Kornimate/medical-research-clean huggingface dataset:
contingency management using smartphone app in patients with sud

Conditions: Substance Use Disorders

Summary: the purpose of this research study is to test the acceptance and efficacy of a smartphone app (dynamicare rewards) for patients with substance use disorder (sud) who are in active treatment and recovery at brightview.

the purpose of this research study was to test the acceptance and efficacy of a smartphone app (dynamicare rewards) for patients with substance use disorder (sud) who are in active treatment and recovery at brightview (www.brightviewhealth.com). patients performed self-tracking of their recovery behavior (e.g., counseling attendance, abstinence from drugs and alcohol) addiction recovery behavior using the dynamicare app, which follows contingency management (cm) model of incentivizing positive behavior. cm is shown as a highly effective, evidence-based methodology for improving substance use disorder (sud) outcomes. it does so by activating the brain's reward and inhibitory systems through both positive and negative reinforcement using immediate, concrete incentives in a progressive reinforcement schedule. cm involves setting frequent (\>1/week), objective goals (usually abstinence or participation in treatment), which patients can achieve to earn tangible rewards (such as cash or vouchers). the dynamicare smart phone app (ios/android) uses cm to incentivize patients to attend scheduled appointments and to submit negative alcohol and drug tests as they are rewarded for these behaviors. the intentions of this project were to assess whether use of the smartphone app as an add-on to treatment as usual could increase treatment retention, increase the percentage of appointments that were kept, and if substance use could be reduced for patients using the app. patients were enrolled in the study on a rolling basis from jan 25, 2019 to march 29, 2019 until the desired cohort group # was reached (n=108). the intervention period (period of time when patients actually used the dynamicare app) lasted four months from the date of their enrollment.

Eligibility criteria:
inclusion criteria: * \>18 years old * substance use disorder (sud) as a primary diagnosis * have and use an android or ios smartphone with acceptable capability * are willing to participate in home testing and use of the smartphone * speak and read the english language adequately to understand smartphone commands and responses * are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature. exclusion criteria: • n/a

Keywords: contingency management smartphone app substance use disorder outpatient addiction treatment brightview dynamicare
evaluation of persistence of immunity in 4-year-old children previously immunised with ipv-al ajv (picovax®)

Conditions: Poliomyelitis

Summary: the trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with ipv-al ajv at 2, 4, 6 and 15 18 months of age in previous trials. levels of antibodies against poliovirus types 1, 2 and 3 after immunisation with ipv al ajv will be measured in the trial subjects at the age of 4 years. an additional ipv-al ajv dose (investigational vaccine) will be administered and the booster response to ipv-al ajv will be investigated one month after administration.


Eligibility criteria:
inclusion criteria: 1. children that have been vaccinated with ipv-al ajv in the vipv-07 and vipv-07 e1 trials and have completed these trials 2. healthy, as assessed from medical history and physical examination 3. parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form 4. parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records 5. parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures exclusion criteria: 1. previous vaccination with opv 2. previous vaccination with ipv outside the vipv-07 and vipv-07 e1 trials 3. known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. hiv is not an exclusion criterion. 4. severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease 5. known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol) 6. uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling 7. treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial period 8. participating in another interventional clinical trial 9. not suitable for inclusion in the opinion of the investigator
paclitaxel in treating patients with metastatic or recurrent salivary gland cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of paclitaxel in treating patients with metastatic or recurrent salivary gland cancer.

objectives: i. estimate the response rate in patients with metastatic or recurrent salivary gland cancer treated with paclitaxel (taxol, tax) by 3-hour infusion. ii. describe the toxicity of tax in these patients. outline: single-agent chemotherapy. paclitaxel (bristol-myers), taxol, tax, nsc-125973. projected accrual: up to 32 patients/histology will be entered. if no response is observed in the first 14 patients in a particular histology, accrual to that group will close; if after 18 months annual accrual is less than 10 patients/histology, accrual to that group may close.

