Kornimate/medical-research-clean huggingface dataset:
early response-adapted intensification of induction chemotherapy in patients with newly diagnosed multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: in this study, the investigators will analyze the long-term outcomes of remission and survival, and identify those with primary resistant disease as more likely to benefit from ctd (thalidomide, cyclophosphamide, dexamethasone) and early intensification of vel-cd (bortezomib and cd) as induction chemotherapy followed by autologous stem cell transplantation for the patients with newly diagnosed multiple myeloma.

this study aims to assess the efficacy and toxicities of ctd and vel-cd induction followed by high-dose therapy with autologous stem cell transplantation as a first line treatment for the patients with multiple myeloma.the investigators already investigated the thalidomide-based chemotherapy in patients with newly diagnosed mm. the combined regimen consisted of cyclophosphamide, thalidomide and dexamethasone (ctd) for induction treatment. ctd chemotherapy resulted in a favorable response with 79.4% overall response rate including 42.6% complete response (cr) or very good partial complete response (vgpr), and tolerable toxicity in mm patients. moreover, ctd chemotherapy did not affect the yield of the stem cell collection.the investigators also published that the clinical efficacy and safety of a four-drug combination of bortezomib, cyclophosphamide, thalidomide, and dexamethasone was assessed for patients with relapsed or refractory multiple myeloma vel-ctd chemotherapy.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed mm 2. aged between 18 and 65 years old 3. with following measurable lesions (serum m-protein ≥ 1 g/dl or urine m-protein ≥ 400 mg/day, or free light chain ≥ 100 mg/l) exclusion criteria: 1. smoldering or indolent myeloma 2. ecog performance status \> 3 point 3. known hypersensitivity to cyclophosphamide, thalidomide or dexamethasone 4. peripheral neuropathy or neuropathic pain grade 2 or higher as defined by nci ctcae version 3 5. uncontrolled or severe cardiovascular disease, including mi within 6 months of enrolment, nyha class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction \<0.5 : severe conduction disorder : hypotension (sitting systolic bp ≤ 100 mmhg and/or sitting diastolic bp ≤ 60 mmhg 6. impaired hepatic function (ast or alt ≥ x 3 upper normal, t-bilirubin ≥ x 2 upper normal) 7. creatinine clearance \< 20 ml/min 8. corrected serum calcium ≥ 14 mg/dl 9. sepsis or current active infection 10. pregnancy or breast feeding 11. uncontrolled diabetes mellitus 12. previous history of recurrent dvt or pulmonary embolism 13. active ulcers detected by gastroscopy 14. serious medical or psychiatric illness likely to interfere with participation in this clinical study. 15. receipt of extensive radiation therapy within 4 weeks

Keywords: age under 65 previous untreated
prevalence of the mutational status of v-ki-ras2 kirsten rat sarcoma viral oncogene homolog (kras) in metastatic colorectal cancer (mcrc) in argentine patients

Conditions: Colorectal Neoplasms

Summary: this observational, prospective, multicentric study is being conducted to record the prevalence of kras mutations in the argentine mcrc population.

this is an observational, prospective, non-interventional, single arm, non-comparative, open label, multi-centric, multi-stage study to record the prevalence of kras mutations in the argentine mcrc population. the study is planned to be conducted in 150 centres (50 in each of 3 stages of four months each, enrolling 500 subjects in each stage). total of subjects: 1500. demographic information, complete medical history and tumour history related data will be captured in the first visit and if any information is missing, then only another visit will be scheduled. data captured will be analysed and presented using statistical tools. objectives: primary objective: * to record the prevalence of kras mutations in the argentine mcrc population. secondary objective: * to record and evaluate certain subject and tumour characteristics for association with kras mutational status (country, gender, age, performance status, body mass index (bmi), ethnic origin, personal and family history of malignancy, personal and family history of familial polyposis coli, smoking status, exercise, diet, tumour characteristics/location, site of origin of the tissue sample sent for kras testing, first line therapy chosen).

