Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and renal effects of apx-115 in subjects with type 2 diabetes and nephropathy

Conditions: Diabetic Nephropathies; Diabetes Mellitus, Type 2; Nephropathy, Diabetic

Summary: this is a proof of concept (poc) trial to evaluate the safety, tolerability and renal effect of apx-115 in subjects with type 2 diabetes and nephropathy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes and nephropathy * first morning void (fmv) uacr between 200 and 3000 mg/g, inclusive * 30 ml/min/1.73m2 ≤ egfr ≤ 90 ml/min/1.73m2 using ckd-epi formula at screening * hba1c ≤ 10% at screening visit * subject who has been taking unchanged dosage of ace inhibitor or arb medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study * willing to be under dietary management for diabetes exclusion criteria: * history of type 1 diabetes mellitus or gestational diabetes * subject's renal impairment and/or albuminuria is considered to be of origin other than diabetic kidney disease * subject with uncontrolled blood pressure * clinically significant abnormal laboratory findings * history of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial * diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study * clinically significant ecg abnormalities on a 12-lead ecg at the screening visit or before randomization * current or history of nyha class iv heart failure
nurses caring for patients with covid-19

Conditions: Nurse; in Northern New Jersey; Providing Care to Adults With Covid-19

Summary: the main goal of this study was to understand the perceptions of nurses who cared for patients with covid-19 at the onset of the pandemic in northeast usa. private interviews were held three times with each participant, over the period of 18 months. the interviews were examined for common themes and expressions used by nurses to describe such topics as their professional image, memories, and advise to other nurses.

this study was conducted in a single institution. forty-one (41) nurses were recruited from various units in the medical center. an effort was made to invite nurses from different clinical units, as well as inexperienced and experienced nurses, and males as well as females. to obtain variety in the participants a randomization list (list of names placed in order by a computer) was used to invite nurses. participants consented and were aware that they would be interviewed three times. the interviews were recorded for transcription and subsequent analysis.

Eligibility criteria:
inclusion criteria: * rn employed by facility; cared for adult patients with covid-19 from march - april 2000, consenting exclusion criteria: * not employed as an rn; did not care for patients with covid-19 from march-april 2000 at designated facility, does not agree to consent

Keywords: nurses, interviews, caring for patients with covid-19
long-term safety and efficacy of rfviiifc in the prevention and treatment of bleeding episodes in previously treated participants with hemophilia a

Conditions: Hemophilia A

Summary: the primary objective of the study is to evaluate the long-term safety of recombinant human factor viii fc fusion protein (rfviiifc) in participants with hemophilia a. the secondary objective of the study is to evaluate the efficacy of rfviiifc in the prevention and treatment of bleeding episodes in participants with hemophilia a.

participant will follow either a prophylaxis or on-demand regimen. the starting dose in this study will be determined by the clinical profile of the participant in the preceding studies a-long - 997ha301 (nct01181128), pediatric study 8ha02ped (nct01458106), 997ha307 (nct02083965) and 997ha309 (nct02502149).

Eligibility criteria:
key inclusion criteria: * subjects who have completed previous rfviiifc studies (nct01181128, nct02083965, nct01458106 and nct02502149) * ability to understand purposes and risks of the study and to provide signed and dated informed consent (or assent, as applicable). key exclusion criteria: * confirmed positive high-titer inhibitor (≥5.00 bu/ml). note: other protocol defined inclusion/exclusion criteria may apply

Keywords: rfviiifc a-long extension
impact of m184v on the virological efficacy to 3tc/dtg (lamres)

Conditions: HIV-1-infection

Summary: in view of the prolongation of patients living with hiv's life expectancy, the question of optimization of art, which is still a life-long treatment, becomes central. while most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. the switch to dual regimen strategies represent one of the approaches for treatment optimization. indeed, dual therapy regimens have shown non-inferior efficacy vs triple therapy as simplification therapy and more recently also as first line therapy. from the real-life data it emerges that today in simplification strategies, the dual regimen therapies are prescribed even in patients with a history of virological failure. circulating hiv-1 resistant variants can be archived in viral reservoirs, where they can persist for years and can reemerge in case of therapeutic selective pressure. in particular, previous selection of m184v may have an impact on virological response to 3tc/dtg. there are few data on a direct comparison of 3tc/dtg efficacy in patients harboring or not harboring the m184v. so, there is a need to assess the efficacy of 3tc/dtg in patients with past m184v mutation in a large set of patients followed in clinical setting. thus, the investigators propose a retrospective study of patients with hiv-rna ≤50 copies/ml who were switched to 3tc/dtg in order to compare the virological efficacy of 3tc/dtg in patients with and without a history of m184v detection in a previous resistance genotype. this study aimed to analyze 800 patients switched to dtg/3tc in clinical real setting in large european (france, italy, spain) database.