Eligibility criteria:
disease characteristics: histologically confirmed salivary gland carcinoma that is metastatic or recurrent, including the following types: mucoepidermoid carcinoma adenocarcinoma pathology review required measurable disease required lesion in a previously irradiated field must be progressing and biopsy- proven patient characteristics: age: 18 and over performance status: ecog 0-2 hematopoietic: wbc at least 3,000/mm3 anc at least 1,500/mm3 platelet count at least 100,000/mm3 hb at least 10 g/dl hepatic: bilirubin no greater than 1.5 mg/dl renal: creatinine no greater than 2.0 mg/dl cardiovascular: no mi within the past 6 months no chf no unstable arrhythmia no current antiarrhythmic, inotropic, or antianginal medication other: no history of allergy to cremophor no prior malignancy within 5 years except: curatively treated nonmelanomatous skin cancer curatively treated in-situ cancer of the cervix no concurrent malignancy not pregnant or nursing effective contraception strongly advised for fertile patients blood/body fluid analyses to determine eligibility and imaging studies and scans/x-rays for tumor measurement completed within 14 days prior to registration prior concurrent therapy: biologic therapy: prior biological response modifier therapy allowed chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: prior radiotherapy allowed with recovery surgery: prior surgery allowed with recovery

Keywords: stage iv salivary gland cancer recurrent salivary gland cancer high-grade salivary gland mucoepidermoid carcinoma salivary gland adenocarcinoma
hemostasis in thyroidectomy, comparison between diathermy and ligasure

Conditions: Thyroid

Summary: thyroidectomy is one of the most surgeries done by surgeons. postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres. atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. these devices reduce operative time and post-operative complication .investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.

thyroid surgery is one of the most frequently performed surgical procedures worldwide . nowadays, total thyroidectomy is the recommended procedure for thyroid disease . as total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization. other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection . atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. these devices reduce operative time and post-operative complication .investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.

Eligibility criteria:
inclusion criteria: * • patient with disburbed thyroid function and candidate for for thyroidectomy exclusion criteria: * low preoperative calcium level and patient with contraindication of uses of ligasure or diathermy.
management of metastatic disease in campania (mametic)

Conditions: Metastatic Disease

Summary: the mametic trial represents the first regional epidemiological study that aims to evaluate patients living in campania with metastatic cancer, with the intent to detect different prevalence of tumors in the metastatic phase and evaluate the local response to the patient's request for assistance. condition or disease: metastatic disease intervention/treatment: radiation treatment

the mametic trial is a multicenter, retrospective and prospective observational study and 17 of 20 rt centers in campania joined it. 1. the retrospective part of the study concerns all patients enrolled with a diagnosis of metastatic disease and treated in rt centers of the campania region with 3dcrt, imrt, vmat, sbrt techniques from january 2019 to august 2020. in 2019, it has been enrolled 12.500 patients in the 17 rt centers and it is estimated that 20-30% of the above mentioned patients had metastasis. thus, approximately 2.560 patients are expected to be enrolled. 2. the prospective part of the study is going to enroll all metastatic patients eligible for palliative rt, treated in rt centers of the campania region with 3dcrt, imrt, vmat, sbrt techniques from september 2020 to september 2025. considering the rt centers that joined the trial, it is expected to enroll approximately 2.500-4.200 patients per year and a total of 12.500-21.000 patients in 5 years. the study will last 61 months, divided as follow: 60 months of enrollment phase and up to 1 month of follow-up for pain and bone metastasis patients. follow-up will be performed on the 15th and 30th day after the end of radiation treatment.

Eligibility criteria:
inclusion criteria: * patients aged \> 18 years resident in campania region; * patients diagnosed with metastatic disease candidates for radiotherapy * metastatic patients candidates for radiotherapy re-treatment * oligometastatic patients candidates for radiotherapy; patients who have given their consent exclusion criteria: * patients aged \< 18 years * patients who are unable to express consent to sensitive data and radiant treatment

Keywords: palliative care metastatic disease radiotherapy cancer pain breakthrough cancer pain quality of life
non-invasive evaluation of hepatic fibrosis in patients with the metabolic syndrome