Eligibility criteria:
inclusion criteria: * subjects who have signed written informed consent before any study-related procedure * subjects with histologically confirmed adenocarcinoma of the colon/ rectum, t1-4 n0-2 m1 or rt1-4 n0-2 m1 * subjects with age above 21 years * subjects willing to provide information required by protocol * no previous systemic treatment for mcrc exclusion criteria: * subjects with known pregnancy * subjects with previous systemic therapy for mcrc * subjects with active infection or any other serious condition which, in the investigator´s mind, may render the subject ineligible for the study * subjects with medical or psychological condition, which, in the opinion of the investigator, would not permit the subject to sign meaningful informed consent

Keywords: colorectal neoplasms metastasis colorectal cancer
periprosthetic fracture registry (ppfx)

Conditions: Periprosthetic Fractures; Periprosthetic Fracture Around Prosthetic Joint Implant

Summary: this registry supports international data collection and research on ppfx treatments after hip and knee arthroplasty. a registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science.

to close the gap of missing clinical evidence regarding the treatment of periprosthetic fractures after arthroplasty of the hip or the knee with osteosynthesis. to drive further study hypotheses and to answer unforeseen questions. main questions to be answered by the registry include (but are not exclusive) the following: 1. influence of implants on outcome 2. influence of surgical techniques on outcome 3. influence of bone grafting on outcome 4. identification of risk factors for failure 5. identification of postoperative rehabilitation programs and its possible influence on the outcome 6. influence of fracture type on outcome 7. to serve as a comparative dataset for future studies with improved implants and techniques

Eligibility criteria:
inclusion criteria: * age ≥18 years * post-operative ppfx after total or hemi hip or total or unicondylar knee arthroplasty (including the acetabulum, femur, patella and proximal tibia) requiring * osteosynthesis alone or * component revision plus plate/nail osteosynthesis * informed consent obtained, i.e.: * ability of the patient or assigned representative to understand the content of the patient information / informed consent form * signed and dated ec / irb approved written informed consent * ability to attend post-operative follow up visits exclusion criteria: * pregnancy or women planning to conceive within the study period * prisoner
a randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and mediterranean diet. about 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. menus with the same energy content but with different content of fat, carbohydrate and protein are designed. breakfast and lunch are served for the patients each day of testing. laboratory samplings are performed six times during the day. the order of the dietary intervention is randomized for each patient. the investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 exclusion criteria: * treatment with insulin or sulfonylurea

Keywords: diet low-carbohydrate postprandial type 2 diabetes mellitus
oral infections: dietary regulation of local and systemic inflammatory responses

Conditions: Periodontal Attachment Loss

Summary: the purpose of this study is to test the hypothesis that dietary n-3 pufa will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical periodontal therapy.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age, male or female 2. at least 20 natural teeth present at the time of periodontal examination 3. be diagnosed with severe, chronic periodontitis; 4. be willing to participate in the study exclusion criteria: 1. \<18 years of age 2. less than 20 natural teeth present at time of periodontal examination 3. unable or unwilling to provide informed consent or follow study protocol 4. systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment 5. use of systemic antibiotics within the last 3 months 6. pregnancy as diagnosed by administered pregnancy test. 7. you are nursing a baby. 8. are allergic to fish or fish products. 9. you are taking any other medications, such as dietary supplements, that could affect the outcome of the study
does rosuvastatin delay progression of atherosclerosis in hiv

Conditions: HIV; Cardiovascular Disease

Summary: this study is a randomised double blind placebo controlled trial comparing rosuvastatin with placebo in hiv positive people who are at intermediate cardiovascular risk. it is possible that hiv positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. current australian guidelines recommend initiation of statin therapy on the basis of cholesterol level and the presence of other risk factors for heart disease (such as diabetes) but do not take into account whether a patient is infected with hiv. this study aims to determine what benefit hiv infected people will receive from starting statin therapy earlier then currently recommended.

participants will be randomised to receive either the active agent (rosuvastatin) or a placebo once daily for 96 weeks. participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid intima media thickness) prior to starting rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * moderate cardiovascular disease (cvd) risk, (10-15% 10 year risk of cvd) * hiv positive * stable combination anti-retroviral therapy (cart) with plasma hiv viral load \<200copies/ml for ≥ 6 months exclusion criteria: * recommended use of lipid lowering therapy according to australian guidelines * prior use of statin, fibrate, ezetimibe within the last six months * contraindication to statin use

