Kornimate/medical-research-clean huggingface dataset:
reprieve cardiovascular system for the treatment of subjects with acute decompensated heart failure mechanistic study

Conditions: Heart Failure

Summary: reprieve cardiovascular system for the treatment of subjects with acute decompensated heart failure mechanistic study

the key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the reprieve cardiovascular system.

Eligibility criteria:
inclusion criteria: 1. hospitalized with a diagnosis of heart failure 2. patients ≥ 18 years of age able to provide informed consent and comply with study procedures. exclusion criteria: 1. inability to place foley catheter or iv catheter 2. hemodynamic instability 3. dyspnea due primarily to non-cardiac causes 4. acute infection with evidence of systemic involvement 5. inability to follow instructions or comply with follow-up procedures. 6. other concomitant disease or condition that investigator deems unsuitable for the study 7. enrollment in another interventional trial during the index hospitalization 8. life expectancy less than 3 months
identification of diagnosis biomarkers in the tears of alzheimer's disease patients: the cog-eye pilot study

Conditions: Alzheimer Disease

Summary: the diagnosis of alzheimer's disease (ad) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., aβ and phosphorylated tau) or through brain imaging. the invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for ad. human tears are an accessible biological fluid that has proven relevant in the biomarker search strategy for both ophthalmological and systemic diseases, especially neurodegenerative conditions. advances in methods for low-volume analysis have facilitated the identification of tear biomarkers. total tau has been reported as elevated in the tears of patients with ad compared to controls (n=65). additionally, metabo-lipidomic analyses offer several advantages (accessibility, non-invasiveness, reproducibility) and also appear promising as a diagnostic tool for systemic and neurodegenerative diseases, such as amyotrophic lateral sclerosis. this supports the relevance of comparing both ad proteins biomarkers and metabo-lipidomic signatures in the tears of patients with ad (mild cognitive impairement (mci) and dementia) with healthy controls.


Eligibility criteria:
inclusion criteria: * age ≥18 years * participant affiliated in french social security scheme * informed and written consent from the participant exclusion criteria: * pregnant or breastfeeding woman * participant under judicial protection measures * participant under guardianship or curatorship * contraindications to participation in the research: other neurodegenerative disease any eye drops or treatment that may interfere with tear production occasional or permanent contact lens use within the last 3 months eye surgery ≤3 months any ocular pathology other than refractive errors, oculomotor disorders, amblyopia any general pathology other than ad with ocular implications -inability to perform tear collection

Keywords: biomarkers tears metabolomic lipidomic alzheimer disease
effect of ranolazine on activity level in patients with angina after ffr based deferred intervention (reptar)

Conditions: Angina

Summary: the post-marketing study is designed to evaluate the activity level and exercise tolerance of patients with deferred percutaneous intervention due to ffr (fractional flow reserve) greater or equal to 0.81 and treatment with ranolazine versus placebo.

ranolazine was approved as ranexa in the united states on january 31, 2006 for the treatment of chronic angina. this post-marketing study is a single-center, double-blind, prospective, randomized, parallel-group evaluation of patients randomized 1:1 between ranolazine and placebo.

Eligibility criteria:
inclusion criteria: 1. subjects must be willing and able to comply with schedules visits, treatment plan, and other study procedures. 2. there must be evidence of personally signed and dated informed consent documents. 3. subjects must have a documented history of anginal chest pain equal to or greater than one (1) episode per week prior to cardiac catheterization. 4. subjects must have greater than or equal to one (1) episode of angina chest pain between screening visit and randomization visit. 5. subject must have documented cardiac catheterization with deferred percutaneous intervention and fractional flow reserve (ffr) greater than or equal to 0.81 within thirty (30) days, or an (ffr) less than 0.81if not a candidate for revascularization based upon operator discretion. - exclusion criteria: 1. subjects with a congenital or acquired qt interval prolongation (greater than or equal to 440ms in men/greater than or equal to 460ms in women). 2. subjects prescibed strong cyp3a inhibitors (including ketaconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir.) and/or strong cyp3a inducers (rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamezepine and st. john's wort). 3. subjects prescribed to simvastatin (zocor) that cannot have dose reduced to appropriate levels (20mg qd) per physician or have medication discontinued during the clinical trial. 4. subjects prescribed metformin that cannot have dose reduced to appropriate levels (less than or equal to 850mg bid) per physician or have medication discontinued during the clinical trial. 5. subjects prescribed digoxin that cannot have dose reduced to appropriate levels (0.125mg qd) per physician or have medication discontinued during the clinical trial. 6. subjects with life expectancy less than the duration of the trial. 7. subjects with a history of liver cirrhosis. 8. subject with chronic renal disease with creatinine clearance of less than 30ml/min. 9. subjects participating in any other clinical trial for the duration of the trial. 10. females who are of childbearing potential, who are unwilling or unable to use highly effective method of contraception -