Eligibility criteria:
inclusion criteria: * hiv-1 infected * age ≥ 18 years * switched to 3tc/dtg while having hiv-rna ≤50 copies/ml on any art regimen * followed for at least 1 year after 3tc/dtg switch * with at least 1 previous genotype * with at least 1 virological follow-up after switching to 3tc/dtg exclusion criteria: * no genotypic resistance test available before switching to dtg/3tc
safety/efficacy study of local anesthetic prior to femoral artery sheath removal

Conditions: Syncope, Vasovagal; Pain Intensity

Summary: this randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.

patients undergoing percutaneous coronary intervention(pci) will be randomized to receive subcutaneous local anesthetic (lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath. they will be assessed for vasovagal reactions and pain intensity during the sheath removal.the incidence of vasovagal reactions and pain intensity scores will be compared between the groups. 200 patients will be enrolled over the course of 2 months.

Eligibility criteria:
inclusion criteria: * percutaneous coronary intervention * femoral arterial sheath exclusion criteria: * less than 18 years old * emergency procedure * transferred out of heart investigation unit prior to sheath removal * radial or brachial sheath * closure devise * venous sheath insitu * intra-aortic balloon pump insitu * tranvenous pacing * mechanical ventilation * cognitive impairment * unable to read english * lidocaine allergy

Keywords: femoral artery sheath vasovagal reaction pain perception
evaluation of the use of azd6244 to induce increased er expression and anti-estrogen response in er-negative/low breast cancer

Conditions: Breast Cancer

Summary: if azd6244 is able to increase er expression in er-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. the investigators propose a single-arm simon two-step study to examine whether treatment with azd6244 will result in increased er expression in er-negative/low primary breast tumors.


Eligibility criteria:
inclusion criteria: * female breast cancer patient \> 18 years. * patients must have biopsy-proven clinical stage ic-iii invasive breast carcinoma with ≤ 10% er expression by immunohistochemistry (ihc) analysis. * patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (er, protein/gene expression analysis). * patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. planned procedure may include lumpectomy or mastectomy as clinically indicated. * patients must have an ecog performance status of 0 - 1. * patients must have the ability to understand and willingness to sign an english or a spanish language written informed consent document. exclusion criteria: * male breast cancer patient. * patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study. * patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer. * patients should not have known or strongly suspected brca mutation by history (genetic testing not required). * patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.

Keywords: breast cancer er-negative allred score
validation of the "tasq" in patients undergoing savr or tf-tavi

Conditions: Aortic Valve Stenosis

Summary: prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five european countries and canada (toronto), with elective patients undergoing tf-tavi (n=120) and isolated savr (n=120), respectively and a control group of 50 patients receiving medical treatment only. all patient groups will fill in three different questionnaires to assess quality of life in 5 different languages (english, french, german, italian and spanish). one of these will be a new questionnaire, the toronto aortic stenosis qol (quality of life) questionnaire (tasq).

currently, there are two cardiovascular disease qol scales which have been used in studies of patients with aortic stenosis - the minnesota living with heart failure (mlhf) questionnaire and the kansas city cardiomyopathy questionnaire (kccq). the kccq has now become the only cited health related (hr) qol validated scale for use among a growing tavi (transcatheter aortic valve implantation) patient population; however questions on the kccq do not reflect the concerns and lifestyle of patients proceeding for aortic valve intervention. many of the questions do not reflect this patient population's perspective of well-being in contrast to perceptions by the general cardiac population on which it was validated. it is important to capture the disruptions caused by a chronic disease and its treatment on lifestyles, activities, and interests; that is interference with psychologically meaningful activity. it has been noted that this interference varies by disease process and treatment by general scales such as the illness intrusiveness scale . due to issues of limited validity of the kccq for tavi / savr (surgical aortic valve replacement) patients related to symptom items not being revised from their original use for congestive heart failure, a new original hr-qol questionnaire was proposed: the "toronto aortic stenosis quality of life questionnaire" (tasq) is a health specific measurement tool designed to measure changes in quality of life in aortic stenosis patients. the aim of this study is to validate this questionnaire in this specific patient population.

