Kornimate/medical-research-clean huggingface dataset:
situational problem solving in adolescents with type 2 diabetes: enhancing a randomized controlled trial (rct)

Conditions: Adolescents With Type 2 Diabetes

Summary: the proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (rct). adolescents subjects with a history of type 2 diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month intervention (n=44) or a "usual care" comparison (n=44). recruitment will take place within the vanderbilt eskind pediatric diabetes clinic. the intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral internet-administered self-management problem solving component. outcomes include self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood pressure, weight/bmi, and glycated hemoglobin (a1c).


Eligibility criteria:
inclusion criteria: patients with a diagnosis of t2dm will be included if they are: 1. age 12-19 years 2. a clinical diagnosis of t2dm (according to the patient and their health provider in the clinic) 3. actively receive diabetes care in the eskind diabetes clinic 4. willingness of patient and a caregiver to access the internet to complete problem solving activities 5. adolescent address is the same as their primary caregiver participating in the study exclusion criteria: patients will be excluded if they meet any of the following: 1. identify an outside practitioner as the main provider of their diabetes care 2. have a significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study 3. life expectancy of \<6 months 4. unable to access the internet from any convenient location 5. blind or deaf parent inclusion criteria: 1. parents must be a primary caregiver of an adolescent with a diagnosis of t2dm between the ages 12-19 seen at the eskind clinic 2. willingness of patient and a caregiver to access the internet to complete problem solving activities. parent exclusion criteria: patients will be excluded if they meet any of the following: 1. identify an outside practitioner as the main provider of their child's diabetes care 2. self report of significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study 3. life expectancy of \<6 months 4. unable to access the internet from any convenient location 5. blind or deaf. joint inclusion criteria: both the primary caregiver (parent) and adolescent must agree to participate in the research.

Keywords: adolescents type 2 diabetes behavioral research
skin cancer prevention with nicotinamide in transplant recipients - pilot trial

Conditions: Non-melanoma Skin Cancer; Carcinoma, Squamous Cell; Carcinoma, Basal Cell

Summary: a common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. this pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. this pilot trial will transition into the pivotal trial if all feasibility targets are met.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. kidney, liver, heart, or lung transplant at least two years ago 3. history of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ 4. currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus) 5. able to attend follow-up visits 6. able to speak and understand english (only for cognitive substudy) exclusion criteria: 1. use of mtor inhibitor (sirolimus, everolimus) within the past 12 weeks 2. biopsy-confirmed acute rejection episode within the past 12 weeks 3. active liver disease (elevated ast or alt \>3 times normal) 4. severe renal failure (estimated glomerular filtration rate \<20 ml/min/1.73 m2) 5. current carbamazepine or primidone use 6. pregnancy and lactation 7. gorlin syndrome or other genetic skin cancer syndrome 8. solid organ or hematologic malignancy, invasive stage ii melanoma, merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive stage i melanoma within the past two years 9. untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment) 10. use of nicotinamide or niacin (250 mg or more daily) within the past 12 weeks 11. use of field therapy for actinic keratoses within the past 12 weeks 12. initiation of systemic chemoprevention within the past 12 weeks
a study to evaluate the tolerance and pharmacokinetics of tqb3804 in subjects with advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: this is a study to evaluate the tolerance, dose-limiting toxicity (dlt), phase ii recommended dose (rp2d), and maximum tolerated dose (mtd) of single and multiple oral doses of tqb3804 in patients with advanced malignant tumors.


