Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety and efficacy of sunitinib, in subject with refractory solid tumors

Conditions: Refractory Solid Tumors

Summary: this study is a single arm, pilot study of sunitinib in patient with ret fusion positive, fgfr2 fusion/fgfr mutation refractory solid tumor and/or specific sensitivity to sunitinib by avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. to investigate the efficacy and safety of sunitinib in patient with refractory solid tumor.


Eligibility criteria:
inclusion criteria: * provision of fully informed consent prior to study specific procedures. * patients must be \>= 19 years of age * ret fusion positive or fgfr2 fusion/other fgfr mutation refractory solid tumor and/or specific sensitivity to sunitinib by avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. * ecog performance status0-2 * have measurable or evaluated disease based on recist 1.1 as determined by investigator. * adequate organ function laboratory values * absolute neutrophil count \>= 1.5 x 109/l, hemoglobin \>= 9g/dl, platelets\>=100 x 109/l bilirubin \<= 1.5 x upper limit of normal ast/alt \<= 2.5 x upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) creatinine\<= 1.5 x unl * patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing * adequate heart function exclusion criteria: * patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years. * has known active central nervous system(cns) metastases * has an active infection requiring systemic therapy * pregnancy or breast feeding * patients with cardiac problem * any previous treatment with sunitinib
glycemic relapse prevention: maintenance dose assessment

Conditions: Type 2 Diabetes

Summary: this purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.

recent large randomized controlled trials have proven that tight glycemic control reduces the microvascular and macrovascular complications of diabetes. reduction of these complications also leads to a great cost savings to healthcare and society. however, it has been difficult to translate the success of these large randomized control trials to everyday practice. a recent cross-sectional analysis of 95 clinicians revealed only 40.5% of type 2 diabetes patients had a glycated hemoglobin (hba1c) less than 7%. the disparity of care between the large trials and a primary care office is largely due to the difference in resources available in the typical medical office. practical, sustainable ways of maintaining tight glycemic control are needed in everyday practice. while diabetes improvement programs are successful in acutely lowering hba1c the long-term effectiveness of these programs is disappointing. approximately 40% of those who return to routine care after completing an intensive diabetes improvement program experience a relapse in their glycemic control within one year. some proportion of the relapse is likely due to a patient's inability to maintain adherence to key self-care behaviors - diet, exercise, self-monitoring of blood glucose and medication regimen. the purpose of this study is to better understand prevention of glycemic relapse. the primary aim of this study is to assess the relative effectiveness of three management approaches, varying in frequency, for preventing glycemic relapse after glycemic control has been achieved through participation in an intensive diabetes improvement program. this study will determine the optimal frequency of intervention needed to prevent glycemic relapse in patients with type 2 diabetes. the authors hypothesize that high intensity intervention will lead to a decrease in glycemic relapse in a dose dependent fashion.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * recent control obtain (hba1c\<8%) after diabetes improvement program * receives care in primary care clinic exclusion criteria: * pregnant

Keywords: diabetes chronic disease management relapse
safety and equivalence of a generic ciclopirox olamine topical suspension compared to the reference ciclopirox topical suspension 0.77% for the treatment of tinea pedis

Conditions: Tinea Pedis

Summary: the objectives of this study were to demonstrate comparable safety and efficacy of ciclopirox olamine topical suspension (test product) and ciclopirox topical suspension 0.77% (reference product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.


Eligibility criteria:
inclusion criteria: * male or female at least 10 years of age, and otherwise healthy * clinically and mycologically confirmed diagnosis of symptomatic tinea pedis * in good health with no clinically significant disease that might have interfered with study evaluations * study participant or legal guardian was willing and able to read and sign an irb approved icf, which included agreement to comply with all study requirements as indicated in the protocol. for subjects 10 to 17 years of age, an assent form for minors was completed. exclusion criteria: * history of hypersensitivity or allergy to ciclopirox * had any skin condition that would interfere with the diagnosis or assessment of tinea pedis * had a history of dermatophyte infection unresponsive to antifungal treatment * had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study * had any condition or used any medication that, in the opinion of the investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk * was unwilling to sign the informed consent * female who was pregnant or lactating