Eligibility criteria:
inclusion criteria: * severe aortic stenosis * age \> 18 years * in case of tavi or savr: intention to treat the as employing an edwards valve exclusion criteria: * patients not providing informed consent * patients with major cognitive impairment * emergency patients

Keywords: qol tavi surgical aortic valve replacement aortic stenosis
comparing the pharmacokinetics of nicotine salt based ends in healthy smokers

Conditions: Nicotine Dependence; Nicotine Dependence, Cigarettes; Tobacco Use; Tobacco Smoking

Summary: a ten sequence, open label, randomized crossover study comparing nicotine pharmacokinetics of juul 1.7% and juul 5% nicotine salt based ends products, in healthy adult smokers.

e-cigarettes may be an acceptable alternative to traditional cigarette smoking. in utilizing vaporization rather than combustion, the generation and inhalation of smoke and carbon monoxide (co) may be reduced or avoided. juul has developed several nicotine based liquid blends for use in e-cigarettes. this study will provide an understanding of the levels of nicotine obtained with use of the company's 1.7% and 5% ends products.

Eligibility criteria:
inclusion criteria: * male or female aged 18 to 60 years of age inclusive. * current smoker or e-cigarette user: * able to participate, and willing to give written informed consent and to comply with the ° study restrictions. exclusion criteria: * clinically significant abnormality on screening ecg. * sustained blood pressure recordings at screening of \ 150 mmhg for systolic blood pressure, or \ 90 mmhg for diastolic blood pressure. * sustained resting heart rate of \> 100 or \< 40 beats per minute at screening. * positive result for urine drugs of abuse test or alcohol breath test at screening. * clinically significant abnormality in laboratory test results at screening, in the opinion of the investigator. * positive urine pregnancy test at screening or assessment days in female subjects of child bearing potential. * any clinically significant concomitant disease or conditions.

Keywords: electronic nicotine delivery system combustible cigarettes nicotine
pet/ct imaging to evaluate cardiac radiation damage in patients with lung or esophageal cancer, euclid trial

Conditions: Lung Carcinoma; Esophageal Carcinoma

Summary: this clinical trial examines positron emission tomography (pet)/computed tomography (ct) in evaluating cardiac radiation damage in patients with lung or esophageal cancer. as part of the treatment for lung or esophageal cancer, patients will undergo radiation therapy. sometimes, during this treatment, the heart is also subjected to some radiation which could affect its function, either increasing or decreasing the function. it is not known the consequences of this change nor is it known if doctors can detect the changes associated with the radiation. sarcoidosis fdg positron emission tomography (pet)-computed tomography (ct) scans are a common way to image cardiac inflammation and myocardial viability. this study may help doctors image the heart before, during and after radiotherapy to monitor any changes.

primary objective: i. to characterize radiation-related functional imaging changes in the heart using sarcoidosis fludeoxyglucose f-18 (fdg) pet-ct imaging. secondary objectives: i. 1. to evaluate the ability of imaging changes in the heart to predict for overall survival (os). ii. to evaluate the ability of imaging changes in the heart to predict for cardiac toxicity. iii. to evaluate the ability of imaging changes in the heart to predict for cardiac related death. exploratory objectives: i. to evaluate radiation treatment planning strategies to reduce risk of cardiotoxicity. ii. to determine the correlation between sarcoidosis fdg pet-ct scans and oncologic fdg pet-ct scans. outline: patients undergo sarcoidosis fdg pet-ct of the heart before, during and, after radiotherapy. after completion of study treatment, patients are followed up at 12 and 24 months.

Eligibility criteria:
inclusion criteria: * provide signed and dated informed consent form * willing to comply with all study procedures and be available for the duration of the study * male or female, aged \>= 18 * life expectancy \>= 3 months as assessed by radiation oncologist * mean heart dose estimated by radiation oncologist to be \>= 5 gy (physics dose or biologically equivalent dose) * pathologically proven (either histologic or cytologic) proven lung cancer or esophageal cancer * planned radiation treatment course for management of lung or esophageal cancer \* both standard and hypofractionation schedules are permitted exclusion criteria: * contraindication for fdg pet-ct scans as assessed by the radiation oncologist or nuclear medicine radiologist * palliative radiation doses defined as 20 gy in 5 fractions
influence of abutment shape on peri-implant marginal bone loss

Conditions: Dental Implant; Bone Resorption

Summary: a study designed as a randomized controlled trial of parallel group design will be conducted at the dental clinic of the university of valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.

a study designed as a randomized controlled trial of parallel group design will be conducted at the dental clinic of the university of valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla (from premolar to premolar).