Conditions: Metabolic Syndrome

Summary: non-alcoholic fatty liver disease (nafld) is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance. in some patients, the disease can progress into steatohepatitis (nash) which associates fatty liver, hepatocellular damage, chronic inflammation and variable and progressive fibrosis. the latter can evolve into cirrhosis and end-stage liver disease. thus the presence of fibrosis sign the severity of the disease, and therefore its accurate detection is crucial for the identification of patients in need of treatment and appropriate follow-up. to date, histological examination of a biopsy of the liver is the gold standard in the diagnosis of fibrosis. the procedure is however associated with significant complication in 0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo the liver. the aim of the study is to evaluate, in a population of patients with the metabolic syndrome, whether non-invasive tests may identify those with hepatic fibrosis. at inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and elastography by mri will be performed. those tests will be repeated within 2 months. a liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography) tests are suggestive of hepatic fibrosis. this study will allow to determine * whether hepatic fibrosis may be detected by non-invasive means in patients with nafld/nash. * whether there is a correlation between non-invase tests and liver biopsy for assessment of fibrosis and it severity * whether the presence of fatty liver interfere with the results of the fibroscan and the elastography. * whether there are metabolic factors associated with an increased risk of fibrosis in this population.


Eligibility criteria:
inclusion criteria: * metabolic syndrome with 3 out of 5 criteria (atp iii definition) exclusion criteria: * alcohol intake \> 20g/day (women), \> 30g/day (men) * chronic liver disease of other cause: viral hepatitis (hbv, hcv), wilson's disease, haemochromatosis, alpha1 anti-trypsin deficiency, drug-induced, ... * decompensated cirrhosis (child-pugh 3) * body weight \> 120 kg

Keywords: metabolic syndrome insulin resistance nash hepatic fibrosis fibroscan elastography by mri
phase 3 study of zandelisib (me-401) in combination with rituximab in patients with inhl - (coastal)

Conditions: Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma

Summary: this is a phase 3 study of the pi3kδ inhibitor zandelisib (me-401) in combination with rituximab, in comparison to standard immunochemotherapy (rituximab-bendamustine or rituximab-chop) in subjects with relapsed or refractory fl and mzl.

this is an open label, randomized, two-arm phase 3 study in subjects with relapsed or refractory fl and mzl to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (rituximab-bendamustine or rituximab-chop). subjects must have relapsed after at least one previous line of systemic immunochemotherapy. previous treatments must have included an anti-cd20 monoclonal antibody (mab) with chemotherapy such as bendamustine (b), chop, cvp, fnd, or similar regimens, or an anti-cd20 mab with lenalidomide (l). approximately 534 randomized subjects will be enrolled in this study.

Eligibility criteria:
inclusion criteria: * male or female subjects ≥18 years of age, ≥19 years in korea, or ≥20 years for subjects in japan and taiwan * histologically confirmed diagnosis of cd20 positive inhl with histological subtype limited to: 1. fl gr 1, gr 2, or gr 3a 2. mzl (splenic, nodal, or extra-nodal) * subjects with relapsed or refractory disease who received ≥1 prior lines of therapy * subjects must have at least one bi-dimensionally measurable lesion \>1.5 cm * adequate hematologic parameters at screening unless abnormal values are due to disease * adequate renal and hepatic function * adequate cardiac function based on ecg and lvef assessments exclusion criteria: * histologically confirmed diagnosis of fl gr 3b or transformed disease * prior therapy with pi3k inhibitors * ongoing or history of drug-induced pneumonitis * known lymphomatous involvement of the central nervous system * tested positive for or active viral infection with hepatitis b or c virus * tested positive or active infection with human immunodeficiency virus * tested positive, or active infection with human t-cell leukemia virus type 1 * any uncontrolled clinically significant illness * history of clinically significant cardiovascular abnormalities such as congestive heart failure * history of clinically significant gastrointestinal (gi) conditions * females who are pregnant
the chapter ii study - congenital heart adolescents participating in transition evaluation research

Conditions: Congenital Heart Disease

Summary: transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. national bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. however, there is no research regarding how to best organize and deliver congenital heart disease (chd) transition programs. data is urgently needed. therefore, the aim of this program is to develop research evidence that will better prepare health care providers to improve how they can help adolescents with transition. this project will determine whether a nurse-led transition intervention program is better at preparing teens with chd to independently manage their medical care, compared to the care that is currently provided. the most important finding of this study will be whether or not these teens subsequently attend the adult cardiology clinic that specializes in chd problems, and the timing of when they attend. hypothesis: a transition intervention in combination with usual care, improved time to first adult congenital heart disease (achd) clinic attendance compared to usual care alone.