Keywords: tinea pedis ciclopirox olamine
treatment of disseminated high grade lymphoma

Conditions: Lymphoma

Summary: interest of the use of pegylated liposomal doxorubicin (caélyx)

r chop is a good standard in the treatment of diffuse high grade lymphoma. howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Eligibility criteria:
inclusion criteria: * high grade lymphoma * disseminated * \> 60 years old and \< 75 * informed consent signed * cardiac state compatible with antracyclin * ecog \</= 2 exclusion criteria: * patients \> 75 years old * cardiac insufficiency

Keywords: diffuse larg cells lymphoma chemotherapy toxicity diffuse high grade lymphoma
a new rehabilitation tool in fibromyalgia

Conditions: Fibromyalgia; Pain

Summary: the aim of the investigators study was to measure reductions in chronic pain in female patients with fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.


Eligibility criteria:
inclusion criteria: * fibromyalgia diagnosed according to the criteria proposed by the american college of rheumatology (acr 1990 and 2010) * subjects aged between 18 and 60 years * visual analog scale (vas) for pain \> 5 exclusion criteria: * presence of concomitant autoimmune diseases * psychiatric disorders * other causes of chronic pain * other diseases that prevented physical loading * severe scoliosis or kyphoscoliosis * surgery of the spine * vertebral fractures * sciatic pain * tumors * enrolled in another type of physical therapy program * myocardial infarction * lower extremity arterial disease * major neurological problems * diabetes * gastrointestinal disease * chronic respiratory disease * kidney disease * poor vision

Keywords: postural exercise back pain tender points fibromyalgia perceptive rehabilitation
mytpill: a novel strategy to monitor antiretroviral adherence among hiv+ prescription opioid users

Conditions: HIV-positive Individuals

Summary: this study compares several different antiretroviral adherence measures, including digital pills, in hiv+ individuals who are maintained on opioid analgesics.

this study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.

Eligibility criteria:
inclusion criteria: * hiv+, viral load \>200copies/ml, on single pill containing tdf/ftc, receiving prescription for opioid analgesics exclusion criteria: * severe renal or hepatic disease * hypersensitivity to silver, magnesium, or zinc following oral use * pregnancy * non-english speaking * history of crohn's disease or ulcerative colitis * history of bowel surgery, gastric bypass, or bowel stricture * history of gastrointestinal malignancy or radiation to the abdomen.
improving prospective memory via telehealth

Conditions: Multiple Sclerosis

Summary: up to 70% of persons with multiple sclerosis (pwms) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. one cognitive domain that has been shown to impact daily functioning, but is understudied in ms, is prospective memory (pm). while there have been successful pm interventions in other clinical populations, to date there has not been a specific pm intervention for pwms that has been tested in a clinical trial. the study will be a double-masked randomized feasibility trial, with 18 participants randomized to a pm intervention and 18 participants randomized to an active control (psychoeducation). participants will meet with an interventionist twice a week for four weeks. feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. a preliminary effect size (cohen's d) will be computed for the group difference using participants' performance on the memory for intentions test, which will be given at baseline (week 1) and post-treatment (week 6). participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ms * able to read, write, and speak in english * between the ages of 18 and 60 * all genders * no history of other serious neurologic or psychiatric illness, including drug or alcohol misuse * no relapses within the past two months * access to the internet and a web camera * not enrolled in a cognitive rehabilitation program within the past six months * self-reported issues "remembering places they have to be" and "things they have to do" exclusion criteria: * no diagnosis of ms * unable to complete the study protocol due to language barriers * younger than 18 or older than 61 * no gender exclusions * history of other serious neurologic or psychiatric illness, including drug or alcohol misuse * had a relapse within the past two months * no access to the internet and/or a web camera * currently enrolled or enrolled in a cognitive rehabilitation program within the past six months * no self-reported issues with "remembering places they have to be" or "things they have to do"

