Kornimate/medical-research-clean huggingface dataset:
studying tissue samples to learn more about drug resistance in patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. purpose: this laboratory study is examining tissue samples from patients with acute myeloid leukemia to learn more about drug resistance in these patients.

objectives: * ascertain whether assessments of p-glycoprotein (p-gp) status using the accumulation assay find greater than 10% positive specimens among 30 specimens (collected from patients with acute myeloid leukemia enrolled on clinical trial ecog-e3999) found to be negative using only the efflux assay. outline: this is a multicenter study. cryopreserved bone marrow specimens are examined for p-glycoprotein (p-gp) by the accumulation assay and the efflux assay using dioc_2 dye. flow cytometry is used for measuring activity in both assays. projected accrual: a total of 40 specimens will be accrued for this study.

Eligibility criteria:
disease characteristics: * cryopreserved bone marrow specimens collected from patients with acute myeloid leukemia enrolled on clinical trial ecog-e3999 meeting the following criteria: * appreciable levels of either cd34+ or cd117+ blasts * appreciable staining with anti-p-gp antibodies * 30 specimens must exhibit low to moderate dye loading for the rh123 efflux assay * 10 specimens must exhibit positive rh123 efflux activities patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adult acute monocytic leukemia (m5b) adult acute megakaryoblastic leukemia (m7) adult acute myeloblastic leukemia with maturation (m2) adult acute myeloblastic leukemia without maturation (m1) adult acute myelomonocytic leukemia (m4) adult acute monoblastic leukemia (m5a) secondary acute myeloid leukemia untreated adult acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (m0) adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b)
remote monitoring and virtual collaborative care for hypertension control to prevent cognitive decline

Conditions: Hypertension; Cognitive Decline

Summary: this purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.


Eligibility criteria:
inclusion criteria: * age 65 and older * active patient in participating primary care clinic * access to compatible "smartphone" or device (i.e., android, kindle or apple with internet connectivity) * elevated blood pressure as defined by: systolic blood pressure \>140 at current visit and documented history of hypertension or systolic blood pressure \> 140 at current visit and at another visit in last 18 months or systolic blood pressure \>160 at current visit * sufficiently fluent in english to participate in study procedures * adequate vision and hearing to complete study procedures exclusion criteria: * clinically significant illness that may affect safety or completion per their treating primary care physician or study physician * end stage renal disease on dialysis * chronic active disease with expected life expectancy \< 2 years as determined by the study team

Keywords: hypertension cognitive decline mild cognitive decline memory loss memory disorders memory impairment blood pressure blood pressure, high
interest of parametric positron emission imaging in the diagnosis of infections on cardiac valve prosthesis

Conditions: Endocarditis

Summary: the objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.

in addition to routine examinations (biological and microbiological tests, transesophageal or transthoracic ultrasound, transesophageal or transthoracic ultrasound, and leukocyte scintigraphy) of a parametric acquisition during the positron emission computed tomography parametric acquisition during positron emission computed tomography , this examination being itself planned in a standard way. the definitive diagnosis according to the duke-li criteria will be established three months later in a multidisciplinary consultation meeting. the final diagnosis according to the duke-li criteria will be made three months later in a multidisciplinary consultation meeting, blinded to the results of the parametric positron emission computed tomography, and with knowledge of the results of the standard positron emission computed tomography and the entire work-up. results and all the complementary work-up.

Eligibility criteria:
inclusion criteria: * age superior to18 years, * effective contraception for women of childbearing age or negative pregnancy test on the day of the exam * good general condition. who ≤ 1 * suspicion of endocarditis on a prosthetic heart valve implanted more than 3 months ago * labeled polynuclear scintigraphy performed within a maximum of 15 days before positron emission computed tomography * standard positron emission computed tomography planned as part of the extension assessment * informed and signed consent before any specific study procedure. * patient affiliated to the social security system exclusion criteria: * presence of an active cancer in the previous three years * pregnancy or breastfeeding * poorly controlled diabetic patients * protected adults (under guardians or curators) * impossible decubitus (orthopnea, ...), * hypersensitivity to fdg or to one of the excipients of the radiopharmaceutical.
treatment of low dose il-2 and ganciclovir in cytomegalovirus infection

