining insulin needed to cover the glucose absorbed from the meal. twelve subjects will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * males and females ≥ 18 and ≤ 65 years of old. * clinical diagnosis of type 1 diabetes for at least one year. the diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); c peptide level and antibody determinations are not needed. * the subject will have been on insulin pump therapy for at least 3 months. * last (less than 3 months) hba1c ≤ 12%. exclusion criteria: * clinically significant nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator. * recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. * pregnancy. * severe hypoglycemic episode within two weeks of screening. • medication likely to affect with the interpretation of the results: prandase, victoza, byetta and symlin * known or suspected allergy to the trial products or meal contents. * other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. * failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc). * unreliable carbohydrate counting * problems with venous access
tocladesine in treating patients with recurrent or refractory multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of tocladesine in treating patients who have recurrent or refractory multiple myeloma.

objectives: i. determine the safety of 8-chloro-cyclic adenosine monophosphate (8-chloro-camp) in patients with recurrent or refractory multiple myeloma. ii. evaluate the efficacy of this regimen in these patients. iii. determine the pharmacokinetics of this regimen in these patients. outline: patients receive 8-chloro-cyclic adenosine monophosphate (8-chloro-camp) over 120 hours every 2 weeks for up to 4 courses. beginning with course 5, patients with stable or responsive disease receive 8-chloro-camp over 120 hours every 3 weeks until disease progression. patients are followed every 3 months until death. projected accrual: a maximum of 29 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed recurrent or refractory multiple myeloma measurable disease by monoclonal serum or urine globulins or malignant plasma cells documented on bilateral bone marrow biopsy refractory after at least one prior therapeutic regimen (no more than 2 prior regimens allowed) patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: creatinine no greater than 1.5 mg/dl and/or creatinine clearance at least 60 ml/min calcium no greater than 8.7 g/dl cardiovascular: no history of arrhythmias no uncontrolled angina pectoris no symptomatic coronary ischemia no grade 3 or 4 congestive heart failure cardiac ejection fraction greater than 35% by gated imaging other: not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 3 weeks since prior chemotherapy endocrine therapy: at least 3 weeks since prior glucocorticoids radiotherapy: not specified surgery: not specified other: no concurrent theophylline therapy

Keywords: refractory multiple myeloma stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
association of coronary artery disease with lewis and abo blood group phenotypes

Conditions: Coronary Artery Disease

Summary: primary objective- to study the association of lewis antigen and a, b, o blood group phenotypes with coronary artery disease patients attending the tertiary care hospital in kerala. the secondary objective-to find the association of lewis antigen and a, b, o blood group phenotypes with smoking, alcohol use, diabetes, hypertension and dyslipidemia. a case-control study to compare the prevalence of lewis(a-b-) blood group among confirmed cardiac cases with the prevalence of the same among the general population and thereby find out if individuals with lewis(a-b-) are more at risk of developing coronary artery disease. this may provide an economical and simple method for identifying subjects at increased risk for coronary artery disease and subsequently lead to more focused preventive measures and eventually to a specific treatment.


Eligibility criteria:
inclusion criteria: - patients in the age group of 30-55 years at the time of data collection diagnosed with coronary artery disease based on positive changes in coronary angiogram (more than 70% coronary stenosis) exclusion criteria: * patients with other systemic illnesses like malignancy, autoimmune diseases. * patients who were not willing to participate in the study.

Keywords: abo blood group system lewis negative phenotype coronary artery disease
differences in epicardial plaque and microvascular function in women with an acute myocardial infarction

Conditions: Myocardial Infarction

Summary: the broad objective is to advance our understanding of both in vivo anatomical and functional changes that are present in the coronary arteries in women who have an acute coronary syndrome. specific focus will be placed on the age of the women as there may be distinct differences in younger women (\< 50 years) given the marked increase in mortality in this population.

the hypothesis of the current study is that plaque erosion and microvascular dysfunction are key features responsible for the increased peri-mi mortality in young women. in order to test this hypothesis the following specific aims are proposed using a special intravascular ultrasound technique called virtual histology and microvascular function (effect of intracoronary adenosine on coronary blood flow) in patients coming to the cardiac catheterization laboratory with an acute mi: 1. to determine if plaque rupture or plaque erosion is more prevalent in young women (\<50 years) compared with older women (≥ 50 years) and men in the development of an acute mi 2. to determine if inflammatory mediators of plaque rupture are higher in older women and men with an acute mi compared with younger women 3. to determine if microvascular function is abnormal in young women undergoing percutaneous coronary revascularization with an acute mi compared to older women and men 4. to determine if alterations exist in the number and function of epcs in young women (\<50 years) compared with older women (≥ 50 years) and men who have had an acute mi and to determine the association with microvascular function

Eligibility criteria:
inclusion criteria: * age of 18 years or older * acute coronary syndrome defined as at least two of the following: a) an elevated cardiac biomarker (troponin or ck-mb), b) new or dynamic ecg changes in at least 2 contiguous standard electrocardiographic leads of st depression \> 1 mm or st elevation of \>1 mm or t-wave inversions, c) chest pain or discomfort of at least 15 minutes duration, d) a new wall motion abnormality by echocardiography * patient who is undergoing coronary angiography * physician planning to perform ivus for treatment of the infarct-related vessel exclusion criteria: * creatinine \> 2.0 mg/dl (most recent) * hemodynamically unstable patients (systolic blood pressure \ 110 beats/ minute or presence of an intra-aortic balloon pump) * coronary revascularization (percutaneously or surgically) within 6 months * the use of chronic immunosuppressive agents * no target lesion was found at the time of cardiac catheterization that will be percutaneously intervened upon (the patient must undergo percutaneous coronary intervention) * inability to give informed consent * pregnant or lactating women * prisoners

Keywords: acute coronary syndrome women
safety and efficacy of moxidex otic

Conditions: Acute Otitis Media

Summary: the purpose of this study is to determine if moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.