Keywords: angina, chest pain
personalized cellular vaccine for recurrent glioblastoma (percellvac2)

Conditions: Glioblastoma

Summary: the treatment option for recurrent glioblastoma is limited. immune cell based therapy for glioblastoma has shown some efficacy. this study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed dcs. immune responses to the immunized antigens will be monitored. safety and efficacy will be observed in this study.

this is an open label, single-arm, single-institution, phase i study designed to investigate the safety and efficacy of personalized cellular vaccines for patients with recurrent glioblastoma (gbm). recurrent gbm patients will undergo tumor resection. the tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. patients will undergo leukapheresis to collect mononuclear cells for dc generation. based on the expression profiles of tumor-associated antigens, in vitro transcribed mrna will be generated to pulse autologous dcs. patients will be conditioned with immune adjuvants before and during immunization. patients will receive biweekly vaccines. the antitumor specific t cell responses will be measured. safety and efficacy will be monitored. the objective is to assess the safety of the personalized cellular vaccines and t cell responses. the efficacy of the vaccines will be evaluated using irano criteria, progression-free survival and overall survival.

Eligibility criteria:
inclusion criteria: * recurrent glioblastoma grade iv * patients at the age of 18-65. * patients undergo tumor resection. * patients with karnofsky scores \> or =70 * patients with normal range of hematologic and metabolic test results. * patients must have no corticosteroids treatment at least one week before vaccination. * patients capable of understanding the study and signed informed consent. exclusion criteria: * breast feeding females. * pregnant women. * infectious diseases hiv, hbv, hcv * documented immunodeficiency * documented autoimmune disease * any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease. * patient inability to participate as determined by pi discretion.

Keywords: recurrent glioblastoma dc vaccine tumor antigen personalized vaccine
clinical study of personalized chemotherapy for breast cancer with low doses of cyclophosphamide

Conditions: Stage IV Breast Cancer

Summary: the goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage iv or disease progression). the main question it aims to answer is: does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? during the preparatory stage, a tumor sample from participant is harvested intraoperatively. the primary culture is obtained from this tumor tissue sample. repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle g2/m phase is identified. the schedule of administering cyclophosphamide and dnamix complex composite preparation is calculated according to the resulting time points. according to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of dnamix administered into prominent tumor nidi and lymph depots. the participant receives from 2 to 6 courses of therapy. the interval between courses is 21 days.


Eligibility criteria:
inclusion criteria: * stage iv breast cancer or progression of the disease with the presence of foci accessible for biopsy of tumor material; * complete awareness of the patient about the prognosis of the disease and the proposed treatment; * the volume of tumor material required for vital assessment of the time parameters of the individual reparative cycle of tumor cells must be at least 4 cm3; * tumor cells transferred to primary culture must be in a state of proliferative activity. exclusion criteria: * severe decompensated cardiovascular, respiratory, hepatic, renal failure; * presence of an acute infectious disease; * intolerance to cyclophosphamide; * severe neutropenia - the content of neutrophils is less than 1000 per 1 μl of blood; * simultaneous participation in another clinical trial.
a phase 1/2 trial of trametinib and erlotinib in patients with egfr-mutant lung adenocarcinomas and acquired resistance to erlotinib

Conditions: Lung Adenocarcinoma; Lung Cancer; Lung Cancer Metastatic; Lung Cancer Stage IV; Recurrent Lung Adenocarcinoma; Recurrent Lung Cancer

Summary: the purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with stage iv or recurrent lung adenocarcinoma that cannot be treated with curative intent.