Conditions: Cytomegalovirus Infections

Summary: cytomegalovirus (cmv) infections is a severe infection in patients of rheumatic disease treated with corticosteroid and immunosuppressive agents. ganciclovir is the main therapy in cmv infection, accompanied with diverse side effects, including neutropenia, anemia, disorder of renal function and so on, which are also common symptoms of rheumatic diseases. additionally, prolonged antiviral treatment may delay recovery of virus, specific immune responses, resulting in an increasing of late-onset cmv disease. il-2 is a pleotropic cytokine which can promote the proliferation and function of cd8+ t cells and nk cells through the combination with il-2 receptor. recently, several studies have revealed that low dose il-2 is an effective and safe therapy for autoimmune disease. in systemic lupus erythematous patients, additionally, patients treated with low-dose il-2 had lower incidence of infection with increased percentages of natural killer (nk) cells. in this prospective clinical trial, we propose to assess the effective and safety of low-dose il-2 combined with ganciclovir in the treatment of cmv infection. meanwhile, we will assess the immune response of after il-2 treatment.

in rheumatic diseases, cmv infection are more frequent in patients after corticosteroid pulse treatment and long-term treatment of corticosteroid and immunosuppressor. if patients are eligible, which cmv-dna are more than 10\^3 copies, it will be randomly distributed in low-dose il-2 and ganciclovir group, or ganciclovir group. low-dose il-2 is defined as 1 million iu per day subcutaneously, the cmv-dna levels will be monitored until it turned out to be negative. in this period, we will simultaneously monitor the immune response in regard to cmv infection, including innate immune response, such as ifn-γ, tnf-α, natural killer cells, and adaptive immune response, such as cmv specific cd8+ t cells, t helper cells and so on. we will follow these patients for at least 3 months after drug withdrawal. if patient belonging to any of these two groups develops a viral infection, then the patient will receive treatment with ganciclovir.

Eligibility criteria:
inclusion criteria: 1. diagnosis of rheumatic disease by the criteria ; 2. patients have current cmv infection, cmv-dna are positive. 3. apply corticosteroid less than 1.0mg/kg/d. exclusion criteria: 1. cmv-dna is negative. 2. other infection, such as bacteremia, hepatitis b and c viruses, hiv, syphilis, bacteremia, epstein-barr virus and so on. 3. known allergies, hypersensitivity, or intolerance to il-2 or its excipients. 4. severe comorbidities: including 1) heart failure (≥ grade iii nyha); 2) renal insufficiency (creatinine clearance ≤30 ml/min); 3) hepatic insufficiency (serum alt or ast \>3 times the uln, or total bilirubin \>uln for the central laboratory conducting the test); 4) other disease including hematopathy, gastrointestinal disease, endocrinopathy, pulmonary, neuropathy. 5. malignancy. 6. had uncontrolled psychiatric or emotional disorder. 7. pregnant or breast-feeding
utilization and efficacy of tenofovir df in adolescents with chronic hepatitis b virus infection

Conditions: Hepatitis B

Summary: the primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir df) treatment in chb-infected adolescents. this includes prospectively evaluating and comparing the bone mineral density (bmd) change between chb-infected adolescents 12 to \< 18 years of age treated with tenofovir df in european treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and bmd measurement.


Eligibility criteria:
key inclusion criteria: 1. 12 to \<16 years of age 2. documented chronic hepatitis b virus (hbv) infection 3. weight ≥ 35 kg 4. able to swallow oral tablets 5. negative pregnancy test for females of childbearing potential 6. adequate kidney (renal) function 7. parent or legal guardian of potential study subjects able to provide written informed consent key exclusion criteria: 1. previously received tenofovir df 2. sexually-active males or females of reproductive potential who are not willing to use an effective method of contraception during the study 3. females who are pregnant or breastfeeding, or females who wish to become pregnant during the course of the study 4. known hypersensitivity to tenofovir df, the metabolites or formulation excipients 5. any condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with treatment requirements note: other protocol defined inclusion/exclusion criteria may apply
direct acting antiviral-post authorization safety study

Conditions: Hepatitis C; Hepatocellular Carcinoma

Summary: this is an independent optional sub-study parallel to target-hcc (nct02954094). the purpose of direct-acting antiviral-post authorization safety study (daa-pass) is to investigate the impact of exposure to direct-acting antivirals (daas) on early recurrence of hepatocellular carcinoma (hcc) in hepatitis c virus (hcv)-infected patients following successful hcc treatment interventions.


