Kornimate/medical-research-clean huggingface dataset:
18f-sodium fluoride (18f-naf) pet-ct imaging to identify vulnerable plaques in patients with diabetes

Conditions: Atherosclerosis; Complications of Diabetes Mellitus

Summary: coronary artery calcification is a sign of heart disease. a nuclear medicine pet-ct test using sodium fluoride (18f-naf) radioisotope has been shown to help identify growing calcification plaques early on in the disease process. it is known that diabetic patients are at a high risk of developing premature coronary disease; the investigators intend to use this new technology to identify those patients at higher risk of developing coronary artery disease.

diabetic patients are at very high risk of suffering premature coronary artery disease events compared to the general population. whether pancreas transplant completely reverses the biochemical imbalances of diabetes mellitus and the high cardiovascular risk of these patients is unclear. investigators in the field of imaging have been looking for ways to identify patients at greater risk of suffering events by searching for plaques in the cardiovascular system more likely to fracture and cause acute intravascular thrombosis (vulnerable plaques) with subsequent precipitation of acute events. recent advances in pet-ct provide an opportunity to pursue such search with limited risk to the patient and high probability of success. ct scanning is used to identify vascular calcification -a marker of atherosclerosis- and pet imaging with 18f-naf helps determine whether the calcification is actively accumulating calcium and phosphorus making it an actively growing plaque. pet imaging with 18f-naf has been used in the setting of acute coronary syndromes to identify the most active and unstable plaques and in patients with severe aortic valve stenosis to follow the natural history of this disease. the investigators propose to perform pet-ct imaging with 18f-naf in a pilot study of 100 patients chosen among the subjects followed in the outpatient diabetes clinics at the university of alberta. the aim is to investigate the presence and extent of unstable plaques in ambulatory patients affected by diabetes, and to identify a set of clinical variables most likely to be associated with a large burden of disease. since there are no published studies in this particular field it is impossible to make precise sample size calculations and these analyses must therefore be considered exploratory.

Eligibility criteria:
inclusion criteria: \> 18 years of age. has an established diagnosis of diabetes mellitus type 1 or 2. stable clinical course with a stable medical regimen for 6 months prior to enrollment. - exclusion criteria: unable to give consent. weight \>250 kg. unable to lie flat for 20-30 minutes to complete the pet-ct session. pregnancy, breast feeding, known history of primary hyperparathyroidism or metabolic bone disease, recent malignancy (\<3 years) or previous thoracic irradiation. -
efficacy, tolerability and adherence of the modified atkins diet on drug-resistant epilepsy

Conditions: Epilepsy, Drug Resistant

Summary: the atkins diet modified (adm) is the best alternative treatment for drug-resistant epilepsy, there is a high prevalence worldwide , especially in latin american countries, including mexico. low income earners, many of which do not have a social security, must meet the high costs by antiepileptic drugs (aeds), which in addition should be used in conjunction or combination therapy, because monotherapy is insufficient . the diet adkins makes some changes in the traditional food habits by others that are accessible and not necessarily expensive, whose mechanism allows for better control of the seizures.

objective: to assess the efficacy, tolerability and adherence of the modified adkins diet in adult patients with drug-resistent epilepsy materials and methods: clinical trial, made up of patients with drug-resistent epilepsy, selected by convenience, who will be handled pharmacologically with the standard treatment of this condition for a period of not less than 6 months, after which they will be treated with adkins diet modified, prior informed consent, to establish its effect and a comparative analysis later. the objective of this work is to analyze the efficacy, tolerability and adherence of the modified atkins diet in adult patients with drug-resistant epilepsy.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years * patients that meet the criteria of drug-resistant epilepsy * patients treated with rational polytherapy, a minimum of 6 months, with no changes in their drug refractory condition. * patients with drug- resistant epilepsy with informed consent signed by themselves and their proxy. * patients with drug-resistant epilepsy of any etiology, except tumor, metabolic, degenerative or progressive. exclusion criteria: * patients with drug-resistant epilepsy simultaneous alternate treatment to the atkins diet modified. * patients with a neurological entity progressive and fatal * patients with congenital diseases and difficulty to metabolize fats or that require high amounts of carbohydrates in the diet.

