Kornimate/medical-research-clean huggingface dataset:
effects of social skills and physical activity training on recreational activities in youth

Conditions: Social Skills; Physical Activity

Summary: the purpose of this study is to examine the effect of social skills training on adolescents physical activity levels. for one week at the beginning and end of the study teens will wear a biotrainer to measure their activity levels and also wear a pager to communicate the types of activities they are doing throughout the day. for 8 weeks participants will be randomized into one of two groups, a social skills training group or a physical activity group. the investigators predict that both groups will experience an increase in physical activity and social involvement (decrease time spent alone).


Eligibility criteria:
inclusion criteria: * boys and girls ages 12-14 * youth who encounter problematic relationships with their peers exclusion criteria: * youth should have no psychopathology, developmental disabilities, or asthma that would limit participation * youth should have no cold or upper respiratory distress or a condition that could influence their activities * youth should not be taking medications that could affect their level of activity

Keywords: social skills physical activity peer relationships childhood obesity changes in physical activity changes in social involvement
comparing the consolidation regimens of ida with intermediate-dose cytarabine versus intermediate-dose cytarabine alone for elderly aml patients

Conditions: AML in Remission

Summary: this study evaluates idarubicin (ida) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly aml in first remission.


Eligibility criteria:
inclusion criteria: * newly diagnosed de novo aml who achieved complete remission (cr), including cri and crp after a maximum number of 2 cycles of induction chemotherapy. * histologically or morphologically confirmed diagnosis of aml except for aml m3 (acute promyelocytic leukemia) * no contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, lvef (left ventricular ejection fraction) \< 50% * age ≥ 60 years and \< 75 years * ecog performance status ≤2 * written informed consent * no psychological, familial, social, or geographic reason that would compromise clinical follow up exclusion criteria: * relapsed or refractory aml * patients with acute promyelocytic leukemia (apl) * patients with secondary type aml (post myelodysplastic syndrome mds or therapy-related aml) * severe pshyciatric or organic disorder, supposed to be independent from aml, that would contraindicate treatment * subjects for which allogeneic hsct is planned in cr1 * known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials * concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk * a co-morbid condition which, in the view of the investigators, renders the subject at high risk from treatment complications
effects of l-thyroxine replacement on serum lipid and atherosclerosis in hypothyroidism

Conditions: Hypothyroidism; Thyroid Diseases; Endocrine System Diseases

Summary: hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. it is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(chd), heart failure(hf) and cardiovascular(cv) death. the effect of l-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. the present study was designed to investigate whether l-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress. studies have shown that hypothyroidism increased the risk of covid-19 composite poor outcomes. this study also aimed to investigate whether l-thyroxine replacement therapy was effective in reducing the incidence and mortality of covid-19, and in improving the severity of covid-19 and covid-19 related complications.


Eligibility criteria:
inclusion criteria: * 40\~75 years old * diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months exclusion criteria: * pregnant or lactating women * severe hepatic or renal dysfunction * psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism * taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism * obviously poor compliance.

Keywords: hypothyroidism lipid atherosclerosis oxidative stress chronic inflammation endothelial function adipocytokine l-thyroxine coronavirus disease 2019 (covid-19)
study of su011248 versus chemotherapy for patients with previously treated triple receptor negative breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to compare progression free survival for su011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (er, pr, her2) locally recurrent or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * recurrent or metastatic breast cancer * estrogen receptor (er), progestin receptor (pr) and her2/neu receptor (her2) negative status * prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting * relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease exclusion criteria: * more than two chemotherapy regimens for advanced disease * uncontrolled/symptomatic spread of cancer to the brain
two-piece zirconia implants with two various platforms

Conditions: Edentulous Alveolar Ridge

Summary: 24 patients with missing premolar teeth and healed sockets will be recruited. they will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. primary and secondary stabilities will be measured with international stability quotient (isq) device. after 3 months, ceramic crowns will be supplied. implant survival rates and parameters in relation to periimplant soft-tissues and bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.