Eligibility criteria:
inclusion criteria: - 1. understood and signed an informed consent form. 2. 18 and 70 years old. 3. histologically or cytologically confirmed advanced malignant tumor. 4. has egfr mutations. 5. life expectancy ≥12 weeks. 6. eastern cooperative oncology group (ecog) performance status score of 0 to 2. 7.adequate organ system function. 8.at least one measurable lesion. exclusion criteria: * 1.hypersensitivity to tqb3804 or its excipient. 2. has diagnosed and/or treated additional malignancy within 5 years with the exception of cured carcinoma in situ of the cervix、intramucosal carcinoma of gastrointestinal tract、breast and non-melanoma skin cancers and superficial bladder tumors. 3.has interstitial pneumonia. 4.brain metastases with symptom . 5.has currently uncontrollable congestive heart failure. 6.has history of arterial thromboembolism within 6 months. 7.has any bleeding tendency or coagulopathy within 6 months. 8.has skin toxicity ≥ grade 2 within 4 weeks. 9.has serious gastrointestinal diseases within 4 weeks. 10.has received any major surgery within 4 weeks. 11.participated in other clinical trials within 4 weeks. 12.has active viral, bacterial and fungal infections within 4 weeks. 13.has received any cancer therapy within 4 weeks or 5 times of t1/2. 14.has ≥ grade 2 toxicity caused by previous anti-tumor treatment. 15. hbsag positive and hbv dna positive (≥uln);hcv antibody and hcv-rna positive (≥uln); hiv positive or ≥hiv uln. 16. has multiple factors affecting oral medication. 17. breastfeeding or pregnant women.; men unwilling to use adequate contraceptive measures during the study. 18. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
use of non steroidal antiinflammatory drugs in patients with community acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: to investigate exposure to nonsteroidal antiinflammatory drugs (nsaids) during outpatient management at the early stage of community-acquired pneumonia (cap) requiring hospital consultation. non-interventional observational study.

recent data suggests that such exposure to nsaids is associated with delay in cap diagnosis and antibiotic prescription that influence cap presention and outcome. the investigators' working hypothesis is that nsaids use may mask initial symptoms and delay antimicrobial therapy, thus predisposing to worse outcomes. all patients presenting at one of the three following locations (emergency department, icu or pneumology ward) with a suspicion of community-acquired pneumonia will be screened for eligibility. exposure or not to nsaids will be investigated. clinical, biological and radioloigcal features and outcome of cap will be compared with respect to nsaids exposure.

Eligibility criteria:
inclusion criteria: at least two among the following signs * temperature \> 37.8 °c * respiratory rate \> 25/min * heat rate \> 100/min * cough * expectoration * chest pain * crackles upon lung auscultation and new infiltrate on the chest x-ray exclusion criteria: * ongoing pregnancy * sickle cell disease * tracheostomy * long term oxygen therapy * cystic fibrosis or bronchiectasis * neutropenia (\< 500 cells/mm3) * ongoing solid or hematologic cancer or anticancerous chemotherapy * hiv infection * liver cirrhosis * long term corticosteroid treatment (20mg per day equivalent prednisone for more than 15 days) * preexisting treatment with nsaids for more than 15 days * hospital admission for more than 48hours * aspiration pneumonia

Keywords: pneumonia, bacterial [c01.252.620] bronchopneumonia [c08.381.677.127] pleuropneumonia [c08.730.610.473] anti-inflammatory agents, non-steroidal
denosumab related osteonecrossi of the jaw : : an emergent and potentially complex bone and joint infection

Conditions: Bone and Joint Infection; Osteomyelitis; Adverse Drug Event

Summary: the aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by denosumab. indeed, one of the adverse effect ot this molecule is to induce mandibular infection.


Eligibility criteria:
inclusion criteria: * patients having a mandibular osteomylelitis due to denosumab exclusion criteria: * none

Keywords: bone and joint infection osteomyelitis mandibular denosumab
pharmacogenomics of hypertension personalized medicine (pgx-ht)

Conditions: Hypertension

Summary: this is a pharmacogenomic prospective , four-arms, parallel groups, active comparator controlled study in essential hypertensive patients never treated before. each patient will be genotyped for snps (single nucleotide polymorphism) in preliminary genetic profiles and will be treated according to their genetic profile with peri (perindopril) 4 mg or hctz ( hydrochlorothiazide) 12.5 mg.

at screening visit each patient will be genotyped for snps in preliminary genetic profiles with a custom snp array. the therapy scheme includes 2-4-week run-in period after which eligible patients will be treated according to their genetic profile with peri 4 mg or hctz 12.5 mg. titration to peri 8 mg or hctz 25 mg could be possible after one month treatment. patients without any genetic profile will be randomly assigned to hctz or peri treatment as control groups. the treatment period will last 8 weeks, while the study about 10-12 weeks four cases may occur: * patient with hctz profile, hctz treatment; * patient with peri profile, peri treatment; * patient without hctz nor peri profile, randomization for hctz or peri; * patient with both profiles, treatment according to the profile with the higher number of positive contributors. eligible patients will be treated according to their genetic profile with peri 4 mg or hctz 12.5 mg/die. titration to peri 8 mg or hctz 25 mg could be possible after 4 weeks treatment. the treatment period will last 8 weeks, while the study about 10-12 weeks