Keywords: epilepsy diet, carbohydrate-restricted drug resistance
the nephroprotective effect of metformin with cisplatin in bladder cancer

Conditions: Muscle-Invasive Bladder Carcinoma

Summary: the goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. the main questions it aims to answer are: * to determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer. * to evaluate the safety of combining cisplatin and metformin on patients with bladder cancer


Eligibility criteria:
inclusion criteria: 1. non-diabetic adults of age between 18 to 65. 2. chemotherapy naïve patients diagnosed with bladder cancer. 3. patients with stable renal function: egfr is above 60 ml/min/1.73 m2 exclusion criteria: 1. patients with history of lactic acidosis. 2. patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, nsaids, aminoglycoside or vancomycin). 3. unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dl or greater suddenly in 48 hours according to the acute kidney injury network (akin) classification 4. patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock). 5. severe infection and sepsis. * any infection requiring hospitalization. * any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure. 6. alcohol intake. 7. respiratory failure. 8. severe hepatic impairment (child-pugh class c). 9. patients with metastasis.

Keywords: metformin cisplatin nephroprotective effect nephrotoxicity bladder cancer
behavioral intervention to increase physical activity in patients with asthma: identifying responders

Conditions: Asthma

Summary: to identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.

adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. after two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).

Eligibility criteria:
inclusion criteria: 1. participants not physically active; 2. partially/uncontrolled asthma; 3. diagnosis of asthma based on the recommendations of the global initiative for asthma (gina 2020); 4. be under outpatient follow-up at the pulmonology or immunology service of the university of sao paulo general hospital; 5. be under outpatient medical treatment for at least six months, with a stable clinical condition for at least , 30 days; 6. being using optimized drug therapy for asthma. exclusion criteria: 1. participation in another research protocol; 2. difficulty in understanding any of the questionnaires used; 3. practitioners of regular physical activity; 4. pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol.

Keywords: asthma physical activity behavioral intervention responders
safety and efficacy of lee011 and lgx818 in patients with braf mutant melanoma.

Conditions: Locally Advanced Metastatic BRAF Mutant Melanoma

Summary: to evaluate the safety, tolerability and efficacy of lee011 and lgx818 when administered orally to patients with braf mutant melanoma.

in response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the phase ib part of the study. consequently, the phase ii part of the study was not performed. early termination of the study was not due to any safety concerns.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * diagnosis of locally advanced or metastatic melanoma along with written documentation of braf v600 mutation. * ecog performance status of 0 - 2. * patients enrolled into phase ib must have evidence of evaluable and/or measurable disease as determined by recist v1.1. * patients enrolled into phase ii (brafi naïve and resistant) must have evidence of measurable disease as determined by recist v1.1. * archival tumor tissue must be obtained for patients enrolled in phase ib and phase ii arm 1a/b- brafi naïve patients. if an archival tumor tissue is not available, a fresh tumor sample is acceptable. * for patients enrolled in the phase ii arm 2, patients must agree to undergo a fresh tumor biopsy unless one was collected prior to study entry but at the time of disease relapse from the most recent brafi treatment. exclusion criteria: * symptomatic brain metastases. * symptomatic or untreated leptomeningeal disease. * patients with inadequate laboratory values during screening. * in the phase ii brafi naïve arms (1a/b), prior exposure to cdk4/6 inhibitor (e.g., pd 0332991) * impaired cardiac function or clinically significant cardiac diseases. * impairment of gastro-intestinal (gi) function or gi disease that may significantly alter the absorption of lee011 or lgx818. * patients with concurrent severe and/or uncontrolled concurrent medical conditions. * previous or concurrent malignancy. * major surgery \< 2 weeks before starting study treatment * known diagnosis of human immunodeficiency virus (hiv) or hepatitis c. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: open-label dose escalation braf inhibitor lee011 cdk4/6 lgx818 raf kinase inhibitor metastatic melanoma braf v600
the effect of aprepitant reducing postoperative nausea and vomiting

Conditions: Obesity; Nausea and Vomiting, Postoperative

Summary: the purpose of this study is to assess the efficacy of aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen

after being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery). the standard antiemetic regimen will be ondansetron 8 mg + metoclopramide 10 mg + dexamethasone 8 mg

Eligibility criteria:
inclusion criteria: * 18 to 65 years old. * non-smokers. * obesity with bmi \> 30 kg/m2. * undergoing laparoscopic gastric sleeve. exclusion criteria: * documented hypersensitivity to any component of the study regimen. * current treatment with: orap (pimozide), seldane (terfenadine), hismanal (astemizole) or propulsid (cisapride). * allergy to opioid drugs used in the anesthetic protocol. * drug or alcohol abuse. * chronic nausea and vomiting. * previous bariatric procedures.

Keywords: laparoscopic gastric sleeve bariatric surgery nausea and vomiting, postoperative aprepitant
allogeneic multipotent stromal cell treatment for acute kidney injury following cardiac surgery

Conditions: Kidney Tubular Necrosis, Acute

Summary: the purpose of this trial is to determine if the administration of allogeneic mscs at defined doses is safe in patients who are at high risk of developing significant acute kidney injury (aki) after undergoing on-pump cardiac surgery.