Keywords: hiv cardiovascular disease inflammation statin
idtect blood performance for the identification of viral or bacterial pathogens in febrile neutropenic patients

Conditions: Febrile Neutropenia; Acute Leukemia; Stem Cell Transplantation; Infection

Summary: prospective, multicentre french observational study assessing the performance and medico-economic utility of idtect blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

febrile neutropenic patients suspected of sepsis will follow the conventional infectious diagnosis work-up over the entire observation period, and will be tested in addition with idtect blood on study day 1.

Eligibility criteria:
inclusion criteria: 1. age \> 5 years and weight \> 16 kg 2. patients having signed the written study informed consent form (icf) prior to any study-mandated procedure. for children/adolescents: icf obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed 3. patient presenting severe neutropenia (absolute neutrophil count \ 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (aml or all) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation 4. febrile episode (oral temperature \> 38.3°c once, or 2 measures \> 38.0°c taken 2h apart). exclusion criteria: 1. known hiv infection or aids diagnosis 2. already microbiologically confirmed infection 3. patient status preventing the study test to be performed 4. patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation

Keywords: metagenomic infection diagnosis
a study of taspoglutide versus exenatide for the treatment of patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both.

Conditions: Diabetes Mellitus Type 2

Summary: this 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. the anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks; * hba1c \>=7.0% and \<=10% at screening; * bmi \>=25kg/m2 (\>23kg/m2 for asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at least 12 weeks prior to screening. exclusion criteria: * history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes; * history of acute metabolic diabetic complications within the previous 6 months; * evidence of clinically significant diabetic complications; * known proliferative diabetic retinopathy; * myocardial infarction (mi), coronary artery bypass surgery, post-transplantation cardiomyopathy (ptcm) or stroke within the past 6 months; * any abnormality in clinical laboratory test or ecg, which precludes safe involvement in the study as judged by the investigator; * known hemoglobinopathy or chronic anemia; * clinically significant gastrointestinal disease.
how menopause affects lipid metabolism in the visceral fat depots

Conditions: Insulin Sensitivity and Lipid Metabolism

Summary: the purpose of the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed t-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in relation to the menopausal transition.

the study is a cross sectional study including 60 women between 45 and 55 years of age. investigators aim to include 20 premenopausal women, 20 postmenopausal women and 20 postmenopausal women taking hormone treatment (ht). all the women are going through gynecological surgery for benign reasons. during the operation investigators will take a visceral fat biopsy from the omentum. maximally 1 month before- or after the operation the subject will meet at the lab for further testing, including: * health examination * blood samples * ogtt * dxa scan * vo2 max testing * mri of the abdomen * hyperinsulinemic euglycemic clamp

Eligibility criteria:
inclusion criteria: * women * 45-55 years old * for ht treated women (ht more than 1 year) exclusion criteria: * infections during the last month * chronic disease * claustrophobia * smoking * alcoholic intake \> 14 servings * hysterectomy before menopause * oophorectomized * early menopause (before 40 yrs) * bmi \> 30
china xt: safety and effectiveness of edwards lifesciences sapien xt thv in the chinese population

Conditions: Aortic Stenosis; Symptomatic Aortic Stenosis; Aortic Regurgitation

Summary: to evaluate the safety and effectiveness of the sapien xt (edwards lifesciences, irvine, california) transcatheter heart valve implantation (tavi) in chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

edwards sapien xt™ transcatheter heart valve and novaflex+ delivery system will be used for this study.