Eligibility criteria:
inclusion criteria: * male/female patients aged 25-60 years. * naive hypertensive patients (newly diagnosed, never treated before). * documented mild to moderate arterial hypertension, as defined below: 1. at visits 1 and 2 (week -4 and week -2 run-in period) the mean of the last 3 consecutive readings of office sbp must be \>= 140 mmhg and/or dbp must be \>=90 mmhg, when measured by office blood pressure (obp); 2. at visit 3 (week 0) enrolment , the mean of the last 3 consecutive readings of sbp must be \>= 140 mmhg and \ = 90 mmhg and \<110 mmhg, when measured by obp. * signed informed consent for genotyping. exclusion criteria: * known causes of secondary hypertension; * pregnant, nursing women or women of childbearing potential taking anti-contraceptive medication; * severe or malignant hypertension; * history of renal artery disease; * significant renal disease (estimated creatinine clearance less than 60 ml/min); * hepatic disease; * cardiac diseases (myocardial infarction, atrial fibrillation, etc); * diabetes (fasting plasma glucose \>125mg/dl); * statin treatment; * obesity (bmi\>30 kg/m2).

Keywords: hypertension pharmacogenomics anti-hypertensive therapy
china liver cancer clinical registry cohort database

Conditions: Liver Cancer

Summary: this study was led by the department of hepatobiliary surgery of the first affiliated hospital of the university of science and technology of china (ustc), in close cooperation with many participating units across the country, to establish a standardized clinical information database of hepatocellular carcinoma cohorts, which will provide a guarantee for conducting high-quality real-world clinical studies and clinical research.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, no gender limit * patients without surgery are initially diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, or metastatic hepatocellular carcinoma based on the results of imaging and laboratory tests, or patients with surgery are diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, or metastatic hepatocellular carcinoma based on the results of pathologic tests * signed informed consent, good compliance, willingness to accept follow-up and provide blood and postoperative pathology residual samples exclusion criteria: * combination of severe central nervous system disease, respiratory disease, autoimmune disease, chronic renal insufficiency, long-term use of immunosuppressive drugs, combination of severe uncontrolled infections * concurrent active cardiovascular disease, cerebrovascular accident within 6 months, myocardial infarction, unstable angina pectoris, or congestive heart failure of class ii or greater according to the new york heart association criteria, severe arrhythmia requiring medication * pregnant or breastfeeding women * participation in other therapeutic clinical trials during the course of the patient's illness in which the treatment cannot be specified or information about the treatment cannot be collected
cutibacterium dermal colonization: implications for total hip arthroplasty

Conditions: Degenerative Osteoarthritis

Summary: this study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called propionibacterium, more specifically p acnes, the same bacterium that is responsible for the majority of acne. information affecting hip surgery is currently unknown.

this study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called propionibacterium. the most common bacterium of this family is p acnes, the same bacterium that is responsible for the majority of acne. there is increasing evidence that infection with p acnes and other propionibacterium is a significant source of failure following certain orthopaedic shoulder procedures. however, information affecting hip surgery is currently unknown. our personal experience leads us to believe that the numbers are actually quite high, since we are seeing an increased rate of propionibacterium infection of hip replacement in the community. however, this type of study has never been done before, and therefore we simply do not know an accurate estimate for the average hip replacement patient's risk for propionibacterium infection following hip replacement.

Eligibility criteria:
inclusion criteria: * patients who are 18 to 79 85 years of age * cjr primary joint arthroplasty patients who are receiving care at porter adventist hospital * cjr established primary knee or hip arthroplasty patients with a native hip joint (no replacement on the biopsy side) who volunteers as a research participant. * cjr patients without a previous arthroplasty procedure who have established care with our practice. exclusion criteria: * previous history of hip infection * current antibiotic use or antibiotic use within the past week * previous history of cutibacterium joint infection * current immunodeficiency disease or disorder * patients with active psoriatic disease or other focal inflammation over the hip * previous total hip arthroplasty (bilateral for the case of tka patients and healthy volunteers, contralateral for tha patients)
the efficacy of transversus abdominis plane block after groin hernia repair

Conditions: Hernia

Summary: the purpose of this study is to determine whether transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.