Eligibility criteria:
inclusion criteria: * single missing maxillary premolar * occlusal stability * good oral hygiene * good general health exclusion criteria: * oral mucosa pathology * dental caries * active periodontitis (non-treated) * systemic diseases and conditions that affect healing or immune capacity

Keywords: dental implants zirconia two-piece
ai-assisted colonoscopy, tandem study

Conditions: Artificial Intelligence (AI); Colonoscopy Education; Adenoma Colon Polyp

Summary: the goal of this clinical trial is to evaluate effect of artifial intelligent (ai) system, endoscopy as ai-powered device (enad) on adenoma miss rate from colonoscopy underwent by trainee endoscopist. it will also evaluate effect of ai on adenoma and polyp detection rate from colonoscopy underwent by trainee endoscopist. the main questions it aims to answer are: • does ai-system lower adenoma miss rate in colonoscopy underwent by trainee endoscopist? researchers will do the tandem colonoscopy and devided the participant in 4 groups as follows: a. first pass: trainee; second pass: expert b. first pass: trainee + ai; second pass: expert c. first pass: trainee; second pass: expert + ai d. first pass: trainee+ai; second pass: expert+ai participants will take bowel preparation in split dose regimen and nothing per oral for 4 hours. they will underwent colonoscopy as above, with sedation by anesthesiologist. details on qualityies of colonoscopy, polyps detection and pathology results will be recorded.

colon cancer accounts for one of the most common cancer worldwide and also cancer-related death. colonoscopy is accepted to be an effective tool in colon cancer screening since the polypectomy of small adenoma can prevent colon cancer. missed adenoma is one of the causes of interval cancer between routine colonoscopy screening. nonvisualization is the cause of missed adenoma during colonoscopy. artificial intelligence (ai)-assisted colonoscopy was superior then routine colonoscopy from parallel study and tandem study. previous studies often used one same endoscopists in doing tandem colonoscopy which may still have bias. only one previous study designed to use trainee endoscopist in the first pass and endoscopist in the second pass, some subgroup used ai-assisted. the result revealed lower adenoma miss rate (amr) in ai-assisted colonoscopy in the first pass. this study designed to evaluate amr of ai-assisted colonoscopy in trainee endoscopist compared to expert endoscopist, the trainee will do colonoscopy in the first pass (with or without ai) and the expert will do colonoscopy in the second pass (with or without ai). the present study aimed to evaluate effect of ai-assisted colonoscopy in trainee endoscopist.

Eligibility criteria:
inclusion criteria: * age 40 - 85 years old * appointment for colonoscopy for colorectal cancer screening exclusion criteria: * previous history of bowel obstruction or perforation * presence of coagulopathy (prothrombin time \>, = 3 second uln; platelet \< 50,000) * previously diagnosed with inflammatory bowel disease or polyposis syndrome * pregnancy or lactation * severe comorbities or american society of anesthesiologist classification \>, = 3 * unable to sign informed consent

Keywords: adenoma miss rate artificial intelligence colonoscopy tandem colonoscopy
molecular pathways of cardiac remodellation in patients with acute and chronic left ventricular disfunction

Conditions: Heart Failure; Ischemic Cardiomyopathy

Summary: chronic heart failure represents an extremely complex clinical syndrome, defined as the inability of the heart muscle to generate a volume adequate to the metabolic needs of peripheral tissues, or to do so only in the face of high filling pressures intracavity. heart failure is one of the leading causes of mortality and morbidity in western countries. despite advances in the therapeutic field, the prognosis of patients with heart failure of ischemic and non-ischaemic aetiology still remains unfavorable, with a mortality rate of 50% 5 years after the first hospitalization.therefore, a deeper understanding of the pathophysiological mechanisms involved in heart failure and adverse ventricular remodeling is essential.

the study will be interventional, prospective, and single-center. partecipants will be divided into three groups: 1. 30 partecipants admitted to our hospital with the diagnosis of stemi-type acs and ejection fraction ≤ 35% on echocardiographic evaluation 2. 30 partecipants with non-ischaemic dilated cardiomyopathy and ejection fraction ≤35% on echocardiographic evaluation 3. 15 partecipants diagnosed with stemi-type acs and ejection fraction \> 50% on echocardiographic evaluation 4. 15 controls with normal left ventricular contractile function. the study foresees a phase of patient recruitment, in which, in the hours immediately following the blood sampling, the isolation of the pbmcs, their incubation and cytofluorimetric analysis will be carried out and the conservation of the material to be analyzed subsequently by molecular biology and immunochemistry.