Eligibility criteria:
inclusion criteria: * documented ischemic coronary heart and/or valvular heart disease:acceptable candidate for elective cabg and/or cardiac valve surgery * patients at high risk for post-op aki:age 18 or older if at high risk for post-op aki because of underlying diabetes mellitus (type i or ii), chf, copd chronic kidney disease (ckd) stage 1-4 * patients at high risk for post-op aki :age \> 65 or combinations * patent femoral artery without aortic aneurysm * ability to give informed consent. exclusion criteria: * presence of ongoing local or systemic infection * younger than 18 * participation in another clinical trial * pregnancy * contraindication to general anesthesia * prisoner * dialysis patient (ckd-6) or patient with ckd-5 * history of malignancy except non-melanoma skin cancer * occluded groin arteries * uncontrolled diabetes mellitus (hba1c \> 10, history of diabetic ketoacidosis or osmolar coma within the last three months) * non-healing foot ulcers. * clinical evidence of severe peripheral vascular disease (abi \< 0.3) * coronary angiogram \< 7 days before surgery * inadequate pre-operative time to obtain baseline kidney function data due to urgent/emergent surgery * unstable myocardium (evolving myocardial infarction), cardiogenic shock

Keywords: acute renal failure cardiac surgery stem cell
conservative treatment in patients with supraspinatus tendon injury.

Conditions: Supraspinatus Injury; Sleep Disturbance

Summary: rotator cuff injuries are a major cause of severe pain, often significantly impacting patients\&#39; sleep quality. for patients waiting for surgery or those not eligible for operative treatment, conservative treatment is recommended. in cases of minor injuries, physiotherapy is as effective as surgical intervention. the aim of this study is: (1) to compare the speed, effectiveness, and durability of four implemented interventions in improving sleep quality, pain, and shoulder function, (2) to select the most optimal form of conservative treatment for patients with shoulder pain affecting sleep quality, and (3) to evaluate the expression of brain-derived neurotrophic factor (bdnf) and probdnf (precursor) at the mrna protein level before the planned intervention (t0), 1 month (t1), 3 months (t3), and 6 months (t6) after intervention. the study results can assist physicians and physiotherapists in providing patients with therapy that not only relieves pain and improves function but also augments sleep quality, an aspect often overlooked in the literature yet greatly impacting patients\&#39; quality of life.


Eligibility criteria:
inclusion criteria: 1. symptomatic partial incomplete thickness tear of the supraspinatus tendon, with a length below 1 cm and not exceeding 50% of the tendon thickness, confirmed by ultrasound examination. 2. sleep disturbance symptoms for at least 1 month due to shoulder pain - psqi score \> 5. 3. shoulder pain disrupting the quality of sleep. 4. bmi \< 30. 5. age 40-75. exclusion criteria: 1. other accompanying pain symptoms. 2. history of shoulder surgery. 3. coexistence of psychiatric or neurological disorders. 4. presence of comorbidities that may disrupt sleep. 5. presence of risk factors impairing tissue regeneration and increasing the likelihood of injury progression - osteoporosis, diabetes, hypercholesterolemia. 6. alcohol dependence, nicotine addiction, passive smoking. 7. taking antibiotics from the fluoroquinolone group, sleep-affecting medications (such as melatonin, trazodone, zolpidem), antidepressants, antipsychotics, anxiolytics. 8. lack of patient consent, lack of cooperation, or impaired verbal-logical communication.
a study of breast cancer risk factors and outcomes of people in florida

Conditions: Breast Cancer; Breast Neoplasms; Breast Diseases

Summary: the purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.


Eligibility criteria:
inclusion criteria: * patients with birads 0-5, seen in breast radiology clinic at university of miami (um), sylvester comprehensive cancer center (sccc), jackson health systems (jhs) for biopsy. * any new breast patient seen at um/sccc or jhs will be invited to participate in the study. * men and women 18 years of age and older are eligible to participate in the study. exclusion criteria: * patients who are less than 18 years of age will be considered ineligible. * patients unable to complete the survey.