Eligibility criteria:
screening inclusion criteria: * current participant in target-hcc * adults, age ≥18 years * first diagnosis of hcc (mixed hcc/cholangiocarcinoma may be included). diagnosis may be histological/cytological and/or radiological. * bclc stage a * underwent, undergoing, or planned to undergo therapy for hcc, with exception that transplant as prior or planned treatment for hcc is excluded. * hcv rna positive screening exclusion criteria: * inability to provide informed consent * hcc-free imaging (as defined in section 9.1.1) after treatment of initial hcc prior to screening (see section 9.2.9 for imaging details) * prior liver transplantation * hepatitis b virus (hbv) surface antigen positive (hbsag) * previously treated with direct-acting antiviral agents (not daa-naïve); note that prior (peg)ifn and/or ribavirin therapy is allowed enrollment inclusion criteria: * continued participation in target-hcc * no recurrence or progression of initial hcc beyond bclc stage a prior to enrollment/baseline * hcc-free imaging (as defined in section 9.1.1) at enrollment/baseline (see section 9.2.9 for imaging details; participants may remain in screening until an hcc-free image is obtained) * remains daa-naïve (prior therapy with (peg)ifn and/or ribavirin is allowed) enrollment exclusion criteria: - liver transplantation since screening
efficacy of a personalized rehabilitation program of facial involvement in systemic sclerosis

Conditions: Systemic Sclerosis; Face; Facial Involvement; Rehabilitation

Summary: systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. facial involvement is frequent and disabling. it causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. it results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss. facial involvement in systemic sclerosis can be assessed using the mouth handicap in systemic sclerosis (mhiss) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face. although common and disabling, facial involvement is underestimated and poorly managed. immunosuppressive and/or anti-fibrosis drugs are not very effective. facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients. the aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yo * systemic sclerosis according to the 2013 acr/eular (american college of rheumatology) classification criteria * systemic sclerosis with facial involvement defined by a mhiss score \> 6 * immunosuppressive and/or anti-fibrosis treatment stable for at least 1 month * subject able to understand the objectives and risks of research and to give informed consent * subject enrolment in the health insurance scheme exclusion criteria: * pregnancy * previous participation in a rehabilitation program of facial involvement * patient under legal protection * impossibility to give clear information of subject

Keywords: face facial involvement rehabilitation systemic sclerosis
hydromorphone hydrochloride epidural preemptive analgesia for postoperative pain after cesarean section

Conditions: Post-surgical Pain

Summary: acute pain often occurs after cesarean section, which can lead to stress and inflammatory response in the body, which will not only affect the postpartum recovery speed of the puerpera, but also inhibit the secretion of prolactin to a certain extent and reduce the secretion of milk. epidural anesthesia is a common anesthesia method for cesarean section, which has the advantages of easy operation and little influence on the fetus. preemptive analgesia can effectively block the transmission of harmful stimuli and reduce the degree of pain after cesarean section. hydromorphone hydrochloride is a derivative of morphine, which has the advantages of rapid onset and good analgesic effect, and has been widely used in clinic. however, it is not clear whether epidural injection of hydromorphone hydrochloride for preanalgesia can bring clinical benefits to puerpera, and the optimal dose of hydromorphone hydrochloride for cesarean section is also unclear. the parturient women who met the inclusion criteria were randomly divided into 3 groups: control group, hydromorphone hydrochloride low-dose administration group and hydromorphone hydrochloride high-dose administration group. all women received epidural combined subarachnoid anesthesia. 15min before the end of the operation, the low-dose hydromorphone hydrochloride group was injected with 0.1mg hydromorphone hydrochloride in the epidural space, the high-dose hydromorphone hydrochloride group was injected with 0.3mg hydromorphone hydrochloride in the epidural space, and the control group was injected with 0.9% sodium chloride injection. post-obstetric visual analogue scale (vas) was followed up to record pca compression times, gastrointestinal peristalsis recovery time, getting out of bed time, lactation time, and related adverse reactions.


Eligibility criteria:
inclusion criteria: * parturients with indications for cesarean section; * american association of anesthesiologists (asa) grade i - ii; * no history of sedative drugs or opioid abuse; * volunteer to join the study exclusion criteria: * people with coagulation disorders; * preoperative use of analgesia, non-steroidal drugs; * abnormal liver and kidney function; * postoperative drainage is urgently needed.
cl[nical study of succide among patient with psychoactive substance use disorders