Eligibility criteria:
inclusion criteria: * pathologic evidence of advanced stage iv or recurrent lung adenocarcinoma reviewed at mskcc * somatic activating mutation in egfr radiographic progression during treatment with erlotinib. * any number of prior chemotherapy regimens is permitted. * measurable (recist 1.1) indicator lesion not previously irradiated * kps \>/= 70% * age \>18 years old * must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of \> 10 unstained slides) * left ventricular ejection fraction \>/= the lower limit of normal by echo or muga * adequate organ function: * ast, alt \</= 2.5 x uln * total bilirubin \</= 1.5 x uln * albumin\>/=2.6g/dl - creatinine \ /=50ml/min * absolute neutrophil count (anc) \>/= 1,200 cells/mm3 * hemoglobin\>/=9.0 g/dl * platelets \>/=100,000/mm3 exclusion criteria: * patients with symptomatic brain metastasis requiring escalating doses of steroids * patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as crohn's disease or malabsorption * pregnant or lactating women * any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol except for a egfr tki * patients who have received prior treatment with a mek inhibitor * any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol. * a history of clinically significant interstitial lung disease or pneumonitis * clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from day 1 of study administration, new york heart association class iii or iv congestive heart failure, or symptomatic uncontrolled arrythmias, prolonged corrected qt interval \>480msec, treatment refractory hypertension, presence of a cardiac defibrillator * history of central serous retinopathy or retinal vein occlusion

Keywords: erlotinib trametinib 15-098
a study of tq-b3101 capsules in subjects with advanced malignant tumor

Conditions: Advanced Malignant Tumor

Summary: the objective of this study is to evaluate efficacy and safety of tq-b3101 in subjects with advanced malignant tumor.


Eligibility criteria:
inclusion criteria: -1. eastern cooperative oncology group (ecog) performance status score of 0 to 1; life expectancy ≥12 weeks. 2. understood and signed an informed consent form. 3. histologically or cytologically confirmed advanced malignant solid tumors. 4. adequate organ system function. 5. patients need to adopt effective methods of contraception. exclusion criteria: * 1. has multiple factors affecting oral medication. 2. the toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 3. other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors. 4. has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension. 5. has cardiovascular and cerebrovascular diseases. 6. has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose. 7. has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease. 8. active hepatitis, hiv positive, syphilis positive. 9. has a history of psychotropic substance abuse. 10. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
comparison of tension free primary closure, karydaks and limberg flap methods

Conditions: Pilonidal Disease; Recurrence; Complication

Summary: pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. the disease seen in between 15-35 years of age and 3-4 times more in males. the incidence of the disease is found as 8.8% in turkish soldiers. the disorder mainly affects the quality of life. there are numerous methods in surgical treatment of pilonidal sinus. the main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. the defect can be closed by primary sutures or it can be left for secondary healing. nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. however, it has been reported that there is no difference between flap procedures and tension free primary closure. this result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. the aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.


Eligibility criteria:
inclusion criteria: * having pilonidal sinus disease * desire for surgical treatment * accept to be involved in the study exclusion criteria: * patients under age of 18 * recurrent cases
study to assess safety and tolerability of azd2171 after multiple doses in patients with advanced prostate cancer

Conditions: Advanced Prostate Adenocarcinoma

Summary: a study to assess safety and tolerability of azd2171 after multiple doses in patients with advanced prostate cancer.


Eligibility criteria:
inclusion criteria: * men, 18yrs and older * histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic) * prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma exclusion criteria: * prior radiotherapy to bone metastases within 4 weeks prior to screening * any unresolved chronic toxicity greater than ctcae grade 2 from previous anticancer therapy * brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.

Keywords: advanced prostate cancer
islet allotransplantation with steroid free immunosuppression

Conditions: Type 1 Diabetes; Hypoglycemia; Metabolic Diseases

Summary: the restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(t1d). after decades of frustrating clinical attempts, the edmonton group set up in 2000 new standards for islet transplantation in patients with brittle t1d by achieving insulin independence in 80 percent of patients. these seminal results have however proved much more difficult to duplicate than initially expected. this single center phase 2 clinical trial, duplicating the edmonton protocol, is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe t1d.