Keywords: breast cancer breast neoplasms breast diseases birads memorial sloan kettering cancer center 24-372
evaluation of bisphosphonate coated pins for extern fixation in tibia osteotomy

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.

the pin fixation and the risk for pin loosening and pintract infection is intimately connected moroni et al., magyar et al. toksvig-larsen and w-dahl) the pin performance ratio for insertion to extraction torque (ppi) varies significantly between screw types. the extraction torque force is the most important value and it is estimated that a removal torque around 300 nm probably will be the best bon-pin fixation in clinical practice. in animal studies and even in clinical studies the hydroxyapatite (ha) coated screw retained the highest level of osseointegration. however, the fixation for hascrews is, especially in diaphyseal bone, the risk for too tight fixation, with extreme difficulties to remove the screws in few cases as a result ( high pain and seldom it is impossible to remove the screw) coating by biphosphonate is a new novel technique with preclinical appealing performance, which theoretically should make this coating very appealing in clinical practice. the theory behind this technique is that it create a good pinfixation reasonable easy to remove. the current most used cortical screw designs performed poorest in terms of fixation (ppi) method using the hemicallotasis technique for correction in high tibial osteotomies today, ha coated (osteotite) conical 130/50 screws is used in the proximal tibia - the metaphysic - and plain (standard) cortical conical screws 110/40 is used in the diaphysis. to study the effect of an improved pin coating a study including 30 patients randomised to the standard procedure today or the novel technique using biphosphonate coated screws. in the metaphysic, the randomisation will be between the ha coated (osteotite) screws and the biphosphonated coated screws 130/50 (screw thread 50mm) in the diaphysis the randomisation will be between the plain standard 110/40 screws and the biphosphonate 110/40 coated screws totally 30 patients will be studied which means totally 120 pins. this has been based on power calculations resulting in 23 patients in each group and calculated on extraction torque force. this is a clinical study and 30 patients is estimated due to expected drop out.

Eligibility criteria:
inclusion criteria: * all patients which are diagnosed with arthr and needs an operation.

Keywords: pin fixation osteotomy hemicallotasis
a study of romosozumab (evenity®) in postmenopausal women in india with osteoporosis at a high risk of fracture.

Conditions: Postmenopausal Osteoporosis

Summary: the primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in india.


Eligibility criteria:
inclusion criteria: * participants diagnosed with osteoporosis who are postmenopausal and have a high risk of fracture who provided inform consent (in-person or through their legally authorized representative) to participate in the use of romosozumab per local label in india. exclusion criteria: * participants who experienced myocardial infarction or stroke within a year prior to entering this study.

Keywords: romosozumab evenity® osteoporosis women health
zerofall - reliability testing of optical sensor to detect bed exit for patients in hospital

Conditions: Delirium of Mixed Origin

Summary: falls are one of the most common nhs adverse events. with an increasing number of frail elderly patients being admitted this risk is likely to increase. in order to be able to assist patients with bed exit in a timely manner monitoring might be of help. in zerofall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

in zerofall we intend to observe patients on risk of fall with two different devices during their hospital stay: the information from a no-touch optical sensing device that analyses movement and an under the mattress sensor that has already been used in a previous study at bangor. both are compatible with an existing monitoring system by philips healthcare and ce marked.

Eligibility criteria:
inclusion criteria: adult patients with risk of fall more than 24 hours on the ward exclusion criteria: patients with predominantly palliative needs
a phase 2 study of sp-02l in patients with relapsed or refractory peripheral t-cell lymphoma (ptcl)

Conditions: Peripheral T-Cell Lymphoma

Summary: this study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of sp-02l monotherapy in relapsed or refractory patients with peripheral t-cell lymphoma.


Eligibility criteria:
inclusion criteria: * patients with a japanese, korean, taiwanese, or chinese ethnic background of each country/region * patients aged ≥20 years on the date of informed consent * patients with histologically confirmed diagnosis of one of the following: * peripheral t-cell lymphoma not otherwise specified (ptcl-nos) * angioimmunoblastic t-cell lymphoma (aitl) * anaplastic large cell lymphoma (alcl), (alk-positive/negative) * relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease * have at least 1 measurable lesion * eastern cooperative oncology group (ecog) performance status of 0 to 2 * patients with a life expectancy of at least 3 months as determined by the investigator
clinical application of novel panels for early precision diagnosis and relapse prediction in high-risk leukemia

Conditions: Leukemia, Acute

Summary: based on the investigator's previous data on risk classification for acute leukemia,the investigators will design a set of panels to detect the gene expression and genomic variants (snps, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk subtypes of acute leukemia, such as ph-like acute lymphoblastic leukemia. furthermore, the target therapy (tyrosine kinase inhibitors,et.al) will be used to treat the identified patients. in addition, more sensitive minimal residual disease (mrd) detection technology will be designed and used to detect the mrd in patients to early predict the disease relapse.

patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.

Eligibility criteria:
inclusion criteria: * newly diagnostic acute lymphoblastic leukemia be willing to start treatment exclusion criteria: * chronic leukemia