Keywords: prospective memory cognitive dysfunction multiple sclerosis
use of sublingual microcirculation and flotrac monitoring during major vascular surgery and its effect on hospital los

Conditions: Carotid Artery Plaque; Aortic Aneurysm; Aneurysm

Summary: the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the flotrac/vigileo device in combination with intraoperative measurement of the sublingual microcirculation with the cytocam-idf device would result in an improvement in outcome in high-risk patients undergoing major vascular surgery, measured by the hospital los in comparison with intraoperative flotrac/vigileo monitoring alone. the flotrac/vigileo device only needs standard arterial access for enhanced, flow-based hemodynamic monitoring. it is reported to be easy to use and easy to set up and calculates the stroke volume (sv) on the basis of the arterial waveform in combination with demographic data. cardiac index (ci), stroke volume index (svi) as an indicator for fluid status and stroke volume variation (svv) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm will be continuously measured during major vascular procedures, including carotid endarterectomy (cea), open abdominal aortic aneurysm (aaa) repair , endovascular aneurysm repair (evar), thoracic endovascular aneurysm repair (tevar) and fenestrated endovascular aneurysm repair (fevar).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * males and females * asa iii classification * written informed consent obtained by the patient * elective hospital admission for major vascular surgery procedures (cea, open aaa, evar, tevar, fevar) exclusion criteria: * age \< 18 years * presence of permanent cardiac arrythmias * weight \ 140kg * pregnancy * emergency surgery * minor vascular procedures * refusal or inability to provide written informed consent (language barrier, mental retardation, dementia)
early- and late-onset candidemia

Conditions: Candidemia

Summary: a timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. in the last years a growing body of knowledge has better characterized health-care associated (hca) infections, which have been described in 2002 in outpatients with mrsa bloodstream infections. so far there is no compelling evidence that patients with hca infections may develop candidemia before the usual timing of around 20-25 days after admission. risk factors associated with hca infections are represented by admission from long term chronic care facilities (ltcf), haemodialysis, previous admission or parenteral broad spectrum antibiotics. there are few data hca features and early onset candidemias in the published literature. in this proposal, the investigators aim at studying early-onset candidemia in a retrospective study in one of the largest referral hospital in italy with a consistent range of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, icu, complex surgery). the investigators speculate that patients with candidemia diagnosed within 10 days (early-onset) by the admission have different risk factors and prognosis of those with a late diagnosis.


Eligibility criteria:
inclusion criteria: * candidemia diagnosed with positive blood culture either from a peripheral vein or cvc exclusion criteria: * candida isolated from a removed cvc tip will not be considered

Keywords: candidemia early-onset late-onset health-care associated nosocomial
surgical resection combined with intraperitoneal hyperthermic chemotherapy

Conditions: Hyperthermic Intraperitoneal Chemotherapy; Hepatocellular Carcinoma; Ruptured Liver

Summary: patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into experimental and control groups. the primary efficacy end point was rfs, and the secondary end point was the rate of abdominal implant metastases and os.to analyze the efficacy of hipec.

patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into groups: experimental group: surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy, and control group: simple surgical resection. at further follow-up, the primary efficacy end point was time to recurrence free survival (rfs) ,the time from the patient's treatment until the discovery of abdominal metastases or until the follow-up period, and the secondary end point was the rate of abdominal implant metastases, that is, according to the postoperative follow-up test and imaging findings, the incidence of abdominal implantation and metastasis, until the end of abdominal recurrence or metastasis or observation period. overall survival os and survival rate: the time from the time the patient underwent partial hepatectomy until death from tumor causes or the end of the observation period. to analyze the efficacy of hipec.

Eligibility criteria:
inclusion criteria: 1. according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology; 2. preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging; 3. age 18-80 years; 4. child-pugh class a or class b after liver protection and albumin correction, without severe heart, lung or renal dysfunction, without absolute contraindication to surgery; 5. ecog-ps score of 0-1; 6. without other neoplastic diseases; 7. sign and perfect the informed consent form before operation; 8. without postoperative liver failure, without major complications such as massive hemorrhage, purulent infection and multiple organ failure, and without discharge from hospital. exclusion criteria: 1. having other active malignant tumor; 2. the expected survival time is less than 3 months; 3. child-pugh class c, complicated with severe organic disease of important organs, complicated with severe cirrhosis.