Eligibility criteria:
inclusion criteria: * any subject requiring two implants in the posterior mandible or maxilla, being at least 18 years old and able to sign an informed consent. final patient inclusion will be made after flap elevation during the implant placement surgery to be able to confirm the presence of a vertical thickness ≥ 3mm of keratinized soft tissues. * bone volumes should allow the placement of implants at least 8 mm long (i.e, 10 mm bone height to the inferior alveolar nerve) and 4.2 mm wide (7 mm wide bone crest) without bone regeneration procedures. * patients will be grouped into: 1) non smokers; 2) light smokers (≤ 10 cigarettes/day); 3) heavy smokers (≥ 11 cigarettes/day) exclusion criteria: * patients unable to commit to follow-up. * general contraindications to implant surgery. * immuno-suppressed/immune-compromised patients. * patients irradiated in the head and/or neck. * uncontrolled diabetes. * pregnancy or lactation. * untreated periodontal disease. * poor oral hygiene and motivation. * addiction to alcohol or drugs. * psychiatric problems and/or unrealistic expectations. * patients with an acute infection (abscess) or suppuration in the site intended for implant placement. * patients treated or under treatment with intravenous amino-bisphosphonates. * patients referred only for implant placement if the follow-up cannot be done at the treatment center. * patients participating in other studies, if the present protocol could not be fully adhered to.
tarc after allosct in hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma Patients Who Underwent an Allogeneic Stem Cell Transplantation

Summary: relapsed and refractory hodgkin's lymphoma (hl) patients may experience long-term survival after allogeneic transplant (allosct), but disease recurrence represents the main cause of treatment failure. pet (positron-emission tomography) -positive patients after allosct have a dismal outcome. serum tarc (thymus and activation-regulated chemokine) is produced by reed-sternberg cells and may be a marker of disease. our study was aimed at assessing whether tarc levels after allosct were correlated to disease status and whether tarc monitoring could increase the ability to predict relapse.


Eligibility criteria:
inclusion criteria: * hodgkin's lymphoma patients who underwent an allosct at fondazione irccs istituto nazionale dei tumori and who were monitored by pet and tarc before and after allosct from 2009 exclusion criteria: * hodgkin's lymphoma patients who underwent an allosct who were not monitored by pet or/and tarc
tourniquet vs. short time tourniquet in primary robotic assisted tka

Conditions: Knee Arthropathy

Summary: the goal of this prospective, randomized study is to compare the outcomes of patients undergoing robotic arm-assisted tka (ra-tka) with the intraoperative use of a tourniquet to those undergoing ra-tka with a short tourniquet time.

the goal of this prospective, randomized study is to compare the outcomes of patients undergoing robotic arm-assisted tka (ra-tka) with the intraoperative use of a tourniquet to those undergoing ra-tka with a short tourniquet time. the primary objectives will be to compare the total duration of hospital stay, quadriceps function, and the amount of postoperative narcotics utilized and vas pain levels. the secondary objective will be to compare variables of patient functionality at five postoperative intervals.

Eligibility criteria:
inclusion criteria: 1. patient is over the age of 21 2. patient is scheduled to undergo a unilateral, cementless primary ra-tka, secondary to osteoarthritis 3. surgical approach is subvastus approach 4. patient's bmi (body mass index) is less than 40 at time of surgery. 5. patient agrees to participate as a study subject and signs the informed consent and research authorization documents 6. patient is able to read and speak english exclusion criteria: 1. patient is under the age of 21 2. patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis) 3. patient is scheduled to undergo a bilateral tka surgery 4. patient bmi is \> 40 5. patient is unable to read and speak english
discordant her2/neu status of breast cancer.

Conditions: Malignant Neoplasm of Breast.

Summary: the purpose of this study is to determine discordant her2/neu status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.

her2/neu status of primary breast tumor and axillary lymph nodes were tested by ihc staining. in the cases of equivocal result of ihc, fish test were performed. the result of her2/neu status between primary breast tumor and axillary lymph node were analyzed.

Eligibility criteria:
inclusion criteria: * breast cancer patients stage i,ii and iii with axillary lymph nodes metastasis. exclusion criteria: * breast cancer patients stage i,ii and iii without axillary lymph nodes metastasis.