the short term effectiveness of islet transplantation for alleviating hypoglycemia and controlling glucose homeostasis while limiting or even avoiding the nedd for exogenous insulin has been established despite protocol modifications in donor selection, islet preparation or recipient treatment, insulin independence with adequate metabolic control was however rarely prolonged beyond two years. the most frequently proposed explanations include chronic allogenic rejection, recurrence of autoimmunity and beta cell toxicity from administered immunosuppressive drugs. fourteen patients were enrolled in this single center phase 2 trial initiated in 2003. eligible patients were males or females between 18 and 65 years of age, with type 1 diabeted documented for more than 5 years, arginine stimulated c-peptide lower than 0.2ng/ml, and hypoglycemia awareness or documented metabolic lability. exclusion criteria included body mass index greater than 28kg/m2, unstable arteriopathy or heart disease, active infection, previous transplantation, insulin daily requirements above 1.2 ui/kg, creatinin clearance below 60 ml/mn/m2 or urinary albumin excretion above 300 mg/day, malignancy, smoking, desire for pregnancy, psychiatric disorders and lack of compliance. the study primary efficacy endpoint was graft survival defined as insulin independence and hba1c\<6.5%. secondary outcomes were graft function and metabolic control.

Eligibility criteria:
inclusion criteria: * type 1 diabetes documented for more than 5 years * arginine stimulated c-peptide lower than 0.2 ng/ml * one of the following:hypoglycemia unawareness or metabolic lability documented by one or more severe hypoglycemias or two or more hospital admissions for ketoacidosis within the previous year. exclusion criteria: * body mass index greater than 28 kg/m2 * non stable arteriopathy or heart disease * active infection * previous transplantation * hyperimmunization * insulin daily needs above 1.2 u/kg * creatinine clearance below 60 ml/mn or urinary albumin excretion above 300 mg/d * malignancy * smoking * desire for pregnancy * psychiatric disorders * lack of compliance

Keywords: diabetes hypoglycemia
observational study on cml patients in any phase of the disease treated with ponatinib (iclusig®)

Conditions: Chronic Myeloid Leukemia

Summary: this is a multicentre ambispective cohort study involving french patients who have started or are receiving for less than 6 months a treatment with ponatinib. this study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with cml patients' therapeutic history.


Eligibility criteria:
inclusion criteria: * presenting a cml in any phase. * having initiated for less than six months a treatment with ponatinib. * the ability to understand the requirements of the study and to comply with the study data collection procedures. exclusion criteria: * patients previously treated with investigational ponatinib (within a clinical trial). * patients receiving an investigational agent. * patients who are pregnant and/or breastfeeding. * patients with contraindications for ponatinib according to summary of products characteristics.

Keywords: chronic myeloid leukemia iclusig ponatinib
recovery management checkups for women offenders

Conditions: Recovery Management Checkup (RMC); Outcome Monitoring

Summary: the proposed study is designed to test the effectiveness of recovery management checkups for women offenders (rmc-wo) released from jail to provide continuity of care immediately upon release and to help them manage their long-term recovery. the hypotheses in the first phase were: 1)women assigned to rmc (versus control) will a) return to treatment sooner after the initial release from jail and b) be more likely to receive treatment in the 90 days after release from jail; 2)women who received treatment in the first 90 days post release (vs. no treatment) will be more likely to sustain their abstinence through 90 days post release from a) any alcohol or drugs, b) alcohol, c) cannabis, d) cocaine, and e) opiates; 3)women who maintained their abstinence from any alcohol and other drugs through the first 90 days post release (vs. any relapse) will be less likely to have a) unprotected sex, b) commit any other illegal activity, and d) be re-incarcerated in jail or prison. in the second phase repeated exposure to these efforts on a quarterly basis is expected to further strengthen each of these effects.

the components of the recovery management checkups will include: on-going monitoring via a re-entry meeting, two monthly meetings and quarterly assessments for 3 years, personalized feedback on substance use and high risk behaviors, linkage to community-based substance abuse treatment (when needed), on-site hiv booster sessions (when needed), and treatment engagement and retention support. motivational interviewing will provide the therapeutic approach to transition women from one step of the change process to another. combined, these components and therapeutic milieu afford an opportunity for immediate linkage to community-based treatment and hiv prevention as well as ongoing monitoring for relapse and early re-intervention for both substance use and hiv risk behaviors (both public health priorities).

Eligibility criteria:
phase 1 inclusion criteria: * adult women offenders with substance problems re-entering the community from county jail programs exclusion criteria: * had not used substances in the 90 days before incarceration * had no abuse/dependence symptoms * were under 18 years old * lived or planned to move outside chicago within the next 12 months * were not fluent in english or spanish * were cognitively unable to provide informed consent and were released before the 14th day of incarceration phase 2 inclusion criteria: * released to the community * agreed to participate in the study * completed the initial interview

Keywords: substance use disorder offenders reentry hiv risk behavior recidivism