Keywords: ruptured and bleeding of hepatocellular carcinoma hyperthermic intraperitoneal chemotherapy recurrence-free survival
computer assisted instruction weight management for low literacy populations

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to develop and evaluate a computer assisted instruction (cai) weight management program in an adult population with low literacy at sheehan memorial hospital's family care center (fcc), an outpatient clinic serving the inner city of buffalo, new york.

background: this was the first study in patient care informatics in which nutrient analysis methodology was used on a day-to-day basis to motivate low literate individuals to improve their food choice behavior and physical activity. the deliverables of this investigation included revised and enhanced software, professional documentation, and a participant workbook. these materials were designed so that they could be integrated into any risk factor reduction program for low literacy populations. design narrative: the cai featured voice recognition, giant cursor movement, and a graphics-based environment using pictures to facilitate an exceptionally easy to use and understand software program and booklet. the voice recognition technology was linked with compact disk read only memory (cd rom) to visually display food choices and physical activities for ease of recording data by the individual. the software was formatted so that health professionals could select preference levels which corresponded to the motivational level of the individual. the four-session cai intervention had two planned maintenance sessions. the output was personalized and in color. it was designed to identify problematic foods in the diet, improve food selections, and increase physical activity. stars were printed for adherence to individual goals. one hundred and fifty (150) men and 150 women, between age 20 and age 44, with a reading level of 8th grade or less, who were between 20 percent and 40 percent over their ideal body weight, were randomly assigned to three groups. the design compared a control group without the intervention, a group experiencing the cai intervention and hands-on computer use, and a group experiencing the intervention but not the cai component or computer use. all groups were pretested, posttested, and follow-up tested at six months and twelve months following baseline. the primary outcome measures were weight loss, nutrient intake, and physical activity. data were analyzed using a two-way analysis of covariance and appropriate t-tests. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
case-control pilot study of the immune modulating effect of feiba on patients with haemophilia a and inhibitors

Conditions: Severe Haemophilia A With Inhibitors

Summary: this study aims to evaluate the immunomodulatory effect of feiba® in patients with severe haemophilia a and inhibitors.

this is an observational, multicentric, case-control and one-single-visit study of patients with severe haemophilia a and inhibitors against fviii in therapy with feiba®. two subject groups will be included: group 1 (cases) will be composed of patients with severe haemophilia a and inhibitors in prophylaxis with feiba®; group 2 (controls) will be composed of patients with severe haemophilia a and inhibitors on-demand treatment with feiba®.

Eligibility criteria:
inclusion criteria: 1. the subject has signed and dated the informed consent form for participation in this study. 2. age ≥ 18 years old. 3. patient with severe haemophilia a (fviii \ 5 ub) at some point in their life, currently on therapy with feiba® to control bleeding. 4. group 1: patients in prophylaxis with feiba®: the patient has been on prophylaxis regimen with feiba® for at least 6 months prior to the study visit. group 2: patients on-demand regimen with feiba®: the patient has been under on-demand treatment with feiba® for at 6 months prior to the study visit. exclusion criteria: 1. the presence of any inflammatory condition at the time of the study visit or the previous 30 days that, according to the medical criterion, would affect the study objectives. 2. the patient is under immune tolerance treatment or has been at any time during the 30 days prior to the study visit. 3. the administration of any anti-inflammatory or immunosuppressive drug 15 days before the study visit. 4. levels of cd4 \<200/l regardless of the hiv status. 5. altered hepatic or renal function defined by the presence of abnormal levels of alanine aminotransferase (alat) or serum creatinine, respectively. 6. administration of any haemostatic treatment to control bleeding within the 5 days prior to the study visit.

Keywords: feiba®