Eligibility criteria:
inclusion criteria: * 6 months to 12 years of age * ear tubes in one or both ears * ear drainage visible by parent/guardian * ear drainage less than 21 days * other protocol-defined inclusion criteria may apply exclusion criteria: * patients not otorrhea-free for 7 or less following tympanostomy tube surgery * ear tube with antimicrobial activity; ear tube longer than 2.5mm * non-tube otorrhea * no otic surgery other than tube placement in the last year * no menarchial females; no diabetic patients * no patients with any disease or condition that would negatively affect the conduct of the study * no patients taking any other systemic antimicrobial therapy during the study * patient must meet certain medication washouts to be eligible * analgesic use (other than acetaminophen) is not allowed * patients may not be predisposed to neurosensory hearing loss * other protocol-defined exclusion criteria may apply

Keywords: ear tubes ear drainage ear infection ear drops acute otitis media
molecular markers in cervical cancer screening in the feasibility of the mathematical markov model analysis

Conditions: Cervical Cancer

Summary: the purpose of this study is to: 1. make p16ink4a as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer. 2. reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.

1. to carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers detect + p16ink4a" methods of screening accuracy and reliability, as well as the screening method of the biological effects. 2. markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. with a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.

Eligibility criteria:
inclusion criteria: * married women aged 25 to 65-year-old with risk factors * no tumor and pelvic radiation therapy history * non-pregnant women at present

Keywords: molecular markers cervical cancer screening makov
study of the role of the induced membrane in the reconstruction of bone loss in the limbs

Conditions: Bone Loss

Summary: masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. the particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). the presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery). in view of the excellent clinical results obtained with this procedure, the masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery. however, orthopedic surgeons sometimes observe failures in bone consolidation. to our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with traumatic bone loss * patient eligible for the induced membrane technique exclusion criteria: * patients with post-tumor bone loss * patients who are immunocompromised or under immunosuppressive treatment * patients with chronic inflammatory disease (diabetes, inflammatory bowel disease) * patients with collagenosis * patient with a contraindication to sampling * pregnant or breastfeeding women

Keywords: masquelet technique induced membrane technique
a phase ii study of hlx22 in combination with trastuzumab deruxtecan in her2-low, hormone receptor positive locally advanced or metastatic breast cancer patients

Conditions: HER2-low Hormone Receptor Positive Breast Cancer

Summary: this is a phase ii study of hlx22 in combination with trastuzumab deruxtecan (t-dxd) in her2-low, hormone receptor positive locally advanced or metastatic breast cancer patients with disease progression or intolerable adverse reaction on standard of care. eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

experimental group: hlx22(15 mg/kg) + trastuzumab deruxtecan( 5.4 mg/kg), once every 3 weeks (q3w).

Eligibility criteria:
inclusion criteria: 1. male/female who are at least 18 years of age on the day of signing the informed consent. 2. with histologically confirmed diagnosis of her2-low, hormone receptor positive locally advanced or metastatic breast cancer. 3. her2-low defined as ihc 2+/ish- or ihc 1+ (ish- or untested) as assessed by a central laboratory on metastatic tumor and was never previously her2-positive，and was documented hr+ disease in the metastatic setting 4. had measurable disease according to the recist v1.1, the target lesion must not be a bone metastatic lesion only. 5. ecog ps: 0-1. 6. expected survival ≥ 6 months. 7. had adequate organ function exclusion criteria: 1. patients with other malignant tumors within 3 years before the randomization 2. previous treatment with any her2-target therapy 3. uncontrolled or significant cardiovascular disease or infection 4. lung-specific intercurrent clinically significant illnesses 5. prior documented interstitial lung disease (ild)/ pneumonitis that required steroids, current ild/ pneumonitis, or suspected ild/ pneumonitis 6. patients with spinal cord compression or clinically active central nervous system metastases
efficacy and safety of fibrin sealant vapor heated solvent/detergent treated (fs vh s/d) for hemostasis in subjects undergoing total hip replacement

Conditions: Hip Replacement Surgery

Summary: the purpose of the study is to monitor the safety of fs vh s/d and evaluate whether fs vh s/d is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.


Eligibility criteria:
inclusion criteria: each subject to be included into the study must fulfill the following inclusion criteria: * subjects receiving a cement free hip prosthesis due to coxarthrosis because of primary or dysplastic arthrosis grade 1 - 3 according to crowe or rheumatoid arthritis as well as subjects receiving a cement free hip prosthesis due to femur head necrosis (crowe classification). * asa and nsaids have been discontinued one week prior to surgery * written informed consent * male and female at least 19 years of age exclusion criteria: subjects fulfilling the following exclusion criteria will not be recruited into the study: * impaired coagulation * previous hip surgery * acetabular roof plastic * known hypersensitivity to aprotinin or other components of the product * immunodeficiency * increased red cell production * pregnant or lactating women (positive urine or serum pregnancy test; this test is required of any female subject who is not post menopausal or surgically sterilized). * subjects concurrently participating in another clinical trial or having received another investigational drug within the last 30 days. also patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.

Keywords: arthroplasty hip prosthesis cement free hip prosthesis femur head necrosis coxarthrosis