Eligibility criteria:
inclusion criteria: 1. subjects who are considered to be operable and high risk for surgical valve replacement: 8 ≤ sts score ≤ 15 or 15 ≤ logistic euroscore ≤ 40. if sts score is below 8 and/or logistic euroscore is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team. 2. severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: ava \ 40mmhg, or peak aortic jet velocity \> 4.0m/sec. 3. nyha functional class ii or greater. 4. the study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ec of the respective clinical site. 5. the study patient agrees to comply with all required post procedure follow-up visits. exclusion criteria: 1. evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment. 2. aortic valve is a congenital unicuspid or is non-calcified. 3. aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (sievers classification type 0). 4. anomalous coronary artery that would interfere with proper placement of the valve. 5. mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).

Keywords: tavi tavr china sapien xt high risk transcatheter aortic valve implantation transcatheter aortic valve replacement
open label safety study of tradipitant in idiopathic and diabetic gastroparesis

Conditions: Idiopathic Gastroparesis; Diabetic Gastroparesis; Gastroparesis

Summary: this is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.


Eligibility criteria:
inclusion criteria: * diagnosed with gastroparesis * demonstrated delayed gastric emptying * presence of moderate to severe nausea * body mass index (bmi) of ≥18 and ≤40 kg/m2 exclusion criteria: * another active disorder or treatment which could explain or contribute to symptoms of gastroparesis * a positive test for drugs of abuse at the screening or evaluation visits * pregnancy or nursing * evidence of uncontrolled blood glucose (including hba1c \>11% at screening or metabolic crisis in past 60 days)

Keywords: gastroparesis idiopathic diabetic tradipitant nausea vomiting stomach motility functional nk-1 antagonist neurokinin 1 receptor substance p
comparison of ostap, esp block,injection of local anesthetic to trocar insertion for elective laparoscopic cholecystectomy

Conditions: Postoperative Pain; Regional Anesthesia

Summary: main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided unilateral oblique subcostal transversus abdominis plane (tap),unilateral erector spinae plane (esp) blocks and port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. total 100 patients, american society of anaesthesiology physical status i-ii aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.


Eligibility criteria:
inclusion criteria: * asa status 1-2 patients exclusion criteria * patients with a body mass index (bmi) of \>40kg/m2 * asa score of \>iii * previous abdominal surgery * pregnant or breastfeeding patients * patients with coagulopathy * known local anesthetic allergy * infection at the injection site
vitamin k2 supplementation in adult episodic migraine

Conditions: Migraine Headache; Arterial Stiffness; Vitamin K Deficiency

Summary: migraine is a debilitating illness and a major cause of disability in the world. it is highly prevalent, especially among women. vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. vitamin k2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix gla protein (mgp). supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. therefore, vitamin k2 supplementation could serve a potential role in migraine patients. the purpose of the study is to test the effect of vitamin k2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. the population will be recruited from the neurology clinic at lau medical center-rizk hospital and will constitute of adult patients. they will be randomized to receive either the supplement of vitamin k2 or a placebo for the duration of 6 months. laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.


Eligibility criteria:
inclusion criteria: * adults aged 18 years or above * history of episodic migraine with or without aura since \> 12 months according to the ichd-3 criteria. * migraine frequency from 4-14 days per month over the 3 months prior to screening. * migraine frequency from 4-14 days per month during the baseline period of assessment. * successful completion of the migraine diary during the baseline evaluation period. exclusion criteria: * migraine patients with superimposed tension type or other forms of primary headaches * patients who are currently on any of the migraine prophylactic treatments (sodium valproate, topiramate, beta-blockers, tricyclic antidepressants, srni, flunarizine, verapamil, lisinopril, candesartan) * patients who have been on any of the previously listed medications within 3 months of screening * patient who takes the following medications: * ergotamine or triptans \> 10 days per month * nsaids or paracetamol \> 15 days per month * opioids more than 4 days per month * patients on anticoagulants * other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, post-herpetic neuralgia...) * history of hypersensitivity to the vitamin k2 * history of soy protein, cheese, eggs and meat allergy * history of thrombotic events * diagnosed coagulopathy or any condition related to coagulation * cardiovascular event in the past month * current or planned pregnancy * lactation * inability to tolerate oral medications * known intestinal malabsorption or hypomotility syndromes * atrial fibrillation * active malignancy * any acute illness in the past month

Keywords: migraine arterial stiffness vitamin k deficiency migraine attack