Eligibility criteria:
inclusion criteria: * 16 and 17 year olds with moderate or complex chd exclusion criteria: * significant developmental delay * previous heart transplantation

Keywords: transition from pediatric to adult clinical care
national children's food survey ii

Conditions: Dietary Habits; Life Style; Body Weight

Summary: the overall objective of this project is to establish for the republic of ireland (roi) a nationally representative database of food consumption in children aged 5-12 years to update 2003-04 data for this group and to complement more recent data on preschool children and adults. the survey will be comparable with existing survey data in roi and with surveys in uk (gb \& ni). the roi database will be designed to address both nutrition and food safety issues of relevance to the development and implementation of public health policy, food safety risk assessment and to the needs of the food industry. in addition to detailed data on food consumption, data will be also be collected on body weight, lifestyle, including physical activity, determinants of food choice, urine, and composition of foods and food recipes. food composition databases will be updated and restructured to facilitate future analyses of food ingredients, packaging materials, residues, contaminants, allergens, bioactives and microorganisms. urine samples will be stored to facilitate future analyses nutrition and metabolic indicators, markers of food intake and for estimating exposure to food chemicals. data will be analysed to estimate intakes of foods and nutrients and compliance with dietary recommendations, to establish the prevalence of overweight and obesity, to investigate physical activity patterns and compliance with guidelines, to identify psychological, social and attitudinal determinants of food choice and eating behaviour. salt intake will be estimated from urine excretion. findings will be disseminated to relevant stakeholders. the project will be carried out by a multi-disciplinary research team with strong linkages to related on-going research in food and health sciences.


Eligibility criteria:
inclusion criteria: * attending primary school exclusion criteria: -
sstr pet/ct for preoperative n stage evaluation in gep-nets

Conditions: Gastro-entero-pancreatic Neuroendocrine Tumor

Summary: the research aims to prospectively include patients with gep-nens, undergo preoperative imaging assessment (including pet/ct and contrast-enhanced ct), and accurately delineate lymph node regions. through postoperative pathological reports, the diagnostic performance of lymph node metastasis (lnm) in gep-nens is evaluated. factors influencing the diagnostic accuracy of sstr-pet/ct and contrast-enhanced ct are also investigated.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years old; 2. patients diagnosed with gep-nen by surgical pathology; 3. complete medical records including basic information and treatment process; 4. patients who have undergone preoperative contrast-enhanced ct and 68ga-sstr-pet/ct, and have consented to the 68ga-sstr-pet/ct project in the nuclear medicine department. exclusion criteria: 1. presence of concomitant malignancies; 2. cases diagnosed pathologically as non-gep-nen.
haic with one-day folfox vs. haic with two-day folfox for unresectable hcc: a non-inferiority study

Conditions: Hepatocellular Carcinoma

Summary: hepatic arterial infusion chemotherapy (haic) with oxaliplatin\&5-fluorouracil was effective in unresectable hepatocellular carcinoma (hcc). the program of folfox-haic in hcc was performed for 1 day (haic 1d) or 2 days (haic 2d). we hereby retrospectively compared the efficacy and safety between these two treatment regimens, and explored the predictive power of thymidylate synthase (tyms), an enzyme involved in the dna synthesis process and metabolism of fluorouracil. patients with hcc staged bclc a-b receive haic only, and patients with hcc staged bclc c receive haic plus systemic treatment, such as sorafenib, a+t, lenvatinib.


Eligibility criteria:
inclusion criteria: * age range from 18-75 years; * kps≥70; * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl), simultaneously staged as bclc a, bclc b or bclc c based on barcelona clinic liver cancer staging system. * patients must have at least one tumor lesion that can be accurately measured * diagnosed as unresectable with consensus by the panel of liver surgery experts * no cirrhosis or cirrhotic status of child-pugh class a only * meet the following laboratory parameters:(a) platelet count ≥ 75,000/μl; b)hemoglobin ≥ 8.5 g/dl;(c) total bilirubin ≤ 30mmol/l;(d) serum albumin ≥ 32 g/l;(e) asl and ast ≤ 6 x upper limit of normal;(f) serum creatinine ≤ 1.5 x upper limit of normal;(g) inr \> 2.3 or pt/aptt within normal limits; (h) absolute neutrophil count (anc) \>1,500/mm3; * ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * evidence of bleeding diathesis. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug * serious non-healing wound, ulcer, or bone fracture * known central nervous system tumors including metastatic brain disease * poor compliance that can not comply with the course of treatment and follow up.