Eligibility criteria:
inclusion criteria: * 18-75 years old * groin hernia repair * written consent * asa 1-3 * bmi 18-35 exclusion criteria: * unable to communicate in danish * relevant drug allergy * pain medication in the last 24 hours * pregnancy * alcohol or/and drug abuse * daily opioid intake * infection at injection site

Keywords: transversus abdominis plane block
diagnostic performance of c reactive protein and delta crp in acute appendicitis

Conditions: Appendicitis

Summary: the diagnosis of acute appendicitis is difficult and despite important advances in medical sciences, detailed patient questioning and precise medical examination are the main keystones of the diagnosis of acute appendicitis and up to now, results still unsatisfactory.

acute appendicitis is the most common surgical emergency and the most common source of community-acquired intra-abdominal infections. the lack of accuracy in the diagnosis of acute appendicitis yields often to two types of outcomes: a delay in diagnosis leads to perforation and peritonitis in up to 15% of the cases and unnecessary appendectomy is associated with post-operative complications such as wound infection and adhesions. crp is an acute phase protein that is often used by many surgeons as a diagnostic marker of acute appendicitis. during the evaluation of patients with possible appendicitis in the emergency department (ed), repeated physical examination of the abdomen may provide further information about the decision making. however, the role of repeated laboratory examinations is not proven. the purpose of this study was to investigate whether repeated serum crp measures could be useful to predict acute appendicitis, after 3 hours of observation, in comparison with the histopathological findings.

Eligibility criteria:
inclusion criteria: * age \> 8 year old * clinical suspicion of acute appendicitis including the presence of direct tenderness in the right lower quadrant, percussion and rebound tenderness, pyrexia, anorexia, nausea and vomiting. exclusion criteria: * patients receiving anti coagulants * pregnant women * patients using antibiotics during the study period.

Keywords: c-reactive protein
efficacy optimizing extension study of chronic hepatitis b patients with inadequate response to nuc therapy

Conditions: Chronic Hepatitis B; Inadequate Response; Nucleos(t)Ide Analogues Treatment

Summary: the purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis b patients with inadequate response to nuc therapy


Eligibility criteria:
inclusion criteria: * subjects who completed the 104-week dragon study. * subjects who are willing to participate the extension study. exclusion criteria: * subjects who could not compliance with the protocol judged by investigators
computer-assisted hiv prevention for young drug users

Conditions: HIV

Summary: in this study, the investigators are developing and evaluating an interactive, computer-assisted hiv, std and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies.

adolescents and young adults who use drugs are at high risk for infection with hiv, stds and other diseases with similar transmission dynamics. although several age-appropriate and effective hiv, std and disease prevention efforts have been identified for young substance abusers, most interventions have been narrow in focus and are generally not structured to readily address changing patterns of drug use among adolescents that place them at risk for infection with these diseases. in this study, we are developing and evaluating an interactive, computer-assisted hiv, std and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. we plan to develop this program with the input from the target population of adolescents and young adults. we also plan to conduct a randomized, controlled trial to evaluate the benefit of including this program in hiv and disease prevention efforts with youth in substance abuse treatment. in so doing, we will evaluate the ability of the program to promote accurate knowledge about hiv and other diseases, promote self-efficacy to reduce risk behavior and change actual rates of risk behavior among young substance abusers. this computer-based program will be designed to promote the increased adoption of effective hiv and disease prevention science for this population. new information about changing patterns of drug use and hiv risk behaviors can be readily incorporated into the program as it becomes available. the program can be easily exported and able to be applied with fidelity. importantly, the program will be structured such that a therapist or educator may customize the program content for use by various sub-populations of substance-abusing adolescents and young adults. thus, the program will be able to address risk factors specific to each young drug user. this program may address many of the challenges associated with the current delivery of evidence-based hiv prevention programs to this population.

Eligibility criteria:
inclusion criteria: * aadolescents in outpatients substance abuse treatment * ages 13 - 18 years * within first month of treatment entry exclusion criteria:

Keywords: hiv hepatitis stds adolescents addiction treatment prevention hiv and related risk behavior among youth in drug treatment