Eligibility criteria:
inclusion criteria: * patients admitted to the gemelli polyclinic with acute coronary syndromes and heart disease; * patients admitted to our polyclinic with the diagnosis of sca type stemi and ejection fraction ≤ 35% at echocardiographic evaluation; * patients with non-ischemic dilated cardiomyopathy and ejection fraction ≤ 35% at echocardiographic evaluation; * patients diagnosed with sca type stemi and ejection fraction \> 50% at echocardiographic evaluation; exclusion criteria: * evidence of inflammatory or infectious disease; * malignancy, or immunological or hematologic disorders; * treatment with anti-inflammatory drugs other than low-dose aspirin; * age \> 85 years; * recent surgery (within one month); * advanced chronic kidney disease (egfr mdrd-4 \<30 ml/min./1.73m2).

Keywords: ejection fraction (ef) sympathetic nervous system (sns) renin-angiotensin-aldosterone system (raas)
lower extremity amputations in persons with diabetes mellitus in the netherlands

Conditions: Lower Extremity Amputations; Diabetes Mellitus

Summary: this is a retrospective, observational study based on an all-payer claims database (apcd) in the period 2011 to 2020) managed by the vektis health care information center. in 2006, vektis was established by dutch health insurers aiming to combine and interpret reimbursement data and enable the main players in the dutch healthcare market to base decisions and policy on reliable, essential, and timely information. vektis receives data from all dutch health care insurers. the apcd covers health care claims of 99.9% of the dutch population. this study is part of the dutch diabetes estimates (dude) initiative. we aim to perform different predefined analyses with the available data: * what is the incident amputation rate in persons with and without dm in the netherlands in the period 2011-2020? * what defines persons with dm who need an amputation as compared to matched persons with dm but without an amputation in 2016, both in aspects of health care use and costs? * what defines persons with dm who need an amputation as compared to matched persons without dm with an amputation? * does social economic status (ses) play a role in amputation incidence and level, or on longer term outcome in persons with dm in the netherlands? * does the presence of a formal multidisciplinary foot clinic / team in a hospital make a difference, especially when comparing previous and actual macrovascular complication rates?


Eligibility criteria:
inclusion criteria: * all persons aged ≥ 18 years, diagnosed with type 1 dm (t1dm) or type 2 dm (t2dm) identified in the vektis data met the inclusion criteria exclusion criteria: * none
amisulpride in schizophrenic acute phase patients

Conditions: Schizophrenia

Summary: to collect the safety and response of using amisulpride in acute schizophrenic patients


Eligibility criteria:
inclusion criteria: * patient diagnosed as diagnostic and statistical manual of mental disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode exclusion criteria: * patients previously treated with amisulpride * patients have comorbidity which may interfere with the treatment or follow-up * patients currently taking depot antipsychotics (at least 30 days washout period is needed) * patients currently/ or recently (\< 3 months) withdrawn from drug or alcohol abuse * pregnant or lactation the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
reality lhon registry

Conditions: Leber Hereditary Optic Neuropathy

Summary: this study is a multi-country retrospective and cross-sectional observational study of affected lhon subjects, based on retrospective subjects' medical chart abstractions and cross-sectional administration of patient-reported outcomes (pros).

the purpose of this study is to understand the evolution of visual functional and structural changes and other associated symptoms in patients with lhon. the relation between genetic, lifestyle and/or environmental factors and the lhon disease will be described, and a better understanding of the natural history of lhon disease and the healthcare associated to with the disease will be sought. in addition, we would also like to understand the economic burden for patients and their families with lhon resulting from direct and indirect costs they may have because of their disease.

Eligibility criteria:
inclusion criteria: * subjects who have a confirmed and genotyped diagnosis of lhon; * subjects with visual function outcomes data including at least 2 visual function assessments between 1 year and 3 years (+/- 4 weeks) after vision loss; * subjects who are willing and able to provide written informed consent if required as per local regulations; * for lhon subjects under the age of 18 years, permission from a legal guardian to participate in the study; exclusion criteria: * subjects who received any investigational drug, or participated in any lhon-related interventional clinical trial during the observational period; * subjects without medical charts data available.

Keywords: heredity optic atrophy leber hereditary optic atrophy leber hereditary optic neuropathy eye diseases hereditary eye diseases inherited retinal dystrophies or degeneration inborn genetic disease gene therapy intravitreal injections mitochondrial disease aav2 vectors nervous system diseases neurodegenerative disease heredodegenerative disorders of the nervous system
serum based diagnosis of and monitoring of infection recovery in orthopedic spine implant infections

Conditions: Staphylococcus Aureus Infection; Surgical Site Infection; Orthopedic Procedures; Spine

Summary: the goal of this study is to test a new way to diagnose and track treatment of spine infections caused by the bacteria staphylococcus aureus.