Conditions: Substance Use Disorders

Summary: detect risk of suicide among patient with substance use disorder

substance use disorder (or drug addiction) is a neuropsychiatric disorder characterized by recurring desire to continue taking the drug despite harmful consequences. substance use disorders are a major risk factor for suicide suicide is a leading cause of premature death in young adults. data from the world health organization indicate that the rate of completed suicide for the world's population is 16 per 100,000 inhabitants, which means that each year more than a million people in the world commit suicide. suicide attempts are five to twenty times more common than the completed suicide.based on the data from the research community, approximately 5% of adults attempts suicide at least once in their lifetime . mental health problems are the most common and best explored risk factor associated suicidal ideas, suicide attempts and completed suicide. about 90% of all people who commit suicide met the diagnostic criteria for one or more psychiatric disorders . people who use alcohol and/or drugs or are dependent on them, attempting suicide nearly six times more often than people who do not use these substances. the rate of completed suicide among addicts is 2 to 3 times higher than among the males who are not addictst, while in a few cases the manner in which the suicide is attempted is not directly related to drugs . although there is a correlation between the disorder caused by the use of substances and suicidal behavior, a large number of addicts will never attempt suicide. it is therefore important to identify those individuals with the disorder caused by the use of substances that may be at higher risk for suicide . many risk factors for suicide in the general population also apply to drug addicts. the older drug addicts are at higher risk for attempts and suicides than younger addicts another very important fact when it comes to suicide attempts is the drug used. it is known that heroin and sedatives are substances with which suicide attempts suicide are most often made, while other drugs are less characteristic .

Eligibility criteria:
inclusion criteria: * patients fulfilling diagnostic criteria of substance use disorder 1. social impairment 2. impaired control 3. risky use 4. pharmacological indicators (tolerance and withdrawal). exclusion criteria: * patient with other psychatric disorders ex schizophrenia, mood disorder
immuno & safety study with 2 formulations of dtpw-hbv/hib when given at birth with hepatitis b at 2, 4 and 6 mths.age.

Conditions: Haemophilus Influenzae Type b; Diphtheria; Tetanus; Hepatitis B; Whole Cell Pertussis

Summary: a trial to characterize the immunogenicity of 2 different formulations of a vaccine from gsk biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis b and haemophilus influenzae type b. a vaccine from commonwealth serum laboratories (diphtheria, tetanus, pertussis) which is co-administered with haemophilus influenzae type b vaccine will also be used as a comparator. reactogenicity and safety of all vaccines will be assessed as well.

"the study will be carried out in a partially double blind manner (i.e. double blind with respect to dtpwgöd-hbv/hib kft and dtpwcsl-hbv/hib kft groups and open with respect to csl's triple antigen \& hib group). subjects will be randomly allocated to one of the three following groups to receive: * gsk biologicals kft's combined dtpwgöd-hbv/hib kft vaccine. * gsk biologicals kft's combined dtpwcsl-hbv/hib kft vaccine. * csl's triple antigen + gsk biologicals' hib vaccines. there will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. serious adverse events reported during the study period will be recorded. "

Eligibility criteria:
inclusion criteria * administration of one dose of hepatitis b vaccine at birth. * a healthy male or female between, and including, 6 and 12 weeks of age at the time of the first dtpw vaccination. exclusion criteria * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis b vaccine for the triple antigen + hib group. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required) * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * bacille calmette-guérin (bcg) vaccine given after the first 2 weeks of life. * previous vaccination against diphtheria, tetanus, pertussis and/or hib/history of diphteria, tetanus, pertussis, hepatitis b and/ or hib disease.
ipf italian observational study (fibronet) in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of the present study is to evaluate the characteristics, management and clinical course of patients with ipf as treated under real-world in italian pulmonary centres, in terms of symptoms, lung function and exercise tolerance during 12 months of observation.


Eligibility criteria:
inclusion criteria: 1. patients aged\>=40 years 2. written informed consent to both participation in the study and privacy 3. physician diagnosed ipf during the last 3 months based upon recent american thoracic society/european resp. society/japanese resp. society/latin american thoracic association guidelines 2011 (see tables a1-a2 for high resolution chest computer tomography and histology criteria): * exclusion of other known causes of interstitial lung disease (e.g. domestic and occupational environmental exposures, connective tissue disease and drug toxicity) * assessment of idiopathic pulmonary fibrosis based on high resolution computed tomography (hrct) or hrct and surgical lung biopsy if available. 4. patient with further follow-up possible with enrolling investigator during planned study period 5. patients capable of discernment and able to read or write in italian language. exclusion criteria: 1. inclusion in clinical trials or other ipf/ild registries 2. lung transplantation expected within the next 6 months 3. pregnancy or breast feeding