ongoing staphylococcus aureus (s. aureus) infections of the spine associated with orthopedic hardware implants elicit prominent immune responses against a repertoire of proteins characteristic of the invading pathogen. antibodies specific for these antigens can be measured in the serum or in a novel sample created by culturing circulating antibody secreting cells (asc) in vitro where they create an analytic fluid called here "medium enriched for newly synthesized antibodies" (mensa). the hypothesis of this study addresses three essential attributes of this analytic approach that can yield both a valuable tool for research on spinal infections and in the future, this can be developed a clinical tool for diagnosis and monitoring of therapeutic success in patients. by measuring the emergence of these signature antibodies in the serum and/or mensa, the goals of this study are: 1) to differentiate between patients with an ongoing s. aureus infections, not just "general infection, in the spine using only blood samples; 2) to track the success (or failure) of therapeutic interventions; and 3) to distinguish spinal infections from s. aureus infections in other sites by the repertoire of antibodies that are elicited.

Eligibility criteria:
inclusion criteria: * patients with known or suspected spinal infections associated with spinal orthopedic implant(s); * patients over 18 years of age and younger than 85; * patients undergoing spinal revision surgery. exclusion criteria: * diagnosed as immuno-compromised or immuno-suppressed based on medication use; * on-going or previously diagnosed musculoskeletal infections associated non-spine hardware (e.g., prosthetic hip, prosthetic knee, prosthetic shoulder); * current diabetic foot ulcer/infection; * patients undergoing cancer treatment (including radiation and chemotherapies); * pregnancy; * absence of a spleen; * over the age of 85 or under the age of 18. * weigh less than 110 pounds, or for which it would otherwise be unsafe for them to undergo a blood draw.

Keywords: spine, orthopedic implant infection
a first-in-human study of the safety of single continuous intravenous (iv) infusions of cxl-1427 for up to 48 hours in healthy volunteers

Conditions: Heart Failure

Summary: this study is designed to assess a safe dosage of the drug cxl-1427 (bms-986231) in healthy volunteers.


Eligibility criteria:
inclusion criteria: * no evidence of any acute or chronic health disorder * not have taken any prescription medication within 15 days of study entry * not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry * not have not have any dietary restrictions * have a body mass index (bmi) of ≥18 to ≤34 * weigh at least 50kg (110 pounds) exclusion criteria: * be a current or recent (within 6 months of the screening visit) smoker or user of any nicotine-containing product * have a history of symptomatic hypotension, orthostatic hypotension or syncope * have a history of headaches or other symptoms attributable to caffeine withdrawal * have a history of any bleeding diathesis * have a positive serology screen for hiv antibody, hepatitis b surface antigen or hepatitis c antibody at screening other protocol defined inclusion/exclusion criteria could apply
effect of a perioperative oral nutritional supplementation on patients undergoing hepatic surgery for liver cancer

Conditions: Liver Cancer; Hepatocellular Carcinoma; Cirrhosis; Liver Fibrosis

Summary: cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. these failures are mainly due to hepatic insufficiency. studies have already shown benefits of oral nutritional supplements in orl, digestive, and cardiac surgery. we aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.

in patients undergoing hepatic resection for liver cancer (with cirrhosis or fibrosis liver), mortality rate can reach 10% and morbidity (ascites, icteria, infections) 70%. these complications are mainly due to hepatic insufficiency: surgery leaves a reduced parenchyma, with oxidative stress lesions due to reperfusion injury. a good preoperative nutritional state has been shown to reduce complications and mortality. this can be amplified by preoperative nutrition with supplements containing l-arginin, ω3 polyunsaturated fatty acids, and nucleotides which boost immune responses, resistance to infections and liver function recovery. in this context, the study randomly assigns 50 patients who were scheduled to undergo hepatic resection, to receive either an oral immune-enhancing nutritional supplement or a placebo, for the 7 last preoperative and the first 3 postoperative days. the aim of the study is to evaluate the effects of this supplementation on liver function, immunity, and incidence of infections after surgery.

Eligibility criteria:
inclusion criteria: * adult over 18 years * hepatectomy of at least 2 segments * for primary or secondary cancer * with cirrhosis (child pugh \<8) or liver fibrosis (fibrosis score of 3) * informed written consent exclusion criteria: * pregnancy * recent weight loss of more than 10% of body weight * immunological deficiency * portal or hepatic arterial thrombosis * biliary duct dilation

Keywords: surgery liver cancer cirrhosis nutrition